CIRCULAR
Regulations on Issuing and Revoking Food Safety Condition Certificates
under the Management Responsibility of the Ministry of Industry and Trade
_____________________________
Pursuant to Decree No. 189/2007/ND-CP dated December 27, 2007, issued by the Government, detailing the functions, tasks, powers, and organizational structure of the Ministry of Industry and Trade;
Pursuant to Decree No. 44/2011/NĐ-CP dated June 14, 2011 of the Government amending and supplementing Clause 3 of Decree No. 189/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Industry and Trade;
Pursuant to the Law on Food Safety No. 55/2010/QH12 dated June 17, 2010;
Pursuant to Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing certain provisions of the Food Safety Law;
The Minister of Industry and Trade issues this Circular regulating the issuance and revocation of Food Safety Condition Certificates for establishments under the management responsibility of the Ministry of Industry and Trade as follows:
Article 1. Scope of Regulation
This Circular regulates the Application Form for Certificate (hereinafter referred to as the Application Form), procedures, authority to issue and revoke Food Safety Condition Certificates (hereinafter referred to as the Certificate) for organizations and individuals engaged in production and business (hereinafter referred to as the establishment) for types of alcohol, beer, beverages, processed milk, vegetable oil, processed flour and starch products, pastries, preserves, candies; food packaging and storage equipment and materials under the management responsibility of the Ministry of Industry and Trade.
Article 1. This Circular applies to establishments producing and trading food products; food packaging and storage equipment and materials under the management responsibility of the Ministry of Industry and Trade, except where otherwise provided for in Clause 2 of this Article.
Article 2. The following entities are not required to obtain a Certificate:
a) Small initial production: Establishments with only two workers or fewer directly involved in production;
b) Small-scale food trade: Establishments with only two employees or fewer directly engaged in trade;
c) Street vendors;
d) Trading pre-packaged food that does not require special storage conditions as prescribed.
APPLICATION FORMS, PROCEDURES, AUTHORITY FOR ISSUING AND REVOKING FOOD SAFETY CONDITION CERTIFICATES
Article 3. Application Dossier
The application form for issuing a Certificate consists of one volume (two sets), including:
1. A request for issuance of a Food Safety Condition Certificate according to Appendix 1 issued together with this Circular;
2. A certified copy of the Business Registration Certificate or Investment Certificate with the relevant business activities in food production and trade;
3. A description of the physical facilities, equipment, and tools ensuring food safety conditions according to Appendix 2 or Appendix 3 issued together with this Circular;
4. The original or certified copy of the certificate confirming the owner and direct producers or traders have been trained in food safety knowledge, or a list of the establishment's staff directly involved in production and trade, issued by the competent authority designated by the Ministry of Industry and Trade;
5. The original or certified copy of the health certificate of the owner and direct producers or traders, or a list of the establishment's staff directly involved in production and trade, issued by the district or higher-level health authority.
Article 4. Receiving and Assessing the Legality of the Application Forms
Clause 1. Receiving and Assessing the Legality of the Application Forms
Within five working days from the date of receiving the application forms, the competent authority specified in Article 8 of this Circular shall organize the assessment of the legality of the application forms for the Certificate submitted by the establishment according to regulations; if the application forms are not legal, the competent authority must issue a written notice and request the establishment to supplement the application forms; the time waiting for the establishment to supplement the application forms will not be counted within the assessment period.
Clause 2. Establishing an Assessment Team
a) After receiving all legal application forms, within fifteen working days, the competent authority will organize the assessment of the content of the application forms and conduct an on-site inspection at the establishment.
b) The assessment team for the application forms and on-site inspection at the establishment shall be established by the competent authority issuing the Certificate or the authorized body, consisting of three to five members, at least two-thirds of whom must be specialized staff in food safety and food safety inspectors (external experts may be invited to participate in the assessment team based on their expertise).
Clause 3. Content of the Assessment of the Establishment
Checking information and assessing the legal validity of the application forms for the Certificate against the original records kept at the establishment according to regulations.
Conditions ensuring food safety as prescribed.
Clause 4. Results of the Assessment of the Establishment
a) The results of the assessment must clearly state "Pass" or "Fail" in the Food Safety Condition Assessment Report for Food Production Establishments according to Appendix 4 or the Food Safety Condition Assessment Report for Food Trading Establishments according to Appendix 5 issued together with this Circular, and must correspond to the type of registered production and trade activities of the establishment.
b) In case of "Fail," the reasons and re-assessment deadline (maximum three months) must be clearly stated. After rectifying the deficiencies noted in the assessment report, the establishment must submit a report on the rectification results according to Appendix 6 issued together with this Circular to the competent authority for re-assessment according to Clause 1 of this Article. If the re-assessment still fails, the assessment team will prepare a report and recommend to the competent authority not to issue a Food Safety Condition Certificate or suspend the operation of the establishment in case of re-application.
The assessment report shall be prepared in two copies of equal value, one retained by the assessment team and one by the establishment owner.
Article 5. Issuing and Reissuing the Certificate
1. Issuing the Certificate
a) Within five working days from the date of receiving the assessment result "Pass", the competent authority must issue the Certificate to the establishment according to Appendix 7 or Appendix 8 issued together with this Circular;
b) The file for issuing the Certificate shall be kept at the establishment and the competent authority issuing the Certificate, including:
- Application file for the Certificate: Original kept at the establishment; copy kept at the competent authority issuing the Certificate;
- Decision on establishing the assessment team and authorization letter (in case of delegation for assessment);
- Assessment report of the establishment by the assessment team with the conclusion "Pass";
- Certificate of the establishment meeting food safety conditions.
2. Reissuing the Certificate
a) Six months before the expiry date of the Certificate (counting from the expiry date), in cases where production and business continue, the establishment must submit an application form according to Appendix 9 issued together with this Circular. The application procedures and files for reissuing the Certificate shall be carried out in accordance with Articles 3, 4, and 5 of this Circular.
b) In cases where the Certificate has been issued but lost, misplaced, or damaged, the food production and business establishments must submit a written request for reissuing the Certificate of the establishment meeting food safety conditions according to Appendix 9 issued together with this Circular to the competent authority that issued the Certificate for consideration. Within five working days from the date of receipt of a valid request, based on the retained file, the competent authority that issued the Certificate will consider and reissue the Certificate to the establishment. If the reissuance is refused, a notification must be issued clearly stating the reasons.
3. The Certificate is valid for three years.
Article 6. Fees and Charges for Issuing the Certificate of Food Safety Conditions
1. Establishments applying for the Certificate are responsible for paying the assessment fees and certificate issuance fees in accordance with the laws on fees and charges.
2. Management of inspection fees and charges shall be carried out in accordance with current state regulations.
Article 7. Competent Authority for Issuing the Certificate
1. Issuing the Certificate for food production and processing establishments:
a) The Ministry of Industry and Trade issues the Certificate for establishments producing food products with design capacity:
- Alcohol: 3,000,000 liters of product/year or more;
- Beer: 50,000,000 liters of product/year or more;
- Soft drinks: 20,000,000 liters of product/year or more;
- Processed milk: 20,000 liters of product/year or more;
- Vegetable oil: 50,000 tons of product/year or more;
- Candy and cookies: 20,000 tons of product/year or more;
- Flour and starch: 100,000 tons of product/year or more;
- Utensils, packaging materials, and containers for the above products.
b) Provincial Departments of Industry and Trade (hereinafter referred to as provincial level) issue the Certificate for:
- Establishments producing food products under the management responsibility of the Ministry of Industry and Trade within the provincial territory with design capacity lower than those specified in point a, Clause 1 of this Article.
2. Issuing the Certificate for food business establishments:
a) The Ministry of Industry and Trade issues the Certificate for business establishments directly affiliated with food producers with scale and product types as specified in point a, Clause 1 of this Article; food business establishments of wholesalers or wholesale agents operating in two or more centrally-administered cities/provinces.
b) Provincial Departments of Industry and Trade issue the Certificate for food business establishments of wholesalers or wholesale agents operating in one centrally-administered city/province and retail food establishments within that city/province; business establishments directly affiliated with producers with scale, product types, and production areas as specified in point b, Clause 1 of this Article.
Article 8. Revocation of Certificate
1. Cases for recovery
The production and business establishments of food shall have their Certificate revoked in the following cases:
a) Ceasing to operate the registered food business activities.
b) Having a decision from the competent state agency to change the business activities at the old establishment.
c) Being deprived of the right to use the certificate according to the provisions of the law on administrative sanctions for violations in the field of food safety.
a) The issuing authority has the right to revoke the issued Certificate;
a) The authority that issues the Certificate has the right to revoke the Certificate.
b) A higher-level competent authority has the right to inspect, audit, and revoke the Certificate issued by a lower-level state competent authority if serious violations of food safety conditions are discovered.
RESPONSIBILITIES OF THE PARTIES INVOLVED
Article 9. Responsibilities of the Competent Authority Issuing the Certificate
The competent authority issuing the Certificate as stipulated in Article 7 shall be responsible for:
1. Issuing the Certificate to food establishments meeting the food safety conditions as specified in Article 2 of this Circular in accordance with the regulations.
2. Retain the certificate issuance files in accordance with the regulations.
3. Cooperating with relevant agencies to organize inspections and audits when there are complaints, reports, or signs of violations of hygiene and food safety regulations as prescribed by law.
Article 10. Responsibilities of the Establishment Applying for the Certificate
1. Registering for the Certificate in accordance with the procedures and formalities prescribed in this Circular.
2. Creating favorable conditions for the inspection team to conduct inspections at the establishment.
3. Retain the certificate issuance files in accordance with the regulations.
4. Paying the fees and charges for inspection and issuance of the Certificate as prescribed by law on fees and charges.
IMPLEMENTATION AND EFFECTIVE DATE OF ENFORCEMENT
Article 11. Implementation Organization
1. The Ministry of Industry and Trade assigns:
a) The Science and Technology Department to be the focal point for receiving applications, organizing the verification of the application's validity, submitting to the leadership of the Ministry of Industry and Trade for consideration to issue the Certificate for food production and processing establishments with the design scale as specified in Point a Clause 1 Article 7 of this Circular, and organizing guidance on the implementation of this Circular nationwide.
b) The Domestic Market Department to be the focal point for receiving applications, organizing the verification of the application's validity, submitting to the leadership of the Ministry of Industry and Trade for consideration to issue the Certificate for food business establishments as specified in Point a Clause 2 Article 7 of this Circular;
2. The Department of Industry and Trade shall guide the implementation of this Circular within its provincial jurisdiction.
Article 12. Effective Date
1. This Circular takes effect from November 19, 2012.
2. During the implementation process, any difficulties should be promptly reported to the Ministry of Industry and Trade for review and resolution./.