Circular No. 58/2014/TT-BCT stipulates the issuance and revocation of certificates for food safety conditions under the management responsibility of the Ministry of Industry and Trade.

CIRCULAR

Article 24Regulations on issuing and revoking certificates of food safety conditions

 fall under the management responsibility of the Ministry of Industry and Tradeg

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BASED ON THE FOOD SAFETY LAW NO. 55/2010/QH12 dated June 17, 2010;

WHEREAS, Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain provisions of the Food Safety Law;

WHEREAS, Decree No. 95/2012/NĐ-CP dated November 12, 2012 of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Industry and Trade;

WHEREAS, Circular Joint No. 13/2014/TTLT-BYT-BNNPTNT-BCT dated April 9, 2014 of the Minister of Health, the Minister of Agriculture and Rural Development, and the Minister of Industry and Trade guiding the division of labor and coordination in state management of food safety;

Based on the proposal of the Director of the Department of Science and Technology;

The Minister of Industry and Trade issues this Circular to regulate the issuance and revocation of Certificates of Food Safety Conditions for facilities under the management responsibility of the Ministry of Industry and Trade.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular specifies the dossier, procedures, and authority for issuing and revoking Certificates of Food Safety Conditions (hereinafter referred to as Certificate) for production and business establishments under the management responsibility of the Ministry of Industry and Trade; comprehensive food business establishments (hereinafter referred to as establishment).

Article 2. Applicability

1. Production and business establishments under the management responsibility of the Ministry of Industry and Trade include: establishments producing and trading various types of alcohol, beer, soft drinks, processed milk, vegetable oil, flour products, starch products, pastries, candies, chewing gum, specialized packaging equipment directly attached and only used for these food products.

2. Comprehensive food business establishments do not include wholesale markets and agricultural product auction markets.

3. This Circular does not apply to:

a) Small-scale production and business establishments;

b) Street vendors;

c) Pre-packaged food business establishments that do not require special storage conditions as prescribed.

The entities specified in this Clause must register or commit to ensuring food safety in production and business operations according to the Food Safety Law with the competent authority at the local level based on the分级管理权限。

Article 3. Explanation of Terms

1. Small-scale production and business establishments are establishments operated by individuals, groups of individuals, or households registered as individual businesses and which have not been issued a Business Registration Certificate, a Business Registration Certificate, or an Investment Certificate as prescribed by law.

2. Street vendors are food traders without fixed locations.

3. A comprehensive food business establishment are food business establishments dealing with multiple types of food products under the jurisdiction of two or more ministries (including supermarkets and other establishments within markets).

4. Special storage conditions for food refer to the use of equipment and tools to maintain temperature, humidity, lighting, and other preservation factors as required by the manufacturer to ensure food quality and safety.

5. Food safety professionals are individuals who have been trained and hold a Degree or Certificate in food, food safety, or food safety management issued by a specialized university or certification organizations designated by authorized government agencies.

Chapter II

PROCEDURES FOR ISSUING AND REVOKING CERTIFICATES OF FOOD SAFETY CONDITIONS

MEETS FOOD SAFETY REQUIREMENTS

c) Health confirmation certificate/Summary health confirmation certificate of the establishment owner and direct food producers and traders issued by a health facility at the district level or higher (certified copy);

1. First-time issuance

a) Application form for Certificate issuance according to Model 1a (for production establishments) or Model 1b (for business establishments) as stipulated in Appendix I attached to this Circular;

b) Business Registration Certificate, Enterprise Registration Certificate, or Investment Certificate with the business scope of food production and trade (certified copy from the establishment);

c) Description of physical facilities according to Model 2a (for production establishments) or Model 2b (for business establishments) as stipulated in Appendix II attached to this Circular;

d) Certificate of knowledge about food safety of the establishment owner and those directly involved in food production and trade (certified copy from the establishment);

đ) Certificate of health fitness for food production and trade of the establishment owner and those directly involved (certified copy from the establishment).

2. Reissuance due to loss or damage of the Certificate

Application form for reissuing the Certificate according to Model 1c as stipulated in Appendix I attached to this Circular sent to the competent authority that issued the Certificate for consideration of reissuance.

3. In cases where reissuance is due to changes in the geographical location of the production and business premises, changes or additions to production processes, traded items, and when the Certificate expires

Application form for reissuing the Certificate according to Model 1c as stipulated in Appendix I attached to this Circular;

Dossier as prescribed in points b, c, d, đ Clause 1 of this Article.

4. In cases where reissuance is due to changes in the establishment name, owner, or authorized representative, address but without changes in geographical location and the entire production process, traded items

a) Application form for reissuing the Certificate according to Model 1c as stipulated in Appendix I attached to this Circular;

b) Certificate of Food Safety Conditions for the establishment that has been issued (a certified copy by the establishment);

c) Documentation proving the change (a certified copy by the competent authority).

Article 5. Procedures and processes for issuing the Certificate

The competent authority as prescribed in Article 6 of this Circular shall be responsible for receiving, checking the validity of the dossier, conducting on-site inspections at the establishment, and issuing the Certificate to establishments meeting food safety conditions. The procedure for issuing the Certificate is as follows:

1. First-time issuance

a) Receiving and checking the validity of the dossier

Within five working days from the date of receipt of the dossier, the competent authority shall organize the verification of the dossier's validity; if the dossier is invalid, the competent authority must issue a notification and request the establishment to supplement the dossier. If the establishment does not respond within thirty working days from the date of sending the notification requesting supplementary dossier, the competent authority has the right to cancel the dossier.

b) Establishing the On-site Assessment Team

Within fifteen working days from the date of completing the verification of a complete and valid dossier, the competent authority shall organize on-site inspections at the establishment. If the superior competent authority authorizes the subordinate competent authority to conduct on-site inspections, a delegation letter must be issued. After the inspection, the subordinate competent authority must send the inspection results back to the superior competent authority as the basis for issuing the Certificate;

The inspection team at the facility shall be established by the competent authority issuing the Certificate or by the authorized body conducting the inspection. The inspection team consists of from three (3) to five (5) members, with at least two-thirds (2/3) of the members being specialists in food safety or related management work. The inspection team may invite independent experts with relevant expertise to participate. The head of the inspection team is responsible for the results of the on-site inspection.

c) Content of the on-site assessment at the facility

Compare information and verify the legality of the registration dossier sent to the competent authority with the original file kept at the facility.

Inspect the food safety conditions at the facility in accordance with the regulations.

d) Results of the on-site assessment at the facility

The inspection result must clearly state "Pass", "Fail", or "Pending Completion" in the Inspection Report on Food Safety Conditions for the Food Production Facility according to Model 3a or the Inspection Report on Food Safety Conditions for the Food Business Facility according to Model 3b as stipulated in Appendix III attached hereto.

For a comprehensive food business facility, the Certificate will be issued when at least one group of products meets the "Pass" criteria. The groups of products that meet the requirements will be recorded on the Certificate of Compliance with Food Safety Conditions.

In cases of "Fail" or "Pending Completion", the reasons must be clearly stated in the Inspection Report. In cases of "Pending Completion", the maximum deadline for rectification is sixty (60) days. After rectification according to the requirements of the inspection team, the facility must submit a report on the rectification results according to Model 4 as stipulated in Appendix IV attached hereto to the competent authority for re-inspection in accordance with Clause c of this Article. The maximum period for re-inspection is fifteen (15) working days from the date the competent authority receives the rectification report.

If the re-inspection still results in "Fail", the competent authority shall notify in writing the local management agency to supervise and require the facility not to operate until it obtains the Certificate.

The on-site inspection report shall be made in two (2) copies of equal validity, one copy retained by the inspection team and one copy by the facility.

e) Issuing the Certificate

Within seven (7) working days from the date of the on-site inspection result being "Pass", the competent authority shall issue the Certificate to the facility according to Model 5a (for production facilities inspected by the Ministry of Industry and Trade), Model 5b (for business facilities inspected by the Ministry of Industry and Trade), Model 5c (for production facilities inspected by the Department of Industry and Trade), or Model 5d (for business facilities inspected by the Department of Industry and Trade) as stipulated in Appendix V attached hereto.

2. Reissuance due to loss or damage of the Certificate

Within ten (10) working days from the date of receiving a valid application, based on the stored files, the competent authority that has previously issued the Certificate shall review and reissue it. If the reissuance is refused, a written notification stating the reasons must be provided.

3. In cases where reissuance is due to changes in the geographical location of the production and business premises, changes or additions to production processes, traded items, and when the Certificate expires

The procedures for reissuing the Certificate shall be carried out in accordance with the provisions of Clause 1 of this Article.

4. In cases where the facility changes its name, owner, or authorized representative, or address but does not change its geographical location or the entire production process and product range.

The procedures for reissuing the Certificate shall be carried out in accordance with the provisions of Clause 2 of this Article.

Chapter III

EFFECTIVENESS, ISSUANCE, REVOCATION OF THE CERTIFICATE FOR FACILITIES MEETING FOOD SAFETY CONDITIONS

- Special tools and packaging materials exclusively used for specific food products.

Article 6. Authority to Issue Certificates

1. The Ministry of Industry and Trade issues the Certificate for:

a) Production facilities for food products with design capacity:

- Alcohol: 3 million liters of product/year or more;

- Beer: 50 million liters of product/year or more;

- Soft drinks: 20 million liters of product/year or more;

- Processed milk: 20 million liters of product/year or more;

- Vegetable oil: 50 thousand tons of product/year or more;

- Candy and sweets: 20 thousand tons of product/year or more;

- Flour and starch: 100 thousand tons of product/year or more;

b) Food business facilities directly under production facilities with design capacity as specified in point a of Clause 1 of this Article; food business facilities (including comprehensive food products) of wholesalers, distributors, or wholesale agents operating in two (2) or more centrally-administered cities or provinces.

2. Departments of Industry and Trade of centrally-administered cities and provinces shall issue Certificates for:

a) Production facilities of food products with design capacity lower than those specified in point a of Clause 1 of this Article;

b) Food business facilities (including comprehensive food products) of wholesalers or wholesale agents operating in one (1) centrally-administered city or province; retail food facilities in that city or province.

3. In cases where production and business facilities at the same location fall within the jurisdiction of both the Ministry of Industry and Trade and the Departments of Industry and Trade for issuing Certificates, the Ministry of Industry and Trade shall handle the application and issue the Certificate in accordance with the regulations.

1. The Certificate is valid for a period of three (3) years. In case of continued production and business operations, six (6) months before the expiry date of the Certificate, organizations and individuals engaged in food production and business must submit an application for reissuance in accordance with Clause 3 of Article 4 of this Circular. The validity period of the newly issued Certificate starts from the expiration date of the previous Certificate.

Article 7. Validity of the Certificate

2. In cases where the Certificate is reissued in accordance with Clause 2 and Clause 4 of Article 5 of this Circular, the validity period of the reissued Certificate is calculated based on the remaining validity period of the previous Certificate.

3. In cases where the Certificate is reissued in accordance with Clause 3 of Article 5 of this Circular, the Certificate is valid for a period of three (3) years from the date of issuance.

3. The number of inspections shall not exceed one (1) time per year for facilities that have been issued a Certificate and hold GMP, HACCP, ISO 22000, or equivalent certification from authorized agencies or organizations.

Article 8. Post-Issuance Inspection of Certificate

1. Competent authorities issuing Certificates as prescribed in Article 6 of this Circular and functional agencies with authority to conduct post-Certificate issuance inspections.

3. The number of inspections shall not exceed once per year.

4. The number of inspections shall not exceed two (2) times per year for facilities that have been issued a Certificate by the competent authority.

1. The revocation of the Certificate shall be carried out in accordance with the provisions of Article 13 of Decree 38/2012/NĐ-CP dated April 25, 2014 of the Government detailing the implementation of certain articles of the Law on Food Safety.

1. Production and business establishments shall have their Certificates revoked in the following cases:

1. In the case of revoking the Certificate of Food Safety Operation in accordance with Article 13 of Decree No. 38/2012/NĐ-CP dated April 25, 2014 of the Government detailing the implementation of certain provisions of the Law on Food Safety.

a) The issuing authority has the right to revoke the issued Certificate;

b) The superior competent authority has the right to revoke the Certificate issued by the subordinate competent authority.

NATIONAL FOOD SAFETY INSPECTION AUTHORITIES FOR IMPORTED FOODS, TESTING ESTABLISHMENTS SERVING STATE MANAGEMENT, TESTING ESTABLISHMENTS PROVIDING CERTIFICATION

Chapter IV

RESPONSIBILITIES OF THE PARTIES INVOLVED

Article 10. Responsibilities of the entity requesting the issuance of the Certificate

1. Comply with the procedures and formalities for issuing the Certificate as prescribed in this Circular.

2. Create favorable conditions for the inspection team to conduct on-site inspections at the entity.

3. Retain the certificate issuance files in accordance with the regulations.

4. Pay the inspection fee and certificate issuance fee in accordance with the laws on fees and charges.

Article 11. Responsibilities of the competent authority issuing the Certificate

1. Issue the Certificate in accordance with the procedures and formalities stipulated in this Circular.

2. Retain the certificate issuance files in accordance with the regulations.

3. Coordinate with relevant agencies to organize inspections, examinations, and the revocation of Certificates when complaints or reports are received or there are signs of violations of food safety regulations as prescribed by law.

4. Manage fees and charges in accordance with the provisions of the law.

Chapter V

IMPLEMENTING PROVISIONS

Article 12. Implementation Organization

1. Ministry of Industry and Trade

a) The Science and Technology Department receives, checks the validity of the file, conducts on-site inspections at the entity, and submits to the leadership of the Ministry of Industry and Trade for consideration to issue the Certificate to production entities and production and trading entities of food products at the same location as prescribed in Point a Clause 1 Article 6 of this Circular; organizes guidance on the implementation of this Circular throughout the country.

b) The Domestic Market Department receives, checks the validity of the file, conducts on-site inspections at the entity, and submits to the leadership of the Ministry of Industry and Trade for consideration to issue the Certificate to trading entities as prescribed in Point b Clause 1 Article 6 of this Circular; production and trading entities of food products at the same location where trading activities fall under the certificate issuance authority of the Ministry of Industry and Trade and production activities fall under the certificate issuance authority of the Department of Industry and Trade.

2. The Department of Industry and Trade guides the implementation of this Circular within the provincial and municipal areas; builds proposals to submit to the People's Committee of the province or city for the delegation of food safety management responsibilities to the entities specified in Clause 3 Article 2 of this Circular.

Article 13. Effective Date

1. This Circular takes effect from February 6, 2015.

2. This Circular replaces Circular No. 29/2012/TT-BCT dated October 5, 2012, issued by the Minister of Industry and Trade, which regulates the issuance and revocation of Certificates for entities meeting food safety conditions under the management responsibility of the Ministry of Industry and Trade.

3. During the implementation process, if any difficulties arise, they should be promptly reported to the Ministry of Industry and Trade for review and resolution.