Thông tư 58/2014/TT-BCT

CIRCULAR

ON ISSUANCE AND REVOCATION OF CERTIFICATE OF FOOD SAFETY UNDER THE MANAGEMENT OF THE MINISTRY OF INDUSTRY AND TRADE

Pursuant to the Law on Food safety No. 55/2010/QH12 dated June 17, 2010;

Pursuant to the Decree No. 38/2012/NĐ-CP dated April 25, 2012 by the Government detailing the implementation of some articles of the Law on Food safety;

Pursuant to the Decree No. 95/2012/NĐ-CP dated November 12, 2012 by the Government defining the functions, tasks, entitlements and organizational structure of the Ministry of Industry and Trade;

Pursuant to the Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT dated April 09, 2014 by the Minister of Health, the Minister of Agriculture and Rural development and the Minister of Industry and Trade providing guidance on the allocation of tasks and the cooperation among regulatory agencies in food safety management;

At the request of the Head of the Department of Science and Technology;

The Minister of Industry and Trade promulgates this Circular providing regulation on the issuance and revocation of the Certificate of Food Safety under the management of the Ministry of Industry and Trade.

Chapter I

GENERAL PROVISION

Article 1. Scope of regulation

This Circular provides regulations on documents, procedures and competence in the issuance and revocation of the Certificate of Food Safety (hereinafter referred to as the Certificate) with regard to establishments producing and/or selling food under the management of the Ministry of Industry and Trade; mixed food sellers.

Article 2. Regulated entities

1. Food-producing and food-trading establishments under the management of the Ministry of Industry and Trade include: establishments that produce and/or trade in alcohols, beer, soft drinks, processed milk, vegetable oil, products for the manufacture of flour, starch, confectionery, jam, instruments and materials particularly for wrapping of such kinds of food.

2. Food-trading establishments excluding wholesale market and agriculture auction market.

3. This Circular does not apply to:

a) Small-scale food producers and/or sellers;

b) Street vendors;

c) Establishments selling prepackaged food without special conditions for preservation according to the regulation.

The entities prescribed in this Clause shall register or make a commitment to ensure the food safety in food production and trading according to the regulations in the Law on Food safety.

Article 3. Interpretation of terms

1. Small-scale food producer and/or seller is an establishment registered by an individual, a group of individuals or a household as home business or an establishment that is not issued with Business registration Certificate or Enterprise registration Certificate or the Investment Certificate according to the regulation.

2. Street vendor is a travelling vendor of food.

3.  Mixed food seller is establishments that sell multiple kinds of food within the managerial competence of multiple Ministries (including supermarkets and the enterprises in the market).

4. Special conditions for food preservation is the use of equipment and tools to maintain the required temperature, humidity, light and other preservation factors at the request of the manufacturer so as for quality assurance and food safety.

5. A food safety specialist is a person who has completed training in food, food safety or food safety management or has got a diploma/certificate in such fields that are issued by a specialized university or an authorized certification agency.

Chapter II

PROCEDURES FOR ISSUANCE AND REVOCATION OF CERTIFICATE OF FOOD SAFETY

Article 4. Application for Certificate of Food safety

1. With regard to the initial issuance, the application shall include:

a) An application form using the Form No. 1a (with regard to producing establishment) or Form No. 1b (with regard to trading establishment) in Annex I enclosed herewith;

b) Certificate of Business registration or Certificate of Enterprise registration or Investment Certificate that covers food manufacture or food trading (a copy certified by the applicant);

c) A description of facilities using Form No. 2a (if the applicant is a producer) or Form No. 2b (if the applicant is a seller) in Annex II enclosed herewith;

d) A certificate of training in food safety the owner and people who directly produces or trades food (a copy certified by the applicant)

dd) A Health Certificate for food production and trading of the owner as well as people who directly produces or trades food product (a copy certified by the applicant)

2. With regard to the application for reissuance of Certificate due to damage or loss of the Certificate, an application form for reissuance using Form No. 1c in Annex I enclosed herewith shall be included and sent to the authorized agency who issued the old certificate for reissuance

3. With regard to the reissuance due to the relocation of the premises; the innovation of manufacturing process, products, or due to the expiration of the Certificate, the application shall include an application form for reissuance using Form No. 1c in Annex I enclosed herewith and the documents prescribed in point b, c, d, dd Clause 1 of this Article.

4. For the application for reissuance due to the change in name of the establishment, the owner or the authorized person or due to the change of the address without relocation or change of the manufacturing process, the application shall include:

a) An application form for reissuance using Form No. 1c in Annex I enclosed herewith;

b) Certificate of fulfillment of food safety conditions (a copy certified by the applicant);

c) Documents, papers proving the change (a copy authenticated by competent agencies).

Article 5. Procedures for Certificate issuance

Competent agencies defined in Article 6 of this Circular are responsible for receiving, examining the conformity of the applications, carry out an on-site inspection, and issue the Certificate to applicants that satisfy food safety conditions. Procedures for the issuance:

1. For initial issuance

a) Receive, examine the conformity of the application

Within 05 working days from the day on which the application is received, the authorized agency shall examine the conformity of the documents; if the application is not satisfactory, the authorized agency shall make a written response providing the notification and request for supplement. After 30 working days from the day on which the notification is sent, if the establishment does not make any response, competent licensing agency may cancel the application.

b) Set up an inspectorate

Within 15 working days from the day on which the application is concluded to be sufficient and conformable, the competent agency shall carry out an on-site inspection. If the competent agency authorizes an inferior agency to carry out the inspection, there must be a letter of attorney.  After the inspection, such authorized agency shall submit the result to the authorizing agency as the basis for the issuance of the Certificate;

The inspectorate is decided by a competent certification agency or an authorized evaluation agency. The inspectorate shall include from 03 to 05 members, 2/3 of whom work as specialists or managers in food safety (an expert in a relevant field may be invited to join the inspectorate). Head of the inspectorate is responsible for the result of the on-site inspection.

c) The contents of the on-site inspection.

The evaluation commission is responsible for:

Examining the legitimacy of the application, making a comparison between the information in the application and the original retained at the food premises;

Evaluating the food safety conditions at the premises according to the regulation

d) The result of the inspection

The inspection result must specify whether the establishment is “Passed”, “Partially passed” or “Failed” in the evaluation record of food safety conditions for food producing establishment using Form No. 3a or in evaluation record on food safety conditions for food producers using Form No. 3b in Annex III enclosed herewith;

A food establishment will be issued with the Certificate of Food Safety when the trading condition of at least 1 group of products is considered “Passed”.  The groups of satisfactory products will be noted in the Certificate of Food safety;

If the result is “Partially passed” or “Failed”, the evaluation record must contain the explanation. If the result is “Partially passed”, rectification must be made within 60 days. When the rectification is completed at the request of the evaluation commission, the establishment shall submit to a competent agency the rectification report using Form No. 4 in Annex IV enclosed herewith so as for re-inspection as prescribed in point c of this Clause. Maximum time limit for re-inspection is 15 working days from the day on which the rectification report is received;

If the result of the re-inspection is “Failed” again, the authorized agency shall request the local regulatory bodies to supervise and request the establishment not to operate until the Certificate is issued;

The evaluation record shall be made in 02 copies with equal value, 01 is kept by the evaluation commission and 01 is kept by the establishment.

dd) The issuance of the Certificate

With regard to the establishment passed the evaluation, within 07 working days from the day on which the result is received, competent agencies shall issue the Certificate using Form No. 5a (for food producers evaluated by the Ministry of Industry and Trade), Form No. 5b (for food sellers evaluated by the Ministry of Industry and Trade), Form No. 5c (for food producers evaluated by the Service of Industry and Trade) or Form No. 5d (for food sellers evaluated by the Service of Industry and Trade) in Annex V enclosed herewith.

2. For the reissuance due to damage or loss of the Certificate:

Within 10 working days from the day on which the satisfactory application is received, based on the archived documents, the competent agency who issued the certificate shall consider the reissuance, if the application is rejected, there must be written notification containing the explanation.

3. The reissuance due to the relocation of production/trade; the change in manufacturing process, products and due to the expiration

Procedures for reissuance are carried out according to the regulation in Clause 1 of this Article.

4. The reissuance due to the change in name of the establishment, the owner or the authorized person, the change in address without relocation and the whole manufacturing process, branches.

Procedures for reissuance are carried out according to the regulation in Clause 2 of this Article.

Chapter III

EFFECTS, COMPETENCE FOR ISSUANCE, REVOCATION OF CERTIFICATE OF FOOD SAFETY

Article 6. Competence for the issuance

1. The Ministry of Industry and Trade is entitled to carry out the issuance to:

a) The establishments that produce:

- Alcohols: at least 03 million liters per year;

- Beer: at least 50 million liters per year;

- Soft drinks: at least 20 million liters per year;

- Processed milk: at least 20 million liters per year;

- Vegetable oil: at least 50 thousand tonnes per year;

- Confectionery: at least 20 thousand tonnes per year;

- Flour and starch: at least 100 thousand tonnes per year;

- Instruments and materials particularly for wrapping of such products.

b) Food-trading establishments inferior to the establishment defined in point a of this Clause; food trading establishments of traders who distribute, trade or act as agent in multiple provinces.

2. Services of Industry and Trade of provinces are entitled to carry out the issuance to:

a) Food producers whose production is lower than the one of the establishments defined in clause 1 of this Article;

b) Food sellers of traders who trade or act as agent in single province; establishment retailing food in single province.

3. With regard to establishment that is within the power of issuance of both the Ministry of Industry and Trade and the Service of Industry and Trade, the application shall be handled by the Ministry of Industry and Trade according to the regulation.

Article 7. Duration of the Certificate

1. The Certificate is effective for 03 years. If the applicant continues their business, an application for reissuance shall be submitted prior to 06 months before the day on which the Certificate expires according to Clause 3 Article 4 of this Circular. The duration of the new Certificate begins from the day on which the old certificate expires.

2. If the Certificate is reissued for the reason defined in Clause 2, 4 Article 5 of this Circular, the expiration date of the new Certificate the same as that of the old one.

3. If the Certificate is reissued for the reason defined in Clause 3, 5 of this Circular, the duration of the new Certificate is 03 years from the day on which it is signed.

Article 8. Post-certification inspection

1. The competent licensing agencies prescribed in Article 6 of this Circular and the inspecting agencies are in charge of carrying out the post-certification examination.

2. Superior agencies are entitled to examine the establishment whose Certificate is issued by an inferior licensing agency.

3. An establishment that has been issued with the Certificate of Food safety and GMP Certificate, HACCP Certificate, ISO 22000 Certificate or other similar certificates issued by a competent agency shall undergo not more than 01 inspection in a year.

4. An establishment that has been issued with the Certificate of Food Safety shall undergo not more than 01 inspection in a year.

Article 9. Revocation of the Certificate

1. The revocation of the Certificate of Food safety shall be performed in accordance with the regulation in Article 13 of the Decree No. 38/2012/NĐ-CP dated April 25, 2012 by the Government detailing the implementation of some articles of the Law on Food safety.

2. Power to revoke Certificates

a) Licensing agencies are entitled to revoke the Certificates they issued;

b) A superior agency is entitled to revoke a Certificate issued by its inferior licensing agency.

Chapter IV

RESPONSIBILITIES

Article 10. Responsibilities of the applicants

1. Follow the procedures for certification regulated in this Circular.

2. Facilitate the on-site inspection.

Retain the application documents according to the regulation.

4. Pay charges and fees for certification according to the regulation.

Article 11. Responsibilities of authorities entitled to issue Certificate

1. Issue the certificate according to procedures prescribed in this Circular.

2. Retain the application documents according to the regulation.

3. Cooperate with relevant agencies in the inspection, examination and revocation of the Certificate in case of complaint, denunciation or if there is signal of violation against the regulation on food safety.

4. Be responsible for the management of charges and fees for the certification according to the regulation.

Chapter V

IMPLEMENTATION

Article 12. Organization of the implementation

1. The Ministry of Industry and Trade

a) Department of Science and Technology shall receive, examine the conformity of the application, carry out the on-site inspection, request the director of The Ministry of Industry and Trade to issue the Certificate to food producing establishment, food producing and trading establishment as prescribed in point a Clause 1 Article 6 of this Circular; provide the guidance on the implementation of the Circular on a national scale.

b) Department of Vietnamese Market shall receive, examine the conformity of the application, carry out the evaluation at the establishment, request the director of The Ministry of Industry and Trade to issue Certificate to food producing and trading establishments that have the producing activities within the issuance power of the Ministry of Industry and Trade the trading activities within the issuance power of the Service of Industry and Trade.

2. The Service of Industry and Trade shall provide guidance on the implementation of this Circular for provinces; make proposal of the management of food safety of the establishment producing and/or selling food and submit it to People’s Committee of provinces as prescribed in Clause 3 Article 2 of this Circular.

Article 13. Effect

1. This Circular takes effect on February 06, 2015.

2. This Circular replaces the Circular No. 29/2012/TT-BCT dated October 05, 2012 by the Minister of Industry and Trade on the issuance and the revocation of the Certificate of Food Safety under the management of the Ministry of Industry and Trade.

3. Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Industry and Trade for consideration.