Thông tư 26/2012/TT-BYT

CIRCULAR

STIPULATING ON GRANT OF CERTIFICATE OF FOOD SAFETY QUALIFICATION ESTABLISHMENTS FOR ESTABLISHMENTS OF PRODUCTION, TRADE OF FUNCTIONAL FOOD, FOOD STRENGTHENING MICRONUTRIENT, FOOD ADDITIVES, FOOD PROCESSING ENHANCERS; NATURAL MINERAL WATER, BOTTLED DRINKS; TOOLS, MATERIALS PACKING, CONTAINING FOODS UNDER MANAGEMENT OF THE MINISTRY OF HEALTH  

Pursuant to the 2010 Law of Food safety;

Pursuant to the Goverment's Decree No. 38/2012/ND-CP of April 25, 2012 detailing a number of articles of the Law of Food safety;

Pursuant to the Goverment's Decree No. 63/2012/ND-CP of August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of Director of the food safety and hygiene Bureau;

The Minister of Health promulgates Circular stipulating on grant of certificate of foods safety qualification establishments in producing, trading foods under management of the Ministry of Health.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular stipulates on dossiers of, procedures for, competence of grant of certificate of food safety qualification establishments (hereinafter referred to as the certificate)  for establishments of production, trade of foods including functional foods, foods strengthening micronutrient, food additives, food processing enhancers; natural mineral water, bottled drinks; tools, packings, tools in direct contact with foods under management of the Ministry of Health (hereinafter referred to as the establishments) 

Article 2. Interpretation of terms

In this Circular, the following terms are construed as follows: 

1. The small scale initial production establishments mean establishments of cultivation, breeding, harvesting and picking, fishing, exploitation of food materials with scale of households, individuals.

2. The small scale food trading establishments mean establishments trading food with scale of households, individual households with or without the food business registration certificate.  

3. The establishments under form of street vendors mean establishments trading instant foods, cooked foods on the streets (no fixed location).

Chapter II

DOSSIERS OF, PROCEDURES FOR AND COMPETENCE OF GRANTING THE CERTIFICATE OF FOOD SAFETY QUALIFICATION ESTABLISHMENTS

Article 3. Dossier applying for the certificate  

Dossier applying for the certificate is set in a book, including the following papers:

1. Application for grant of certificate of food safety qualification establishments (in according to the Form 1 promulgated together with this Circular).

2. The certificate of Business registration in which having registered for food business (copy with confirmation of establishment).

3. The written explanation of material facilities, equipment, and tools to ensure food safety condition (with confirmation of establishment), includes:

a) Drawing of ground design diagram of establishment and the surrounding areas;

b) Diagram of food manufacturing process or process of product preservation, distribution and written explanation of material facilities, equipment, and tools of establishment. 

4. Written confirmation of training knowledge on food safety of the owner of the establishment and of persons directly producing, trading foods:

a) For establishments having less than 30 persons: To submit copies of written confirmation (confirmed by establishment);

b) For establishments having 30 persons or more: To submit list of trained persons (confirmed by establish).

5. Written confirmation of efficiency of health of the owner of the establishment and of persons directly producing, trading foods; the result of stool culture test of persons directly producing foods, that is reported as negative for pathogens causing intestinal diseases (cholera, dysentery, bacillus and typhoid), applied to regions having development of diarrhea epidemics under announcement of the Ministry of Health:  

a) For establishments having less than 30 persons:  To submit copies of written confirmations (confirmed by the establishment);

b) For establishments having 30 persons or more:  To submit the list of results of health examination, stool culture test of the owner of establishment and of persons directly producing, trading foods (confirmed by the establishment).

Article 4. Competence of granting the certificate 

1. The Food Safety Bureau grants for:

The establishments producing, trading functional foods, foods strengthening micronutrient, food additives, food processing enhancers, except the establishments of small scale production and trade; other establishments in case having special demand (at the request of countries importing products of the establishments). 

2. The Food Safety Branches of central-affiliated cities and provinces grant for:

a) The establishments producing and trading natural mineral water, bottled water, packings, tools in direct contact with foods under scope of management of health sectors in their localities;

b) The small scale establishments producing functional foods, foods strengthening micronutrient, food additives, food processing enhancers.

c) The small-scale establishments trading functional foods, foods strengthening micronutrient, food additives, food processing enhancers which having special product preservation requirements.

Article 5. The procedures for granting the certificate

Agencies receiving dossiers shall consider and appraise dossiers, appraise establishments and grant the certificate for establishments having qualification of food safety. The procedures for granting the certificate as follows:

1. Consideration and appraisal for dossiers

a) Within 05 working days as from receiving full dossiers, the agencies receiving dossiers must appraise and consider the validity of dossiers and notice in writing to the establishments in case dossiers are not valid;

b) If after 60 days, from the day of receiving the notice of invalid dossier, the establishments fail to reply or supplement, complete dossier as the request, the receipt agencies will cancel dossiers.

2. Appraisal at establishments

a) After having valid result of consideration and appraisal of dossier, the competent agencies shall appraise the establishment within 10 working days.  If authorizing appraisal at establishments for an inferior competent agency, it must have written authorization;

b) Appraisal delegation at establishments

- The appraisal delegation at establishments is established under decision issued by agencies competent to grant the certificate or agencies authorized for appraisal;

- The appraisal delegation for condition of establishment includes from 5 to 9 persons (for establishments of small scale food production and trade of from 3 to 5 persons) in which there must be at least 2/3 members being officers doing works specialized in food safety (may invite experts who have suitable specialist to participate in the appraisal delegation at establishment).

- The head of appraisal delegation is responsible for result of appraisal at establishments;

c) Content of appraisal at establishments:

Comparing information and appraising legality of dossier applying for grant of the certificate to original dossier archived at establishments as prescribed; appraising the condition on food safety at the establishment as prescribed and writing in the form of record promulgated together with this Circular.

3. Grant of the certificate:

a) In case the establishment is qualified on food safety as prescribed, the agency receiving dossier shall grant the certificate made in according to the form promulgated together with this Circular.  For establishments producing and trading foods according to season, the operation duration must be written clearly in the certificate;

d) In case an establishment has not yet been qualified on food safety and must wait for completion, the content and time for completion must be written clearly but not exceeding 60 days. The appraisal delegation shall organize re-appraisal when the establishment has a written confirmation that requirements on condition of food safety of the appraisal delegation in prior time have been completed fully;

c) In case the establishments do not meet requirements on food safety conditions, the agencies receiving dossier shall notice in writing to the local management agencies for supervision and  require the establishments are not permitted to operate until being grant the certificates. The establishments must submit dossier again in order to consider grant of the certificate as prescribed.

Article 6. Renewal of the certificate 

1. Renewal of the certificate is implemented in the following cases:

a) The certificate may be modified if it is unexpired;

b) When changing name of enterprises or/and changing owner of the establishments, changing address but not changing location and all the process of food production and trade;

2. The dossier applying for renewal (a set) includes papers confirmed by the establishment as follows:

a) Application for renewal of the certificate:  (made in according to the Form 4 promulgated together with this Circular);

b) The the latest minutes of appraisal (copy confirmed by the establishment);

c) The certificate (original);

d) The lawful written indicating above changes (notarized copy);

e) The confirmation of health sufficiency, training knowledge on food hygiene safety of the new owner of the establishment in case changing name of the owner of the establishment (copy confirmed by the establishment). 

3. Within 7 working days after receiving dossier applying for renewal of the certificate, agency receiving dossiers shall renew the certificate for the establishment; if refusal, it must be informed in writing on reason of refusal for renewal of the certificate to the establishment.  

Article 7. Withdrawal of the certificate

1. The certificates will be withdrawn in the following cases:

a) Organizations, individuals of production and trade fail to operate in the food business sector registered; 

b) Having a decision of the competent state agencies on change of the business lines at the old establishment; 

c) The establishment producing and trading food is deprived the right to use the Certificate as prescribed by law on administrative violation sanction in the field of food safety.

2. Competence of withdrawal:

a) Agencies granting the certificates have competence of withdrawal of the certificates granted;

b) The superior competent agencies have competence of withdrawal of the certificates which are granted by their inferior agencies;

Article 8. Inspection after granting the certificate

The agencies receiving dossiers and competent functional agencies implement inspection after granting the Certificate as follows:

1. Not more than twice/year for establishments having been granted the certificates and had certificates of GMP, HACCP, ISO 22000 and equivalent ones granted by competent agencies.

2. Not more than three times/ year for establishments having been granted the certificates which are granted by competent agencies.

Chapter III

PROVISIONS FOR THE ESTABLISHMENTS PRODUCING AND TRADING FOODS BEING SUBJECTS WHICH ARE NOT REQUIRED FOR GRANT OF THE CERTIFICATE

Article 9. The establishments being subjects which are not required for grant of the certificate

The establishments of production, trade of functional foods, foods strengthening micronutrient, food additives, food processing enhancers; natural mineral water, bottled drinks; packings, tools in direct contact with foods under the management scope of the Ministry of Health including: 

1. The small scale initial establishments of production of functional foods.

2. The small scale business establishments having no requirement of special product preservation.

3. The establishments under form of street vendors.

4. The establishments of trading foods packed in advance not required special condition on preservation.

5. The establishments of trading packings, tools in direct contact with food.

6. Drugstores which have been granted the certificates of GPP satisfaction, trading functional foods, foods strengthening micronutrient.

Article 10. The inspection for the establishments being subjects which are not required for grant of the certificate

1. The establishments being subjects which are not required for grant of the certificate must elaborate the plan on internal inspection, supervision on conditions of food safety of the establishments at least once/year.

2. The Branches of food safety and hygiene of central-affiliated cities and provinces and competent agencies implement inspection at the establishments not required for grant of the certificate on their localities.

2. The frequency of inspection is not more than four times/year for the establishments not required for grant of the certificate.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 11. Effectiveness

1. This Circular takes effect on January 15, 2013.

2. To annul the Decision No. 11/2006/QD-BYT of March 09, 2006 of the Minister of Health on promulgation of the “Regulation on issuance of qualification certificates of hygiene and food safety for establishments of production, trade of food of high-risk” as from the effectiveday of this Circular.

Article 12. Organization of implementation

1. The Food Safety Bureau – the Ministry of Health shall guide implementation of this Circular in nationwade.

2. The Departments of Health, provincial-level Branches of food safety and hygiene shall guide, carry out implementation of this Circular in their management localities.