Circular No. 48/2015/TT-BYT dated December 01, 2015 of the Ministry of Health on food safety inspection in food production and trading under the administration of the Ministry of Health

THE MINISTRY OF HEALTH

Circular No. 48/2015/TT-BYT dated December 01, 2015 of the Ministry of Health on food safety inspection in food production and trading under the administration of the Ministry of Health

Pursuant to the Clause 5, Article 68 of the Law on Food Safety dated June 17, 2010;

Pursuant to the Decree No. 38/2012/ND-CP on detailing the implementation of a number of Articles of the Law on Food Safety dated April 25, 2012 by the Government;

Pursuant to the Decree No. 63/2012/ND-CP regulating on functions, powers, and organizational structure of the Ministry of Health;

Upon the request of the Head of the Department of Food Safety;

The Minister of Health issues regulations on food safety inspection in food production and trading under the administration of the Ministry of Health.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of adjustment

This Circular regulates the responsibilities for food safety inspection; the scope of inspection, modes of inspection, the inspection process and handling of inspection results in food production and trading under the administration of the Ministry of Health.

Article 2. Subject of application

1. 1. Entities producing and/or trading in sectors of the bottled water, mineral water, functional food, micronutrient-fortified food, food additives and substances; toolkits and packages under the administration of the Ministry of Health.

2. Food and beverage businesses and food street vendors.

3. Food manufacturers and businesses whose products are out of the control of the Ministry of Agriculture and Rural Development, the Ministry of Trade and Industry; food manufacturers and businesses whose products are under the administration of at least 02 Ministries including the Ministry of Health as promulgated in the Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT- BCT provides guidance on assignment and cooperation in food safety management dated April 09, 2014 by the Minister of Health, the Minister of Agriculture and Rural Development, the Minister of Trade and Industry (hereinafter referred to as the Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT- BCT).

4.The competent authority of food safety inspection and the inspectorate established by this competent authority.

5.Other relevant entities.

6.This Circular shall not be applied to:

a) The State inspection of exported and imported food safety conducted by the appointed government inspectorates.

b) The inspection of conformity certification by the appointed certifying organization.

Article 3. Principles of inspection

1.In conformity with Clause 4, Article 68 of the Law on Food Safety;

2.No repetitions of inspected entities, location and time of inspection. Any repetitions of the inspection plan of the subordinate food safety authorities and that of the superior authorities shall be solved in accordance with Clause 3, Article 5 of the Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT.

Chapter II

RESPONSIBILITIES, SCOPES AND MODES OF FOOD SAFETY INSPECTION

Article 4.Food inspection agencies; responsibilities and powers of food inspection agencies and inspectorates.

1.Food inspection agencies:

a) The Department of Food Safety carries out the inspection of food safety nationwide.

b) The Departments of Health, Sub-Departments of Food Safety of provinces and central-affiliated cities (hereinafter referred to as provinces) conduct the inspection of food safety within their provinces.

c) People’s Committees of districts, the Public Health Office of the People’s Committee of the district and the Health Center of the district shall responsible for inspecting food safety within their districts.

d) People’s Committees of communes, the Public Health Stations of the wards shall responsible for inspecting food safety within their wards.

2.The competent authority of food safety inspection shall deliver its responsibilities and powers as regulated in Article 69 of the Law on Food Safety.

3.The inspectorate, appointed by the competent authority of food safety inspection, has its responsibility and power as regulated in Article 70 of the Law on Food Safety.

Article 5. Basis of Inspection

1.National technical regulations on food products; Vietnam’s regulations of laws on food safety in food industry.

2.Standards related to food safety applied by manufacturers to producing and trading food.

3.Regulations on food safety applicable to food manufacturers and food-trading businesses; food and beverage businesses and street food vendors.

4.Regulations on food advertising and food labeling.

5.Regulations on food testing.

6.Other regulations on food safety.

Article 6. Scope of inspection

1.For food manufacturers and food-trading businesses:

a) Administrative records and legal certificates: Business Registration Certificate, Certificate of Food Safety, Certificate of Training in Food Safety; a) Health Certificate of the owner or persons who directly involve in food production and trading; Certificate of ISO/ HACCP (Hazard Analysis Critical Control Point) and the equivalent;

b) Certificate of Submission of the Declaration of conformity/ and Certificate of the Declaration of conformity with food safety regulations, Certificate of Approval for Advertisement Contents;

c) Documents about the conformity with regulations on facilities and equipment of the owner or persons who directly engaging in food production and trading; the process of food production and processing; the origin and expiry date of food ingredients, substances and additives; other regulations related to food manufacturers and food-trading businesses and food products.

d) Contents of food labels:

đ) The periodic inspection of food products;

e) The implementation of regulations on food advertising (if any);

g) Relevant papers related to the State inspection of imported foods (for businesses importing food or trading in imported food).

h) Food samples shall be taken, if necessary. Food sampling shall comply with regulations in the Circular No. 14/2011/TT-BYT providing guidance on food sampling for inspection and examination of food safety, quality and hygiene dated April 01,2011 by the Ministry of Health .

2.Food and beverage businesses and street food vendors.

a) Administrative records and legal certificates of food manufacturers: Business Registration Certificate, Certificate of Food Safety and Certificate of Training in Food Safety . The Health Certificate of the manufacturer’s owner or persons who directly engage in food production and trading;

c) Records, documents and the conformity of the Owner; or workers who directly engaging in food production and trading, with the provisions of facility and equipment; the process of food production and processing; practices of food hygiene and safety; food transportation and preservation; sources of water used for food processing and production; the origin of food ingredients, substances and additives; sample storage and other relevant regulations.

c) Collect sample of food or ingredients for testing, if necessary.

Article 7. Planned inspection

1.Development of an inspection plan:

a) The competent inspection agency shall annually develop the inspection plan as promulgated in point a, Clause 2, Article 69 of the Law on food safety based on the requirements of food quality management and its movement, the assessment of the observance of the law on food safety; the last inspection results; its budget and the direction of its superior management authority.

b) The completion time of development of the inspection plan is as follows: before November 1 applicable to authorities of communes, November 15 for the authorities of districts, December 01 for the authorities of provinces and December 15 for the Department of Food Safety. The inspection plan shall be developed as the form indicated in the Annex 01 of this Circular.

2.Prior notice of the inspection: the inspection authority shall inform the inspected facility at least 01 day in advanced before the date of inspection, apart from food businesses or street food vendors that are not required to apply for business registration.

3.Frequency of inspection:

a) The frequency of inspection applicable to street food businesses is prescribed as the Article 9 of the Circular No. 30/2012/TT-BYT providing provisions on food safety of street food businesses dated December 05, 2012 by the Minister of Health.

b) The frequency of inspection applicable to food manufacturers and businesses under the administration of the Ministry of Health is regulated in the Article 14 of the Circular No. 16/2012/TT-BYT providing provisions on food safety of food manufacturers and food-trading businesses, equipment, packages under the administration of the Ministry of Health dated December 22, 2012 by the Minister of Health.

Article 8. The surprise inspection

1.The food inspection authority shall conduct a surprise inspection in the following cases:

a) Violations against regulations on food safety are suspected or there are food incidents; a surprise inspection is required during an intensive inspections period or requested by a superior authority;

b) Warnings are issued by domestic, foreign or international organizations related to food safety;

c) Food safety-related issues are reported by organizations or individuals.

2.The inspection authority is not required to notify the inspected food manufacturers, food and beverage businesses or food street vendors of the surprise inspection in advance.

Chapter III

THE PROCESS OF AN INSPECTION AND HANDLING OF INSPECTION RESULTS

Article 9. Process of an inspection

1.Issuance of an inspection decision:

The Head of food safety authority shall issue the decision of the inspection with the following items: the location and scope of inspection, modes of inspection (under schedule or surprise inspections), the term of inspection, time limit of the inspection, members of the inspectorate, and duty of the inspectorate. The inspection decision shall be made as regulated in the Annex 02 of this Circular.

2.The inspectorate shall conduct the inspection in accordance with the following order:

a) Notify the inspection decision to the inspected entity;

b) Carry out the inspection as regulated in Article 6 of this Circular;

c) Make a Record of Inspection: the Record of Inspection of food manufacturers and food-trading businesses shall be made using the form regulated in the Annex 03 of this Circular; the Record of Inspection of entities in food and beverage services shall be made as the form in the Annex 04 of this Circular; the Record of Inspection of street food vendors shall be made as the form in the Annex 05 of this Circular.

d) Report the inspection results according to the Article 11 of this Circular;

đ) Issue the decision on handling inspection results as prescribed in the Article 10 of this Circular;

Article 10. Handling of inspection results

The handling of violations of food safety during the inspection shall be conducted under the regulations in point c, Clause 1, Article 69 of the Law on Food Safety. Some particular cases of handling of food safety violations are specified as follows:

1.Violations of food labeling or inconsistencies between the sample testing results and the description of the product or the product ingredients in the specifications or the label enclosed in the Certificate of Submission of the Declaration of conformity/ and Certificate of the Declaration of conformity with food safety regulations or the Certificate of Conformity, issued by the competent agency, shall be solved in compliance with laws on revocation and handling of food safety in the jurisdiction of the Ministry of Health.

2.Any discovered administrative violations of food safety, depending on the nature and seriousness, shall be dealt with in accordance with corresponding regulations as follows:

a) Any violations of conditions of food safety and periodic testing shall be punished under the regulations of the Decree No. 178/2013/ND-CP on administrative penalties on violations of food safety (hereinafter referred to as the Decree 178/2013/ND-CP).

b) Any violations of the announcement of conformity or the announcement of regulation conformity of food safety; inconsistencies between the sample testing results and the indicators in the description of food products or the label or the public applicable criteria, failures to meet the national technical standards or food safety regulations shall be settled in accordance with regulations of the Decree No. 80/2013/ND-CP on administrative penalties in aspects of the product criteria, measurement and quality dated July 19, 2013 by the Government (hereinafter referred to as the Decree No. 80/2013/ND-CP) or the Decree No. 178/2013/ND-CP.

c) Any violations of product labeling shall be settled in accordance with the Decree No. 80/2013/ND-CP

d) Any violations of food advertising shall be dealt with in accordance with the regulations of the Decree No. 158/2013/ND-CP on administrative penalties on violations of culture, sport, tourism and advertising dated Novembers 12, 2013 by the Government.

a) Any violations of commerce, production and trading in counterfeit and banned commodities shall be punished under the regulations of the Decree No. 185/2013/ND-CP on administrative penalties on violations of commerce, production and trading in counterfeit or banned commodities and consumer protection dated November 11, 2013 by the Government.

3.These cases beyond the jurisdiction of an authority shall be transferred to its superior authority or to an investigation agency to verify and handle under Vietnam Laws.

Article 11. Report on inspection results

The Head of the Inspectorate shall submit a written report on the inspection result to the Head of the authority, which issues the decision on the inspection, within 15 working days from the end of inspection, according to the content in the Annex 06 of this Circular.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 12. Effect

This Circular takes effect on January 15, 2016.

Article 13. Reference terms

In cases of any changes, supplementation or replacement of legal normative documents and regulations presented in this Circular, the new legal normative document shall prevail.

Article 14. Implementation responsibilities

The Head of the Departments of Food Safety; the Chief of the Ministry Office; the Chief Inspector of the Ministry; Heads of Divisions, Heads of Departments, the General Department under the Ministry of Health; Heads of units under Ministries: The Director of The Department of Health of the province; Heads of the Health authorities of Ministries, Departments, relevant organizations and individuals shall be responsible for implementing this Circular.

Any difficulties arising in the course of implementation shall be promptly reported to the Ministry of Health (the Department of Food Safety)./.

For the Minister

The Deputy Minister

Nguyen Thanh Long

*All Appendices are not translated.