Circular No. 48/2015/TT-BYT stipulates food safety inspection activities in food production and business under the management scope of the Ministry of Health.

CIRCULAR

Regulations on food safety inspection activities in production and business of food under the management of the Ministry of Health. business of food falls within the jurisdiction of the Ministry of Healthpolicies

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

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

Pursuant to Decree No. 63/2012/NĐ-CP dated August 31, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Food Safety Administration;

The Minister of Health issues this Circular regulating food safety inspection activities in production and business of food under the management of the Ministry of Health.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the responsibility for food safety inspections; the content and form of inspections; the inspection procedures and handling of inspection results for food safety in production and business of food under the management of the Ministry of Health.

Article 2. Applicability

2. Business establishments providing catering services and street food.

4. Authorities with the power to inspect food safety and inspection teams established by such authorities.

5. Relevant agencies, organizations, and individuals.

6. This Circular does not apply to:

a) State inspection activities on food safety for imported and exported food conducted by designated state inspection authorities.

b) Inspection of conformity certification activities for food conducted by designated conformity certification organizations.

Article 3. Principles of Inspection

1. Adhering to the principles prescribed in Clause 4, Article 68 of the Food Safety Law.

Chapter II

RESPONSIBILITIES, CONTENTS AND FORMS OF FOOD SAFETY INSPECTION

Article 4. Food safety inspection authority, responsibilities and powers of the inspection authority, inspection team

1. Food safety inspection authorities include:

a) The Food Safety Agency conducts food safety inspections nationwide.

d) People's Committees of communes, wards, towns (collectively referred to as commune level), Commune Health Stations are responsible for food safety inspections within their respective communes.

2. Authorities with the power to inspect food safety perform the duties and powers of food safety management authorities as stipulated in Article 69 of the Food Safety Law.

3. Inspection teams established by authorities with the power to inspect food safety have the duties and powers as prescribed in Article 70 of the Food Safety Law.

Article 5. Basis for inspection

1. National technical standards for food products; legal provisions on food safety for food production and business activities.

2. Standards related to food safety published and applied by organizations and individuals for food production and business activities.

3. Provisions on food safety conditions for food production and business establishments; food service business establishments and street food vendors.

4. Provisions on food advertising and labeling.

5. Provisions on food testing.

6. Other legal provisions on food safety.

Article 6. Contents of Inspection

1. For food production and business establishments:

c) Documents, materials, and compliance of the establishment owner regarding facility conditions, equipment; persons directly involved in food production and business; production and processing procedures; transportation and storage of food; origin, source, and expiration date of raw materials, additives, and finished food products; other relevant regulations concerning food production and business establishments and food products;

d) Product labeling content;

e) Implementation of food advertising regulations (for establishments engaging in food advertising);

g) Inspection of documents related to state inspections on food safety for imported foods (for establishments importing and trading in imported foods);

2. For food service business establishments and street food vendors:

b) Inspection of documents, materials, and compliance of the establishment owner regarding facility conditions, equipment; persons directly involved in food production and business; production and processing procedures; food safety practices of staff; transportation and storage of food; water sources; origin and source of food and raw materials used for production and processing; sample retention; other relevant regulations;

Article 7. Planned Inspection

1. Establishing an inspection plan:

a) Annually, the competent authority shall establish an inspection plan based on management requirements, the quality of products and goods, compliance with food safety laws, results from previous inspections, financial situation, and directives from higher-level management authorities, in accordance with Point a, Clause 2, Article 69 of the Food Safety Law.

b) The deadlines for completing the annual inspection plan are as follows: before November 1st for commune level, before November 15th for district level, before December 1st for provincial level, and before December 15th for the Food Safety Agency. The inspection plan must be implemented according to the model specified in Appendix No. 01 attached hereto.

2. Pre-inspection notification: Prior to conducting an inspection, the inspecting agency must notify the inspected entity at least one day in advance, except for food business establishments that are not required to register their operations and street food vendors.

a) For food service establishments and street food vendors, the frequency of inspections shall be carried out in accordance with Article 9 of Circular No. 30/2012/TT-BYT dated December 5, 2012, issued by the Minister of Health regarding food safety conditions for food service establishments and street food vendors.

b) For food production and trading establishments under the jurisdiction of the Ministry of Health, the frequency of inspections shall be carried out in accordance with Article 14 of Circular No. 16/2012/TT-BYT dated October 22, 2012, issued by the Minister of Health regarding food safety conditions for food production and trading establishments, food utensils, and packaging materials under the jurisdiction of the Ministry of Health.

Article 8. Unannounced Inspections

1. The competent authority for food safety inspections shall conduct unannounced inspections in the following cases:

a) When there are signs of violations related to food safety, food safety incidents, special inspection campaigns, and food safety management requirements as directed by higher-level authorities;

b) When there are warnings from domestic and international organizations concerning food safety;

c) Based on reports from organizations and individuals related to food safety.

2. The inspecting agency does not need to notify in advance the food production and trading establishments, food service establishments, and street food vendors about the inspection.

Chapter III

PROCEDURE FOR INSPECTION AND HANDLING OF INSPECTION RESULTS

Article 9. Inspection Procedure

1. Issuing an inspection decision:

The head of the competent authority for food safety inspections issues an inspection decision containing the following contents: inspection area and scope, inspection method (planned or unannounced), inspection period, inspection deadline, inspection team composition, and inspection team tasks. The inspection decision must be implemented according to the model specified in Appendix No. 02 attached hereto.

2. The inspection team conducts inspections in the following sequence:

a) Announce the inspection decision to the inspected entity;

b) Conduct inspections according to the contents stipulated in Article 6 of this Circular;

c) Prepare an inspection record: The food safety inspection record for food production and trading establishments shall be prepared according to the model specified in Appendix No. 03 attached hereto; the food safety inspection record for food service establishments shall be prepared according to the model specified in Appendix No. 04 attached hereto; the food safety inspection record for street food vendors shall be prepared according to the model specified in Appendix No. 05 attached hereto.

d) Report the inspection results in accordance with Article 11 of this Circular.

đ) Issue a decision to handle the inspection results in accordance with Article 10 of this Circular.

Violations during the food safety inspection process shall be handled in accordance with Clause 1, Point c, Article 69 of the Food Safety Law. Specific cases shall be handled as follows:

1. In cases where there are violations of labeling regulations for goods or where the test results of samples do not meet the declared specifications in the detailed product information or on the product label, along with the declaration registration dossier approved by the competent authority issuing the Certificate of Acceptance of Compliance Declaration or the Confirmation of Compliance with Food Safety Regulations, such violations shall be handled in accordance with the laws on the recall and disposal of unsafe food products under the jurisdiction of the Ministry of Health.

2. During the inspection process, if violations by organizations or individuals are discovered and administrative penalties are required, they shall be applied according to the nature and severity of the violation, as stipulated in the following administrative penalty documents:

a) For violations concerning food safety assurance conditions and periodic testing of products, handle the violations in accordance with Decree No. 178/2013/ND-CP dated November 14, 2013, of the Government on administrative penalties for violations of food safety (hereinafter referred to as Decree No. 178/2013/ND-CP).

b) For violations concerning compliance declarations or declarations of conformity with food safety regulations for food products; goods with test results that do not meet the declared specifications in the detailed product information or on the product label, or do not comply with applicable standards, national technical regulations, or food safety regulations, handle the violations in accordance with Decree No. 80/2013/ND-CP dated July 19, 2013, of the Government on administrative penalties for violations in the field of standards, measurement, and product quality (hereinafter referred to as Decree No. 80/2013/ND-CP) or Decree No. 178/2013/ND-CP.

c) For violations concerning product labeling, handle the violations in accordance with Decree No. 80/2013/ND-CP.

d) For violations concerning food advertising, handle the violations in accordance with Decree No. 158/2013/ND-CP dated November 12, 2013, of the Government on administrative penalties for violations in the fields of culture, sports, tourism, and advertising.

đ) For violations in commercial activities, production, and sale of counterfeit or prohibited food products, handle the violations in accordance with Decree No. 185/2013/ND-CP dated November 15, 2013, of the Government on administrative penalties for violations in commercial activities, production, and sale of counterfeit or prohibited products and consumer protection.

3. In cases exceeding the authority, transfer the case file to a higher level for handling or transfer it to the investigation agency for verification and handling in accordance with the law.

Article 11. Reporting Inspection Results

Within fifteen working days from the end of the inspection, the head of the inspection team shall report in writing the inspection results to the head of the agency issuing the inspection decision, in accordance with the contents specified in Appendix No. 06 issued together with this Circular.

Chapter IV

IMPLEMENTING PROVISIONS

Article 12. Effective Date

This Circular takes effect from January 15, 2016.

Article 13. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

The Director of the Food Safety Administration; the Head of the Ministry's Office; the Head of the Ministry's Inspectorate; the Heads of Departments, Directors of Bureaus, and General Directors of units under the Ministry of Health; the Heads of agencies and units directly under the Ministry: Provincial Health Department Directors of provinces and centrally-administered cities; the Heads of health agencies of Ministries and sectors, and relevant agencies, organizations, and individuals are responsible for implementing this Circular. Any difficulties encountered during implementation should be promptly reported to the Ministry of Health (Food Safety Administration) for study and resolution.

Any difficulties encountered during implementation should be promptly reported to the Ministry of Health (Food Safety Administration) for study and resolution./.