Circular No. 45/2012/TT-BCT stipulates the activities related to quality and food safety inspection during food production under the management responsibility of the Ministry of Industry and Trade.

CIRCULAR

Regulations on quality and safety food inspection activities during food production under state management responsibility
during the process of food production under the state management responsibility
of the Ministry of Industry and Trade

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

Pursuant to the Food Safety Law No. 55/2010/QH12 dated June 17, 2010, and the Government's Decree No. 38/2012/NĐ-CP dated April 25, 2012 detailing certain provisions of the Food Safety Law;

Pursuant to the Product Quality Law No. 05/2007/QH12 dated November 21, 2007, and the Government's Decree No. 132/2008/NĐ-CP dated December 31, 2008 detailing certain provisions of the Product Quality Law;

Pursuant to Decree No. 94/2012/NĐ-CP dated November 12, 2012 of the Government on production and trade of alcohol;

The Minister of Industry and Trade issues this Circular regulating quality and safety food inspection activities during the production of food products under the state management responsibility of the Ministry of Industry and Trade as follows:

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the principles, procedures, and formalities for quality and safety food inspections during the production of food products under the state management responsibility of the Ministry of Industry and Trade including:

1. Beer - Wine - Beverages;

2. Processed Milk;

3. Vegetable Oil;

4. Processed Flour and Starch Products;

5. Cakes, Preserves, Candies;

6. Packaging containers for products specified in Clause 1, 2, 3, 4, and 5 of this Article.

Article 2. Applicability

This Circular applies to:

Organizations and individuals producing food products as specified in Article 1 of this Circular must register their business operations according to Vietnamese law.

2. Other relevant agencies, organizations, and individuals.

Article 3. Explanation of Terms

In this Circular, certain terms are understood as follows:

1. A food production facility (hereinafter referred to as the production facility) is a facility that performs one, several, or all of the activities of preliminary processing, manufacturing, packaging, and storage to produce food.

2. Quality and safety food inspection is the activity of inspecting compliance with current laws regarding ensuring food quality and safety during food production.

3. Food testing involves conducting one or more testing activities to assess conformity with relevant standards or technical regulations concerning food, food additives, food processing aids, food supplements, packaging, utensils, and materials containing food.

4. Batch of food product is a defined quantity of a type of product with the same name, quality, raw material, shelf life, and produced at the same facility.

Article 4. Principles of Inspection

Quality and safety food inspection activities must ensure the following principles:

1. Protecting confidential information, documents, and inspection results of the inspection agency and the production facility until an official conclusion is made.

2. Being responsible before the law for the results of inspections and related conclusions.

3. Ensuring clear division of responsibilities and effective coordination; not causing harassment or inconvenience affecting the operation of the inspected production facility.

4. Objectivity, accuracy, transparency, fairness, and non-discrimination; members of the inspection team must not have direct or indirect economic interests with the inspected production facility.

Chapter II
PROCEDURES AND FORMALITIES FOR QUALITY AND SAFETY FOOD INSPECTION

DURING FOOD PRODUCTION

Article 5. Regular Inspection

1. Based on actual conditions and requirements for quality and safety food inspections for each production facility, the inspection agency shall develop an annual quality and safety food inspection plan (hereinafter referred to as the plan) and budget for implementing the plan before November 1st of each year for approval by the competent authority. The inspection plan must clearly specify the products to be inspected, the number of production facilities to be inspected, and the inspection content.

2. Frequency of inspection: not more than once per year for each production facility.

3. The inspection agency must notify the production facility of the inspection plan at least fifteen (15) days prior to the inspection date.

Article 6. Spot checks

1. The inspection agency shall conduct spot checks in any of the following cases:

a) When products circulating on the market do not meet quality standards, food safety regulations, or are inconsistent with announced standards or corresponding technical regulations.

b) When there are warnings from domestic and international organizations regarding product quality and food safety.

c) Upon request of the competent state management agency for product quality and food safety.

2. The inspection agency does not need to notify the food production facility in advance about the inspection.

Article 7. Content of Inspections

The content of food quality and safety inspections includes:

1. Reviewing relevant documents related to products and food production processes.

2. Inspecting the current status of ensuring food quality and safety during food production at the production facility.

Article 8. Basis for food quality and safety inspections

1. National standards and technical regulations corresponding to the products under the responsibility of the Ministry of Industry and Trade, and the basic standards published and applied to such products.

2. Current legal provisions concerning food quality and safety in food production.

3. Current legal provisions concerning product labeling.

Article 9. Inspection of documents related to food and food production processes

1. Certificate of registration for the relevant business activity according to Vietnamese law.

2. Certificate of food safety conditions for the establishment.

3. Production permit for alcohol for establishments producing alcohol.

4. Receipt of declaration of conformity or confirmation of compliance with food safety regulations, product standard certificate.

5. Declaration of conformity, detailed product information, and reference product samples.

6. Product testing results within the last twelve months conducted at a laboratory designated by the Minister of Industry and Trade or recognized.

7. Water quality test report.

8. Sample retention records for each batch of food products produced at the establishment.

9. Purchase and sale contracts, invoices, and other documents related to food raw materials, food additives, processing aids, and food preservatives.

10. Confirmation of training in food safety knowledge for the establishment owner and those directly involved in food production.

11. Health certificate for the establishment owner and those directly involved in production, or a list of establishment staff directly involved in production issued by a health authority at district level or higher according to regulations.

12. Product labeling content consistent with that registered with the competent authority.

13. Certificates of compliance with HACCP or ISO 22000 or equivalent standards, quality and food safety management records for establishments applying HACCP and ISO 22000 systems (if applicable).

14. Most recent inspection and supervision record of the competent state agency (if available).

Article 10. Inspection of the current status of the food production facility

1. The inspection of the current status of the food production facility includes:

a) Physical facilities: Location, environment; design, structure, layout of workshops; ventilation system; lighting system; water supply system; steam and compressed air supply; waste treatment and disposal system; toilet and protective clothing changing room; waste collection and disposal system; drainage and wastewater treatment system.

b) Equipment and tools for food production and processing: Food production and processing equipment; food packaging equipment; cleaning equipment; monitoring and measuring equipment; hand washing and disinfection facilities; sample storage and preservation facilities; pest control facilities; use of cleaning chemicals.

c) Personnel directly involved in food production and processing: Protective clothing; personal hygiene.

d) Food storage during production: Raw material, packaging, food additive, processing aid, and food product storage warehouse; raw material and finished product shelving; temperature and humidity control equipment; transportation means for raw materials and finished products.

2. The inspection results are evaluated according to Appendix I attached hereto.

3. Sampling for testing and verification of suspected substandard food quality and safety according to Appendix II attached hereto.

Article 11. Handling of Inspection Results

1. The inspection team shall prepare a record according to Model Appendix I issued together with this Circular and notify the inspection results to the competent authority for quality and food safety management and the inspected production facility.

2. In cases where food does not meet the required standards for quality and food safety as stipulated, the inspection team shall require the production facility to rectify the non-compliant aspects of the product within the time limit specified in the inspection record.

3. In cases where the production facility fails to implement the corrective measures set out in the previous inspection record, the inspection team must report to the Department of Industry and Trade in the locality of the facility and the competent food safety management authority for supervision and handling.

4. In cases where the production facility repeatedly fails to ensure food safety during food production or fails to implement the corrective measures outlined in the inspection record, the inspection team must submit a written recommendation to the competent food safety management authority to handle the matter in accordance with the provisions of the law.

Article 12. Funding for Inspections and Testing

1. The funding for inspections to ensure food quality and safety for food production facilities shall be sourced from:

a) State budget funds annually as prescribed by current laws;

b) Other legitimate sources of funding.

2. Costs for sampling and testing food samples shall be carried out in accordance with the provisions of Article 41 and Article 58 of the Law on Product Quality and Safety, Article 48 of the Food Safety Law, and other relevant legal provisions.

Chapter III

DUTIES AND LIMITATIONS OF THE INSPECTION AUTHORITY,

THE INSPECTION TEAM AND ASSOCIATED ORGANIZATIONS AND INDIVIDUALS

Article 13. Duties and Authorities of the Inspection Authority

The food quality and safety inspection authority has the following duties and authorities:

1. To develop an annual inspection plan for food quality and safety to be submitted to the competent authority for approval.

2. Decide to establish an Inspection Team to carry out inspection work according to the regular or ad hoc inspection plan.

3. To issue a decision on handling no later than three working days from the date of receipt of the inspection team's report on temporarily suspending production and business activities, sealing food products, and halting advertising for unsafe food.

4. To handle violations during the inspection of food quality and safety in accordance with Article 30 of the Law on Product Quality and Safety and related legal provisions.

5. To inform the production facility of the inspection results and related conclusions.

6. Resolve complaints and denunciations concerning decisions of the Inspection Team and actions of members of the Inspection Team in accordance with the law on complaints and denunciations.

Article 14. Duties and Authorities of the Inspection Team

During food quality and safety inspections, the inspection team has the following duties and authorities:

1. To conduct inspections of food quality and safety at food production facilities in accordance with the Decision establishing the inspection team approved by the competent authority.

2. To comply with the law and fully implement the inspection principles stipulated in Article 4 of this Circular.

3. To compile and report the inspection situation and results of food quality and safety inspections to the provincial People's Committee, the Ministry of Industry and Trade, and the competent food quality and safety management authority.

4. To request the inspected production facility to present relevant documents when necessary.

5. To require food production facilities that do not meet food quality and safety standards to take corrective actions.

6. To take samples for testing when necessary.

Article 15. Responsibilities and Authorities of Food Production Facilities

1. Cooperate with Inspection Teams and inspection agencies during the process of inspecting food quality and safety at the facility.

2. Establish and manage record-keeping systems to monitor and fully document issues related to food quality and safety at the facility.

3. Retain at the production facility and provide materials, technological processes, and equipment related to products subject to inspection as stipulated in Articles 9 and 10 of this Circular.

4. Comply with activities ensuring food quality and safety conducted by inspection agencies and decisions on handling violations made by competent authorities.

5. Implement reporting

a) The situation of rectifying non-compliance with food quality and safety standards during production to the food quality and safety inspection agency and the Department of Industry and Trade within the locality according to Appendix V issued together with this Circular;

b) Compliance with legal regulations on food quality and safety work when requested by competent authorities according to Appendix VI issued together with this Circular.

6. Maintain conditions ensuring food quality and safety in accordance with legal provisions.

7. Rectify deficiencies noted in the inspection report as required by the inspection agency or Inspection Team.

8. Appeal the conclusion of the Inspection Team in accordance with the law.

Chapter IV

IMPLEMENTING PROVISIONS

Article 16. Effective Date

1. This Circular takes effect from February 20, 2013.

2. Circular No. 47/2010/TT-BCT dated December 31, 2010 of the Ministry of Industry and Trade regarding the inspection of food quality and hygiene safety for food products during production under the management responsibility of the Ministry of Industry and Trade ceases to be effective from the date this Circular takes effect.

Article 17. Implementation Organization

1. The Light Industry Department of the Ministry of Industry and Trade shall take the lead and coordinate with relevant units to be responsible for inspecting food production facilities listed in Appendix VII issued together with this Circular.

2. Departments of Industry and Trade of provinces and centrally-administered cities (hereinafter referred to as Departments of Industry and Trade) shall inspect food production facilities within their jurisdiction not included in the List in Appendix VII issued together with this Circular and those food production facilities mentioned in Clause 1 of this Article pursuant to the authorization of the Ministry of Industry and Trade.

3. The Light Industry Department and Departments of Industry and Trade shall have the responsibility to receive and compile difficulties encountered during the implementation of this Circular, report to the Minister of Industry and Trade for consideration and revision.

                                                                                                         KT. MINISTER

                                                                                                         VICE MINISTER

                                                                                                       Nguyen Nam Hai