Circular No. 54/2014/TT-BCT stipulates food safety conditions for establishments producing and trading processed milk.

CIRCULAR
Article 24stipulating food safety conditions
for establishments producing and trading processed milk

Pursuant to the Law AFood Safety Law number 55/2010/QH12 dated June 17, 2010;

Pursuant to Decree number 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing certain provisions of the Law Ais an organization with legal personality designated by the Ministry of Industry and Trade to conduct one or more testing and conformity assessment activities with technical standards and corresponding standards for food, food additives, food processing aids, food supplements, packaging materials, food containers.

Pursuant to Decree 95/2012/NĐ-CP dated November 12, 2012 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Industry and Trade;

Based on the proposal of the Director of the Department of Science and Technology;

The Minister of Industry and Trade issues this Circular stipulating food safety conditions for establishments producing and trading processed milk.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates food safety conditions for establishments producing and trading processed milk (hereinafter referred to as establishments) under the management responsibility of the Ministry of Industry and Trade.

Article 2. Applicability

1. This Circular applies to:

a) Establishments producing and trading processed milk;

b) State management agencies with competent authority and organizations and individuals related to the production and trading of processed milk.

2. This Circular does not apply to:

a) Small-scale establishments producing and trading processed milk;

b) Food service establishments and street food vendors within the scope regulated by Circular 30/2012/TT-BYT dated December 5, 2012 of the Ministry of Health stipulating food safety conditions for food service establishments and street food vendors.

Article 3. Explanation of Terms

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

1. Establishment producing processed milk includes all physical facilities, workshops, machinery and equipment, environmental conditions necessary for producing processed milk products.

2. Establishment trading processed milk is an establishment carrying out activities such as introducing, storing, transporting, purchasing, and selling processed milk products.

3. Processed milk product is a product made from animal milk with or without added nutrients, food additives, flavorings, or vitamins.

4. Small-scale establishment producing and trading processed milk is an establishment carried out by individuals, groups of individuals, or households registered as individual businesses and not granted a Business Registration Certificate or a company registration certificate or investment certificate according to the law.

Article 4. General provisions for establishments producing and trading processed milk

Establishments producing and trading processed milk must comply with the provisions of Circular 15/2012/TT-BYT dated September 12, 2012 of the Ministry of Health stipulating general food safety conditions for food production and trading establishments and the provisions of this Circular.

Chapter II
CONDITIONS FOR ENSURING FOOD SAFETY
FOR PRODUCTION ESTABLISHMENTS

Article 5. Production establishment of processed milk

1. Production Site

a) Must be constructed according to the current planning approved by the competent state agency;

b) Must be far from sources of pollution and harmful substances, not affected by other pollution factors from the surrounding environment that may impact the quality and safety of processed milk products;

c) Must have sufficient floor space to arrange production lines suitable for the designed capacity of the establishment, ensuring that each production stage meets technological requirements and industrial hygiene measures.

2. Layout and Design of Factory Buildings

a) Arrange production lines appropriately, not adversely affected by pollution sources such as steam boilers, wastewater treatment plants, solid waste collection areas, and sanitary facilities;

b) Design workshops following the principle of unidirectional flow from raw materials at the input to the final processed milk product;

c) Isolate different zones: raw material warehouse; supplies and packaging warehouse; finished goods warehouse; production area (raw material preparation; processing; filling, bottling, packaging, and finishing; cleaning-in-place (CIP) system; mechanical power); chemical warehouse; solid waste collection area and wastewater collection and treatment system; auxiliary facilities to prevent cross-contamination;

d) Internal traffic systems must be designed and constructed to ensure durability, stability, dust-free conditions, and high-rise walkways must have guardrails or partitions for easy observation and labor safety;

đ) Drainage systems (production wastewater, domestic wastewater, rainwater) must be designed and constructed separately, covered, ensuring proper slope for drainage and preventing water accumulation;

3. Factory Building Structure

a) The production area floor must ensure easy drainage, made from durable, non-peeling, slip-resistant, and easily cleanable materials. Drainage systems in the production area must be covered;

b) Septic tanks and wastewater collection pits must have odor traps, insect barriers, and limit microorganisms from septic pipes entering the workshop;

c) Piping systems must be designed and manufactured from appropriate materials, painted in different colors, and clearly marked for easy identification;

4. Ventilation System

a) Workshops must have ventilation doors ensuring air circulation, heat dissipation, and gas emission during production; in case of forced ventilation, the equipment must provide sufficient clean air for circulation;

b) Areas where filling machines are installed must always be dry, well-ventilated, and clean;

5. Water supply and storage system

a) Must ensure adequate water supply meeting standards;

b) Must have sufficient pumping, water treatment, water storage tanks, and piping systems in good working condition; regular inspections must be conducted to prevent backflow or blockages;

c) Water supply pipelines must be separate, clearly marked, easy to clean, and ensure safe drinking water, avoiding contamination;

d) Water storage tanks, settling tanks, and filters must be compatible with water treatment technology; regular cleaning must be performed as required or when necessary;

đ) In case of water quality incidents, production must be immediately halted and products isolated during the incident period;

e) Backup generators and pumps must be available in case of power failure or pump malfunction to meet continuous production requirements;

g) Treated water used for milk production must be stored and preserved to prevent contamination from other pollution sources;

6. Steam, heat, and compressed air supply system

a) Boilers must be designed and manufactured from appropriate materials, located in separate areas isolated from production areas, regularly inspected and tested according to current regulations;

b) Steam and compressed air pipeline systems must be designed and manufactured from appropriate materials, installed safely, clearly marked for differentiation from other pipeline systems, and regularly inspected according to current regulations;

7. Wastewater, waste, and exhaust gas collection and treatment system

a) For solid waste

- Must be collected and stored in appropriate containers placed in suitable locations for easy collection, treatment, and not affecting production processes;

- Waste containers must be clearly labeled or marked to distinguish them from raw material, semi-finished, or finished product containers; made of non-porous, corrosion-resistant materials; sealed to facilitate cleaning (if reused multiple times) or disposal (if single-use);

- Must be treated by organizations or individuals permitted by state management authorities to operate in environmental treatment fields;

b) For production wastewater and domestic wastewater

- Wastewater treatment areas must be separated from production areas;

- Treatment capacity and technology must match peak discharge volumes to ensure treated wastewater meets environmental standards.

- Shall not discharge untreated wastewater directly into the surrounding environment; drainage ditches within the production area must ensure flow from cleaner to less clean areas and ensure complete drainage under conditions of stopped flow;

- Manholes must be covered; the processing area must carry out sewer manhole cleaning after each day of production; regularly clear sewers and manholes according to regulations;

c) Exhaust gases from the production area and boiler system must be treated to avoid adverse effects on other production areas;

d) For hazardous waste

- Must be collected, stored, transported, and handled separately in accordance with current regulations;

- Shall be managed and treated by organizations or individuals permitted by competent state management agencies to operate in the field of hazardous waste treatment;

8. Storage System

a) Raw Material and Additive Warehouse

- Shall be arranged separately from the production area;

- Raw materials and additives shall be placed on shelves/racks, avoiding direct sunlight;

- Shall ensure temperature, humidity, storage time, and other storage conditions as specified in the manufacturer's guidelines or regulations;

- For raw materials and additives that have been opened but not fully used, they must be resealed after each use and stored according to regulations;

- Raw materials and additives stored in the warehouse must record information such as the name of the raw material, additive, and expiration date;

- For raw milk storage warehouses: At intermediate collection stations, there must be cooling systems, equipment, tools, and chemicals for testing the quality of raw milk, storing samples of collected milk; raw milk storage tanks must have insulation layers, inner surfaces made of non-contaminating materials, ensuring constant maintenance at temperatures between 4°C to 6°C;^°C to 6°C;^°The storage period of raw milk from milking to processing shall not exceed 48 hours; tanks must be cleaned immediately after emptying, ensuring no residual microorganisms or detergent residues as required;

- Shall implement regular maintenance and cleaning schedules according to the facility's regulations;

- Only responsible persons or those assigned may enter the raw material warehouse;

b) Packaging and Chemical Warehouse

- Shall be arranged separately from the production area;

- Packaging and materials shall be arranged to avoid direct sunlight;

- Direct contact packaging with products must comply with the manufacturer's packaging regulations;

- Storage time and conditions shall follow the manufacturer's guidelines or regulations;

- Shall implement regular maintenance and cleaning schedules according to the facility's regulations;

c) Finished Product Warehouses

- Shall be arranged separately from the production area, facilitating product entry and exit;

- Shall maintain the prescribed temperature, dryness, cleanliness, ventilation, and avoid direct sunlight to prevent changes in product quality, sensory characteristics, and safety;

- Shall have a designated area for substandard products awaiting processing;

- Shall implement regular maintenance and cleaning schedules according to the facility's regulations;

- Finished product stored in the warehouse must record information such as the product name, batch number, production date, production shift, and expiration date;

- For products requiring cold storage conditions:

+ Products must be stored in cold rooms, ensuring continuous circulation of cold air to each product in the cold room;

+ Cold room temperature must be maintained according to the requirements of each product type;

9. Production Area

a) Raw Material Preparation Area

- Raw materials for production must be separated by type and placed on shelves or racks;

- Flavorings must be prepared separately to ensure no cross-contamination;

- Measuring devices must be accurate and functioning properly;

- Regular cleaning must be conducted to ensure no dust or water accumulation;

- Only responsible persons or those assigned may enter the raw material preparation area;

b) Processing Area

- Processing equipment must be thoroughly cleaned before use for each daily production cycle;

- Waste must be collected and placed in plastic bags in designated locations;

- Personnel working in mixing and direct product contact areas must wear waterproof, durable, light-colored gloves and ensure food safety;

- Daily cleaning or immediate cleaning after each production cycle of different product types;

- Only responsible persons or those assigned may enter this area to prevent cross-contamination;

c) Filling, Bottling, and Packaging Area

- Filling and bottling rooms must be sealed, sterile, maintaining temperatures between 20°C to 28°C, and positive pressure relative to the outside;^°- Filling and bottling equipment inside the room must remain sterile throughout the filling and bottling process;^°- The inner surface of the pipes leading to the filling and bottling equipment must be sterilized according to regulations;

- Daily cleaning or immediate cleaning after each production cycle of different product types;

d) Finished Product Area

- Finished product packaging areas must be thoroughly cleaned before packaging, ensuring constant dryness;

- Only responsible persons or those assigned may enter this area to prevent cross-contamination;

- Packaging equipment and tools (shrink wrapping, printing expiration dates, conveyor belts, box packaging) must be thoroughly cleaned;

a) The facility owner must specify in writing the means, methods, conditions for storage and safe food management during internal transportation of processed milk products;

b) Processed milk products shall not be transported together with materials, raw materials, chemicals that could cause cross-contamination affecting product quality and food safety;

10. Internal Transportation

a) Quality control areas must be arranged separately, conveniently for quality control during production; equipped with minimum machinery, equipment, and tools for measuring and testing basic quality indicators for main raw materials and finished products. Microbiological testing units must be sterile and isolated from other testing units;

b) In cases where there is no quality control room, the facility must have a contractual agreement with a capable and specialized unit for analyzing and controlling basic indicators of main raw materials and finished products;

11. Quality Control System for Raw Materials and Products

a) The quality control area shall be arranged separately, facilitating quality control during production; it shall be equipped with a minimum system of machinery, equipment, and tools for measuring and testing basic quality indicators for main raw materials and finished products. The microbiological testing section must ensure sterility and be isolated from other testing sections;

b) In cases where there is no quality control room, the facility must have a contractual agreement with a competent and suitably specialized unit to conduct testing and analysis for the basic quality indicators of main raw materials and finished products.

c) There must be a sample storage area, sample record files, and ensure compliance with sample retention and disposal procedures according to the preservation requirements of each type of sample;

12. Record Management

a) Possess complete management files (contracts, invoices, certificates, quality testing reports, declaration of conformity to technical regulations or food safety standards, and other related documents) for raw materials, auxiliary materials, food additives, processing aids, supplies, packaging materials, chemicals used for traceability, quality control, and food safety;

b) Possess complete food safety management files as prescribed (Certificate of Food Safety Conditions, Notification of Declaration of Conformity to Technical Regulations or Confirmation of Declaration of Compliance with Food Safety Standards) for processed milk products produced at the facility.

Article 6. Utensils, equipment, and packaging containers for processed milk

1. Utensils and packaging containers that come into direct contact with processed milk products shall comply with the provisions set forth in Circular No. 34/2011/TT-BYT dated August 30, 2011, issued by the Ministry of Health on national technical standards for hygiene and safety of packaging and utensils that directly contact food.

2. Machinery, equipment, and tools that come into contact with milk and ingredients must be designed and manufactured in a coordinated manner, made from non-corrosive materials that do not cause harm when used as intended, and must be easily cleaned, sanitized, and maintained to prevent contamination.

3. Equipment used for heating, cooling, chilling, and maintaining cold temperatures for milk must be designed to quickly achieve the required technical temperature and maintain it effectively; temperature monitoring and control must be possible according to regulations.

4. Direct air blowing onto the product (if applicable) must ensure sterility.

5. There must be a system to alert when processing parameters (temperature, pressure) exceed specified limits.

6. Waste containers and hazardous chemical containers must be designed appropriately and safely, clearly identifiable, made from durable materials that are less prone to damage.

7. Equipment and tools used for production, processing, and inspection must be regularly maintained and replaced when damaged or showing signs of damage.

Testing, measuring, and experimental equipment, and equipment with strict safety requirements must be calibrated and inspected according to regulations.

8. Repairs and maintenance of equipment, machinery, and tools can only be carried out outside the production area or during production stoppages. In cases where repairs or regular maintenance are conducted on-site, immediate cleaning must follow upon completion of work.

Lubricating oils for parts of equipment and machinery that come into contact with the product must be types approved for use in food production.

Article 7. Facility owners, direct producers, and visitors

1. Facility owners and direct producers must hold valid Food Safety Knowledge Certificates issued by authorized agencies or units designated by competent authorities.

2. The facility owner must organize health examinations for the owner and direct participants in production at least once every year at district-level or higher healthcare facilities. Health records of individuals must be fully retained at the facility.

3. Only hire individuals who meet the health standards prescribed by the Ministry of Health for those directly involved in food production and processing.

4. When a direct producer falls ill, they must report to the competent authority to arrange alternative work or rest for treatment according to regulations and may only resume work after obtaining a certificate of recovery and meeting health standards for food production from the competent health authority.

5. Those involved in production and processing must ensure personal hygiene before starting work and change into appropriate protective clothing based on their job positions.

6. Visitors to the facility must change into protective clothing and strictly follow the facility's personal hygiene regulations.

Chapter III
CONDITIONS FOR ENSURING FOOD SAFETY
FOR BUSINESS FACILITIES DEALING WITH PRODUCTS

Article 8. Business Premises for Processed Milk Products

1. Display areas, storage areas, and containment areas for products must always be dry and clean, ensuring that they do not alter the characteristics of the products, and are free from harmful chemical contamination, impurities, or microorganisms that may affect the health of users.

2. Adhere to the stacking height guidance provided by the manufacturer.

3. Establish a hygiene procedure for the premises and maintain hygiene logs as prescribed by the business owner.

Article 9. Equipment and Facilities for Business Premises for Processed Milk Products

Business premises must have complete equipment and facilities to ensure compliance with temperature, humidity, lighting, and other conditions required by manufacturers for each type of product throughout the storage and sale processes of processed milk products.

Article 10. Record Management

Business premises for processed milk products must retain all legal documentation files proving the origin and quality of the products to serve traceability, quality management, and food safety of the products.

Article 11. Transportation of Processed Milk Products

1. Transport vehicles must ensure protection against insect intrusion, contamination from other sources, and ease of cleaning.

2. During transportation, different types of milk products must be classified and arranged separately, ensuring that the storage conditions required by manufacturers are maintained throughout the transportation process.

3. Processed milk products shall not be transported together with hazardous goods or goods that could cause cross-contamination affecting the quality and food safety of the products.

4. Transport vehicles and containers used during transportation must be regularly cleaned and sanitized.

5. The business premises must have internal regulations specifying the conditions to ensure food safety during the transportation of processed milk products.

Chapter IV
IMPLEMENTING PROVISIONS

Article 12. Implementation Organization

1. The Ministry of Industry and Trade assigns the Department of Science and Technology to take the lead and coordinate with relevant units to organize the dissemination and guidance on the implementation of this Circular nationwide.

2. Provincial/Municipal Departments of Industry and Trade are responsible for guiding and implementing this Circular within their jurisdiction.

3. During the implementation process, based on management requirements and actual circumstances, the Department of Science and Technology has the responsibility to recommend the Ministry of Industry and Trade to supplement and amend this Circular when necessary.

Article 13. Effective Date

This Circular takes effect from February 3, 2015.