GB 31647-2018National food safety standard - General Hygienic Regulation for Production of Food Additives (English PDF)

2.1 Site selection

2.1.1 The plant shall not choose the area that have significant contamination towards

the product.

2.1.2 The plant shall not affect the living and safety of the surrounding residents.

2.1.3 The plant shall not choose the area that is prone to floods; there shall not be the

potential sites where large number of insects breed around the plant; if it is difficult to avoid, then take necessary precautions.

2.2 Plant environment

2.2.1 The potential contamination risks associated with environment to the production

of food additives shall be considered; and appropriate measures shall be taken to minimize such risks.

2.2.5 Pest control procedures shall be developed according to the situation; and

effective measures shall be taken to prevent the breeding of the pests.

2.2.6 The power, heating, air-conditioning room, water supply and drainage system, waste water and slag treatment system, other auxiliary building and facilities shall not affect the hygiene of the production site; neither it shall pollute the surrounding environment; for the waste with special requirements, its treatment method shall conform to the relevant provisions.

3.4 The inspection room set up in the plant shall be separated from the production

zone.

3.5 The signs for various zones and facilities in the plant shall be clear. The sites where

using and storing hazardous chemicals shall have obvious warning signs.

3.6 The production sites that may generate pollution sources such as harmful gases, dust, sewage and waste slag shall be set separately; take corresponding protective measures; so that impose no impact on the surrounding environment and final products. The discharge of the waste gas, waste water and waste slag shall conform to the relevant state regulations.

3.7 The floors, walls, doors and windows, ceilings, etc. shall be easy to maintain, clean

or disinfect. They shall be constructed with suitable durable materials. The cleaning operation area and accurate cleaning operation area shall meet the corresponding hygienic requirements according to the product characteristics.

4.1 Facilities

4.1.1 Water supply and drainage facilities

Appropriate water supply and drainage facilities shall be provided. The water quality of the production water shall conform to the provisions of GB 5749; if there are special requirements, it shall conform to the relevant provisions.

4.1.3 Personal hygiene facilities

4.1.3.1 The locker room shall be set up at the production site; if necessary, the locker

room can be set up at the entrance of the specific operation area; The size and facilities of the locker room shall be compatible with the number of the production personnel;

the work clothes shall be isolated from the personal clothe and other articles.

4.1.3.2 If necessary, changing shoes (wearing shoes covers) facilities or work shoes

and boots disinfection facilities shall be provided; the size of which shall meet the disinfection requirements.

4.1.4 Ventilation facilities

Take appropriate natural or artificial ventilation measures; if necessary, effectively control the temperature and humidity of the production environment through natural ventilation or mechanical facilities. The ventilation facilities shall be properly set up for easy cleaning, maintaining and replacement; the air shall be avoid flowing from the area with low cleanliness requirements to the area with high cleanliness requirements.

The processing area generating dust or odor shall have the dust removal facilities or take ventilation measures.

4.1.5 Lighting facilities

The illumination in the production workshop shall meet the requirements for production and processing; the lighting equipment located above the workbench and exposed products shall take protective measures. Emergency lighting equipment shall be provided in the operation area of the plant; the explosion-proof lighting facilities shall be provided for the production and storage area of the flammable and explosive products.

4.1.6 Storage facilities

4.1.6.1 The storage facilities that are compatible with the quantity and storage

requirements of the producing products shall be provided. Raw materials, semi-finished products, finished products, packaging materials, etc. shall be divided to store or stack in different areas according to their different natures; and mark clearly; so that prevent the cross-contamination.

4.2 Equipment

4.2.1 Production equipment appropriate to production capacity shall be provided.

4.2.2 The equipment and utensils that come into contact with the raw materials, semi-

finished products, finished products shall be made of non-toxic, odorless, anti-corrosive and non-shedding materials; shall be easy to clean and maintain.

5.1 Hygienic management system

5.1.1 Establish the product personnel and enterprise production hygienic management

system and corresponding assessment criteria; confirm the job responsibilities.

According to the characteristics of the product and hygienic requirements during the production and storage processes, establish monitoring system for key control links to ensure the product quality and safety.

5.2 Hygienic management of factory and facilities

5.2.1 When damage is occurred to the factory floor, wall, door and window, ceiling, etc.;

repair them immediately.

5.2.2 All facilities in the factory shall be kept clean; promptly repair and update if

problems occur.

5.2.3 Production, packaging, storage and other equipment and tools, production

pipelines, exposed product contact surface, etc. shall be regularly cleaned and disinfected as needed. For the processes that are not suitable for disinfection, there shall be other appropriate measure to ensure the hygiene.

5.3 Personnel health management and hygienic requirements

5.3.1 Establish and implement a health management system for practitioners. The

practitioners shall receive health training before they are employed.

5.4 Workwear management

5.4.1 Special workwear shall be provided according to the production characteristics

of food additives, cleaning and protection requirements. Workwear shall be worn in the operation area.

5.4.2 The workwear in the areas with different cleanliness requirements shall be clearly

distinguished in style, color or marker; the workwear in different areas shall be used in the corresponding areas instead of mixing use.

6.1 General requirements

6.1.1 Establish the purchase, acceptance, transportation and storage management

system for raw materials and relevant products; ensure that the used raw materials and relevant products conform to state relevant regulations; keep the records of purchase, acceptance, storage, use and transportation.

6.1.3 After the raw materials and relevant products are checked qualified for

acceptance, they shall be classified, partitioned and stored separately; the rejected raw materials shall be placed separately from the qualified products in designated area;

marked clearly; then they shall be returned or replaced in time.

6.1.4 The warehouse of the raw materials and relevant products shall be managed by

special personnel; establish management system; regularly check the quality and hygiene conditions; timely deal with the raw materials and relevant products that have deteriorated or exceeded the shelf life. Warehouse shipment order shall follow the principle of first in, first out.

6.1.7 The transportation tools and containers of raw materials shall be kept clean, well

maintained; and disinfected if necessary. The food raw materials may not be shipped together with the toxic or harmful substances to avoid contamination.

6.1.8 Chemicals such as lubricants, cleaning agents, disinfectants shall be classified, labeled according to their use and stored safely; so as not cause pollution to the products.

6.2 Purchase requirements

6.2.1 The raw materials for food purchased shall be subject to the examination of the

supplier’s license and the product qualification certificate; the food raw materials that canot be provide the qualified certification documents shall be inspected in accordance with the food safety standards. When purchasing the raw materials of livestock and poultry, their quarantine and inspection certificate shall be checked. Prohibit to purchase the spoilage, recycling or hazardous waste after industrial processing as food raw materials.

6.2.2 When purchasing the food additives, the supplier’s license and product certificate

shall be checked.

6.2.5 When purchasing the imported food raw materials, food additives, the qualified

certificate that meet the requirements of entry-exit inspection and quarantine department shall be checked. When purchasing the imported food raw materials and food additives domestically; the supplier’s qualification shall also be checked.

7.1 Organize the production and processing in strict accordance with the raw material

and processes specified in the relevant food safety standards; so that ensure the product quality meet the requirements of food safety standards. The product shall maintain its functionality during the warranty period.

7.2 According to the product characteristics and process type, set the corresponding

process parameters through scientific methods; record each batch of process parameters; implement and set the comparative inspection of the process parameters;

so that ensure the eating safety and product performance of the food additives.

7.4 Food additives produced by chemical process shall strictly control the order of

feeding materials and the temperature, time and pressure of the chemical reaction equipment; monitoring equipment and means shall be provided for the side reactions that may affect the quality of products.

7.5 Food additives produced by the extraction process shall strictly control the pressure, temperature, extraction time, flow rate of extraction solvent; and strictly control the residual amount of the solvent.

7.6 The production of compound food additives shall strictly control the formula; the

mixing process shall control the corresponding process parameters to ensure the uniform mixing of materials.

7.9 It shall be avoided producing and processing the products used different raw

materials on the same production line or production equipment; prevent the cross-contamination. If it is necessary to share the production line, establish the cleaning and disinfection systems; clean the production line and production equipment when the products are switched; if necessary, disinfect them; check the cleaning and disinfection effects; ensure the food additives are not contaminated.

7.10 Management systems shall be established to prevent the biological, chemical and

physical contamination of the product; analyze the possible contamination source and ways; develop appropriate control plans and procedures.

7.13 Encourage the use of more advanced quality management systems for quality

and safety control of the production process.

8.1 Food additives shall take shaped package.

8.2 The packaging materials and forms of food additives shall be able to ensure the

product safety and quality maximumly on the conditions of normal storage, transportation and sales.

9.1 The food additives shall be carried out self-inspection or commissioned qualified

inspection agency to inspect.

9.2 The self-inspection shall have the inspection room and capability that are suitable

for the inspection items; the qualified inspection personnel shall inspect the products according to the specified inspection methods; the inspection apparatus shall be regularly verified or calibrated.

9.5 The product retention sample system shall be established to retain the samples

timely. The shelf life of samples shall be no less than the shelf life of the product.