Hygienic Standard for Food Additive Manufacturing Enterprises
Shanghai Nina Environmental Technology Co., Ltd. 2008-10-27 14:17:44
Chapter One General Provisions
Article 1 In order to strengthen the hygiene supervision and management of food additive manufacturing enterprises, ensure the hygiene safety of food additives, according to the relevant provisions of the "Health Law of the People's Republic of China" and the "Hygiene Management Measures for Food Additives", this hygienic standard is formulated.
Article 2 This standard stipulates the basic hygiene requirements and management principles for site selection, design and facilities, raw material procurement, production process, storage, transportation, and employees of food additive manufacturing enterprises.
Article 3 Any enterprise engaged in the production of food additives, including enterprises producing food flavorings, fragrances, and processing aids for the food industry, must comply with this standard.
Article 4 The health administrative departments of governments at all levels shall supervise the implementation of this standard.
Chapter Two Hygiene Requirements for Site Selection, Design, and Facilities
Article 5 For newly built, renovated, or expanded food additive manufacturing enterprises, the site selection, design, and construction of the production area, in addition to following the national regulations on construction project management, should also meet the requirements of this standard. It must be reviewed by the health administrative department of the province, autonomous region, or municipality directly under the Central Government, and a completion inspection must be carried out.
Article 6 Food additive manufacturing enterprises should be located in areas with dry terrain, abundant water sources, and convenient transportation. Factory roads should be hardened to prevent dust from flying around and water accumulation. The surrounding environment of the factory area should be greened. Within 25 meters, there should be no dust, harmful gases, radioactive substances, and other diffusive pollution sources, and there should be no potential places where insects can breed in large numbers.
Article 7 During the production process, corresponding hygiene safety facilities should be available. Production sites that may produce harmful gases, dust, noise, and sewage pollution sources must be set up separately and maintain an appropriate sanitary protective distance and measures from residential areas.
Article 8 Buildings, equipment layout, and production processes should be reasonably connected to prevent cross-contamination and mixing between different varieties.
Article 9 Enterprises should set up production rooms such as raw material warehouses, product processing areas, product packaging areas, finished goods warehouses, inspection rooms, hazardous materials warehouses, etc., based on the characteristics of the products and process requirements.
Article 10 The setting up of power, heating, air conditioning rooms, water supply and drainage systems, wastewater and waste residue treatment systems, and other auxiliary buildings and facilities should not affect the hygiene of the production area and should not pollute the surrounding environment.
Article 11 There should be production rooms that are commensurate with the product type and production scale. The net height should not be less than 3 meters, and the usable area should not be less than 150 square meters.
Article 12 The walls and roofs of the product packaging area for food additives and the production area for compound food additives should be made of light-colored, moisture-proof, corrosion-resistant, non-toxic, non-leaching, and non-detachable non-toxic materials. The floor should be flat, slip-resistant, wear-resistant, non-toxic, corrosion-resistant, impermeable, and easy to clean. The floor of work areas that need cleaning should have a slope of 1~2°. Windowsills should be set or not set at the lowest point, and floor drains should be installed. The floor should not accumulate water.
Article 13 The workshop and warehouse should have good ventilation. When using natural ventilation, the ratio of ventilation area to floor area should not be less than 1:16; when using mechanical ventilation, the air change rate should not be less than three times per hour.
Article 14 The workshop or workplace should have sufficient natural lighting or artificial lighting. The mixed illuminance of the working surface in the inspection area should not be less than 540LX, the working surface in the processing area should not be less than 220LX, and the general area should not be less than 110LX. Food additives that require light avoidance during production are excluded.
Article 15 Equipment, tools, pipelines, containers used in the production of food additives must be dedicated and meet the corresponding hygiene requirements. They should be made of non-toxic, odorless, corrosion-resistant, non-leaching, and non-deformable materials. Production water should meet the requirements of the hygienic standard for drinking water quality.
Article 16 Buildings and various facilities should be equipped with effective dustproof, rodent-proof, and mosquito-fly-proof facilities according to the hygiene requirements of the production process and the characteristics of the product production.
Article 17 In places where strong acids, strong alkalis, and other corrosive chemicals are produced, used, or stored, there should be clear warning signs, and emergency handling facilities should be set up.
Article 18 At the entrance of workshops producing food additives other than food processing aids, changing rooms should be set up with corresponding changing facilities. If there are microbial indicators, handwashing and disinfection facilities with running water should also be provided.
Article 19 If there are microbial indicators in the product quality standards, there should be a dedicated packaging area, which should be equipped with air disinfection and purification facilities. Ultraviolet disinfection should be set up at 30 watts/10~15 square meters, and it should be suspended more than 2 meters above the ground.
Chapter Three Hygiene Requirements for the Production Process
Article 20 Food additive manufacturing enterprises should establish and improve the hygiene safety assurance system, formulate job operation procedures and hygiene management systems according to the production process, and equip hygiene management personnel to strictly follow the procedures.
Article 21 Food additive manufacturing enterprises should establish and improve the inspection system, set up hygiene quality inspection rooms suitable for product characteristics, and equip corresponding inspection instruments and equipment. Inspection personnel who have undergone professional training and passed the assessment should be employed.
Article 22 Raw materials purchased must meet relevant standards and regulations. For imported food additives, a health certificate issued by the port food hygiene supervision and inspection institution should be obtained. When purchasing raw materials that meet the requirements of food additives, the supplier should be asked to provide the health permit of the product and the inspection qualification certificate of the same batch. Varieties outside the use hygiene standards for food additives or the list announced by the Ministry of Health should not be used. Non-food additives should not replace food additives, and acceptance should be conducted upon entry into the warehouse.
Article 23 All original records of the production process (including the inspection results of key factors in the process specifications) should be properly kept. The retention period should be six months longer than the shelf life of the product. Each batch of products must be inspected, and only those that pass can leave the factory. The original inspection records and inspection report forms of each batch of products should be properly kept for verification.
Article 24 Packaging containers and materials should be intact and meet the corresponding national hygiene standards for food containers and packaging materials.
Article 25 Product labels and instructions for use should comply with the provisions of the "Food Hygiene Law of the People's Republic of China" and the "Hygiene Management Measures for Food Additives."
Article 26 Equipment, tools, pipelines, containers, venues, etc., should be cleaned and disinfected before and after use, and records should be kept. Maintenance and inspection of equipment should not pollute the product.
Article 27 Harmful gases, strong acids, strong alkalis, and other chemical corrosive substances, dust, noise, and other factors that may affect workers' health generated during the production process should be treated to meet the corresponding national standards.
Chapter Four Hygiene Requirements for Storage and Transportation
Article 28 Raw materials, packaging materials, and finished products must be stored in separate warehouses. Raw material, finished product, and hazardous material warehouses should be adapted to the production scale and product characteristics and managed by designated personnel.
Article 29 Raw materials should be classified, accepted, and registered by variety and then stored in classified zones.
Article 30 After the product has been inspected and found qualified, it should be stored by variety and batch, and labels should be added according to the requirements of the "Hygiene Management Measures for Food Additives" to prevent mutual mixing. The storage conditions should meet the corresponding hygiene requirements according to the product characteristics.
Article 31 Chemical corrosive, flammable, and explosive items should be stored in special warehouses and managed according to the relevant requirements of hazardous material warehouses.
Article 32 The transportation of raw materials and finished products should choose appropriate transportation tools according to the product characteristics and meet relevant hygiene requirements. The transportation tool must be clean and non-toxic. Dust-proof, rain-proof, and sun-proof measures should be taken during transportation to ensure the hygiene and safety of the product.
Chapter Five Hygiene Requirements for Employees
Article 33 Employees should undergo hygiene knowledge training before taking up their posts. Only those who pass the examination can take up their posts.
Article 34 Personnel engaged in food additive production (including temporary workers) should undergo a health check once a year and obtain a preventive health examination certificate before taking up their posts. Those suffering from active tuberculosis, viral hepatitis, intestinal infectious diseases, and pathogen carriers, suppurative or chronic exudative skin diseases, and other infectious diseases should not engage in food additive production.
Article 35 Smoking, eating, and other activities that hinder the hygiene of food additives are prohibited in the production area. Personal items should not be brought into the production area. Employees should not wear rings, earrings, or spray perfume during the production process.
Article 36 Personnel engaged in the packaging and production of compound food additives must wash their hands thoroughly before entering the production area, wear clean work clothes and hats, and keep their hair covered.
Chapter Six Supplementary Provisions
Article 37 This standard shall be interpreted by the Ministry of Health.
Article 38 This standard shall come into effect from the date of its issuance.