Hygiene Specifications for Cosmetics Manufacturing Enterprises
Shanghai Nina Environmental Protection Technology Co., Ltd. 2008-10-27 13:44:13
Hygiene Specifications for Cosmetics Manufacturing Enterprises
(2007 Edition)
Chapter One General Provisions
Article 1 To strengthen the hygiene management of cosmetics manufacturing enterprises and ensure the hygiene quality of cosmetics and consumer safety, these specifications are formulated in accordance with the "Cosmetics Hygiene Supervision Regulations" and its detailed rules.
Article 2 These specifications stipulate the hygiene requirements for site selection, facilities and equipment, raw materials and packaging materials, production process, finished product storage and entry-exit warehouse, hygiene management, and personnel of cosmetics manufacturing enterprises.
Article 3 All cosmetics manufacturing enterprises within the People's Republic of China shall abide by these specifications.
Article 4 The health administrative departments of governments at all levels supervise the implementation of these specifications.
Chapter Two Hygiene Requirements for Site Selection, Facilities, and Equipment
Article 5 Cosmetics manufacturing enterprises should be built in environmentally clean areas. There must not be any pollution sources within a 30-meter radius that could affect product safety; workshops producing toxic or harmful substances during the production process should maintain a sanitary protection distance of no less than 30 meters from residential areas.
Article 6 The design and construction of production plants and facilities should maximize the protection of products, facilitate effective cleaning and maintenance, and ensure that the transfer of products, raw materials, and packaging materials does not lead to confusion.
Article 7 The layout of the factory area should comply with hygiene requirements. The production and non-production zones should be set up to ensure the continuity of production and avoid cross-contamination.
Article 8 The building structure of the production plant is preferably chosen as reinforced concrete or steel structure to have appropriate flexibility; structures prone to water leakage, water accumulation, and mold growth should not be selected.
Article 9 Enterprises should have usage sites that match their production processes and capacities, including production, warehousing, inspection, auxiliary facilities, etc. Based on the characteristics and requirements of the products and production processes, one or more workshop operation lines should be set up. The total area of the making, filling, and packaging rooms for each workshop operation line must not be less than 100 square meters. The total warehouse area should correspond to the enterprise's production capacity and scale.
For workshops solely engaged in repackaging, the total area of the filling and packaging rooms must not be less than 80 square meters.
Article 10 The layout of the production workshop should meet the requirements of the production process and hygiene, preventing cross-contamination. According to actual production needs, changing rooms, buffer zones, raw material pre-entry rooms, weighing rooms, making rooms, semi-finished product storage rooms, filling rooms, packaging rooms, container cleaning disinfection rooms, drying rooms, storage rooms, raw material warehouses, finished product warehouses, packaging material warehouses, laboratories, sample retention rooms, etc., each functional room (area) should be no less than 10 square meters.
The production process flow should achieve vertical connections, with separate human and material flows to avoid crossing. The routes for raw materials and packaging materials, products, and personnel should be clearly defined.
Article 11 If the production process generates dust or uses flammable, explosive, or other hazardous materials, a separate production workshop and dedicated production equipment should be used, implementing corresponding hygiene and safety measures, and complying with relevant national laws and regulations.
Workshops generating dust should have dust removal and dust recovery facilities. Workshops producing cosmetics containing volatile organic solvents (such as perfumes, nail polish, etc.) should be equipped with corresponding explosion-proof facilities.
Article 12 Auxiliary buildings and facilities such as power supply, heating, air purification and air conditioning rooms, water supply and drainage systems, and wastewater, waste gas, and waste residue treatment systems should not affect the hygiene of the production workshops.
Article 13 The design and construction of floors, walls, ceilings, doors, and windows in production workshops should be convenient for cleaning.
(1) Floors should be flat, wear-resistant, slip-resistant, and impermeable, facilitating cleaning and disinfection. Floors in work areas requiring cleaning should have a slope, with floor drains installed at the lowest point. Clean workshops preferably use clean floor drains. Floor drains should prevent insect vectors and the entry or contamination of exhaust gases from sewage pipes. Drainage ditches in production workshops should be covered, and drainage pipes should prevent wastewater backflow.
(2) Walls and ceilings inside production workshops should meet requirements such as smoothness, non-dusting, and easy dust removal. Light-colored, non-toxic, corrosion-resistant, heat-resistant, moisture-proof, mildew-proof, and non-peeling materials should be used for coating and lining, facilitating cleaning and disinfection. Waterproof layers in making rooms should extend from the ground to the ceiling. Waterproof layers in other production workshops should not be less than 1.5 meters high.
Article 14 Logistics channels in production workshops should be spacious and adopt obstruction-free designs.
Article 15 Production workshops with visiting corridors should be separated from the production area by glass walls to prevent contamination.
Article 16 Roof beams, pipelines should be avoided being exposed whenever possible. Exposed pipelines should not contact walls and should preferably be suspended or supported by brackets, maintaining sufficient spacing for cleaning.
Article 17 Warehouses should have shelving or pallet boards, and stored goods should be stacked at least 10 cm above the ground and away from walls, and at least 50 cm below the ceiling, leaving passage ways. Warehouse floors should be flat, with ventilation, dustproofing, moisture-proofing, rodent-proofing, and insect-proofing facilities, and should be regularly cleaned to maintain hygiene.
Article 18 Changing rooms in production workshops should be equipped with cabinets, shoe racks, and other facilities. Shoe cabinets preferably use obstruction-free designs. Cabinets and shoe cabinets should be made of sturdy, non-toxic, anti-mold, and easily cleaned and disinfected materials. Changing rooms should be equipped with non-touch hand washing and disinfection facilities using running water.
Enterprises should set up secondary changing rooms as needed.
Article 19 Air in the making room, semi-finished product storage room, filling room, clean container storage room, changing room, and its buffer zone should be purified or disinfected according to production process needs, maintaining good ventilation and appropriate temperature and humidity.
Semi-finished product storage rooms, filling rooms, and clean container storage rooms for eye care, infant and children skincare cosmetics should reach 300,000-grade cleanliness requirements; semi-finished product storage rooms, filling rooms, and clean container storage rooms for other skincare cosmetics should preferably reach 300,000-grade cleanliness requirements. The cleanliness indicators of clean workshops should comply with relevant national standards and specifications.
Other workshops adopting disinfection treatment should have mechanical ventilation or natural ventilation, and necessary disinfection facilities should be provided. Air and surface disinfection should use safe and effective methods. For example, if ultraviolet disinfection is used, the irradiation intensity of ultraviolet lamps in use should not be less than 70 micro-watts per square centimeter, and should be configured according to 30 watts per 10 square meters.
Article 20 The mixed illumination on the working surfaces in production workshops should not be less than 200 lux, and the mixed illumination on the working surfaces in inspection areas should not be less than 500 lux.
Article 21 Toilets should not be located inside production workshops and should be flush toilets. A buffer zone should be set between the toilet and the workshop, with odor prevention, mosquito and fly insect prevention, and ventilation and exhaust facilities.
Article 22 Enterprises should have production equipment that matches the characteristics, processes, and output of their products to ensure product hygiene quality.
All equipment and pipelines that come into contact with cosmetic raw materials and semi-finished products should be made of non-toxic, harmless, and corrosion-resistant materials. Inner walls should be smooth without peeling, facilitating cleaning and disinfection. The bottom, interior, and surroundings of the equipment should be convenient for maintenance and cleaning.
Article 23 It is recommended that cosmetic manufacturing enterprises adopt automated, pipelined, and enclosed production methods. Production equipment, electrical circuits, air pipelines, and water pipes should not produce dripping or condensation that can contaminate raw materials, packaging materials, products, containers, and equipment. Pipeline design should avoid stagnation or contamination. Different purpose pipelines should be distinguished by color or labeled with contents.
Article 24 Water quality treatment equipment should be equipped according to product production process needs. The water quality and quantity should meet production process requirements.
Article 25 Tools and containers for taking raw materials during the production process should be distinguished by purpose and not mixed. They should be made of non-toxic materials such as plastic or stainless steel.
Chapter Three Hygiene Requirements for Raw Materials and Packaging Materials
Article 26 Corresponding rules and regulations should be established for the procurement, acceptance, inspection, storage, and use of raw materials and packaging materials, and designated personnel should be responsible.
Article 27 Raw materials must comply with national standards and requirements. Enterprises should establish archives for the raw materials they use and have corresponding inspection reports or quality assurance proof materials. Inspection certificates should be obtained from suppliers for imported raw materials requiring inspection and quarantine.
Production water quality should meet the national drinking water hygiene standard (GB5749-2006) requirements (except pH value).
Article 28 Various raw materials should be stored separately based on inspection status, qualification, and non-qualification. Non-qualified raw materials should be handled promptly according to relevant regulations and have handling records.
Article 29 After acceptance or inspection, qualified raw materials should be stored separately by type and batch, with Chinese labels or information including name (INCI name [if required] or Chinese chemical name), supplier name, specifications, batch number or production date and expiration date, and entry date. Raw material names marked with codes should have corresponding INCI names (if required) or Chinese chemical names.
Article 30 Raw materials with specific temperature, relative humidity, or other special requirements should be stored under specified conditions, monitored regularly, and records kept.
Article 31 Stored raw materials should follow the first-in-first-out principle, with detailed entry and exit records, and regular checks and inventory counts.
Article 32 Containers and auxiliary materials in packaging materials that directly contact cosmetics must be non-toxic, harmless, and pollution-free.
Article 33 Raw materials, packaging materials, and finished products should be stored separately in different warehouses (areas). Flammable, explosive materials, and toxic chemicals should be stored separately and strictly adhere to national regulations.
Chapter Four Hygiene Requirements for the Production Process
Article 34 The cosmetics production process should follow the relevant provisions of the enterprise's hygiene management system, formulate corresponding standard operating procedures, produce according to the procedures, and keep records.
Article 35 Production operations should be carried out in specified functional areas, reasonably connecting and transferring materials or items between functional areas, and taking effective measures to prevent contamination and confusion during operations or transfers.
Article 36 During production, regular monitoring of pH, conductivity, and microbial indicators in production water should be conducted. Water quality treatment equipment should be maintained regularly and records kept; after reactivation following downtime, corresponding treatments and monitoring should be performed.
Article 37 Raw materials for products should be weighed, recorded, and verified strictly according to the corresponding product formula. Weighing records should clearly record the preparation date, person responsible, product batch number, batch size, and raw material name and proportion. Relevant tools used in the mixing and feeding process should be clean and free from contamination. Opened raw material packaging should be resealed.
Article 38 Production equipment, containers, and tools should be cleaned and disinfected before and after use, and the floors and wall skirts in production workshops should be kept clean. Ceilings, doors and windows, screens, and ventilation exhaust covers in the workshop should be cleaned regularly.
The bacterial colony count in the air of semi-finished product storage rooms, filling rooms, clean container storage rooms, and changing rooms in the production process should be ≤1000 cfu/cubic meter; the bacterial colony count on the workbench surface in the filling room should be ≤20 cfu/square centimeter, and the bacterial colony count on the worker's hand surface should be ≤300 cfu/hand, with no detection of pathogenic bacteria. Sampling methods and inspection methods refer to GB15979-2002 "Hygiene Standards for Disposable Sanitary Products."
Article 39 Items unrelated to cosmetics production should not be stored in the functional areas of the production workshop, and the purposes of functional areas should not be changed arbitrarily. Unqualified products and waste generated during the cosmetics production process should be collected in fixed storage areas or dedicated containers and handled promptly.
Article 40 Personnel, semi-finished product storage containers, and packaging materials entering the filling room should not cause secondary contamination of finished products. Semi-finished product storage containers should undergo strict cleaning and disinfection and be transferred to the filling stage through pass-through ports. Outer packaging of containers or auxiliary materials should not enter the filling workshop without treatment.
Article 41 Various original records in the cosmetics production process (including raw material and finished product in and out of warehouse records, product formulas, weighing records, batch production records, batch number management, batch packaging records, position operation records, and key control points monitoring records in the process specifications) should be properly preserved. The preservation period should extend six months beyond the product's shelf life, and all records should be complete and traceable.
Article 42 During the production process, the hygiene quality of raw materials, semi-finished products, and finished products should be monitored. Enterprises should have the capability to inspect microbial projects (including total bacterial count, fecal coliform group, Staphylococcus aureus, Pseudomonas aeruginosa, molds, and yeasts).
Article 43 Semi-finished products can only be filled after passing inspection.
Article 44 The hygiene requirements for finished products should comply with the "Cosmetic Hygiene Specifications." Each batch of cosmetics must undergo hygiene quality inspection before being released to the market, and can only be released after passing inspection.
Product identification labels must comply with relevant national regulations.
Chapter Five Hygiene Requirements for Finished Product Storage and Entry-Exit Warehouse
Article 45 Product storage should have management systems, including storage requirements related to product hygiene quality, specifying the necessary storage conditions for products to ensure storage safety.
Article 46 Finished products entering the warehouse without self-inspection should have obvious pending inspection marks. Inspected finished products should be marked as qualified or unqualified based on inspection results, and stored separately. Unqualified products should be stored in designated areas, isolated and sealed, and handled promptly.
Article 47 The storage conditions for finished products should comply with the provisions of the product standard, and finished products should be stacked in batches by variety.
Article 48 Finished product entry into the warehouse should have records, including production batch numbers, inspection result numbers for semi-finished products and finished products.
Article 49 Product release should follow the first-in-first-out principle. Before release, the production batch number and inspection results should be verified. Release should have complete records, including consignee unit and address, shipping date, product name, specifications, quantity, batch number, etc., and the hygiene condition of the transportation vehicle should be confirmed.
Article 50 Regularly summarize outgoing and sales records by product name and quantity. Records should be kept for at least half a year beyond the expiration date of the cosmetics.
Unqualified products transported out of the warehouse for handling should have complete records, including product name, specifications, batch number, quantity, handling method, handler.
Article 51 The warehouse should have a return area for storing returned products. Returned products should be clearly marked and have complete records, including returning unit, product name, specifications, quantity, batch number, date, reason for return, and kept for reference.
After inspection, returned products can be incorporated into either the qualified or unqualified product area, and unqualified products should be handled promptly and recorded.
Chapter Six Hygiene Management
Article 52 Enterprises should establish hygiene management organizational structures commensurate with their scale and product categories, with an independent quality management department. The quality management department is responsible for formulating and revising various hygiene management systems of the enterprise, organizing and coordinating training and regular physical examinations for employees, and quality inspection work for products.
Article 53 The quality management department should be led by trained and evaluated personnel with experience in cosmetics production and quality management. The quality management department and relevant departments such as workshops should be equipped with full-time hygiene managers, who, according to their management scope, do supervisory, inspection, evaluation, and other work.
Article 54 Enterprises should appoint full-time cosmetic hygiene administrators.
Cosmetic hygiene administrators should understand the hygiene requirements for cosmetic production stipulated by national hygiene laws, standards, and normative documents, be familiar with pollution factors and control measures in the production process, have experience in cosmetic hygiene management, participated in relevant professional training, be in good health, and possess valid health certificates for employees.
Cosmetic hygiene administrators undertake the functions of hygiene management for cosmetic production activities in their units. Their main responsibilities include:
(1) Organizing hygiene law and hygiene knowledge training for employees, organizing health check-ups for employees.
(2) Formulating cosmetic hygiene management systems and position responsibility systems, and urging and checking their implementation.
(3) Inspecting the hygiene status of the cosmetic production process and recording it, promptly stopping actions that do not meet hygiene requirements and proposing handling opinions.
(4) Managing cosmetic hygiene inspection work.
(5) Establishing cosmetic hygiene management archives.
(6) Cooperating with product recalls, adverse reaction complaint handling, and other related work.
(7) Cooperating with health supervision institutions in conducting hygiene inspections on cosmetics in their units and truthfully providing relevant information.
(8) Participating in other hygiene management work to ensure the safety and hygiene of cosmetics.
Article 55 The quality management department of the enterprise should be directly led by the person in charge of the enterprise, establishing a hygiene quality inspection room matching the production capacity, responsible for the entire quality management and inspection of cosmetics production. The quality management department should be equipped with a certain number of quality management and inspection personnel. The premises, instruments, equipment, and other hardware facilities of the quality inspection room should at least meet the inspection requirements for cosmetic microbiology.
The quality management department must set up a sample retention room or cabinet matching the scale, variety, and storage requirements of cosmetic production. Each batch of products should have samples retained and stored until six months after the product's shelf life.