Hygienic standard for cosmetics manufacturers
(2007 Edition)
Chapter I General Provisions
Article 1 in order to strengthen the hygiene management of cosmetics production enterprises and ensure the hygiene quality of cosmetics and the use safety of consumers, these specifications are formulated in accordance with the regulations on hygiene supervision of cosmetics and its implementation rules.
Article 2 this specification specifies the hygienic requirements for the site selection, facilities and equipment, raw materials and packaging materials, production process, storage and warehousing of finished products, health management and personnel of cosmetics production enterprises.
Article 3 all enterprises engaged in the production of cosmetics within the territory of the people's Republic of China shall comply with these specifications.
Article 4 the public health administrative departments of the people's governments at various levels shall supervise the implementation of these standards.
Chapter II sanitary requirements for site selection, facilities and equipment
Article 5 cosmetics production enterprises shall be built in a clean and tidy area, and there shall be no pollution sources that may affect the safety of products within 30 meters around; The production workshop that may produce toxic and harmful factors in the production process shall have a health protection distance of not less than 30 meters from the residential area.
Article 6 the design and structure of production plants and facilities shall ensure the protection of products to the greatest extent; Facilitate effective cleaning and maintenance; Ensure that the transfer of products, raw materials and packaging materials will not cause confusion.
Article 7 the plant planning shall meet the hygiene requirements, and the production area and non production area shall be set to ensure the continuity of production without cross pollution.
Article 8 the building structure of the production plant should be reinforced concrete or steel frame structure to have appropriate flexibility; It is not suitable to select building structures that are prone to water leakage, ponding and mildew.
Article 9 a production enterprise shall have a place for production, storage, inspection, auxiliary facilities and other uses that are commensurate with its production technology and production capacity. According to the characteristics and requirements of the product and its production process, one or more production workshop lines shall be set. The total area of the manufacturing, filling and packaging room of each production workshop line shall not be less than 100 square meters. The total area of the warehouse shall be commensurate with the production capacity and scale of the enterprise.
The total area of the filling and packaging room in the production workshop with simple sub packaging shall not be less than 80 square meters.
Article 10 the layout of production workshops shall meet the requirements of production process and sanitation to prevent cross contamination. According to the actual production needs, the dressing room, buffer zone, raw material pre feeding room, weighing room, manufacturing room, semi-finished product storage room, filling room, packaging room, container cleaning and disinfection room, drying room, storage room, raw material warehouse, finished product warehouse, packaging material warehouse, inspection room, sample retention room and other functional rooms (areas) shall not be less than 10 square meters.
The production process flow shall be connected from top to bottom, and the flow of people and logistics shall be separated to avoid crossing. The flow routes of raw materials, packaging materials, products and personnel shall be clearly defined.
Article 11 where dust is generated in the production process or inflammable, explosive and other dangerous goods are used, separate production workshops and special production equipment shall be used, corresponding health and safety measures shall be implemented, and relevant national laws and regulations shall be complied with.
The production workshop generating dust shall have dust removal and dust recovery facilities. Workshops producing cosmetics containing volatile organic solvents (such as perfume, nail polish, etc.) shall be equipped with corresponding explosion-proof facilities.
Article 12 auxiliary buildings and facilities such as power, heating, air purification and air conditioning machine rooms, water supply and drainage systems and waste water, waste gas and waste residue treatment systems shall not affect the health of the production workshop.
Article 13 the floors, walls, ceilings, doors and windows of production workshops shall be designed and constructed to facilitate cleaning.
（1） The ground shall be flat, wear-resistant, anti-skid, impervious to water, and convenient for cleaning and disinfection. The floor of the work area to be cleaned shall have a slope, and a floor drain shall be set at the lowest place. The clean floor drain shall be used in the clean workshop, and the floor drain shall be able to prevent the entry or pollution of insect vectors and waste gas from the sewage pipe. The drainage ditch of the production workshop shall be covered, and the drainage pipe shall prevent the backflow of waste water.
（2） The surfaces of walls and ceilings in the production workshop shall meet the requirements of flatness, smoothness, non dusting, easy dust removal, etc. It shall be coated with light color, non-toxic, corrosion-resistant, heat-resistant, moisture-proof, mould proof and non peeling materials for easy cleaning and disinfection. The waterproof layer of the fabrication room shall be lined from the ground to the ceiling, and the waterproof layer of other production workshops shall not be less than 1.5m.
Article 14 the logistics channel of the production workshop shall be spacious and adopt the unobstructed design.
Article 15 the production workshop with a visiting corridor shall be separated from the production area by a glass wall to prevent pollution.
Article 16 roof beams and pipes shall not be exposed as far as possible. Exposed pipes shall not touch the wall, and should be hung or supported by brackets with sufficient spacing around for cleaning.
Article 17 the warehouse shall be equipped with goods shelves or pallets. The stored goods shall be stacked more than 10 cm from the ground, the wall and the top, and more than 50 cm from the top, with channels reserved. The warehouse floor shall be flat, with ventilation, dust-proof, moisture-proof, rat proof, insect proof and other facilities, and shall be cleaned regularly to maintain hygiene.
Article 18 the changing room of the production workshop shall be equipped with wardrobe, shoe rack and other facilities, and the shoe changing cabinet should adopt the blocking design. The wardrobe and shoe cabinet are made of solid, non-toxic, mould proof and easy to clean and disinfect materials. The changing room shall be equipped with non-contact mobile water hand washing and disinfection facilities.
The production enterprise shall set up a secondary dressing room as required.
Article 19 the air in the manufacturing room, semi-finished product storage room, filling room, clean container storage room, changing room and its buffer zone shall be purified or disinfected according to the needs of the production process to maintain good ventilation and appropriate temperature and humidity.
The semi-finished product storage room, filling room and cleaning container storage room for the production of skin care cosmetics for eyes, infants and children shall meet the cleaning requirements of 300000 level; The semi-finished product storage room, filling room and cleaning container storage room of other skin care cosmetics should meet the cleaning requirements of 300000 grade. The cleanliness index of the purification workshop shall comply with the provisions of relevant national standards and specifications.
Other workshops that adopt disinfection treatment shall have mechanical ventilation or natural ventilation, and be equipped with necessary disinfection facilities. Safe and effective methods shall be adopted for air and surface disinfection. For example, if ultraviolet disinfection is adopted, the irradiation intensity of ultraviolet lamp in use shall not be less than 70 micro watts / square centimeter, and shall be set at 30 watts / 10 square meters.
Article 20 the mixed illumination on the working face of the production workshop shall not be less than 200 lux, and the mixed illumination on the working face of the inspection site shall not be less than 500 lux.
Article 21 toilets shall not be set inside the production workshop, but shall be water flushing toilets; A buffer zone shall be set between the toilet and the workshop, and facilities such as odor prevention, mosquito and fly prevention, ventilation and exhaust shall be provided.
Article 22 a production enterprise shall have production equipment that is appropriate to the characteristics, process and output of its products and that ensures the hygienic quality of its products.
All equipment and pipelines contacting cosmetic raw materials and semi-finished products shall be made of non-toxic, harmless and corrosion-resistant materials, and the inner wall shall be smooth without falling off, so as to facilitate cleaning and disinfection. The bottom, interior and surrounding of the equipment shall be convenient for maintenance and cleaning.
Article 23 cosmetic production enterprises are encouraged to adopt automatic, pipelined and airtight production methods. Production equipment, circuit pipelines, gas pipelines and water pipes shall not produce dripping or condensation that may pollute raw materials, packaging materials, products, containers and equipment. Piping shall be designed to avoid stagnation or contamination. Pipes for different purposes shall be distinguished by color or marked with the name of the contents.
Article 24 water quality treatment equipment shall be provided according to the needs of product production process, and the quality and quantity of production water shall meet the requirements of production process.
Article 25 the tools and containers used for raw materials in the production process shall be differentiated according to their purposes, and shall not be mixed. They shall be made of non-toxic materials such as plastic or stainless steel.
Chapter III hygienic requirements for raw materials and packaging materials
Article 26 the purchase, acceptance, inspection, storage and use of raw materials and packaging materials shall be subject to corresponding rules and regulations, and shall be in the charge of a specially assigned person.
Article 27 raw materials must meet the relevant standards and requirements of the state. The enterprise shall establish the archives of the raw materials used, with corresponding inspection reports or quality assurance certificates. For imported raw materials requiring inspection and quarantine, the inspection and quarantine certificate shall be obtained from the supplier.
The quality of production water shall meet the requirements of the national sanitary standard for drinking water (GB5749-2006) (except pH value).
Article 28 various raw materials shall be stored separately according to the requirements for inspection, qualified and unqualified; Unqualified raw materials shall be handled in a timely manner according to relevant regulations, with handling records.
Article 29 the raw materials that have passed the acceptance or inspection shall be stored separately according to different varieties and batches, and shall be provided with Chinese marks or information such as product name (inci name [if necessary] or Chinese chemical name), supplier name, specification, batch number, production date and expiry date, warehousing date, etc; If the name of raw material is identified by code or code, there must be corresponding inci name (if any) or Chinese chemical name.
Article 30 raw materials with temperature, relative humidity or other special requirements shall be stored according to the specified conditions, regularly monitored and recorded.
Article 31 the inventory of raw materials shall be kept in accordance with the principle of first in first out, with detailed inbound and outbound records, and shall be checked and counted regularly.
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 shall be stored in separate warehouses (areas). Inflammables, explosives and toxic chemicals shall be stored separately and strictly in accordance with the relevant provisions of the state.
Chapter IV hygienic requirements for the production process
Article 34 The production process of cosmetics shall comply with the relevant provisions of the enterprise's health management system, formulate corresponding standard operating procedures, produce according to the procedures, and keep records.
Article 35 The production operation shall be carried out in the specified functional areas, the materials or articles between the functional areas shall be reasonably connected and transferred, and effective measures shall be taken to prevent pollution and confusion in the process of operation or transfer.
Article 36 during production, the pH, conductivity, microorganism and other indicators of production water shall be regularly monitored. Water treatment equipment shall be regularly maintained and recorded; If it is used again after being stopped, it shall be handled accordingly and monitored to be qualified.
Article 37 the raw materials of products shall be weighed, recorded and verified in strict accordance with the corresponding product formula. The weighing record shall clearly record the batching date, responsible person, product batch number, batch number, raw material name and proportioning amount. Relevant instruments used in the process of mixing and feeding shall be clean and free from pollution. The opened raw material packages shall be sealed again.
Article 38 production equipment, containers and tools shall be cleaned and disinfected before and after use, and the floor and dado of the production workshop shall be kept clean. The top surface, doors and windows, screen windows and ventilation and exhaust net cover of the workshop shall be cleaned regularly.
During the production process, the total number of bacterial colonies in the air of semi-finished product storage room, filling room, clean container storage room and changing room shall be ≤ 1000 cfu/ m3; The total number of bacterial colonies on the surface of the workbench in the filling room shall be ≤ 20 cfu/ m2, and the total number of bacterial colonies on the surface of workers' watches shall be ≤ 300 cfu/ hand, and no pathogenic bacteria shall be detected. Sampling method and inspection method shall refer to GB15979-2002 hygienic standard for disposable sanitary articles.
Article 39 articles irrelevant to the production of cosmetics shall not be stored in the functional areas of the production workshop, and the purpose of the functional areas shall not be changed without authorization. Unqualified products and wastes in the production process of cosmetics shall be collected in fixed storage areas or special containers and treated in time.
Article 40 operators, semi-finished product storage containers and packaging materials entering the filling room shall not cause secondary pollution to finished products. Semi finished product storage containers shall be strictly cleaned and disinfected, and pass through the transfer port to the filling link. The outer packaging of storage containers or auxiliary materials shall not enter the filling workshop without treatment.
Article 41 all original records in the production process of cosmetics (including the warehouse entry and exit records of raw materials and finished products, product formula, weighing records, batch production records, batch management, batch packaging records, post operation records and monitoring records of key control points in the process procedures, etc.) shall be properly kept. The retention period shall be six months longer than the shelf life of the product. All records shall be complete and traceable.
Article 42 during the production process, the hygiene quality of raw materials, semi-finished products and finished products shall be monitored. The production enterprise shall have the ability to inspect microbial items (including total bacterial count, fecal coliform, Staphylococcus aureus, Pseudomonas aeruginosa, mold and yeast, etc.).
Article 43 semi finished products can be filled only after passing the inspection.
Article 44 the hygienic requirements of finished products shall comply with the hygienic standards for cosmetics. Before each batch of cosmetics is put on the market, the hygiene quality inspection must be carried out, and only after passing the inspection can they leave the factory.
The product identification label must comply with relevant national regulations.
Chapter V hygienic requirements for storage and warehousing of finished products
Article 45 the storage of products shall have a management system, which shall include the storage requirements related to the hygiene and quality of products, specify the necessary storage conditions for products, and ensure the safety of storage.
Article 46 the finished products that have not been self inspected shall be put into the warehouse with obvious signs to be inspected; The inspected finished products shall be marked with qualified products or unqualified products according to the inspection results and stored separately; The nonconforming products shall be stored in the designated area, isolated and sealed for timely treatment.
Article 47 the storage conditions of finished products shall comply with the provisions of product standards, and finished products shall be stacked in batches according to varieties.
Article 48 the warehousing of finished products shall be recorded, including the production batch number, the inspection result number of semi-finished products and finished products.
Article 49 products shall be delivered first in first out. Before ex warehouse, check whether the production batch number of the product is consistent with the inspection results. Complete records shall be kept for ex warehouse, including the receiving unit and address, delivery date, product name, specification, quantity, batch number, etc., and the sanitary condition of transport vehicles shall be confirmed.
Article 50 the ex warehouse records and sales records shall be regularly summarized according to the product name and quantity, and the records shall be kept for at least half a year beyond the validity period of cosmetics.
Complete records shall be kept for handling nonconforming products out of the warehouse, including product name, specification, batch number, quantity, handling method and handler.
Article 51 the warehouse shall set up a return area to store the returned products. The returned products shall be clearly marked and have complete records, including the return unit, product name, specification, quantity, batch number, date and return reason, and shall be kept for future reference.
The returned goods can only be included in the qualified or unqualified product area after inspection. The unqualified products shall be handled in time and recorded.
Chapter VI health management
Article 52 a manufacturing enterprise shall establish an organizational structure for health management that is appropriate to its scale and product category, and shall have an independent quality management department. The quality management department is responsible for formulating and revising various health management systems of the enterprise, organizing and coordinating the training and regular physical examination of employees and the quality inspection of products.
Article 53 the quality management department shall be in the charge of personnel who have been trained and assessed and have experience in cosmetics production and quality management. The quality management department, workshop and other relevant departments shall be equipped with full-time health management personnel to do a good job of supervision, inspection and assessment according to the management scope.
Article 54 production enterprises shall set up full-time cosmetics hygiene administrators.
The cosmetic hygiene administrator shall master the hygienic requirements of the relevant national health regulations, standards and normative documents for the production of cosmetics, be familiar with the pollution factors and control measures in the production process, have experience in the hygienic management of cosmetics, have participated in relevant professional training, be healthy and have the health certificate of the employees.
The cosmetics hygiene administrator is responsible for the hygiene management of the cosmetics production activities of the unit. The main responsibilities include:
（1） Organize employees to receive training on health laws and health knowledge, and organize employees
