Unofficial translation
Footnote. It became invalid by Order of the Minister of Health of the Republic of Kazakhstan dated 21.06.2021 No. RK DSM - 53 (effective after ten calendar days after the date of its first official publication).In accordance with paragraph 6 of Article 144 of the Code of the Republic of Kazakhstan dated September 18, 2009 "On Public Health and Healthcare System", I ORDER:
1. To approve the attached Sanitary rules "Sanitary and epidemiological requirements for production, sale and storage of perfumery and cosmetic products".
2. To recognize as invalid the order of the Minister of National economy of the Republic of Kazakhstan dated February 25, 2015 № 135 "On approval of Sanitary rules "Sanitary and epidemiological requirements for production, sale and storage of perfumery and cosmetic products and oral hygiene products" (registered in the Register of state registration of regulatory legal acts under № 10623 published on May 22, 2015 in the Legal Information System "Adilet").
3. The Committee for public health protection of the Ministry of Healthcare of the Republic of Kazakhstan in accordance with the procedure established by the legislation of the Republic of Kazakstan shall ensure:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) within ten calendar days from the date of state registration of this order, sending its copy in paper and electronic form to the Republican state enterprise on the right of economic management "Republican Center for Legal Information" for official publication and inclusion to the Standard control bank of regulatory legal acts of the Republic of Kazakhstan;
3) placement of this order on the Internet resource of the Ministry of Healthcare of the Republic of Kazakhstan;
4) submission of information on implementation of measures provided by subparagraphs 1), 2) and 3) of this paragraph in legal Department of the Ministry of Healthcare of the Republic of Kazakhstan within ten working days after the state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.
4. Control over execution of this order shall be assigned to the Vice-Minister of Healthcare of the Republic of Kazakhstan A.V. Tsoy
5. This order shall be enforced upon expiry of twenty-one calendar days after its first official publication.
| Minister of Healthcare | |
| of the Republic of Kazakhstan | E. Birtanov |
| Approved by the order of the Minister of Healthcare of the Republic of Kazakhstan dated March 18, 2019 |
|
| № KR MHC-11 |
Sanitary rules "Sanitary and epidemiological requirements for production, sale and storage
of perfumery and cosmetic products"
Chapter 1. General provisions
1. These Sanitary rules "Sanitary-epidemiological requirements for production, sale and storage of perfumery and cosmetic products" (hereinafter – Sanitary rules) are developed in accordance with subparagraph 2) of paragraph 1 of Article 7-1, paragraph 6 of Article 144, paragraph 1 and paragraph 2 of Article 145 of the Code of the Republic of Kazakhstan dated 18 September 2009 "On Public Health and Healthcare System" (hereinafter – the Code) and includes sanitary and epidemiological requirements for selection of a land plot, designing, reconstruction, production, storage and sale of perfumery and cosmetic products.
2. The following terms and definitions are used in these Sanitary rules:
1) shelf life – the period after which perfumery and cosmetic products are considered unsuitable for use on their intended purpose. The expiration date shall be set by the product manufacturer in the technical documents.
2) perfumery and cosmetic products (hereinafter-PCP) – a substance or mixture of substances, intended for application directly to external human skin (skin, hair, nails, lips, and external genitals) or on the teeth and oral mucosa with a single or main purpose of cleaning them, changing their appearance, giving a pleasant smell, and (or) correcting the body odor, and (or) protecting and (or) preserving them in good condition, and (or) caring for them.
The terms, not defined in this chapter are used in these Sanitary rules in the meanings, established by the Code, technical regulation of the Customs union "On Safety of Perfumery and Cosmetic Products "(hereinafter - TR CU 009/2011).
Chapter 2. Sanitary and epidemiological requirements for selection of land plot, designing
and reconstruction of objects for production of perfumery and cosmetic products.
3. The choice of a land plot of facilities for production of PCP shall be determined taking into account the requirements of sanitary rules and hygienic standards, approved by state body in the sphere of sanitary and epidemiological welfare of population according to paragraph 6 of Article 144 and Article 145 of the Code and the requirements of state standards in the field of architecture, urban planning and construction, approved by the authorized body for architecture, town planning and construction according to subparagraph 23-16) of Article 20 of the Law of the Republic of Kazakhstan dated July 16, 2001 "On architectural, urban planning and construction activities in the Republic of Kazakhstan".
Legal entities and individuals, carrying out activity on production of PCP shall notify the territorial body in the field of sanitary and epidemiological welfare of population about the beginning of activity in accordance with paragraph 30 of Appendix 3 and Article 17 of the Law of the Republic of Kazakhstan dated May 16, 2014 "On Permits and Notifications".
4. When choosing a land plot for construction, it is not allowed to place objects for production of PCP on the land plots:
1) used for animal burial grounds, toxic waste disposal sites, landfills, manure storage facilities, drainage fields, cemeteries, as well as having soil contamination of an organic and chemical nature;
2) upon exceeding radiation safety standards;
3) which are soil foci of stationary and unfavorable points for anthrax;
4) in the first zone of sanitary protection of water sources;
5) in dangerous areas of dumps of coal and other mines and sections.
5. When designing and reconstructing, space-planning and design solutions for the premises of objects for production of PCP are envisaged in compliance with the flow of technological processes, excluding contamination of raw materials, packaging materials, unpacked and finished products.
The territory shall be divided into production and economic zones:
1) in the production zone are located: production building, which includes production facilities, warehouses for raw materials and finished products, household facilities, medical center;
2) in the economic zone are located: repair shops, warehouses for storing containers and fuel, boiler room, garage, site with containers for garbage collection, outdoor toilet.
7. The economic zone shall be located on the leeward side in relation to the production area and is separated by green spaces. Driveways and pedestrian paths are paved.
8. Slopes directed from buildings and other structures to water collectors are equipped to drain atmospheric water. Water collectors and drains are regularly cleaned and repaired in a timely manner.
9. Metal containers, installed on the site with a waterproof coating are used for collecting waste and garbage. Waste and garbage are removed as they are filled in.
10. For interior decoration, materials that are easily exposed to wet cleaning and treatment with disinfectants are used.
11. Industrial premises shall be isolated from sanitary, office, and administrative premises.
12. There is a dressing room with a shower and a toilet for the staff, which are equipped with sanitary devices.
13. Canteen or a buffet for employees shall be located in the household premises or in separate buildings.
14. All changes in the technology for obtaining PCP are allowed when implementing measures that ensure safe working conditions, environmental protection and do not entail a deterioration in the consumer qualities of the finished product.
Chapter 3. Sanitary and epidemiological requirements for water supply, drainage, heat
supply, lighting, ventilation and air conditioning systems for the production of perfumery and
cosmetic products
15. Buildings of PCP production facilities are provided and equipped with centralized water supply, drainage, heating, lighting, ventilation and air conditioning systems.
16. Separate pipelines for technical and drinking water shall be provided, they are painted in distinctive colors and do not have connections between them.
17. The sewage system in the production premises shall be designed and constructed taking into account the elimination of risk of products contamination.
18. Laying of household waste water pipelines in the premises for production, storage of raw materials and finished products shall not be allowed.
19. When placing the objects in non-canalized settlements, a local sewerage system shall be provided. A concrete pit for receiving waste water has a lid and is cleaned as it accumulates.
20. Discharge of waste water into open reservoirs and the surrounding area, as well as installation of absorbing wells shall not be allowed.
21. The buildings of objects for PCP production shall be equipped with central heating systems. In the absence of a centralized heat supply source, an autonomous boiler room or other heat sources shall be provided.
22. Natural and artificial lighting shall be provided at the object for PCP production in accordance with the requirements of Hygienic standards for physical factors, affecting a person, approved by the Order of the Minister of National Economy of the Republic of Kazakhstan №169 dated February 28, 2015 (registered in the Register of state registration of regulatory legal acts dated May 23, 2015 under №11147) and the requirements of state standards in the field of architecture, urban planning and construction.
23. Lighting systems in production premises shall ensure the ability to localize all fragments and prevent them from entering the product.
24. Ventilation and air conditioning systems shall be provided in the buildings of objects for PCP production. Design of ventilation and air conditioning systems in the buildings shall be carried out in accordance with the requirements of sanitary rules, hygiene standards, approved in accordance with paragraph 6 of Article 144 and Article 145 of the Code and state standards in the field of architecture, urban planning and construction.
25. The places for storage of initial products and semi-products that emit harmful or strongly smelling substances into the air of the premises, located inside the production premises shall be equipped with special shelters with exhaust ventilation.
26. Ventilation and air conditioning systems, installed in the production premises shall ensure entering of the air into production premise, which excludes contamination of products.
Chapter 4. Sanitary and epidemiological requirements for the objects on production
of perfumery and cosmetic products
27. The activities of objects for production of PCP shall be carried out in compliance with these Sanitary rules in accordance with Articles 21, 21-1, 62 of the Code, Article 17 of the Law of the Republic of Kazakhstan dated May 16, 2014 "On Permits and Notifications".
28. Arrangement and operation of equipment at the objects for production PCP shall be ensured in compliance with the technological process flow, excluding contamination of raw materials, packaging material, unpacked and finished products, the possibility of free access to the equipment for maintenance, washing, disinfection and repair, with the exception of possibility of contact of raw materials and finished products.
If necessary, the production equipment shall be placed taking into account the continuity of the technological process and compliance with the conditions of sterility during operation.
9. Safety of PCP in the production process shall be controlled by the personnel of the object and shall be ensured by:
1) determining the controlled stages of technological process and products at the stages of its production;
2) control of raw materials, technological tools and auxiliary materials used in the production of PCP, control of non-packaged and finished products;
3) control over operation of technological equipment in the manner, ensuring production of safe PCP;
4) ensuring documentation of information on the controlled stages of technological process and the results of control of PCP at the stages of its production;
5) ensuring accounting and registration of technological operations for each stage (indication of added raw materials, temperatures, speeds, mixing time, sampling, cleaning, sanitary processing of equipment, transfer of non-packaged products);
6) compliance with the storage conditions of PCP;
7) determining the methods and frequency of cleaning, washing, disinfection, disinsection and deratization of production premises, technological equipment and inventory used in the production process of PCP;
8) maintaining and storing documentation, confirming compliance of manufactured products with the requirements of TR CU 009/2011; on traceability of PCP;
9) control of the finished product before placing it on the market;
10) saving samples from each batch of PCP.
30. Methods for collecting, storing and transporting of raw products, semi-products, and waste shall be carried out in ways, that prevent the possibility of pollution of environmental objects and ensuring safety of the personnel engaged in all stages of decontamination and cleaning of industrial waste.
31. Equipment made of materials that are not resistant to the effects of chemicals, temperature influences and capable to release harmful chemicals into in contacting media shall not be allowed.
32. Dosing equipment for liquid harmful and (or) strong-smelling substances are equipped with devices, preventing their overflow.
33. Loading and unloading of bulk substances is carried out in a way, excluding dust emission.
34. Loading of liquid raw materials is carried out through closed communications. Feeding solutions of harmful and (or) strongly smelling substances with open jets shall not be allowed.
35. It is not allowed to clean rooms with compressed air, use organic solvents for cleaning rooms and work surfaces. Cleaning is carried out using water solutions of detergents.
36. Animals, including rodents and insects, are not allowed to enter the production premises.
37. Production premises are equipped with UV irradiators.
38. Special clothing must be worn in production premises.
39. Storage of special clothing is carried out in an open way, for which the dressing rooms of household premises are equipped with hangers or open cabinets, stands for shoes.
The number of places for storing home and special clothing is assumed to be equal to the number of employees in all shifts.
It is not allowed to store special and home clothing together.
40. It is not allowed to bring items that are not used in the performance of official duties and can become sources of contamination of products, smoke and eat in these premises.
41. At the entrance to the canteen, hangers for clothes, a washbasin with hot and cold water, equipped with soap and electric towels are installed.
42. Containers, construction and household materials are stored in warehouses. Storage of containers and their temporary storage under a canopy on paved areas is allowed.
43. The producer (manufacturer) shall ensure compliance of manufactured PCP with the requirements of TR CU 009/2011.
Chapter 5. Sanitary and epidemiological requirements for storage and sale of perfumery and cosmetic products
44. Products, raw materials, materials, and reagents are stored in special rooms isolated from the main production, subject to conditions that ensure their safety during regulated storage periods and prevent mixing and contamination.
45. Rejected batches of raw materials, materials and reagents are marked and stored separately to prevent their accidentally entering the production process.
46. Warehouses have capacities, corresponding to the range of products, auxiliary materials and raw materials. The size, constructions and location provides for rational placement of products, cleaning and other necessary technical operations. Finished products are stored on racks and (or) pallets.
47. Separate room (zones) for storing toxic and flammable substances are provided at the warehouse.
48. Realization of PCP is carried out in the presence of conditions declared by the manufacturer and the documents of conformity assessment of sold products (declaration of conformity or certificate of state registration), according to the requirements of TR CU 009/2011.
49. When storing and transporting PCP in warehouses and points of sale, the conditions, ensuring the quality and safety of products are observed.
50. Storage and sale of PCP is carried out separately from food products, construction and finishing materials, auto parts, fuel and lubricants.
51. PCP is realized in the presence of consumer packaging, ensuring safety of properties of the finished products during the specified shelf-life.
52. It is not allowed to realize PCP with expired shelf-life, defects in consumer packaging and violations of storage conditions.
