Russia

Ministry of Health of the Russian Federation


ORDER

July 20, 1998 No. 217

Moscow

 

On Hygienic Assessment of the Manufacture, Delivery and Distribution of Products and Commodities

For the purposes of more effective protection of human life and health, of bringing the system of hygienic assessment of products, commodities as well as manufactures into conformity with applicable laws of the Russian Federation and harmonizing such procedure with international requirements, and pursuant to Russian Federation Law No. 1034-1 "On the Sanitary and Epidemiological Well-Being of the Population", dated April 19, 19911, the Russian Federation Law "On Consumer Rights Protection" (as amended by Federal Law No. 2-FZ "On Amendments and Supplements to the Russian Federation Law "On Consumer Rights Protection" and the RSFSR Code of Administrative Offences", dated January 9, 1996)2, and the Regulations on the Ministry of Health of the Russian Federation approved by resolution No. 659 of the Russian Federation Government "On Approval of the Regulations on the Ministry of Health of the Russian Federation", dated June 3, 19973,

I HEREBY ORDER THAT:

1. The following shall be approved:

1.1 Regulations on Hygienic Assessment of Products, Commodities as well as Manufactures (Annex 1);

1.2 Form of Hygienic Approval of Products/Commodities (Annex 3); and

1.3 Form of Hygienic Approval of Manufactures (Annex 4).

2. It shall be determined that:

2.1 A hygienic approval shall be issued by the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation, centers of state sanitary and epidemiological supervision in the subjects of the Russian Federation, regional centers of state sanitary and epidemiological supervision in transport, the Federal Center for State Sanitary and Epidemiological Supervision at the Ministry of Health of the Russian Federation or centers of state sanitary and epidemiological supervision of the Federal Agency for Medical, Biological and Extreme Problems under the Ministry of Health of the Russian Federation, authorizing manufacture, delivery and distribution of products and commodities in accordance with the Regulations on Hygienic Assessment of Products, Commodities as well as Manufactures (Annex 1) and the List of Products and Commodities Subject to Hygienic Assessment (Annex 2);

2.2 All and any organizational and technical activities associated with hygienic assessment of products, commodities as well as manufactures and issuance of hygienic approvals by the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation shall be carried out by the Center for Sanitary and Epidemiological Regulation, Hygienic Certification and Examination of the Ministry of Health of the Russian Federation;

2.3 Forms of hygienic approvals encoded as required for protection, shall be produced and distributed by the Center for Sanitary and Epidemiological Regulation, Hygienic Certification and Examination at the Ministry of Health of the Russian Federation;

2.4 A register of hygienic approvals of products and commodities shall be generated and maintained by the Center for Sanitary and Epidemiological Regulation, Hygienic Certification and Examination of the Ministry of Health of the Russian Federation; and

2.5 The Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation shall conduct hygienic assessment of any socially significant, potentially hazardous types of products and commodities in accordance with the List (Annex 5).

3. Any previously issued hygienic certificates shall be valid throughout their effective term.

4. Any product that has passed hygienic assessment may, if so desired by the manufacturer (seller, supplier), be furnished with a mark certifying that such product has passed such hygienic assessment (Annex 6).

5. The chief medical authorities of all centers for state sanitary and epidemiological supervision in the subjects of the Russian Federation, the chief medical authorities of all regional centers for state sanitary and epidemiological supervision in transport and the chief officers of other organizations as listed in Section 2.1 shall:

5.1 ensure the performance of activities associated with hygienic assessment of products, commodities as well as manufactures in accordance with the Regulations approved hereby; and

5.2 ensure that the public, governmental authorities and local governments are informed, on an ongoing basis, of the results of supervision over the quality of products and commodities subject to hygienic assessment and over compliance with applicable sanitary laws at all stages of their manufacture, storage and distribution.

6. The First Deputy Minister, Chief State Sanitary Physician of the Russian Federation, shall:

6.1 submit proposals on the composition of Expert Councils to be engaged by the Center for Sanitary and Epidemiological Regulation, Hygienic Certification and Examination of the Ministry of Health of the Russian Federation in conducting hygienic assessment of products, commodities as well as manufactures; and

6.2 approve the list of leading test centers/laboratories at research institutes and centers affiliated with the Ministry of Health of the Russian Federation and the Russian Academy of Medical Sciences.

7. resolution No. 1 of the Russian State Committee for Sanitary and Epidemiological Supervision "On the Procedure for Issuance of Hygienic Certificates for Products", dated January 5, 1993 (registered with the Ministry of Justice of the Russian Federation on January 18, 1993, No. 118) shall be invalidated.

8. The control over the compliance with this order shall be performed by G.G.Onishchenko, First Deputy Minister, Chief State Sanitary Physician of the Russian Federation.

9. This Order shall take effect upon the expiration of 10 days after its official publication.

O.V.Rutkovsky Minister

 


  Annex 1

Approved by Order No. 217
of the Ministry of Health
of the Russian Federation,
dated July 20, 1998

 

Regulations on Hygienic Assessment of Products, Commodities as well as Manufactures

I. General Provisions

1. This document establishes general requirements for the procedure for hygienic assessment of products, commodities as well as manufactures.

2. Hygienic assessment of products, commodities as well as manufactures constitutes a special procedure to be carried out by agencies and institutions of the State Sanitary and Epidemiological Service in order to assess any potential hazard of products or commodities for human health, which includes the performance of special sanitary and epidemiological investigations and examinations as well as the issuance of a hygienic approval of a standard format and its entry into the Register. A hygienic assessment identifies allowed areas and conditions for use of products and commodities and imposes, where necessary, additional requirements upon the processes of manufacture, storage, transportation, operation/use or disposal of such products or commodities so that to ensure their safety for humans.

3. Following a hygienic assessment, there will be issued a standard format approval (hereinafter "approval"), which serves to certify that the products or commodities conform to the applicable requirements of sanitary legislation.

4. Products and commodities will be permitted for manufacture, use and sales after completion of their hygienic assessment and provided that an approval of a standard format is available.

5. Any laboratory or instrumental testing of products and commodities with respect to hygienically significant indicators and any hygienic assessment will be conducted on the basis of appropriate contracts.

6. Any work associated with hygienic assessment of products or commodities, the issuance of approvals, hygienic assessment of manufactures and the entry of the approvals into the Register will be carried out on the basis of a contract between the applicant and the center of state sanitary and epidemiological supervision or any other authorized institution.

7. Any work associated with hygienic assessment of manufactures will be carried out by agencies and institutions of the State Sanitary and Epidemiological Service in accordance with the relevant contract made with the entity intending to start manufacturing a given product.

8. Hygienic assessment of any products, commodities or manufactures proceeds by reference to the requirements determined by applicable legislation.

9. The decision whether any product, commodity or, in the case of hygienic assessment of manufactures, type of product is safe, is made based on the examination of available documents and test results. If such data are fully consistent with the requirements of sanitary legislation, the center of state sanitary and epidemiological supervision or another authorized institution will prepare an approval of the standard format. Such approval will be signed by the Chief State Sanitary Physician of the Russian Federation or his deputies, chief state sanitary physicians of the subjects of the Russian Federation, cities and regions in transport, or their deputies.

10. If the data so submitted do not meet the requirements of sanitary legislation, the center of state sanitary and epidemiological supervision or another authorized institution will make the decision to deny their approval and forward a written notice thereof containing the grounds for such decision to the applicant. If the applicant disagrees with the decision to deny an approval, it may lodge an appeal with the Appellate Board at the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation.

11. Any product that has passed a hygienic assessment may, if so desired by the manufacturer (seller, supplier), be furnished with a mark certifying that such product has passed such hygienic assessment.

12. Copies of hygienic approvals issued by the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation, centers of state sanitary and epidemiological supervision in the subjects of the Russian Federation, regional centers of state sanitary and epidemiological supervision in transport, the Federal Center of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation, and centers of state sanitary and epidemiological supervision of the Agency for Medical, Biological and Extreme Problems at the Ministry of Health of the Russian Federation, must be duly encoded for protection.

 

II. Procedure for Implementation of Hygienic Assessment of Products and Commodities

1. Hygienic assessment of products and commodities includes:

- acceptance and registration of an application for hygienic assessment of products or commodities;

- identification of the scope and cost of work, entry into a hygienic assessment contract with the applicant;

- examination of the documentation and product samples submitted;

- decision based on the outcome of the hygienic assessment of such products or commodities; and

- execution and issuance of a hygienic approval and its entry into the Register of hygienic approvals for products and commodities that have passed hygienic assessment.

2. For the purposes of hygienic assessment and of issuance of a standard format approval, an applicant (legal or physical entities) must submit to an agency or institution of the State Sanitary and Epidemiological Service an application together with the following documents:

for domestic products:

- regulatory or technical documentation for such product or commodity (performance specifications, production manuals, product contents etc.);

- a brief description of the designation of the product or commodity and recommendations for their use;

- test reports on the product or commodity, if available;

- other documents confirming the safety of the product; and

- product/commodity samples as required for hygienic assessment;

for imported products:

- manufacturer's certificate of the quality of the product/commodity;

- certificate of safety issued in the country of manufacture by the authorized bodies, and/or the manufacturer's certificate (confirmation), and other materials obtained in the country of manufacture in confirmation of safety of such product or commodity;

- test reports on the product or commodity, if available;

- product/commodity samples in such quantity as required for hygienic assessment; and

- manufacturing specifications of the product/commodity indicating the recommended conditions of its use, and other regulatory or technical documents reflecting its contents and conditions of use.

3. Any documents issued in the country of manufacture or origin must be submitted to agencies of the State Sanitary and Epidemiological Service attached with their duly certified Russian translation.

4. The term of hygienic assessment is determined depending on the type and scope of analysis of a specific type of product or commodity, but in any case must not exceed two months. For newly developed domestic products and otherwise where additional tests are necessary, the term of hygienic assessment may be extended to three months.

5. An approval will be issued:

5.1 with respect to a type of product, indicating the available nomenclature of articles, upon hygienic assessment of the manufacturing factory;

5.2 with respect to a particular article of nomenclature:

- when starting its production (provided that duly approved regulatory and technical documentation - GOSTs, OSTs, specifications, production manuals - is available);

- following any change in the contents, composition, production process of or regulatory or technical documentation for any products, commodities or structures;

- for the purpose of entry into contracts for the purchase of product abroad;

- upon the expiry of an earlier issued approval;

- for any pilot lot of a product; or

- for any shipment of foreign-made products imported to the Russian Federation, unless an approval is available with respect to such imported products under the given regulatory or technical documentation.

6. An approval for national products must always include an assessment of the conditions of their manufacture, which determine their safety.

7. Regulatory or technical documentation must be agreed with agencies of the State Sanitary and Epidemiological Service according to the outcome of hygienic assessment, and an approval with respect to the finished product will be issued thereafter.

8. The effective term of an approval is determined by the issuing authority or agency of the State Sanitary and Epidemiological Service, depending on the potential hazard of the specific product or commodity, on the basis of data describing the sanitary, hygienic and epidemiological importance of such product or commodity, the specific features of its manufacture and will be:

- up to five years for any type of product (including imports);

- up to one year for a pilot lot of a product; and

- a period not exceeding the shelf life of the product, for a shipment of foreign-made product imported to the Russian Federation (unless an approval for such type of product of such manufacturer was issued in the stage of making the relevant supply contract).

9. Hygienic assessment of any products listed in Annex 5 to Order No. 217 of the Ministry of Health of the Russian Federation dated July 20, 1998 is to be carried out at the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation.

10. Any laboratory and instrumental testing and measurements, and expert works necessary to carry out hygienic assessment of products and commodities at the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation, will be performed by head testing centers/laboratories at research institutes and centers affiliated with the Ministry of Health of the Russian Federation and the Russian Academy of Medical Sciences. The list of such testing centers must be approved by the Chief State Sanitary Physician of the Russian Federation.

 

III. Procedure for Hygienic Assessment of Manufactures

1. Hygienic assessment of a manufacture for the purpose of issuance of a hygienic approval of a type of product will be carried out on a voluntary basis upon the manufacturer’s application, and will not preclude agencies and institutions of the State Sanitary and Epidemiological Service from subjecting such manufacture to scheduled sanitary supervision.

2. Hygienic assessment of domestic products manufacture must be carried out at the stage of product launch.

3. Hygienic assessment of domestic products manufacture as well as manufacture of foreign products located in the Russian Federation will be carried out by the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation, centers of state sanitary and epidemiological supervision in the subjects of the Russian Federation, regional centers of state sanitary and epidemiological supervision in transport, the Federal Center of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation and centers of state sanitary and epidemiological supervision of the Agency for Medical, Biological and Extreme Problems at the Ministry of Health of the Russian Federation.

4. Hygienic assessment of any manufactures located in the Russian Federation will always include an assessment of labor conditions and hygienic requirements for environmental protection.

5. Hygienic assessment of manufactures located outside the Russian Federation and supplying products to the Russian Federation will be carried out by the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation.

6. A hygienic approval is issued to a specific manufacturing entity and indicates the type of product manufactured (or, in the case of foreign manufacturers, exported to the Russian Federation) and the nomenclature of products manufactured as at the time of the hygienic assessment.

7. Upon any change in or expansion of the nomenclature of products or the production process, the manufacturer must renegotiate its approval with the institution to have issued the original hygienic approval, without having to undergo another hygienic assessment. Following this, a hygienic approval of manufacture will be issued in accordance with Annex 3 to Order No. 217 of the Ministry of Health of the Russian Federation, dated July 20, 1998.

8. Hygienic assessment of manufactures includes:

- acceptance and registration of an application for hygienic assessment of manufacture;

- identification of the scope and cost of work, entry into a contract with the applicant for the performance of works of registration of the manufacture;

- examination of the documentation and product samples submitted;

- performance of a hygienic assessment of the applicant's manufacture;

- decision on the outcome of the hygienic assessment of the manufacture; and

- execution and issue of a hygienic approval and its entry into the Register of manufactures to have passed hygienic assessment.

9. Hygienic assessment of a manufacture will be conducted directly on the premises of the applicant.

10. For the purposes of hygienic assessment and issuance of a standard format approval, the applicant (legal or physical entities) must submit to an authority or agency of the State Sanitary and Epidemiological Service an application of a standard format together with the following documents:

- a brief description of the manufacture and technological processes, indicating (for manufactures of foreign products as well as manufactures located abroad) any regulatory requirements for product safety applicable in the country of manufacture as well as the nomenclature of manufactured products and any arrangements for laboratory monitoring;

- information as to whether a system for controlling the critical points of operations is implemented at the enterprise;

- regulatory or technical documentation for the products;

- any certificates, official approvals or other documents from the country of manufacture to confirm the safety of the products;

- any other documents of the manufacturer confirming that the manufacture conforms to hygienic requirements.

- the list of documents to be submitted is subject to adjustments and additions with regard to specific types of products as well as manufactures.

11. Documents issued in the country of manufacture or origin must be submitted to agencies of the State Sanitary and Epidemiological Service together with a duly certified Russian translation.

12. Products manufactured by a manufacturing factory to have passed hygienic assessment and included in the Register will not be subject to any further hygienic assessment.

13. The hygienic assessment of a manufacture located in the territory of the Russian Federation proceeds by reference to the following:

- whether the enterprise has the necessary conditions for the manufacture of such type and quantity of products;

- any possible adverse impact of the operations on the living conditions of the population;

- the labor conditions at the enterprise;

- the organization of production monitoring at the enterprise with respect to the quality of initial raw materials, the production process and the safety indicators of end products; and

- whether the available production facilities correspond to the production process.

14. In order to allow a specific corporate manufacturer to manufacture a certain type of product, it is necessary that the regulatory or technical documentation for the proposed nomenclature of products should be duly approved by the authorities and agencies of the State Sanitary and Epidemiological Service.

15. For the purposes of examination of a corporate manufacturer located outside the Russian Federation and supplying its products to the Russian Federation, the following must be assessed:

- whether the manufacturer has the necessary conditions for the manufacture of such type and quantity of products;

- the status of production monitoring with respect to the quality of initial raw materials, the production process and the safety indicators of end products; and

- whether the products are consistent with the requirements of the sanitary regulations and standards applicable in the Russian Federation.

16. A hygienic approval of a manufacture will be issued for a term up to five years. Such a term may be reduced following a breach of any of the conditions based on which the approval was issued.

 


  Annex 2

Approved by Order No. 217
of the Ministry of Health
of the Russian Federation,
dated July 20, 1998

 

List of Types of Products and Commodities Subject to Hygienic Assessment

  1. Alimentary raw materials, foodstuffs, food additives, biologically active additives, preservatives; materials and their derivatives contacting foodstuffs.
  2. Products for children: games and toys, clothes (including bed-linen), footwear, teaching aids, stationery, furniture, baby carriages, knapsacks, artificial polymer and synthetic materials used in the manufacturing of products for children.
  3. Materials, equipment and substances used in commercial and potable water supply practices.
  4. Perfumes, cosmetics, mouth care agents.
  5. Chemical and petrochemical products for industrial use, household chemicals.
  6. Polymer and synthetic materials intended for use in construction, transport and manufacture of furniture and other home-use articles; chemical threads and fibers, textile, sewed and knitted materials containing chemical fibers and textile auxiliary materials; artificial and synthetic leather and textile materials for footwear.
  7. Products of mechanical engineering and instrument-making of industrial, medicinal and home use designation.
  8. Printed products.
  9. Products derived from natural raw materials treated (painting, impregnation, ionizing radiation etc.) in the course of production.
  10. Materials for products in contact with human skin.
  11. Products and articles constituting a source of ionizing radiation, including generating radiation, as well as products and commodities containing radioactive substances.
  12. Building stock and materials in which the content of radioactive substances is restricted by hygienic standards, including industrial waste intended for recycling and use in business, as well as metal scrap.
  13. Mobile vehicles and products of transport designation.

 


  Annex 3

Approved by Order No. 217
of the Ministry of Health
of the Russian Federation,
dated July 20, 1998

 

 

___________________________________________________________________

(name and details of the institution)

 

 

Hygienic Approval of a Product/Commodity

No. _______________ dated _________________

 

Product: ________________________________________________________________

________________________________________________________________________

________________________________________________________________________

(name)

is hereby allowed for manufacture/supply/distribution/use in the Russian Federation (cross out as appropriate).

The developer of the regulatory documentation:

________________________________________________________________________

The manufacturer:

________________________________________________________________________

The recipient of the hygienic approval:

________________________________________________________________________

Regulatory and technological documentation:

________________________________________________________________________

Test Data:

________________________________________________________________________

(name of the institution that performed the testing)

________________________________________________________________________

Details of foreign-made product:

________________________________________________________________________

Hygienic Description of the Product

Substances,
indicators/factors
Hygienic standard (sanitary
regulations and standards,
maximum allowed level,
maximum allowed
concentration etc.)

Field of application: ___________________________________________________

The necessary conditions of use, storage and transportation and safety measures:

________________________________________________________________________

Label information:

________________________________________________________________________

This approval is valid until:

________________________________________________________________________

 

 

Chief State Sanitary Physician

(Deputy Chief State Sanitary Physician)

 

Name, signature:

__________________

 

 

Seal

 

 


  Annex 4

Approved by Order No. 217
of the Ministry of Health
of the Russian Federation,
dated July 20, 1998

 

Ministry of Health of the Russian Federation

Hygienic Approval of a Manufacture

dated ___________ 19____ No. ________

 

 

Issued to ________________________________________________________________

(name of the enterprise, shop or section)

 

 

Type(s) of products manufactured ____________________________________________

 

Product Nomenclature Number and name of the Regulatory or technical Document on the basis of which the product is manufactured Description of the Sanitary Standards and Regulations or other regulatory documents duly approved by the State Sanitary and Epidemiological Service, the product must conform to
     

Safety conditions and measures that must be observed in the production process:

________________________________________________________________________

________________________________________________________________________

Production control over product quality and safety will extend to:

________________________________________________________________________

This approval is valid until ____ ___________ 19___ .

This approval is issued by: __________________________________________________

(name of the institution of the state sanitary and epidemiological service)

 

Chief State Sanitary Physician

(Deputy Chief State Sanitary Physician)

 

Name, signature:

__________________

Seal

 

 


  Annex 5

Approved by Order No. 217
of the Ministry of Health
of the Russian Federation,
dated July 20, 1998

 

List of Socially Significant and Potentially Hazardous Products and Commodities Subject to Hygienic Assessment by the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation

 

1. Foodstuffs

1.1 specialized baby food products, including components for their production;

1.2 food additives (buffers, preservatives, stabilizers, leavening agents);

1.3 food products and alimentary feedstock made from new (unconventional) raw materials and produced using new processes;

1.4 products intended for therapeutic or preventive nutrition.

2. Products for children:

2.1 materials used in the manufacture of products for newborns and babies under one year old;

2.2 perfumes and cosmetics for children;

2.3 teaching aids, textbooks, didactic materials.

3. Dyes, finishing, felt-proofing and water-repelling materials, softeners.

4. Products for home-use:

4.1 reagents for potable water treatment;

4.2 household devices intended for after-treatment of potable water;

4.3 perfumes, cosmetics and mouth care agents containing biologically active components, essential oils, fragrance compounds, preservatives, pigments, sunscreen and fluorine-containing compounds, home-use skin protection substances; new and unconventional raw materials usable in perfumes, cosmetics and mouth care agents.

5. Products intended for industrial use:

5.1 personal protective agents, including ointments, pastes and creams usable in industry;

5.2 equipment and apparatus for collective protection, materials for the manufacture of ventilation systems; and

5.3 waste-incinerating furnaces and units.

6. Medical equipment, tools and hygienic agents:

6.1 physiotherapeutic, diagnostic and medical treatment equipment.

7. Products containing sources of ionizing radiation, including generating one, which are intended for full-scale production or new technology use. Industrial waste containing natural or artificial radio-nuclides which are used as building materials, fertilizers or otherwise.

8. Antenna feeder systems of radio transmitting stations, radar stations (including ones for space tracking), outdoor switch-gears for high and ultrahigh voltage substations, satellite telecommunications systems.

 


  Annex 6

Approved by Order No. 217
of the Ministry of Health
of the Russian Federation,
dated July 20, 1998

 

 

image of the Mark Certifying that the Product Has Passed Hygienic Assessment

 

Scale 1:1

Scale 4:1

Hologram size: 24 mm

 

 


Registered with the Ministry of Justice of the Russian Federation
on August 7, 1998 Registration No. 1587


1Gazette of the RSFSR Soviet of People's Deputies and Supreme Soviet, 1991, No 20, Art.641
2Collection of Russian Federation laws, 1996, No 3, Art.140
3Collection of Russian Federation laws, 1997, No 23, Art.2691