|
Sanitary-Epidemiological Conclusion (Hygiene Certificate)
 Ordering
The so-called sanitary values compose a separate group of merchandise safety indicators. These values are typical for food products, preservation agents, materials (and derivatives thereof) which come in contact with food products, perfumes and cosmetics, textiles, sewing and knitted materials containing chemical fibers, some types of engineering products, and other types of industrial products. If the quality of the mechandise is defined by the sanitary values, obtaining a hygiene certificate is part of the product certification.
The Sanitary-Epidemiological Conclusion is issued by the Sanitary-Epidemiological Service of the Russian Federation bodies when arranging normative documents and starting production of goods or execution of contracts for offshore purchases. An appropriate examination is carried out, factors of production are considered, and a protocol of tests is issued. The results of the hygienic assessment of the goods and the results of the examination of the standards and normative documents on the goods, their production and usage are the basis for issuing the sanitary-epidemiological conclusion. For imported goods, the estimate of the supplier country' safety certificate and the results of product examination performed in Russia is such basis. The issue of the sanitary-epidemiological conclusion is prescribed by the Federal Law of 30.03.1999 ¹ 52-FL "On Sanitary and Epidemiological Welfare of the Population". The list of goods which are subjects to expertise is specified in the Federal Supervision Agency for Customer Protection and Human Welfare Order of 21.11.2005 ¹ 776 "On Sanitary-Epidemiological Expertise of Types of Activity, Products and Project Documentation".
What products are subjects to hygieniñ assessment?
In accordance with the Federal Law of 30.03.1999 ¹ 52-FL «On Sanitary and Epidemiological Welfare of the Population»(as amended of 31.12.2005), the Law of 27.12.2002 ¹ 184-FZ «On Technical Regulating», the «Consumer Protection Law» (articles 1, 2.7), «Technical and industrial goods whose production, transportation, storage, usage and utilisation require manned operation, as well as products intended for personal and domestic needs (hereinafter referred to as products) should not be harmful to man and environment. Product characteristics should meet sanitary requirements».
The procedure of product examination and issuance of the conclusionYou file an application for the sanitary-epidemiological assessment and provide the documents depending on the origin of the products.
1. Imported products
The recipient should submit the following documents:
- application with the applicant firm's seal;
- copy of the contract;
- copy of the specification or appendix to the contract;
- the product description;
- copies of the quality management certificate (ISO), safety certificate, hygienic certificates, the producer country's certificate of origin (if possible);
- copy of the certificate of registration;
- copy of the tax registration certificate;
- copy of the certificate of record in the uniform state register;
- copy of the Mosgorkomstat certificate.
Sanitary-epidemiological conclusion validity period is 5 years. Copies of all documents should be authenticated with the applicant firm's seal. Documents of the producer country (supplier country) should be submitted along with their translation into Russian verified in the prescribed manner. The manufacturer should submit the following documents:
- application with the applicant firm's seal;
- short description of the products and their production;
- copies of the certificates (ISO, for instance), licences, or other documents of the producer country, confirming the product safety (if possible).
The remaining documents needed for the obtaining of the sanitary-epidemiological conclusion for the foreign manufacturer are discussed with each client individually. Sanitary-epidemiological conclusion validity period is 5 years. Copies of all documents should be authenticated with the applicant firm's seal. Documents of the producer country (supplier country) should be submitted along with their translation into Russian verified in the prescribed manner. 2. Domestic products
The recipient should submit the following documents:
- application with the applicant firm's seal;
- copies of the normative or technical documents on the products (technical conditions, technology regulations, etc);
- the description of the product, makeup, technical characteristics, pictures, equipment drawings;
- copy of the sanitary-epidemiological conclusion on the production;
- copy of the conclusion on the production.
Sanitary-epidemiological conclusion validity period is 5 years. Copies of all documents should be authenticated with the applicant firm's seal. The manufacturer should submit the following documents:
- application with the applicant firm's seal;
- copy of the sanitary-epidemiological conclusion on the production;
- copy of the examination of the production;
- copies of the normative or technical documents on the products (technical conditions, technology regulations, etc);
- copy of the certificate of registration;
- copy of the rental contract for the premises used for the production;
- copy of the technical conditions.
Sanitary-epidemiological conclusion validity period is 5 years. Copies of all documents should be authenticated with the applicant firm's seal. The list of documents can be specified and enlarged depending on the actual type of goods and the manufacturer. In addition, in some cases the following documents should be submitted:
For domestic products:
- technical passport (operation manual or user's guide);
- process regulations or technology regulations or other documents describing the production technology;
- other documents confirming the product safety (certificates of conformity, hygiene certificates on raw materials and supplies).
For imported products:
- Safety certificate of the producer country (for products of organic and inorganic chemistry, household cleaning products, paint materials, products of organic and inorganic synthesis, perfumes and cosmetics, oral hygiene preparations);
Documents of the producer country should be submitted to the State Sanitary-Epidemiological Service bodies along with their translations into Russian, verified in the prescribed manner.
Certification of production realised under the condition that it has the hygiene certificate is possible only if the product has the hygiene certificate.
Hygiene certificate validity period is 5 years.
The drawing up of the sanitary-epidemiological conclusion has the following peculiarity: products which are subject to testing are listed in Appendixes 2 and 3 of the Order MZ of 15.08.2001 ¹ 325, but, due to imprecise wording, it is not always clear if the products are subject to health-inspection or testing or not. Ordering
|
|
