BUD Registration
Certificate on state registration of biologically active additives (BUDS) and food additives (PD) gives out organ of Federal Agency of supervision in sphere of protection of rights of consumers and well-being of a person of Russian Federation (ROSPOTREBNADZOR). It certifies BUD'S and PD conformity to state sanitary - epidemiological rules and specifications.
Experts of the Center of Certification "Standards-group" will help to legalise papers and will assist the prompt registration of biologically active and food additives in ROSPOTREBNADZOR.
BUD'S certification in GOST P system, and also reception of a sanitary-and-epidemiologic conclusion is not obligatory.
Period of validity of the Certificate on BUD'S state registration is established for all term of industrial manufacturing of Russian production or import deliveries.
List of documents necessary for BUD registration to food of home production:
1. demand (demand sample) established sample;
2. certificate of the organisation-applicant and manufacturer of BUD about statement on tax account, bringing into a uniform state structure.
3. Standard or engineering specifications (THAT, TI, compoundi ng), coordinated in the established order;
4. Sanitary-and-epidemiologic conclusion on the BUD manufacture which has been given out by Center of GOSSANEPIDNADZOR in subject of Russian Federation (in a place of its manufacture);
5. A consumer label or its project, confirmed manufacturers and containing information according to SanPiN 2.3.2.1290-03;
6. An explanatory note containing scientific substantiation of composite BUD structure , scientifically well-founded recommendations about application with instructions of duration of reception and accepted BUD quantities, contra-indications, restriction on BUD application at their presence; materials (original and literary for analogues) by a toksikologo-hygienic both biological BUD estimation and its clinical efficiency, reports or certified copies of results of clinical tests in comparison with control group with instructions of the establishment conducting these tests;
7. For BUD, containing:
Live microorganisms, sort and a species of microorganism, a designation stamm is underlined in Latin language, presence of patent certifying deposition in VKPMNII of genetics in a collection of microorganisms of Institute of physiology of biochemistry of microorganisms of Russian Academy of Sciences, way of manufacture of used culture (TU № ... or Pharma article) should be specified;
1. GMI - declaration on use or absence in BUD compounding components received from genetically modified sources;
Parts of plants, botanical name in Latin language, form and way of preparation (example: an extract - 1:4, an infusion - 1-10, etc.);
Intended for sportsmen, for escalating of muscular weight of a body, for persons with raised physical activities, from the BUD’s manufacturer representation of document confirming absence in its structure of substances and components, carried to dopes is necessary.
8. Reports of researches, tests (if present);
9. BUD samples, in quantity necessary for carrying out sanitary - epidemiological examination; in case of carrying out toxicological or clinical tests quantity of necessary samples is defined additionally;
10. Act of selecting samples of established form in which date and sampling place, their quantity, production name, address of location of the legal person of manufacturer, date of BUD manufacture, surnames, posts and signatures of persons, chosen samples are specified;
11. Document on right of reception of sanitary - epidemiological conclusion to BUD (letter of attorney, order, constituent contract, etc.);
List of the documents necessary for BUD registration of foreign manufacture:
1. Demand.
2. Certificate of sampling of the established form (date, sampling place, their quantity, production name, legal address of the enterprise of manufacturer, date of BUD manufacture, surnames, posts and signatures of persons, selecting samples).
3. Letter of attorney on registration BUD works with specifying addressee of the registration certificate both its owner and right to sign contract.
4. Certificates of quality and safety of firm of the manufacturer, containing data on safety indicators, ingredient structure and its characteristic, working lives, storage conditions.
5. For BUD, containing parts of plants, its biological name and form (an extract, infusion, etc.) is underlined in Latin language .
6. Documents of officially authorised body of the country-exporter, confirming safety of given production and its efficiency, document on registration in the country of the manufacturer.
7. Short data on "know-how", enterprise standard on BUD release.
8. Explanatory note, describing BUD, areas of its application, recommendation about application, contra-indications, restrictions on BUD application if present.
9. Project of a consumer label.
10. Data for instruction.
11. Materials (original and literary for analogues) by a toksikologo-hygienic both biological estimation of BUD and its clinical efficiency, reports or certified copies of results of clinical researches in which establishments conducting these tests, scheme of carrying out tests and results in comparison with control group are specified.
12. Hygienic certificate in which it is underlined that manufacture of the given production is carried out according to national and-or international requirements, for BUD to food (requirements GMP-Good manufacture practice, to standards of the International organisation of standardization - ISO 9000, 9001, 9002); or Certificate of national and-or international ("EuroNett") organisations about conformity of the manufacturer to requirements specified above. ISO may be presented in a form of special signs on firm forms.
14. Certificate on registration of firm (by registration chamber).
All materials are given in original and (or) copies assured notarially and in translation into Russian, assured in established order.
*Samples not less than 6 pieces in consumer packing (volume of presented samples should be sufficient for carrying out laboratory researches)
*For preparations of vegetative origin in addition one more sample (not less 100g) for radiological research.
15. Documents of authorised organs of the country-manufacturer confirming that given production is classified as BUD (foodstuff) or is not a medical product, and also confirming that it is resolved to manufacture and sale (certificate of free sale) (obligatory legalisation of documents is required).
16. GMI-declaration from the manufacturer about use or absence in BUD compounding of components received from genetically modified sources; and also about absence of psychotropic, narcotic, strong substances.
In course of BUD's and PD registration a hygienic examination is being carried out which includes:
- Examination of the accompanying documentation;
- Carrying out of sanitary-chemical, biological and other kinds of researches;
- Estimation of results of researches;
- Delivery of the certificate on state registration.
We recommend to acquaintance:
- Federal law from March, 30th, 1999 N 52-FZ "About sanitary-and-epidemiologic well-being of population" (with changes from December, 30th, 2001, on January, 10th, on June, 30th, 2003, on August, 22nd, 2004, on May, 9th, on December, 31st, 2005, 18, 29, on December, 30th, 2006, on June, 26th, on November, 8th, on December, 1st, 2007)
- Order of the Ministry of Health of Russian Federation from April, 15th, 1997 N 117 "About order of examination and hygienic certification of biologically active food additives"
- Decision of the Main state health officer of Russian Federation from September, 15th, 1997 N 21 "About state registration of biologically active food additives "
- Information letter of the Moscow western customs from November, 15th, 1999 N I-126 "About customs registration of food and biologically active food additives "
- Decisions of the Main state health officer of Russian Federation from April, 17th, 2003 N 50 "About introduction in action of sanitary-and-epidemiologic rules and SanPiN specifications 2.3.2.1290-03"
- Decision of the Main state health officer of Russian Federation from August, 15th, 2003 N 146 "About sanitary-and-epidemiologic examination of biologically active additives"
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