CERTIFICATE
On the STATE REGISTRATION of BIOLOGICALLY ACTIVE ADDITIVES To FOOD
ROSPOTREBNADZOR (Consumers' Control) of the Ministry of Health of
the Russian Federation
Biologically active additives
to food under the Russian legislation demand before their import
on territory of Russia of necessarily check and by its results of
reception the CERTIFICATE On STATE REGISTRATION of Rosportebnadzor
(Federal service on supervision in sphere of protection of the rights
of consumers and well-being of the population) of the Russian Federation.
The list of necessary documents for reception
of the Certificate on the state registration of biologically active
additives to food of Rospotrebnadzor of Ministry of Health of the
Russian Federation.
1. The power of attorney of firm-applicant in
the established form that manufacturer of these additives trusts
the legal person to represent the interests to Russia on registration
and to certification of production.
2. Documents of the authorized bodies of the
country-manufacturer confirming, that given production is carried
to the additives (foodstuff) or is not a medical product, and also
confirming, that it is resolved to manufacture and sale.
3. The document; Confirming, that manufacture of given production
is carried out according to national and-or international requirements
for additives to food concerning the organization of manufacture.
4. Full ingredients' structure BAA.
5. Brief data on the "know-how", the standard
of the organization on release of these additives.
6. The explanatory note containing a scientific
substantiation of composite structure BAA, scientifically proved
recommendations on application with the instruction of duration
of reception and accepted quantities , contra-indications, restriction
on application at their presence; materials (original and literary
for analogues) for hygienic and biological estimation of them and
its clinical efficiency, reports or the certified copies of results
of clinical tests in comparison with control group with the instruction
of the establishment spent these tests.
7. For additives, containing: -
- Alive microorganisms, the sort and a kind of a microorganism,
a stamm designation, data on registration (the passport, the information,
etc.) is underlined in latin language; - GMO- the declaration on
use or absence of genetically modified organisms;
- Parts of plants - the botanical name in latin language, the form
and a way of preparation (an example is underlined: an extract -
1:4, mixture - 1-10, etc.);
- intended for sportsmen, for escalating muscular weight of a body,
for persons with the raised physical activities, representation
from manufacturer of the document confirming absence in its structure
of substances and components, относимых to dopes is necessary.
8. A consumer label or its project, certified by the manufacturer,
and also the sample of the original label issued in the country-manufacturer.
9. Reports of researches, tests (at their presence).
10. Samples of additives, in the quantity necessary
for carrying out of sanitary-and-epidemiologic examination; in case
of carrying out of toxicological or clinical tests the quantity
of necessary samples is defined in addition.
11. The certificate of sampling of the established
form in which date and a place of sampling, their quantity, the
name of production, the address of the location of the legal person
of manufacturer, date of manufacture is underlined, surnames, posts
and signatures of the persons, selected samples. All documents of the country-manufacturer are represented in
the original with translation into Russian, certified when due hereunder
Prices & terms of formalizing the The CERTIFICATE
On the STATE REGISTRATION DISINFECTANT, DESINSECTION And DERATISATION
MEANS depends on particular characteristics of product itself, other
certificates and details of lab tests.
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