The Russian system of chemicals management - Bef-de.org

4.3. Registration and classification of mixtures
According to the Federal Law of March 30, 1999 No. 52-FЗ “On sanitary and epidemiological
welfare of the population” the specific types of products for which registration is
obligatory, are materials, equipment, appliances and other technical facilities for purification
of water, intended for use in water supply systems for industrial and household
needs, disinfecting, disinsection and deratization chemicals used in household, medical
treatment and prophylactic institutions and other facilities to ensure safety and health of
people Household chemicals.
The Government Regulation of April 4, 2001 N. 262 “On state registration for specific types
of products posing potential threats to human health, аs well as specific types of products imported
in the territory of Russian Federation for the first time” further specifies the above list.
The registration of mixtures (products) is performed by regional departments of RosPotrebNadzor.
Chemical products which are subject to registration must have a sanitarytechnical
assessment of the production, the use and the disposal. Based on this assessment,
the Public Health Protection Service issues a hygienic certificate for a product.
The assessment procedure performed for a mixture is based on its components is similar
to the substance registration:
>> Literature search: hygienic norms, data on homological rows of organic substances,
norms of other countries, toxicological parameters, predicted or calculated
concentrations for the substances in the mixture as well as the mixture as such
>> The need for further assessment depends on the purpose of the assessment, e.g.
if a mixture with known ingredients and known toxicity is assessed in order to establish
a new purpose of use– no tests are carried out.
>> If there is suspicion that a mixture contains unevealed components or additive / synergetic
toxicological effects could be presumed – tests are conducted to obtain data.
The stage of testing is relatively simple (express techniques are applied to test mixtures)
and is taking into account the economic feasibility (including amount of product produced):
certain limit tests are carried out, e.g. test on integrated toxicity with daphnia.
A risk based approach is implemented in elaborating the testing plan for a product: the
extent of testing depends on the knowledge about the properties of its components. If a 1 st
class substance is used in a mixture as raw material during industrial production, the conditions
of the whole mixture shall be classified as 1 st class of hazardousness. No calculation
method is applied as Russian toxicologists consider that a living organism’s response
to exposure from that mixture would not be linear, and the concentration of the substances
would not allow predicting the effects. Indeed, normally it is confirmed that effects from
exposure to mixtures substantially differ from effects of the most hazardous component.
If there is suspicion that special health effects can occur (carcinogens, etc.) and the
product has large production volumes, further specific tests are carried out, e.g. Ames
test on mutagenicity or tests on carcinogenic properties, etc.
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