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

3. Substance assessment
Assessment of hazardousness of substances involves the following two main steps:
1. The data collection on the hazards of a substance, and
2. the comparison of data with criteria to decide, whether an environmental quality
standard (MPC) is needed. There are official methodological guidelines available
to decide, and if the criteria are met to establish MPC, this can be done by applying
an “express method”, a temporary norm can be established, or it can be decided
that a full scale assessment is required.
The assessment can be performed by any accredited organisation having access to accredited
laboratories. Assessments are performed separately for toxicological properties
(hygienic assessment described in Chapter 3.1) and for ecotoxicological properties (as
described in Chapter 3.2).
After a substance assessment is completed, the dossier is given to competent authorities
for evaluation and establishing MPCs:
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for hygienic assessments, RosPotrebNadzpor is in charge
For fishery water assessments, the Federal Fishery Agency with approval of the
Ministry of Natural Resources and Ecology is responsible.
3.1. Toxicological assessment
The assessment of toxicological properties of substances for registration is done according
to the provisions of the Hygienic Regulation GN 1.1701-98 “Hygienic criteria for
rating the necessity for setting up MPCs and TSELs/ODU of harmful substances in the
occupational air, the ambient air of residential areas and the water of water bodies hygienic
norms”, adopted in 1998. The substance assessment focuses on the hazardous
properties of substances from the viewpoint of human health.
The scope of the assessment depends on the substance’s physico-chemical properties,
the level of toxicity to humans and other organisms, the production volume, the
amount of people potentially being exposed, economic priority or importance7, presence/concentrations
in different environmental compartments, stability and other parameters
which may have relevance for defining impacts on human health. There are
four stages involved in making decision:
7 If there is economic pressure to use the substance, it is assessed if it is possible to assign
MPC by express methods or to assign a temporary norm.
18 | The Russian System of Chemicals Management