Decree of the Ministry of Environment No. 306 / 1998 Coll.
Ordinance of the Ministry of the Environment laying down a procedure for assessing the risk of hazardous chemicals to the environment
Valid
Order
Effective from 01.01.1999
Text versions:
01.01.1999
31.12.1998
306
DECLARATION
Ministry of Environment
of 10 December 1998
laying down a procedure for the environmental risk assessment of hazardous chemicals
According to § 9 (4) of Act No. 157 / 1998 Coll., on Chemicals and Chemical Products and on the amendment of certain other laws, hereinafter referred to as "the Act":
The purpose of the decree is to establish a procedure for assessing the ecological risk of substances which, by their nature, pose a serious risk to the environment; (1) the list of such substances is laid down in a separate Regulation (2).
For the purposes of this decree:
(a) the hazard of the substance and preparation within the meaning of Article 2 (8) (o) of the Act is determined by the physical, chemical and biological properties of the substance which are inseparably linked to the existence of the substance;
(b) the risk is determined by the probability that adverse effects may occur under defined exposure conditions;
(c) exposure of the substance to the external borders of the entity referred to in point 1 of Annex 1;
(d) the amount of the substance accepted by the body referred to in point 1 of Annex 1;
(e) a response to the extent of damage to the entity referred to in point 1 of Annex 1;
(f) an environmental risk assessment procedure that uses the synthesis of all available data according to current scientific knowledge to determine the type and degree of hazard posed by a substance, the extent to which they have been, are or may be exposed in the future to an individual environmental component and, finally, includes a characterisation of the risks arising from those findings.
(1) The environmental risk assessment shall be carried out in four successive steps:
(a) identification of hazards;
(b) evaluation of dose-response relationships;
(c) exposure assessment;
(d) risk characterisation.
(2) The environmental risk assessment shall be carried out in accordance with the procedure laid down in Annex 1 and on the basis of the data set out in Annex 2 provided by the manufacturer or importer of the substance or preparation. Methods for the detection of these data are laid down in a separate Regulation (3).
(3) The result of the environmental risk assessment referred to in Annex 1 shall be a determination of whether the environmental risk is present and what is the level of that risk.
(4) The results of the risk assessment are the basis for amending the list of substances and preparations issued under Section 15 (3) of the Act.
This Decree shall take effect on 1 January 1999.
Minister:
RNDr. Kužvart v. r.
Příloha č. 1
Annex No 1 to Decree No. 306 / 1998 Coll.
PROCEDURE FOR THE EVALUATION OF ECONOMIC RISK
1. The hazard shall be determined by one of the following entities:
(a) the population of the animal or plant species,
(b) the community of species and their interaction in individual environmental aspects;
(c) a model ecosystem consisting of several communities as referred to in (b);
(d) a multi-ecosystem model region as referred to in (c).
2. Evaluation of dose relationship - response is based on the assumption of threshold effect. The objective of the analysis is to find a concentration at which an adverse effect is not observed (NOEC) or, where appropriate, an effective concentration at which the effect is expressed in x% of the population under consideration (ECX). Both values are multiplied by uncertainty factors ("UFs') if the uncertainties associated with their estimation are quantifiable. These values are quantitative parameters for characterising environmental risk.
The first step in the exposure assessment is the estimation of the likely local concentration of the substance (PECL) in individual environmental components according to the following scheme:
| SYSTÉM | MÉDIUM |
|---|---|
| Vodní (aquatický) | povrchová voda |
| sediment | |
| Suchozemský (terrestrický) | půda |
| podzemní voda | |
| Ovzduší | vzduch |
3. Data obtained in the components shall be used to estimate PECL values
(a) emission inventories;
(b) monitoring results (air, water, soil, food chains);
(c) model calculations.
From the PECL values, regional concentrations of the substance (hereinafter referred to as PECR) are estimated to represent the distribution and fate of the substance after entry into the environment. It is based on the assumption of steady-state concentrations of the substance in each component and on the balance of the mass transfer between them. The PECL and PECR values are multiplied by the UF values if the uncertainty associated with their estimation is quantifiable.
4. The characterisation of environmental risk consists of quantitative parameters and qualitative discussion of inaccuracies and uncertainties associated with their determination or estimation. The following ratios of values described in points 2 and 3 are the basis of quantitative characterisation.
The following situations shall be distinguished provided that the uncertainty factors are of the same order:
(a) PECL / NOEC and PECR / NOEC ratios or PECL / ECX and PECR / ECX ratios are equal to or less than 1; this situation justifies the conclusion that further information on the substance, its further tests and any risk reduction measures are not necessary;
(b) PECL / NOEC and PECR / NOEC ratios or PECL / ECX and PECR / ECX ratios are greater than 1; this situation justifies the conclusion that additional information on the substance, its further tests and any risk reduction measures are needed.
5. The quantitative part of the risk characterisation referred to in point 4 shall complement the description of the inaccuracies and uncertainties in the steps referred to in points 1 to 3.
6. If the uncertainty factors are different in order, repeat the steps referred to in points 2 and 3.
Příloha č. 2
Annex No 2 to Decree No. 306 / 1998 Coll.
DATA REQUIREMENTS FOR THE EVALUATION OF ECONOMIC RISK
GENERAL INFORMATION
1.1. Name of the compound corresponding to IUPAC nomenclature
1.2. EINECS No
CAS number
1.4 Synonyms
1.5. Purity
1.6. Impurities
Total formula
1.8. Structural formula
1.9 Responsibility to group substances
1.10 Country
1.11 Identification of the data author
1.12. Quantity of substance (produced or imported) if more than 1000 tonnes per year
1.13. Information if the substance has been manufactured or imported in the last 12 months
1.14 Classification and labelling
1.15. Methods of use
1.16. Has the full data already been submitted by another manufacturer (importer)?
1.17 Other information (e.g. disposal options)
2. PHYSICAL-CHEMICAL PROPERTIES
2.1. Melting point
2.2. Boiling point
2.3 Density
2.4. Saturation vapour pressure
2.5 Distribution coefficient n-octanol / water (log POW)
2.6 Solubility in water
2.7 Flash point
2.8 Flammability
2.9 Explosivity
2.10 Oxidation properties
2.11 Other information
3. PERSONS AND TRANSPORT OF SUBSTANCES IN THE ENVIRONMENT
3.1 Stability
3.1.1. Photodegradation
3.1.2. Water stability
3.1.3. Soil stability
3.2 Environmental monitoring data
3.3 Distribution in exposed environmental components (including estimated concentrations in environmental components and transport routes)
3.4 Biodegradation
3.5 Bioaccumulation
3.6 Other information
4. ECOTOXICITY
4.1 Toxicity to fish
4.2 Toxicity to Daphne and other aquatic invertebrates
4.3 Toxicity to algae
4.4 Toxicity to bacteria
4.5 Toxicity to terrestrial organisms
4.6 Toxicity to soil organisms
1) Paragraph 2 (8) (o) of Act No. 157 / 1998 Coll., on Chemicals and Chemicals and on the amendment of certain other laws.
2) Article 9 (1) of Act No. 157 / 1998 Coll.
3) Decree No. 299 / 1998 Coll., laying down methods for the detection of the physico-chemical and chemical properties of chemicals and chemical products and properties of chemicals and chemical products hazardous to the environment.
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Regulation Information
| Citation | Decree No. 306 / 1998 Coll., laying down a procedure for assessing the risk of hazardous chemicals to the environment |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.1998 |
|---|---|
| Effective from | 01.01.1999 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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