Decree of the Ministry of Health No. 184 / 1999 Coll.
Decree of the Ministry of Health laying down a procedure for assessing the risk of hazardous chemicals to human health
Valid
Order
Effective from 24.08.1999
Text versions:
24.08.1999
184
DECLARATION
Ministry of Health
of 12 August 1999
laying down a procedure for assessing the risk of hazardous chemicals to human health
The Ministry of Health (hereinafter referred to as "the Ministry ') provides, pursuant to § 9 (3) of Act No. 157 / 1998 Coll., on Chemicals and Chemical Products and amending certain other acts (hereinafter referred to as" the Act'):
Subject matter
This Decree establishes a procedure for assessing the risk to human health of hazardous chemicals (hereinafter referred to as "the substance ') in accordance with the list provided for in the Specific Regulation (1) or registered under § 6 to 8 of the Act.
For the purposes of this decree:
(a) the hazards of the substance, one or more of the physico- or chemically identified hazardous properties of the substance (2), inextricably linked to its existence;
(b) the risk to human health of the likelihood that, under defined exposure conditions, the adverse effect of a substance on human health may occur due to one of its inseparable properties;
(c) the amount or concentration of the substance exposed to the human organism;
(d) exposure of the substance to the external borders of the human organism;
(e) an assessment of the exposure to the determination of the emission, route and rate of movement of the substance and its transformation or degradation to estimate the dose or concentration of the substance exposed to man;
(f) a response to the extent of the substance's exposure to the human organism;
(g) a risk characterisation estimate of the occurrence and severity of adverse effects that may occur in the human population due to actual or anticipated exposure to the substance; may include a "risk estimation ', i.e. quantification of this probability;
(h) recommendations to reduce the risk of proposing measures which may reduce the risks associated with the placing on the market of a substance (e.g. modification of the classification, packaging or labelling of a substance, modification of the safety data sheet, modification of health measures in the management of a substance, in accidents or in poisoning).
Risk assessment
(1) The assessment of the risk to human health includes four successive steps:
(a) the determination of the hazard of the substance;
(b) an assessment of the relationship between dose and response;
(c) an exposure assessment for each group of persons (i.e. workers, consumers and people exposed indirectly to the environment) for which such exposure can reasonably be expected due to available information on the substance (hereinafter referred to as the exposed group);
(d) risk characterisation;
(e) conclusions.
(2) The risk assessment of substances registered under Sections 6 to 8 of the Act is carried out on the basis of basic or, where appropriate, supplementary data submitted by the importer or the manufacturer of the substance. When assessing the risk of these substances, the properties that have not been tested shall not be taken into account.
(3) The conclusions of the risk assessment shall be expressed as one of the following options:
(a) the substance does not present a significant health risk for the exposed group of persons, no further information on the substance and its further testing is needed;
(b) the substance presents a potential health risk. However, there is insufficient information for a final risk assessment. The risk assessment shall be continued on the basis of further information if the amount of substance placed on the market reaches an additional limit quantity; 3)
(c) the substance presents a health risk to the exposed group of persons. Further information or further tests shall be necessary for the final evaluation;
(d) the substance presents a significant risk to the exposed group of persons and the Ministry recommends the Ministry of the Environment to implement risk reduction measures in accordance with Section 15 (3) of the Act.
(4) Where the substance is subject to the conclusions referred to in paragraph 3 (a), (b) and (c), the conclusions referred to in paragraph 3 (b) shall apply. (c) or (d), the Ministry shall inform the manufacturer or importer of its conclusions and give him the opportunity to submit comments on those conclusions and provide additional information.
(5) The procedure for assessing the risk of a substance to human health is set out in the Annex.
This decree shall take effect on the day of its publication.
Minister:
Dr. David, CSc.
Annex to Decree No. 184 / 1999 Coll.
Procedure for assessing the risk of substances to human health
1. In determining the hazard of the substance, account shall be taken of whether the substance is explosive, flammable, oxidising, acutely toxic, irritating, corrosive, sensitising, repeated dose toxic, mutagenic, carcinogenic or toxic for reproduction. Information on the hazardous properties of the substance is obtained by the established methods.4)
2. When assessing the dose-response relationship in patients treated with
(a) substances toxic at repeated doses and toxic for reproduction are determined by the highest dose at which no statistically significant adverse response of the test animal organism is observed compared to the control group (NOAEL). If NOAEL cannot be determined, the lowest dose at which a statistically significant adverse response of the test animal organism is already observed as a result of the toxic effects of the substance compared to the control group (LOAEL) shall be determined. By dividing the NOAEL (LOAEL) value by the uncertainty factor (UF) and the modifying factor (MF), the reference dose (RfD) is calculated, i.e. the daily dose at which the adverse effect of the substance on human health is unlikely to occur at a lifetime exposure level. UF and MF quantify uncertainties associated with the estimation of the quantities used and determined.
In the case of substances with cumulative effect, it is preferable to use for further evaluation instead of RfD the value of the tolerated intake ("TI '), i.e. a weekly dose at which the adverse effect of the substance on human health is unlikely to occur at a lifetime exposure. TI shall be calculated mutatis mutandis as RfD;
(b) carcinogenic substances are expected to have an adverse effect on health at any dose (threshold-free effect). The basic step in assessing the relationship between dose and effect is the design of an appropriate model to extrapolate the likelihood of tumour development from doses used in experimental studies or found in epidemiological studies towards zero dose. The factor of the directive (CSF) expresses the ability of the substance to cause cancer;
(c) acutely toxic substances for which the NOAEL (LOAEL) value cannot be determined on the basis of the tests carried out by the established methodium4) shall only be determined whether, at the detection of LD50, LC50 or a discriminatory dose, it may cause acute poisoning;
(d) substances corrosive, irritating and sensitising shall only be determined whether and how the substance can adversely affect the skin, eyes and mucous membranes;
(e) substances exploding, flammable and oxidising the relationship between dose and effect shall not be evaluated.
3. The exposure assessment shall be carried out for each group of persons (workers, consumers, people exposed indirectly through the environment) for which exposure may be expected to occur. The evaluation shall be based on the information contained in the supporting documents submitted during the registration of the substance (5) and other appropriate and available information. Particular consideration should be given to the results of exposure measurements, the quantity of the substance on the market, the form in which the substance is placed on the market or used (e.g. substance itself, product ingredient), the purpose and method of use, the production data (if relevant), the physico-chemical properties of the substance, the likely routes of exposure and the bioavailability of the substance, the frequency and duration of exposure, the type and size of the specifically exposed population group. Where a substance is placed on the market as part of a preparation, exposure to that substance shall be considered only if the product is classified as hazardous on the basis of its properties.
The aim of the exposure assessment is to make a quantitative or qualitative estimate of the dose or concentration that the population is or may be exposed to. The estimate of the daily dose offered (hereinafter referred to as "I ') can be calculated as the product of the average concentration of the substance in a particular environmental component, the rate of contact of persons with the contaminated environmental component (hereinafter referred to as" CR'), the frequency of exposure (hereinafter referred to as "EF ') and the duration of exposure (hereinafter referred to as" ED') divided by the product of the average body weight of exposed persons (hereinafter referred to as "BW ') and the period during which the average concentration of the substance is considered to be constant (hereinafter referred to as" AT'). For EF, ED, BW and AT variables, data from literature, C and CR are usually obtained by direct measurement.
4. The risk characterisation of substances with known NOAEL (LOAEL) may be performed on the basis of the hazard index (HI) established by proportion I and RfD (TI). If the HI value is less than 1, the conclusion in accordance with § 3 (3) (a) is justified. Where the HI value is equal to or greater than 1, the conclusion referred to in Article 3 (3) (b), (c) or (d) shall be justified taking into account the quality of the information used and the degree of uncertainty and inaccuracy of the estimates made.
In order to characterise the risk of carcinogenic substances, it is first necessary to calculate the lifetime average exposure daily dose (LADD) as the product of the average concentration of the substance in a particular environmental component, the rate of contact of persons with the contaminated environmental component (CR), the frequency of exposure (EF) and the duration of exposure (ED) divided by the product of the average body weight of exposed persons (BW) and the expected life expectancy of the average person in the population (AT). For EF, ED, BW and AT variables, data from literature, C and CR are usually obtained by direct measurement. The risk of a carcinogenic effect of a substance is then measured by the increase in the lifetime probability of tumour development above the general mean (CVRC) of the relationship 1 minus e (CSFxLADD). If the CVRC is less than 10- 6 for a population exposed outside the working environment or less than 10-4 for groups of persons exposed in the working environment, the conclusion referred to in Article 3 (3) (a) shall be justified. Where the CVRC value is equal to or greater than 10- 6 for a population exposed outside the working environment or equal to or greater than 10-4 for groups of persons exposed in the working environment, the conclusion referred to in Article 3 (3) (b), (c) or (d) shall be justified taking into account the quality of the information used and the degree of uncertainty and inaccuracy of the estimates made.
The characterisation of the risk of substances with other dangerous properties is based on an assessment of the likelihood of adverse effects on human health under the foreseeable conditions. In the case of explosive, flammable and oxidising substances, the conclusion referred to in Article 3 (3) (a) shall normally apply if the assessment indicates that the adverse effect will not occur and usually the conclusion referred to in Article 3 (3) (d), if the assessment indicates that the adverse effect will occur.
5. In deciding which of the four conclusions referred to in Article 3 (3) shall apply, account shall be taken in particular of the uncertainties arising from the inaccuracies of the estimates made, the dispersion of experimental data and differences between species, the nature and severity of the effect and the nature of the population groups covered by qualitative or quantitative exposure information.
1) Article 9 (1) of Act No. 157 / 1998 Coll., on Chemicals and Chemicals and on the amendment of certain other laws.
2) Paragraph 2 (8) (a) to (o) of Act No. 157 / 1998 Coll.
3) Paragraph 8 (2) to (4) of Act No. 157 / 1998 Coll.
4) For example, Decree No 251 / 1998 Coll., laying down methods for the detection of toxicity of chemicals and preparations, Decree No 316 / 1998 Coll., establishing a method for the detection of explosives of chemicals and chemical products.
5) Decree No. 250 / 1998 Coll., on the Registration of Chemicals.
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree No. 184 / 1999 Coll., laying down a procedure for assessing the risk of hazardous chemicals to human health |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 24.08.1999 |
|---|---|
| Effective from | 24.08.1999 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0