Decree No. 427 / 2004 Coll.
Ordinance laying down detailed conditions for the assessment of the risk of chemicals to human health
Valid
Order
Effective from 01.08.2004
Text versions:
01.08.2004
21.07.2004
427
DECLARATION
of 2 July 2004
laying down detailed conditions for the assessment of the risk of chemicals to human health
According to Articles 24 (6) and 25 (6) of Act No 356 / 2003 Coll., on Chemicals and Chemical Products and on the amendment of certain laws, hereinafter referred to as "the Act ', the Ministry of Health provides:
Subject matter
This decree sets out, in accordance with the law of the European Communities (1), the procedure for assessing the risk of chemicals (hereinafter referred to as "substances') to human health for substances registered at the time of registration under Sections 12 and 13 of the Act (hereinafter referred to as" new substances') and chemicals listed in the national list of priority substances under Section 29 of the Act (hereinafter referred to as "priority substances').
Basic concepts
For the purposes of this decree:
(a) the risk of a substance to human health - the likelihood that, under defined conditions of exposure to a substance, its adverse effect on human health will occur due to one of its inseparable properties;
(b) identification of the hazard of the substance - identification of potential adverse effects of the substance,
(c) evaluation or assessment of the dose-response relationship - determination of the relationship between the dose of the substance and the expression and intensity of response or effect;
(d) evaluation or assessment of exposure - determination of emissions, pathways and rates of movement of the substance and its transformation or degradation to estimate the concentrations or doses to which groups of persons are or may be exposed;
(e) risk characterisation - an estimate of the occurrence and intensity of adverse effects of a substance that may occur in the human population as a result of actual or anticipated exposure to the substance and may include an estimate or risk assessment, that is to say a quantification of this probability;
(f) recommendations for risk reduction - recommendations for measures that may reduce the risks to humans associated with placing the substance on the market.
Principles for assessing the risk of substances
(1) Data provided for the registration of a substance under § 12 or § 13 and additional information under § 24 (3) of the Act are used to assess the risk of a new substance. Data notified under Section 28 of the Act and additional information under Section 25 (3) of the Act are used to assess the risk of a priority substance.
(2) Information supporting the risk assessment of new substances for human health shall be documented, including:
(a) identification of the hazard of the substance;
(b) assessment of the relationship between dose (concentration) and response (effect),
(c) an estimate of the exposure of persons in the working process, consumers and persons exposed indirectly through the environment (hereinafter referred to as the "exposed group of persons") for whom such exposure can reasonably be expected due to available information on the substance, in particular with regard to its production, storage, processing, use and disposal; or
(d) risk characterisation.
(3) The risk assessment of a new substance may result in one or more of the following conclusions:
(a) the substance is not of immediate interest and is not to be further evaluated until further relevant information on its effects in compliance with the provisions of the law is obtained;
(b) the substance is of interest, it presents a potential health risk to exposed groups of persons. The Ministry of Health (hereinafter referred to as "the Ministry ') shall determine, in accordance with Articles 12 (2) and 13 (2) to (4) of the Act, what additional information must be provided until the limit quantity of the substance placed on the market has been reached,
(c) the substance is of interest, presents a health risk to the exposed group of persons and further information is required by the Ministry immediately; or
(d) the substance is of interest, presents a significant health risk to the exposed group of persons, and the Ministry will immediately develop recommendations for risk reduction.
(4) Recommendations to reduce the risk of a new substance may include:
(a) modifications to the classification, packaging or labelling proposed in the framework of the registration of a substance pursuant to Article 12 or Article 13 of the Act;
(b) modifications to the safety data sheet proposed in the framework of the registration of a substance under Section 12 or Section 13 of the Act;
(c) adaptation of the conditions for handling the substance, storage conditions, transport conditions, fire-technical conditions, instructions in case of undesirable leakage of the substance from packaging, instructions for protection of persons and for emergency assistance in the event of an accident, proposed by a person in accordance with Section 10 of the Act requesting the registration of the substance;
(d) recommendations to competent administrative authorities to take appropriate measures to protect the environment against identified risks.
(5) Where the risk assessment of a new substance indicates that it is covered by one or more of the conclusions referred to in paragraph 3 (b), (c) or (d), the Ministry may inform the person who submitted the application for registration of the substance of the knowledge obtained and provide it with the possibility to submit comments on those conclusions and other additional information.
(6) When drawing up a recommendation to reduce the risk caused by the substance, it should be considered whether a reduction in exposure of one group of exposed individuals may result in an increase in exposure of another group of exposed persons.
(7) The risk assessment of priority substances and other existing substances for human health is regulated by the European Community2). The existing substance is a substance listed in the Einecs list under Section 11 (1) (a) of the Act.
Risk assessment procedure for human health and final report
(1) The first phase of the risk assessment of substances registered under Sections 12 and 13 of the Act is the identification of the hazard of the substance with a minimum focus on the characteristics and potential adverse effects of Annex 1, Part A and Annex 2, Part A. After identification of the hazard, continue in accordance with Annex 1, Part B and Annex 2, Part B
(a) an assessment of the relationship between dose (concentration) and response (effect),
(b) an assessment of the exposure of those exposed groups of persons referred to in Article 3 (2) (c) for which exposure to the substance can be expected;
(c) a description of the risk and a summary of the conclusion or conclusions referred to in Article 3 (3).
(2) By way of derogation from paragraph 1:
(a) if an appropriate test has been carried out to identify the hazards of a substance in relation to its particular hazardous property but the results have not led to the classification of the substance for the endpoint as hazardous, the risk assessment related to that characteristic may not include the activities referred to in paragraph 1 (a) and (b) and the conclusion referred to in § 3 (3) (a) shall apply;
(b) where appropriate tests have not yet been carried out to identify the hazard in relation to a particular effect or property, this effect or property shall not be included in the risk assessment unless there are other serious reasons for monitoring.
(3) The final report on the risk assessment of new substances is set out in Annex 3.
Repeal
Decree No. 184 / 1999 Coll., laying down a procedure for assessing the risk of hazardous chemicals to human health, is hereby repealed.
Efficacy
This Decree shall take effect on 1 August 2004.
Minister:
Dr. Kubinyi, Ph.D. v. r.
Příloha č. 1
Annex No 1 to Decree No 427 / 2004 Coll.
Risk assessment of registered chemicals for human health (toxicological properties)
Interpretation of terms
(1) NOAEL (No Observed Adverse Effect Level) is the highest dose or exposure concentration of a substance at which no statistically significant adverse effect on the body is observed compared to the control group.
(2) LOAEL (Lowest Observed Adverse Effect Level) is the lowest dose or exposure concentration of a substance at which a statistically significant adverse effect on the body is still observed compared to the control group.
(3) The median lethal dose (LD50) is a statistically calculated single dose of a substance that is likely to cause death at a defined time of 50% of the subjects who received it. The LD50 value is given as the mass of the test substance per unit weight of the individual (milligrams per kilogram).
(4) The median lethal concentration (LC50) is the statistically calculated concentration of a substance likely to cause the death of 50% of subjects exposed for a certain period of time after exposure. The LC50 is given as the mass of the test substance in the standard volume of the environment (milligrams per litre).
(5) The elimination dose is the highest of the pre-determined dose levels that can be administered to the test animal or organism without mortality.
(6) The exposure concentration is the concentration of the substance being exposed to.
When assessing the risk of a substance under § 4, the hazardous properties of a substance under § 2 of the Act and its possible adverse effects on exposed groups of persons are identified.
Effects
1. Acute toxicity
2. Irritability
3. Rage
4. Sensitisation
5. Repeated dose toxicity
6. Mutagenicity
7. Carcinogenicity
8. Toxicity for reproduction
Exposed groups of persons
1. Persons exposed in the working process
2. Consumers
3. Persons exposed indirectly through the environment
1. Hazard identification
1.1 In those cases where tests have been carried out to identify the hazards related to the potential effect, but the results have not led to the classification of the substance as hazardous in accordance with Section 2 (5) of the Act, it is not necessary to characterise the risk related to this effect in accordance with the provisions of Section 4 (2) (a), unless there are other serious reasons for monitoring such as positive in vitro mutagenicity tests.
1.2 In those cases where tests have not yet been carried out to identify the hazard related to the potential effect, it is not necessary to characterise the risk related to the effect in question in accordance with Paragraph 4 (2) (b), unless there are other serious reasons for monitoring.
2. Assessment of dose (concentration) - response (effect)
2.1 The dose-response relationship shall be evaluated for repeated dose toxicity and reproduction toxicity and, where possible, the dose (concentration) value without observed adverse effect (NOAEL) shall be determined. If NOAEL cannot be determined, the lowest dose or concentration associated with the observed adverse effect (LOAEL) shall be determined.
2.2 For acute toxicity, corrosivity and irritability, it is usually not possible to determine the NOAEL or LOAEL on the basis of the results of tests performed according to the requirements of the law. For acute toxicity the LD50 or LC50 or the discriminatory dose shall be determined if a fixed dose procedure has been applied. For other effects, it is sufficient to determine whether the substance has such effects.
2.3 For mutagenicity and carcinogenicity it is sufficient to establish whether the substance has the characteristics for which it can act as mutagenic or carcinogenic. However, where it is to be demonstrated that a substance identified as a carcinogen is not genotoxic, it is necessary to establish NOAEL or LOAEL as referred to in paragraph 2.1.
2.4 In case of skin sensitisation and respiratory sensitisation, if it is not possible to determine the dose or concentration at which the substance is unlikely to exhibit these effects, the natural ability of the substance to exhibit these effects shall be assessed.
3. Exposure assessment
3.1. The exposure assessment shall be carried out for each treatment group of persons for which exposure to the substance can reasonably be expected. The purpose of this assessment is to make a quantitative or qualitative estimate of the dose or concentration of the substance that is or may be exposed to the exposed group. This estimate shall take into account spatial and temporal changes in the exposure course.
3.2 The exposure assessment is based on information provided under § 12 or 13 of the Act in connection with the registration of a substance and on other available and relevant information. Particular consideration should be given to:
(a) adequately measured exposure data;
(b) the quantity of substance on the market;
(c) the form in which the substance is placed on the market or used (e.g. the substance itself or as an ingredient of the preparation),
(d) the method of use and, where appropriate, the various restrictions for use;
(e) production data, if available;
(f) the physicochemical properties of the substance, including those caused by the manufacturing process, if relevant (e.g. aerosols);
(g) likely routes of exposure and absorption potential;
(h) frequency and duration of exposure;
(i) the type and size of the specifically exposed population group (s) where this information is available.
3.3 Where qualified estimation methods are used for the estimation of exposure, appropriate data from the monitoring of substances with similar uses and the course of exposure shall be preferred.
3.4 Where a substance is placed on the market as part of a preparation, the exposure to that substance shall be evaluated only if the product is classified as hazardous in accordance with Section 2 (5) of the Act on the basis of the properties of that substance.
4. Risk characterisation
4.1 Where for any of the effects listed in Annex 1 a part of: A determined NOAEL or LOAEL shall include a risk characterisation related to the individual effects of a comparison of NOAEL or LOAEL with an estimate of the dose or concentration to which the exposed group (s) will be exposed. Where a quantitative exposure estimate is available, the exposure level / N (L) OAEL shall be determined. The Ministry shall decide on the basis of a comparison of the quantitative or qualitative estimate of the exposure and N (L) OAEL, which of the four conclusions referred to in Section 3 (3) of the Decree is applicable.
4.2 Where no part of the effects listed in Annex 1 has been A determined NOAEL or LOAEL, the risk characterisation of the individual effects is based on an assessment of the likelihood that this effect will occur, based on quantitative or qualitative exposure data from the population concerned. Where, although the NOAEL or LOAEL value has not been established, the results of the tests indicate the existence of a relationship between dose or concentration and the severity of the adverse effect, or where, when applying a method involving the use of only one dose or concentration, it is possible to evaluate the relative severity of the effect, such information should be taken into account when assessing the likelihood of occurrence of the effect. After that assessment, the Ministry shall decide which of the four conclusions referred to in Paragraph 3 (3) is applicable.
4.3. When deciding which of the four conclusions referred to in Paragraph 3 (3) is applicable, it shall take into account, inter alia:
(a) the uncertainty arising, among other factors, from the dispersion of experimental data and intra-species and inter-species differences;
(b) the nature and severity of the effect;
(c) population groups covered by quantitative or qualitative exposure data.
5. Summary
Risk characterisation may be performed in relation to more than one potentially adverse effect or population. In such cases, the Ministry shall assess which of the four conclusions referred to in Paragraph 3 (4) is applicable to each of these effects. After assessing the individual conclusions, the Ministry shall prepare a summary report on the overall toxicity of the substance.
Příloha č. 2
Annex No 2 to Decree No 427 / 2004 Coll.
Assessment of the risk of registered chemicals to human health (physicochemical properties)
The risk assessment of a substance in accordance with Section 4 identifies potentially adverse properties of a substance that may have an adverse effect on exposed groups of humans.
Unfavourable properties
1. Explosivity
2. Flammability
3. Oxidation Potential
Population groups
1. Persons exposed in the working process
2. Consumers
3. Persons exposed indirectly through the environment
1. Hazard identification
1.1 In those cases where tests have been carried out to identify hazards relating to a given property, but the results have not led to the classification of a substance as hazardous under Section 2 (5) of the Act, it is not necessary to characterise the risk related to that property in accordance with the provisions of Section 4 (2) (a), unless there are other reasonable reasons for monitoring.
1.2 In those cases where tests have not yet been carried out to identify hazards in relation to a given potential effect, it is not necessary to characterise the risk related to this property in accordance with Paragraph 4 (2) (b), unless there are other serious reasons for monitoring.
2. Exposure assessment
2.1. If the risk characterisation provided for in Section 3 is to be carried out, it is necessary to establish the reasonably foreseeable conditions of use, on the basis of information on the substance submitted under Sections 12 and 13 of the Act.
3. Risk characterisation
3.1. Risk characterisation shall include an assessment of the likelihood of adverse effects under reasonably foreseeable conditions of use. If the assessment shows that there will be no adverse effect, the conclusion referred to in Article 3 (3) (a) shall normally apply. If it can reasonably be assumed that the adverse effect will occur, the conclusion referred to in Article 3 (3) (b) shall normally apply.
4. Summary
If different recommendations for different effects or groups of exposed persons have been developed to reduce the risk, these recommendations will be incorporated in the final report in summary form.
Příloha č. 3
Annex No 3 to Decree No 427 / 2004 Coll.
Content of the final risk assessment report for new substances
The final report on the risk assessment of new substances contains:
(a) a summary of the conclusions of the risk assessment of the registered substance referred to in Article 3 (3); and
- a statement that the substance does not present a significant health risk for any exposed group of persons, no further information on the substance and its further tests is needed and no further evaluation is necessary if no new data on the substance are submitted if the conclusion referred to in Article 3 (3) (a) applies to all adverse effects and to all exposed groups of persons,
- a description and justification of the additional information required if the conclusion referred to in Article 3 (3) (b) or (c) applies to the substance in relation to one or more adverse effects and groups of exposed persons, or
- a description and justification of the risk reduction recommendation if the conclusion referred to in Article 3 (3) (d) applies to the substance in relation to one or more adverse effects and groups of exposed persons,
(b) where the procedure laid down in Article 3 (5) has been applied, a summary of the comments of the person who submitted the application for registration of the substance and of any relevant additional information;
(c) the exposure concentration / NOAEL / exposure concentration / LOAEL ratio, if the risk characterisation includes these ratios or factors.
1) Council Directive 67 / 548 / EEC on the approximation of laws, regulations and administrative measures relating to the classification, packaging and labelling of dangerous substances. Commission Directive 93 / 6 / EEC on the principles for the assessment of risks to man and the environment for substances notified in accordance with the Directive. Council Regulation (EEC) No 793 / 93 on the evaluation and control of the risks of existing substances. Commission Regulation (EC) No 1488 / 94 laying down the principles for the assessment of existing substances for man and the environment in accordance with Council Regulation (EEC) No 793 / 93.
2) Council Regulation (EEC) No 793 / 93 on the evaluation and control of the risks of existing substances. Commission Regulation (EC) No 1488 / 94 laying down the principles for the assessment of existing substances for man and the environment in accordance with Council Regulation (EEC) No 793 / 93.
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree No. 427 / 2004 Coll. |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.07.2004 |
|---|---|
| Effective from | 01.08.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0