Decree of the Ministry of Health No. 304 / 2002 Coll.
Decree of the Ministry of Health laying down detailed specifications of the principles and procedure for evaluation of biocidal products and active substances
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Effective from 09.07.2002
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09.07.2002
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304
DECLARATION
Ministry of Health
of 24 June 2002
laying down detailed specifications of the principles and procedure for the evaluation of biocidal products and active substances
The Ministry of Health (hereinafter referred to as "the Ministry ') provides, pursuant to Article 6 (4) of Act No. 120 / 2002 Coll., on the conditions for placing biocidal products and active substances on the market and amending certain related acts (hereinafter referred to as" the Act'):
Subject matter
The Decree sets out a detailed specification of the principles and procedure for the evaluation of biocidal products (hereinafter referred to as the product) for the purpose of issuing authorisations for their placing on the market and the evaluation of active substances proposed for inclusion in the list of active substances, the list of low-risk active substances and the list of basic substances.
Evaluation
The evaluation of the product shall be based on data submitted by the applicant in accordance with Article 4 of the Act. The principles and procedure for evaluating products are set out in the Annex to this Decree.
Evaluation of active substances
The evaluation of active substances proposed for inclusion in the list of active substances, the list of low-risk active substances or the list of basic substances shall be carried out in accordance with specific legislation laying down a procedure for assessing the risk of hazardous chemicals to humans and the environment, (1) on the basis of data submitted by the appellant pursuant to Article 12 of the Act.
This decree shall take effect on the day of its publication.
Minister:
Prof. MUDr. Fisher, CSc.
Annex to Decree No. 304 / 2002 Coll.
Detailed specifications of the principles and process for evaluation of products
1. Explanation of terms
1.1. The risk is the likelihood that, under defined conditions of exposure, the harmful effect of the active substance or the controlled substance contained in the preparation will be demonstrated on humans, animals or the environment.
1.2. Determination of hazard is the determination of the harmful effects that the product may cause.
1.3 The assessment of the dose (concentration) / response (effect) relationship is an estimate of the dose or level of exposure to the active substance or the monitored substance present in the preparation, on the one hand, and the incidence and intensity of effect on the other.
1.4. The exposure assessment shall be the determination of the emissions, pathways and rates of movement of the active substance or of the monitored substance present in the preparation and their transformation or degradation to determine the estimation of concentrations or doses to which humans, animals or individual environmental components are or may be exposed.
1.5. Risk characterisation is an estimate of the occurrence and severity of harmful effects that may occur in humans, animals or individual environmental compartments as a result of actual or anticipated exposure to each active substance or monitored substance present in the preparation. It may include quantification of this probability.
1.6. The environment is water, including sediment, air, soil, wild flora and fauna species, and any interaction between them, as well as any relationship with living organisms.
1.7. Exposure is the contact of the product, active substance or controlled substance with the external borders of the living organism or environmental component.
1.8. The dose is the quantity of product, active substance or controlled substance received by humans, other living organisms or an environmental component.
1.9. Exposure concentration is the concentration of the product, active substance or controlled substance exposed to humans, other living organisms or an environmental component.
1.10. NOAEL (No Observed Adverse Effect Level) is the highest dose or exposure concentration of the product, active substance or monitored substance at which no statistically significant adverse response of the organism is observed compared to the control group.
1.11. LOAEL (Lowest Observed Adverse Effect Level) is the lowest dose or exposure concentration of the product, active substance or monitored substance at which a statistically significant adverse response of the organism is still observed compared to the control group.
1.12. LD50 (median lethal dose) is a statistically calculated single dose of the product, active substance or monitored substance likely to cause death over a defined time period of 50% of the subjects to whom it was given. The LD50 value is given as the weight of the test preparation or substance per unit weight of the individual (milligrams per kilogram).
1.13. LC50 (mean lethal concentration) is a statistically calculated concentration of the product, active substance or monitored substance likely to cause the death of 50% of test animals exposed for a certain period of time after exposure. The LC50 is given as the weight of the test product or substance in the standard volume of the environment (milligrams per litre).
1.14. PNEC (Predicted No- Effect Concentration) is an estimate of the highest concentration of the product, active substance or monitored substance at which the harmful effects of the substance in the environmental compartment are not anticipated.
1.15. PEC (Predicted Environmental Concentration) is an estimate of the likely local concentration of the product, active substance or monitored substance in individual environmental components.
1.16. The bioconcentration factor (BCF) is the ratio between the concentration of the chemical in the organism and the concentration of the same chemical in the environment surrounding the organism.
1.17. The professional user of the product is an entrepreneur (1), which produces or uses the product professionally in its business activities (such as wood impregnation, extermination). Other users are considered to be unprofessional users.
2. ASSESSMENT
2.1. General principles
2.1.1. The completeness and professional level of the supporting documents submitted by the applicant under Section 4 of the Act shall be evaluated. The applicant's justification for not submitting certain data shall also be evaluated. The risk assessment shall be based on documents that are well-trained. The proposed purpose and method of use of the product shall be taken into account in the evaluation.
2.1.2. It is necessary to identify all risks from the use of the product and to decide whether they are acceptable or unacceptable in terms of ensuring a high level of protection of human health, animal protection and the environment. This takes into account not only the data submitted by the applicant, but also other relevant information on possible routes of exposure, the properties of the product, its constituents, metabolites or residues, if known.
2.1.3. The risk assessment of the active substance present in the preparation shall always be carried out. In addition, where there is any substance in the product, the risk assessment shall be carried out for each of them. The risk assessment shall include the proposed normal use of the product together with a scenario for the least favourable case, including all manufacturing, handling and disposal problems, either for the product itself or for each material treated by it.
2.1.4. For each active substance and each monitored substance, the risk assessment shall include hazard identification, NOAEL, dose (concentration) and response (effect), together with exposure assessment and risk characterisation.
2.1.5. The results obtained from the comparison of the exposure found with NOAEL for each active substance and each endpoint shall be aggregated to obtain an overall risk assessment for the product. Where quantitative results are not available, the results of the qualitative evaluation shall be combined to obtain the overall result.
2.1.6. A safety limit (MOS) is established. The MOS value may be 100 for a typical case, but the MOS values may be higher or lower depending on the nature of the critical toxicological effect.
2.1.7. The risk assessment shall include the determination of:
(a) risks to humans and animals;
(b) risks to the environment;
(c) the measures necessary for the protection of humans, animals and the environment as a whole during both the proposed normal use of the product and the situation of the least favourable case.
2.2. Evaluation of Human Effects
2.2.1. Based on the properties of the active and monitored substances, the following potential effects of the preparation on the human population related to its use are taken into account:
- acute and chronic toxicity,
- irritability,
- corrosivity,
- sensitisation,
- repeated dose toxicity,
- mutagenicity,
- carcinogenicity,
- reproductive toxicity,
- neurotoxicity,
- all other special characteristics of the active substance or the controlled substance,
- other effects caused by physicochemical properties.
2.2.2. The human population monitored shall include:
- professional users,
- unprofessional users,
- persons exposed indirectly through the environment.
2.2.3. The hazard identification relates to the properties and potential harmful effects of the active substance and to each monitored substance. If it indicates that the product is classified as hazardous (2), an assessment of the dose (concentration) / response (effect) relationship, exposure assessment and risk characterisation shall be performed.
2.2.4. For chronic toxicity and reproductive toxicity, the relationship between dose (concentration) and response (effect) for each active substance and the monitored substance shall be assessed and the NOAEL shall be determined. If the NOAEL cannot be determined, the LOAEL shall be determined.
2.2.5. For acute toxicity, LD50 or LC50 values are calculated or, where a fixed dose procedure has been used, a discriminatory dose of 3) is derived. In the case of corrosive and irritating effects, it is sufficient to establish whether the active substance or the substance under consideration has the ability to cause such effects during use of the product.
2.2.6. For mutagenicity and carcinogenicity, it is sufficient to establish whether the active substance or the controlled substance has the potential to cause mutagenic or carcinogenic effects during use of the product. However, if it can be demonstrated that the active substance or the monitored substance identified as a carcinogen is not genotoxic, NOAEL or LOAEL shall be determined.
2.2.7. For skin and airway sensitisation, if the level of dose or concentration below which such effects are unlikely for a substance-already sensitised body, it is sufficient to assess whether the active substance or the monitored substance has the ability to cause such effects during use of the product.
2.2.8. In cases where toxicity data have been obtained from human exposure observations, for example from information obtained from production, literature or epidemiological studies, the risk assessment should be based on all of these data.
2.2.9. The exposure assessment shall be performed for each group of persons, i.e. professional users, non-professional users and persons exposed indirectly through the environment for which exposure to the product occurs or can reasonably be expected to occur. The purpose of the evaluation is to make an estimate of the dose or exposure concentration of each active substance and of the monitored substance to which the population is exposed or may be exposed during use of the product.
2.2.10. The following data shall be taken into account in the exposure assessment:
- exposure measurement data,
- the form in which the product will be sold,
- the type of product,
- method of application and application dose,
- the physico-chemical properties of the preparation,
- likely exposure and absorption levels,
- anticipated frequency and exposure time
- the type and size of the specifically exposed group of persons where such information is available.
2.2.11. Where adequately measured, representative exposure data are available, these data shall be used in the exposure assessment. Where they are used to estimate the level of exposure to the calculation method, appropriate model tests shall be carried out.
These model tests shall:
- provide the best possible estimate of exposure for all procedures in which exposure may occur, taking into account realistic parameters and assumptions,
- be subjected to an analysis taking into account possible elements of uncertainty,
- be reliably verified by measurements carried out in circumstances appropriate to the application of the model,
- comply with the conditions of use.
2.2.12. Where NOAEL or LOAEL values have been found for the effects referred to in paragraph 2.2.1, a comparison of NOAEL or LOAEL with the dose or exposure concentration exposed to the population shall be included in the risk characterisation.
2.3. Evaluation of animal effects
The evaluation of the effects of the product on animals shall be carried out in accordance with similar principles to those laid down in paragraph 2.2.
2.4. Evaluation of environmental effects
2.4.1. The risk assessment resulting from the use of the product shall take into account the harmful effects arising from any environmental component.
2.4.2. When identifying hazards, account shall be taken of the properties and potential harmful effects of the active substance or of the monitored substance present in the preparation. If the product is classified as hazardous (2) for the environment, an assessment of the dose (concentration) / response (effect) relationship, exposure assessment and risk characterisation is required.
2.4.3. In cases where the product is not classified as hazardous (2) for the environment, risk characterisation is not necessary unless there are other serious reasons for its implementation. Such reasons may result from the properties and effects of any active substance or of a controlled substance present in the preparation, in particular as regards:
- any manifestations of bioaccumulation potential,
- the possibility of persistence,
- the adverse shape of the time-dependent curve in ecotoxicity tests,
- indications of other harmful effects based on toxicity studies (e.g. classification as mutagen),
- data on structurally similar substances,
- endocrine effects.
2.4.4. An assessment shall be made of the relationship between dose (concentration) and response (effect) to estimate PNEC. This procedure shall be carried out for the active substance and for each of the monitored substances present in the preparation. If PNEC cannot be determined, an estimate of the dose (concentration) relationship to the response (effect) must be made.
2.4.5. The PNEC shall be determined from the data on effects on organisms and from the ecotoxicity studies provided by the applicant. The PNEC shall be determined from data such as LD50, LC50, EC50 (mean effective concentration), IC50 (concentration causing 50% inhibition of the parameter, e.g. growth), NOEL (C) (value of the dose (concentration) without observed effect), or LOEL (C) (lowest dose (concentration) causing harmful effect) and assessment factor, i.e. numbers expressing uncertainty in extrapolation of test data to a limited number of animal species on the real environment. The larger the data set and the longer the test duration, the lower the uncertainty and the magnitude of the assessment factor.
2.4.6. For each environmental component, an exposure assessment shall be carried out to determine the PEC in that environmental component. Where PEC cannot be determined, a qualitative estimation of exposure shall be made.
2.4.7 A PEC or a qualitative estimation of exposure is required only for those environmental compartments in which the presence of the product can be expected as a result of emissions, discharges, disposal or distribution, including any corresponding contribution from materials treated with the products.
2.4.8. The following data shall be taken into account for the determination of PEC or qualitative exposure estimation:
- measured exposure data,
- the form in which the product is placed on the market,
- the type of product,
- methods of application and application doses,
- physicochemical properties,
- degradation / transformation products,
- likely routes of entry into environmental compartments and the ability to adsorption, desorption and degradation,
- frequency and duration of exposure.
2.4.9. Where adequately measured, representative exposure data are available, the exposure assessment shall mainly be based on these data. Where they are used to estimate the exposure level of the calculation method, the corresponding models shall apply. The characteristics of these models are as specified in paragraph 2.2.11. Where possible and effective, appropriate data from the monitoring of substances with similar uses and exposure methods or with similar properties shall also be considered.
2.4.10. The risk characterisation shall include a comparison of PEC with PNEC for each of the environmental compartments in order to derive the PEC / PNEC ratio. Where it is not possible to derive the PEC / PNEC ratio, the risk characterisation shall include a qualitative assessment of the probability that the effect will be applied under expected exposure conditions.
2.5. Evaluation of unacceptable effects
2.5.1. It shall be assessed whether, in its effect on the target vertebrate species, the product causes unnecessary suffering. This procedure shall include an evaluation of the mechanism which produces the effect and the evaluation of the observed effects on the behaviour and health of target vertebrates; where the intended effect is to kill the target vertebrate, the time necessary for its killing and the conditions under which death occurs shall be evaluated.
2.5.2. The possibility of developing resistance of the target organism to the active substance in the preparation shall be evaluated.
2.5.3. If there are indications that any other unacceptable effects may occur, the likelihood of such effects shall be evaluated. Such unacceptable effect may, for example, be the possibility of adverse reaction by persons in contact with wood products treated with wood protection products.
2.6. Efficacy assessment
2.6.1. The assessment of the efficacy of the product shall assess whether the recommended method of use achieves the declared efficacy on the target organism and whether the recommended dose is the minimum necessary to achieve the desired effect. The fact that the recommended dose is the minimum necessary to achieve the desired effect must be documented in the supporting documents submitted by the applicant for efficacy tests at doses lower than those recommended.
2.6.2. The methods set out in the Directives of the European Communities, if they exist and are suitable for the purpose pursued, or the methods established in the professional institutes of the Czech Republic (e.g. the National Health Institute, the Institute for State Control of Veterinary Bioprafts and Medicines, the Central Control and Testing Institute of Agricultural), are used for efficacy tests. Other validated methods may also be used that meet the characteristics, mechanism of action and purpose of the product and are reproducible according to normal scientific examination criteria. (e.g. the methods recommended by the Organisation for Economic Cooperation and Development (OECD), the methods referred to in the International Organisation for Standardisation (ISO), the European Committee for Standardisation (CEN) or other international standards).
2.6.3. The results of the efficacy tests shall guarantee at least the same level, conformity and duration of protection, regulation or other intended effect as the authorised product if any. Where there is no comparable product, tests shall demonstrate that the product provides a defined level of protection or control in the areas of proposed use throughout the Czech Republic, except where the product is intended for use under special conditions.
2.7. Summary of evaluation
2.7.1. In each of the areas where the risk assessment, i.e. human, animal and environmental effects assessment, has been carried out, the results for the active substance shall be combined with those for each of the substances monitored in order to obtain an overall evaluation of the product. This takes into account any synergistic effects of the active substance (s) and of the controlled substances present in the preparation. The result is:
- a summary of the effects on humans,
- a summary of the effects of the product on animals,
- a summary of the effects on the environment,
- a summary of the efficacy assessment,
- a summary of unacceptable effects.
2.7.2. For products containing more than one active substance, any unacceptable effects of these substances shall be combined to obtain an overall effect for the preparation.
3. CONCLUSIONS
3.1. General principles
3.1.1. The conclusions of the evaluation of the product shall be adopted on the basis of the results of the sum of the risks of each active substance together with the risks of each of the monitored substances present in the preparation. The risk assessment shall include the normal use of the product together with a realistic worst case scenario, including the disposal process of the product itself or any material treated by it.
3.1.2. The conclusions of the evaluation shall take into account the following:
- the results of the risk assessment, in particular the relationship between exposure and effect,
- nature and intensity of effect,
- the risk limitation that may be applied,
- area of use,
- the efficacy of the product,
- the physical characteristics of the preparation,
- the benefit of the use of the product,
- the degree of uncertainty arising from the diversity of data used in the evaluation process.
3.2. Effects on man
3.2.1. The issue of authorisations for placing on the market of a product shall not be recommended if the risk assessment confirms that, in the case of the intended use, including the least favourable case, the product poses an unacceptable risk to humans. This will consider possible effects on professional users, non-professional users and persons exposed directly or indirectly through the environment.
3.2.2. The analysis of the relationship between exposure and effect shall take into account the nature of the harmful effect of the substance, in particular those characteristics such as acute, subacute, subchronic and chronic toxicity, irritability, corrosivity, sensitisation, mutagenicity, carcinogenicity, neurotoxicity, reproductive toxicity, together with physical-chemical properties and any other harmful properties of the active substance or of the substance under consideration.
3.2.3. Where necessary to reduce the exposure of workers and professional users, the authorisation of the use of personal protective equipment such as breathing appliances, masks, respirators, working clothes, gloves and goggles shall be provided for.
3.2.4. The authorisation to place the product on the market is not recommended if the use of personal protective equipment for non-professional users is the only possible method of reducing exposure.
3.2.5. The issue of marketing authorisations is not recommended if the relationship between exposure and effect cannot be reduced to an acceptable level.
3.3. Effects on animals
3.3.1. The issue of authorisations for placing the product on the market shall not be recommended if the risk assessment reveals that the product presents an unacceptable risk to non-target animals when intended for use.
3.3.2. The risks posed by the product to animals with adequate application of criteria similar to those for humans shall be considered when adopting conclusions.
3.4. Effects on the environment
3.4.1. General principles
3.4.1.1. The issue of authorisations for placing the product on the market shall not be recommended if the risk assessment confirms that the active substance or the controlled substance or any breakdown or reaction product poses an unacceptable risk in any environmental component. This includes risk assessment for non-target organisms in all environmental components. The criteria set out in paragraphs 3.4.2 to 3.4.6 shall be taken into account in the adoption of the conclusions.
3.4.1.2. The basic criterion is the PEC / PNEC ratio or, if this ratio is not available, its qualitative estimate. Consideration shall be given to the accuracy of this ratio, given the diversity of data used in concentration measurements and estimation. A model that takes into account the fate and behaviour of the product in the environment is used for the determination of PEC.
3.4.1.3. If the PEC / PNEC ratio is equal to or less than 1 for any environmental component, no further information or testing is required.
3.4.1.4. Where the PEC / PNEC ratio is greater than 1, it shall be assessed, on the basis of the value of that ratio and the indicators referred to in paragraph 2.4.3, whether further information or tests are needed to clarify the elevated PEC / PNEC ratio, or whether it is necessary to provide for risk reduction measures, or whether authorisation to place the product on the market cannot be recommended.
3.4.2. Water
3.4.2.1. The authorisation to place the product on the market is not recommended if, under the proposed conditions of use, the expected concentration of the active substance or any other monitored substance or relevant metabolites or breakdown or reaction products in water (or sediment) has an unacceptable effect on non-target species in the aquatic environment unless it is demonstrated that there is no unacceptable effect under appropriate field conditions.
3.4.2.2. The issue of authorisations for placing the product on the market shall not be recommended if, under the proposed conditions of use, the expected concentration of the active substance or any other monitored substance or relevant metabolites or breakdown or reaction products in groundwater exceeds the lower of the following concentrations:
(a) the value of the sanitary limit for drinking water laid down by specific legislation4); or
(b) the concentration value indicated in the procedure for the inclusion of the active substance in the list of active substances, active substances at low risk or essential substances under the law
unless it is demonstrated that this concentration is not exceeded under field conditions of use.
3.4.2.3. The authorisation to place the product on the market is not recommended if, under the proposed conditions of use, the expected concentration of the active substance or any other monitored substance or relevant metabolites or breakdown or reaction products in surface water or their sediment after use of the product under the proposed conditions of use in cases where surface water from the areas of intended use is intended for the collection of drinking water is likely to exceed:
(a) the characteristics laid down for watercourses by special legislation5); or
(b) hygiene limits for drinking water4), the source of which is water flow;
unless it is demonstrated that this concentration is not exceeded under field conditions of use.
3.4.2.4. It shall be assessed whether the proposed instructions for use of the product, including procedures for cleaning the application equipment, are such as to minimise the likelihood of accidental contamination of water or its sediment.
3.4.3. Soil
3.4.3.1. The issue of authorisations for placing on the market of a product shall not be recommended if soil contamination and the active substance or the controlled substance are likely to occur when using the product.
- remains in the soil for more than one year during field tests, or
- during laboratory tests, produce non-extractable residues in excess of 70% of the initial dose after 100 days with a mineralisation rate of less than 5% per 100 days,
- has unacceptable consequences or effects on non-target organisms,
unless it is demonstrated that there is no unacceptable accumulation in soil under field conditions.
3.4.4. Air
3.4.4.1. The issue of a marketing authorisation shall not be recommended if unacceptable effects on the air can be expected when the product is used unless it is demonstrated that there is no unacceptable effect under appropriate field conditions.
3.4.5. Effects on non-target organisms
3.4.5.1. The issue of authorisations for placing the product on the market shall not be recommended if exposure to non-target organisms by the product and for each active substance or controlled substance can be expected when the product is used:
(a) the PEC / PNEC value is greater than 1 unless the risk assessment indicates that there are no unacceptable effects in field conditions after use of the product under the recommended conditions; or
(b) the value of the bioconcentration factor (BCF) relative to the fat content of non-target vertebrate tissues is greater than 1 unless the risk assessment indicates that there are no unacceptable direct or indirect effects in field conditions after use of the product under the recommended conditions.
3.4.5.2. The authorisation to place the product on the market shall not be recommended if exposure to non-target aquatic organisms of the product can be expected and for each active and monitored substance or its metabolites or breakdown products:
(a) a PEC / PNEC value higher than 1; or
(b) a bioconcentration factor (BCF) value greater than 1000 for substances that are readily biodegradable or more than 100 for substances that are not readily biodegradable (this condition does not apply to micro-organisms in waste water treatment plants);
unless it is demonstrated that there are no such effects under field conditions.
3.4.5.3. The provisions of paragraph 3.4.5.2 shall not apply until 31.12.2009 to anti-fouling products intended to be used for the protection of ships for the transport of goods and humans, unless a similar effect can be achieved by other means.
3.4.5.4. The authorisation to place the product on the market is not recommended if it can be assumed that micro-organisms in municipal cleaners will be exposed to the product and, for the active substance, the active substance, the relevant metabolites, breakdown and reaction products, the PEC / PNEC ratio is greater than 1, unless there is a risk assessment that there is no unacceptable impact, direct or indirect, on the viability of these organisms in field conditions.
3.4.6. Unacceptable effects
3.4.6.1. If resistance to the active substance is likely to occur within a short period of time, the conditions for minimising the consequences of this resistance shall be determined and, if this is not possible, authorisation to place the product on the market shall not be recommended.
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Regulation Information
| Citation | Decree of the Ministry of Health No. 304 / 2002 Coll., laying down detailed specifications of the principles and procedure for evaluation of biocidal products and active substances |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.07.2002 |
|---|---|
| Effective from | 09.07.2002 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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