304/2002 Sb.
The DECREE
The Ministry of health
of 24 June. June 2002,
laying down the detailed specification of the principles and the evaluation procedure
biocidal products and active substances
The Ministry of health (hereinafter referred to as "the Ministry") determined in accordance with § 6
paragraph. 4 Act No 120/2002 Coll., on conditions for the placing of biocidal
products and the active substances on the market and on the amendment of certain related
laws (hereinafter referred to as "the Act"):
§ 1
The subject of the edit
The Decree provides for a detailed specification of the principles and the evaluation procedure
biocidal products (hereinafter referred to as "the product") for the purposes of the authorisation to
their placing on the market and evaluation of active substances proposed for the
inclusion in the list of active substances, the list of active substances with a low
risk and basic substances list.
§ 2
The evaluation of the product
The evaluation of the product shall be carried out on the basis of the data submitted by the applicant
under section 4 of the Act. The principles and the evaluation procedure of the products are listed in the
the annex to this Decree.
§ 3
Evaluation of active substances
Evaluation of active substances proposed for inclusion in the list of active
substances, the list of active substances with low risk or a list of the basic
substances shall be carried out in accordance with the specific legislation laying down
the procedure for risk assessment of hazardous chemicals for humans and
the environment, "^ 1") on the basis of the data submitted by the applicant under
section 12 of the Act.
§ 4
This Decree shall take effect on the date of publication.
Minister:
Prof. MUDr. Fisher, PhD. in r.
Annex.
Detailed specification of the principles and the evaluation procedure of the products
1. Explanation of terms
1.1. Risk is the probability that under defined conditions of exposure
occurs when the expression of a harmful effect of the active substance or substance of concern
contained in the product to people, animals or the environment.
1.2. determination of the hazard is to determine the harmful effects that can
product recall.
1.3. the evaluation of the relationship between the dose (concentration)-response (effect) is
an estimate of the relationship between dose, or level of exposure to the active substance or
substance of concern present in the product, on the one hand and the incidence and
the intensity of the effect on the other side.
1.4. the exposure assessment is the determination of the emissions, pathways and the speed of movement
of the active substance or substance of concern present in the product and their transformations
or degradation in order to estimate the concentrations or doses to which
are or may be exposed to people, animals or individual folders
the environment.
1.5. Risk Characterization is the estimation of the incidence and severity of harmful
effects occur in humans, animals or the individual components
the environment due to actual or predicted exposure
of each active substance or substance of concern present in the product. Can
include quantification of that likelihood.
1.6. The environment is water, including sediment, air, land, wild
wild species of flora and fauna, and any interrelationship between them, as well as
and any relationship to living organisms.
1.7. The exhibition is the product, contact the active substance or substance of concern with
external borders of the living organism or environmental.
1.8. The dose is the quantity of the product, of the active substance or substance of concern
another man received a living organism or a component of the
environment.
1.9. Exposure concentrations is the concentration of the active substance or the preparation
a substance that is exposed to a man, the other a living organism or
the environment.
1.10. The NOAEL (No Observed Adverse Effect Level) is the highest dose or
exposure concentrations of the product, of the active substance or substance of concern,
that is not observed no statistically significant unfavourable response
in comparison with the control group.
1.11. the LOAEL (Lowest Observed Effect Level Adverce) is the lowest dosage
or exposure concentrations of the product, of the active substance or tracked
the substance, which is still observed statistically significant unfavourable
the response of the organism compared with the control group.
1.12. The LD50 (median lethal dose) is a statistically derived single
the dose of the product, of the active substance or substance of concern, which may
causes for the defined period of the death of 50% of the individuals to whom it was submitted.
The LD50 value is expressed as weight of test preparation or substance on the
the unit of weight of the individual (milligrams per kilogram).
1.13. LC50 (median lethal concentration) is a statistically derived
the concentration of the product, of the active substance or substance of concern,
likely causes for a period of time after the exposure of the death of 50% of the test
animals exposed after a defined period of time. LC50 is given as
the mass of the test substance in a preparation, or a standard volume
environment (milligrams per litre).
1.14. The PNEC (Predicted No-Effect Concentration) is an estimate of the highest
the concentration of the active substance of the preparation, the substance of which is
do not foresee harmful effects of the substance in the watch folder of the
environment.
1.15. The PEC (Predicted Environmental Concentration) is an estimate of the
likely local concentration of the active substance or the preparation
substance in the different environmental compartments.
1.16. Bioconcentration factor (BCF) is the ratio of concentrations of chemicals
in the organism and concentrations of the same chemicals in the environment, which
the body surrounds.
1.17. A professional user of the product is an entrepreneur "^ 1"), which
the product is manufactured or used professionally in their business activities
(for example, wood impregnation, rodent control). Other users are considered
for non-professional users.
2. evaluation of the
2.1. General principles
2.1.1. Evaluates the completeness and support level of documentation submitted
by the applicant pursuant to section 4 of the Act. Evaluate and justify why the applicant
some data have not been submitted. When the risk assessment is based on the
documents, which are professionally processed. When the guest is taken in
account and the proposed purpose and method of use of the product.
2.1.2. It is necessary to identify all risks arising from use of the product and
decide whether they are acceptable or unacceptable in terms of ensuring
a high level of protection of human health, animal protection and environment
environment. In doing so, shall take into account not only the data submitted by the applicant,
but also other important information about the potential exposure of the roads,
the properties of the product, its components, metabolites, or residues;
If they are known.
2.1.3. always carry out a risk assessment of the active substance present in the
of the product. In addition, if there is any substance in the preparation,
the risk assessment shall be carried out for each of them. The risk assessment
includes the proposed normal use of the product along with the script for the
in real terms, at least favourable case involving all the problems of the production,
treatment and disposal, either for itself or for each product
the material treated with it.
2.1.4. For each active substance and each substance of concern include
hazard identification, risk assessment, determination of the NOAEL,
evaluation of the relationship between the dose (concentration)-response (effect) along with
exposure assessment and risk characterisation.
2.1.5. the results obtained from the comparison of the levels of exposure with observed NOAEL
for each active substance and each substance are added to
they won the overall risk assessment for the product. Where there are
available quantitative results, combined with the results of the qualitative
Guest, so that the overall result.
2.1.6. a safety margin (Margin of Safety-MOS). The value of the
The MOS is for a typical case is equal to 100, but the value of the MOS can be
higher or lower according to the nature of the critical toxicological effect.
2.1.7. The risk assessment shall include the determination of:
and the risks to people and the) animals,
(b)) the risks to the environment,
(c) the measures necessary for the protection) of humans, animals and the environment
environment as a whole during normal use of the product as proposed,
so in real terms, at least the favourable situation of the case.
2.2. Evaluation of effects on human
2.2.1. On the basis of the properties of the active substances, and shall take into
consider the following possible effects of human population
associated with its use:
-acute and chronic toxicity,
-irritation,
-CMR effects carcinogenity,
-awareness raising,
-repeated dose toxicity,
-mutagenicity,
-carcinogenicity,
-Reproduction toxicity,
-neurotoxicity,
-any other special properties of the active substance or tracked
the substance,
-other effects due to physico-chemical properties.
2.2.2. Monitored the human population includes:
-Professional users,
-non-professional users,
-humans exposed indirectly via the environment.
2.2.3. The identification of the hazard of relates to properties and potential
the harmful effects of the active substance and each substance of concern. If it
shows that the product is classified as dangerous ^ 2), the
evaluation of the relationship between the dose (concentration)-response (effect)
exposure assessment and risk characterisation.
2.2.4. in the case of chronic toxicity and reproductive toxicity shall be assessed the relationship
between dose (concentration)-response (effect) for each active substance
and the substance and determined the value of the NOAEL. If it is not possible
to identify a NOAEL, the LOAEL value.
2.2.5. For acute toxicity, the LD50 or LC50 value calculated, or in
cases where the procedure has been used, the discriminating dose shall be derived,
discriminating ^ 3) dose. In the case of corrosive and irritant effects will
determine whether the active substance or substance of concern has an ability to cause
such effects during use of the product.
2.2.6. For mutagenicity and carcinogenicity is sufficient to determine whether the active substance
or substance has the ability to cause mutagenic or carcinogenic
effects during use of the product. However, if it is possible to prove that
an active substance or a substance of concern identified as a carcinogen is not
both genotoxic, the NOAEL or LOAEL.
2.2.7. For skin sensitisation and respiratory tract, if it cannot provide
the level of dose or concentration below which the value for the body already
sensitized to a given substance, the effects of such unlikely, just
assessing whether the active substance or substance of concern has an ability to cause
such effects during use of the product.
2.2.8. In cases where data on the toxicity of the sighting in the received
human exposure, for example, from the information gathered from the literature
or epidemiological studies, it is necessary when assessing the risk based on
above all of these data
2.2.9. The exposure assessment shall be conducted for each group of people, i.e..
Professional users, non-professional users and humans exposed
indirectly via the environment, for which the exposure of the product
occurs or can reasonably be expected that may occur. The objective of the evaluation
the estimation of dose or exposure concentration of each active substance
and the substance of which is the population exposed, or may be exposed to
during use of the product.
2.2.10. the exposure assessment shall take into account the following information:
-data from the measurement of exposure,
-the form in which the product will be sold,
-type of preparation,
-method of application application rate,
-the physico-chemical properties of the product,
-the likely routes of exposure and the level of absorption,
-the estimated frequency and duration of exposure
-the type and size of specific exposed groups of people where they are
such information is available.
2.2.11. Where available, the measured, appropriately
representative exposure data, it is necessary, when assessing the exposure of the
use of these data. In cases where used to estimate the level of
exposure calculation method, it is necessary to perform the corresponding model
of the test.
These model tests must:
-make a best possible estimation of exposure for all procedures
which can lead to exposure, taking into account the realistic
parameters and assumptions,
-be subjected to analysis, which takes into account possible elements of uncertainty,
-be reliably validated with measurements carried out under circumstances
the appropriate use of the model,
-comply with the requirements in the area of use.
2.2.12. In cases, when detected the NOAEL or LOAEL for
the effects referred to in paragraph 2.2.1, shall be included in the risk characterization
comparison of the NOAEL or LOAEL with the values of the dose or exposure
concentration, which the population was exposed.
2.3. the assessment of the effects on the animals of the assessment of the effects of the product on animals,
shall be carried out according to similar principles, which are listed in paragraph 2.2.
2.4. Evaluation of effects on the environment
2.4.1. When assessing the risk arising from the use of the product is
take into account the harmful effects arising in any of the environmental
environment.
2.4.2. the hazard identification shall take into account the characteristics and
the potential harmful effects of the active substance or substance of concern present in the
of the product. If the product is classified as dangerous ^ 2) for
the environment, requires the evaluation of the relationship between the dose of
(concentration)-response (effect) assessment of exposure and characterization
the risks.
2.4.3. In cases when the product is not classified as a safe ^ 2)
environmental risk characterization is not required if
There are other compelling reasons for its implementation. Such reasons may
result from the properties and effects of any active substance or tracked
substances present in the preparation, in particular as regards:
-any bioaccumulation potential,
-possibility of persistence,
-the negative shape of the toxicity/time curve in the tests
ecotoxicity,
-indication of other harmful effects on the basis of toxicity studies
(for example, the classification as a mutagen),
-data on structurally similar substances,
-endocrine effects.
2.4.4. Performs the evaluation of the relationship between dose (concentration)-response
(effect) in order to estimate PNECS. This procedure is carried out for the active
a substance and for each substance of concern present in the product. If The PNEC
It is not possible to establish, it must make an estimate of the relationship between dose,
(concentration)-response (effect).
2.4.5. The PNEC shall be determined from the data on effects on organisms and studies
ecotoxicity from the applicant. The PNEC shall be determined from the data as it is
for example, LD50, LC50 or EC50 (median effective concentration), IC50
(concentration causing 50% inhibition of a given parameter, e.g. growth),
NOEL (C) (the value of the dose (concentration), no observed effect level), or
(C) LOEL (lowest dose (concentration)-inducing harmful effect) and
factor evaluation, i.e.. number expressing the degree of uncertainty in
the extrapolation of data from tests on a limited number of species to
real environment. The more extensive the data and the
the longer the duration of the tests, the smaller is the degree of uncertainty and the size of the factor
Guest.
2.4.6. For each environmental assessment shall be carried out
for the purpose of determination of the PEC in the environmental sphere. In
cases where it is not possible to fix the FURNACE, it must perform a qualitative
estimation of exposure.
2.4.7. The PEC, or qualitative estimation of exposure shall be required to provide for only
for those components of the environment, in which you can assume
the presence of the product as a result of the emissions, discharges, disposal or
distribution, including any relevant contribution from material
the treated products.
2.4.8. When determining the PEC or qualitative estimate of exposure,
consider the following information:
-the measured exposure data,
-the form in which the product is marketed,
-type of preparation,
-method of application benefits
-the physico-chemical properties
-degradation/transformation,
-the likely routes of the inputs to the environmental components and the ability to
adsorption, desorption and degradation,
-the frequency and duration of exposure.
2.4.9. If available, measured, appropriately
representative exposure data, it is necessary, when assessing the exposure of the
based on primarily from these data. In cases where it will be used for
an estimate of the level of exposure of the calculation method shall be applied to the corresponding models.
The characteristics of these models are such, as stated in paragraph
2.2.11. Where possible and appropriate, considering also the corresponding
data from the monitoring of substances with similar use and routes of exposure or with
similar characteristics.
2.4.10. the risk characterisation shall include, for each of the folder of the
comparison of the PEC with the PNEC environment so that they could derive a PEC/PNEC ratio.
If it is not possible to derive a PEC/PNEC ratio, the risk characterization shall include
qualitative evaluation of the likelihood that the effect will be applied for
the expected conditions of exposure.
2.5. evaluation of unacceptable effects
2.5.1. Assess whether the product in its effect on target vertebrates
does not cause unnecessary suffering. This procedure shall include the assessment of
the mechanism that produces the effect and observed the effects on
the behavior and health of the target vertebrates; in the event that the intended effect
killing the target vertebrate the time necessary, for his
the killing and the conditions under which death occurs.
2.5.2. Evaluates the possibility of the development of resistance of the target organism to the
the active substance in the preparation.
2.5.3. If there are indications that there may be any
other unacceptable effects, evaluate the likelihood of the occurrence of such
effects. Such an unacceptable effect may be, for example, the possibility of
the adverse reaction of persons coming into contact with the wood products
treated wood protection products.
2.6. Assessing the effectiveness of
2.6.1. When evaluating the efficacy of the product when assessing whether
Learn how to use achieves the declared efficiency on
the target organism and whether the recommended dose is the minimum necessary to
achieve the desired effect. The fact that the recommended dose
represents the minimum needed to achieve the desired effect, must be
documented in the documentation submitted by the applicant, the tests of effectiveness in the
lower doses than are recommended.
2.6.2. For testing the effectiveness of the methods laid down by the directives are used
Of the European communities, if they exist and are for reference purpose
appropriate, or the methods established in professional institutions of the Czech Republic
(eg. Institute of public health, Institute for State control of veterinary
Biologicals and medicaments, the central control and testing Institute of agriculture).
You can also use other proven (validated) methods that comply with the
characteristics, mechanism of action and purpose of use of the product and are
According to the normal criteria reproducible scientific examination. (eg.
the method recommended by the Organisation for economic cooperation and development
The OECD), the method referred to in the standards of the International Organization for Standardization
(ISO), the European Committee for Standardisation (CEN) or other
international standards).
2.6.3. the results of the tests the efficacy of the product must guarantee a minimum
the same level, and duration of protection, control or other
the intended effect, which is similar to the released product, if such
the product exists. Where there is no comparable product, must
tests show that the product provides to define the level of protection or
control in the areas of proposed use throughout the territory of the Czech
with the exception of cases, when the product is intended for use in
Special terms and conditions.
2.7. Summary evaluation
2.7.1. In each of the areas, where the risk assessment carried out, IE.
evaluation of effects on humans, animals and the environment are combined
the results for the active substance together with the results for each monitored
substance, that an overall assessment of the product. When it is taken in the
account any synergistic effects of the active substance (s) and tracked
the substances present in the preparation.
The result is:
-a summary of the effects of the product on humans,
-a summary of the effects of the product on animals,
-a summary of the effects of the product on the environment,
-a summary of the evaluation of the effectiveness,
-a summary of the unacceptable effects.
2.7.2. For preparations containing more than one active substance,
any unacceptable effects of these substances are combined so that the
the overall effect of the preparation.
3. The conclusions of the
3.1. General principles
3.1.1. The findings from the evaluation of the product shall be adopted on the basis of the outcome of the
the sum of the individual risks of active substances, together with the risks from each
substance of concern present in the product. The risk assessment will include normal
use the product together with a realistic worst case scenario
including the disposal of the product itself or any
the material treated.
3.1.2. In the conclusions of the evaluation of the product, taking into account the following
fact:
-the results of the risk assessment, in particular the relationship between exposure and effect,
-the nature and intensity of the effect,
-the risk constraints that may apply,
-the area of the use of the product,
-the effectiveness of the product,
-physical properties of the product,
-benefits of using the product,
-the level of uncertainty resulting from the diversity of the data used in the process
Guest.
3.2. Effects on humans
3.2.1. the issue of the authorisation for placing the product on the market shall not,
If the risk assessment confirms that, in the case of the envisaged
use, including realistically at least favourable case, preparation
represents an unacceptable risk to humans. While considering the possible
effects on professional users, non-professional users and humans
exposed directly or indirectly through the environment.
3.2.2. In analysing the relationship between the exposure and the effect is taken into account
the nature of the harmful effect of the substance, in particular property as are acute,
subacute, subchronic and chronic toxicity for reproduction, together with
physico-chemical properties and any other harmful
the properties of the active substance or substance of concern.
3.2.3. Where it is necessary to reduce the exposure of workers and
Professional users shall be laid down as a condition of the authorization application
personal protective equipment such as breathing apparatus, masks,
respirators, overalls, gloves and goggles.
3.2.4. the issue of the authorisation for placing the product on the market shall not,
If for non-professional users the wearing of personal protective
means the only possible method for reducing exposure.
3.2.5. the issue of the authorisation for placing the product on the market shall not,
If the relationship between the exposure and the effect cannot be reduced to
an acceptable level.
3.3. Effects and animals
3.3.1. Authorisation to place the product on the market shall not, if the
When the risk assessment finds that the product in the intended use of the
represents an unacceptable risk to non-target animals.
3.3.2. when adopting conclusions considering the risks posed by the product
for animals for a fair use similar criteria, such as
the criteria for a person.
3.4. Effects on the environment
3.4.1. General principles
3.4.1.1. the issue of the authorisation for placing the product on the market shall not,
If the risk assessment confirms that the active substance or substance of concern
or any degradation, or reaction product represent an unacceptable
the risk in any folder of the environment. This includes the evaluation of the
the risks for non-target organisms in all environmental compartments. When
adoption of conclusions, taking into account the criteria referred to in paragraph 3.4.2 to
3.4.6.
3.4.1.2. The basic criterion is the PEC/PNEC ratio or, if this is not
the ratio of available, its qualitative estimation. Taking into account the accuracy of the
This ratio due to the diversity of the data used in the measurement of
concentration and estimation. When setting the OVEN uses a model that
It takes account of the fate and behaviour of the product in the environment.
3.4.1.3. If the PEC/PNEC ratio is for any of the
the environment is equal to or less than 1, no additional information is necessary
or testing.
3.4.1.4. If the PEC/PNEC ratio is greater than 1, on the basis of the
the value of this ratio and indicators referred to in paragraph 2.4.3, whether they are
required additional information or tests to clarify the increased value
the PEC/PNEC ratio or, if it is necessary to provide for measures for the reduction of
risks, or whether it could not recommend the issuance of the authorization to place the product on the
the market.
3.4.2. Water
3.4.2.1. the issue of the authorisation for placing the product on the market shall not,
If the proposed conditions of use, the foreseeable concentration of has
of the active substance or of any other substance of concern or of relevant
metabolites or breakdown or reaction products in water (or in the
sediment) unacceptable impact on non-target species in the aquatic environment,
If it is proven that under relevant field conditions there is no
no unacceptable effect.
3.4.2.2. the issue of the authorisation for placing the product on the market shall not,
If, under the proposed conditions of use exceeds the estimated
the concentration of the active substance or of any other substance of concern or
relevant metabolites or breakdown or reaction products in
the underground water of the lower of the following concentrations:
and the value of the limit for the health) of drinking water provided for special
the law ^ 4), or
(b) the value of the reported concentrations in) the procedure for inclusion of an active substance in
list of active substances, active substances with low risk or basic
substances under the Act if it is proven that under field conditions the use of the
the product is not this concentration is exceeded.
3.4.2.3. the issue of the authorisation for placing the product on the market shall not,
If the proposed conditions of use, the foreseeable concentration of
of the active substance or of any other substance of concern or of relevant
metabolites or breakdown or reaction products in surface water
or its sediments after use of the product under the proposed conditions of
use in cases where surface water from the areas of anticipated
the use is intended for the abstraction of drinking water, may exceed
and indicators established for water) flows of a particular legal
^ 5 regulation), or
b) limits for drinking water ^ 4), which is the source of water supply
the flow, if it is proven that under field conditions the use of the
This concentration is not exceeded.
3.4.2.4. Evaluate whether the proposed use of the product, the instructions for the
including procedures for cleaning application equipment, are such that
minimise the likelihood of accidental contamination of water or its
the sediment.
3.4.3. Soil
3.4.3.1. the issue of the authorisation for placing the product on the market shall not,
If the use of the product is likely to pollution of soil and
the active substance or substance of concern
-in the course of field tests remain in the soil for more than one year, or
-During laboratory tests creates non-extractable residues in the
quantities in excess of 70% of the initial dose after 100 days and speed
mineralization of less than 5% in 100 days,
-has unacceptable consequences or effects on non-target organisms,
If it is not demonstrated that under field conditions there is no
unacceptable accumulation in soil.
3.4.4.
3.4.4.1. Issue authorisation for placing the product on the market shall not,
If when using the product, you can assume the unacceptable effects on
the air, if not proven, that in the relevant field conditions
There is no unacceptable effect.
3.4.5. Effects on non-target organisms
3.4.5.1. the issue of the authorisation for placing the product on the market shall not,
If when using the product, you can assume the exposure of non-target
organisms of the product and for each active substance or substance of concern:
and) is the PEC/PNEC is above 1 unless it does not follow from the risk assessment,
in field conditions there are no unacceptable effects
the product under the recommended conditions, or
(b)) the bioconcentration factor (BCF) related to fat content in
tissues in non-target vertebrates is above 1 unless the risk assessment
It does not follow that in field conditions there are no unacceptable
direct or indirect effects after use of the best
terms and conditions.
3.4.5.2. Issue authorisation for placing the product on the market shall not,
If when using the product, you can assume the exposure of non-target
aquatic organisms of the product and for each active substance and the
or their metabolites or degradation products is
and the PEC/PNEC) value greater than 1, or
(b)) the bioconcentration factor (BCF) is greater than 1000 for substances
that is easily biodegradable or greater than 100 for substances
that is easily biologically decompose readily (this condition does not apply to
micro-organisms in sewage treatment plants),
If it is proven under field conditions to such manifestations of effect
the product does not occur.
3.4.5.3. The provisions of paragraph 3.4.5.2 shall not apply in the case of 31.12.2009
preparations against rot intended for use on ships for protection
the transport of goods and people, if you like this effect cannot be achieved by other
resources.
3.4.5.4. Issue authorisation for placing the product on the market shall not,
If it can be assumed that the micro-organisms in municipal agglomerations
will be exposed to the product and for the active substance, substance of concern,
relevant metabolites, degradation and reaction products is the value of the ratio
The PEC/PNEC is above 1 unless does not result from the risk assessment that, in
field conditions there is no unacceptable impact, no direct
or indirect, to the viability of these organisms.
3.4.6. Unacceptable effects
3.4.6.1. If the likely emergence of resistance to the active substance in
short period of time, the conditions to minimise the consequences of this
resistance and if this is not possible, the issue of the authorization to place the product
the market is not.
3.4.6.2. Authorisation for the placing of the product intended to be skinny
vertebrates are not, if
-death does not occur at the same time with the extinction of consciousness,
-death does not occur immediately, or
-the functions are reduced gradually without signs of obvious
the suffering.
3.4.6.3. Repellent product used to repel vertebrate
not for the issue of authorisation for placing on the market, if the intended
the effect of reach without unnecessary suffering and pain for the target vertebrate.
3.4.7. The effectiveness of the
3.4.7.1. In the conclusions of the includes the evaluation of the efficacy of the product under
paragraphs 2.6.1 and 2.6.3.
3.4.7.2. Recommends the authorisation for the placing on the market of the product,
that does not have an acceptable efficiency, if used according to the recommended
conditions or other conditions set out in the authorization.
4. The overall integration of conclusions
4.1. Each received the conclusions to the effect of the product on humans, animals, and
the environment are combined to obtain a conclusion for the total
effect of the product.
4.2. Assess the unacceptable effects, efficacy and benefits
obtained by using preparation.
4.3. Select one of the following conclusions for each product type, and
for each area of use of the product for which an application has been made:
and it is recommended to enable the product) to be placed on the market without the specific
conditions or restrictions
(b) it is recommended to allow) for the placing on the market for the specific
conditions or restrictions
(c)) for the evaluation of the product will require additional information, or
(d) the product is not recommended) to allow the placing on the market.
4.4. Where appropriate, conditions or restrictions. The nature and
the severity of these conditions shall be selected on the basis of and in accordance with the nature and extent of the
the expected advantages and the risks likely to appear when you use the
of the product.
1) Decree No. 306/1998 Coll., laying down the procedure for the assessment of risk
dangerous chemical substances to the environment.
Decree No. 184/1999 Coll., laying down the procedure for the assessment of risk
dangerous chemical substances for human health
1) § 2 (2). 2 of the Act No. 513/1991 Coll., the commercial code, as amended by
amended.
2) § 2 (2). 8 of Act No. 157/1998 Coll., on chemical substances and
chemical preparations and on the amendment of certain other acts, as amended by
amended.
3) annex part B 1. bis of Decree No. 251/1998 Coll., laying down the
methods for the detection of toxicity of chemical substances, as amended
regulations.
4) Decree No. 376/2000 Coll., laying down the requirements for potable water
and the extent and frequency of its inspections.
5) Government Regulation No. 82/1999 Coll., laying down the indicators and values
the permissible degree of water pollution.
