Specification Of The Principles And The Evaluation Procedure For Biocidal Products

Original Language Title: specifikace zásad a postup hodnocení biocidních přípravků

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=53642&nr=304~2F2002~20Sb.&ft=txt

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.