Decree of the Ministry of Health No. 305 / 2002 Coll.
Ordinance of the Ministry of Health laying down the content of the application and detailed specifications of the data submitted before the placing on the market of the biocidal product or active substance
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Effective from 09.07.2002
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01.01.2008
09.07.2002
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305
DECLARATION
Ministry of Health
of 24 June 2002
laying down the content of the application and the detailed specification of the data submitted before the placing on the market of the biocidal product or active substance
The Ministry of Health (hereinafter referred to as "the Ministry ') provides, pursuant to Article 4 (7) 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'):
(1) This Decree implements the relevant provisions of the European Community (1) and regulates the content of the application for authorisation to place a biocidal product on the market and the detailed specification of the biocidal product data and the active substance.
(2) The application for authorisation for the placing on the market of a biocidal product with a chemical active substance pursuant to Article 4 (3) of the Act contains the essential information set out in Annexes 1 and 2.
(3) The application for authorisation to place a biocidal product, the active substance of which is a micro-organism, on the market in accordance with Article 4 (3) of the Act contains the essential information set out in Annexes 3 and 4.
(4) The application for authorisation to place a low-risk biocidal product on the market pursuant to Article 4 (4) of the Act shall contain the essential information set out in Annex 7.
(5) The application for authorisation to place a biocidal product with a framework formulation on the market pursuant to Article 4 (4) of the Act shall contain the essential information set out in Annex 8.
(6) The proposal for the inclusion of an active substance in the list of active substances, the list of low-risk active substances or the list of basic substances referred to in Article 12 (1) of the Act shall contain the essential information set out in Annex 1, in the case of a chemical active substance, or in Annex 3, if the active substance is a micro-organism. In addition, the proposal shall contain the basic data set out in Annex 2 for a biocidal product with a proposed chemical active substance or the basic data set out in Annex 4 for a biocidal product whose active substance is the proposed micro-organism and additional data for an active substance listed in Annex 5 for a chemical substance.
(7) The notification of the placing on the market of an active substance referred to in Article 8 (1) of the Act contains the essential information set out in Annex 1, in the case of a chemical active substance, or in Annex 3, if the active substance is a micro-organism.
This decree shall take effect on the day of its publication.
Minister:
Prof. MUDr. Fisher, CSc.
Příloha č. 1
Annex No 1 to Decree No. 305 / 2002 Coll.
Basic data for the active substance (chemical)
1. IDENTIFICATION OF APPLICANT AND MANUFACTURER
1.1. Identifying information of the applicant
Name, surname, permanent residence and place of business of the applicant, if the applicant is a natural person; name or business name and registered office, if the applicant is a legal person, telephone and fax numbers, e-mail address, ICO, if assigned.
1.2. Identification details of the active substance manufacturer, if not applicant
the name, surname, permanent residence and place of business of the manufacturer of the biocidal product and of the manufacturer of the active substance, if the manufacturer is a natural person; name or business name and registered office, if the manufacturer is a legal person, country of manufacture, telephone and fax numbers, e-mail address, ICO, if any, address of the manufacturing plant.
2. IDENTIFICATION OF THE ACTIVE SUBSTANCE
2.1. Name and synonym
Enter ISO (International Standards Organisation) name, trade name, other commonly used names and synonyms.
2.2. Chemical name
Chemical name according to IUPAC (International Union for Pure and Applied Chemistry). For substances which may occur as isomers, the correct identification of the isomer shall be provided, if possible. For substances with undefined or variable composition, identification and proportion of compounds in the reaction mixture shall be provided.
2.3. Coding number of the substance, if used by the manufacturer
2.4. CAS and EC No
CAS number means Chemical Abstract Services number. The EC number means the number in the EINECS, ELINCS or NLP1a list. For a mixture of isomers, the CAS number and the EC number shall be given both for the mixture and for the individual isomers, if available.
2.5. Primary and structural formula and molecular weight
The primary formula shall be reported according to Hill and, if different, according to CAS. For substances with undefined or variable composition, an empirical formula shall be provided. For polymers, the average molecular weight and the molecular weight distribution characteristics shall be given.
2.6. Production process
Briefly describe the synthesis process, the ongoing chemical reactions, the starting substances and the constituent substances. The method of substance isolation shall also be provided. Chemical engineering data is not required. Where those data relate to laboratory or semi-operational production, they shall be adjusted when full production is achieved.
2.7. Purity
Indicate the average purity and the upper and lower purity limits of commercial products in g / kg or g / l, whichever is more appropriate. For substances with undefined or variable composition, purity is given as 100% minus unreacted starting substance. Where those data relate to laboratory or semi-operational production, they shall be adjusted when full production is achieved.
2.8. Identification of impurities and additives
Where possible, the following data for individual impurities and additives, including by-products of synthesis, optical isomers, degradation products, etc.: general and chemical name, mutatis mutandis, as specified in points 2.1 and 2.2, CAS and EC numbers (if available), the sum and structural formula and the molecular weight, the average concentration and the range of concentrations.
2.9. Origin of natural active substances or active substance precursors
The origin of the substance shall be sufficiently accurately described; for example, in the case of plant extract, the scientific name of the species, the common name and the genus of the plant must be given.
2.10. Exposure data
That information shall provide real evidence to assess the potential exposure of workers in the manufacturing process and users, the environmental risk assessment in the manufacture, use and disposal of the substance. Details of the production process that are commercially sensitive are not required. For substances manufactured outside the Czech Republic and the European Communities, data relating to the production process shall not be required. An estimate of the exposure level shall also include possible worst-case situations, except for accidental exposure and cases of substance abuse. Exposure levels or concentrations shall be derived from relevant measurement results, model measurements or qualified estimates.
3. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES
3.1. Melting point, boiling point, relative density
If the melting point or boiling point of the active substance cannot be determined, the temperature of sublimation or degradation should be reported. Determination of boiling point and melting point shall be made up to 360 ° C if not earlier. Determination of boiling point shall be performed at normal atmospheric pressure unless decomposition occurs. In this case the test may be used at reduced pressure. Usually, the freezing point of liquids is determined if above - 20 ° C. For viscous liquids, a liquefaction point may be indicated. The gas density is determined from the molecular mass using the ideal gas equation.
3.1.1. Melting Point
3.1.2. Boil point
3.1.3. Relative density
3.2. Tension par
The vapour tension shall be determined at 20 ° C and 25 ° C or in the form of a vapour tension curve. Tension par is expressed in Pascal (Pa). If the vapour tension is less than 10- 5 Pa, the vapour tension from the vapour tension curve shall be determined. The determination is not necessary if the melting point of the substance is more than 300 ° C.
For solid and liquid substances, Henry's constant must always be given if it can be calculated. This constant depends on the solubility of the substance in water and on the vapour tension of the substance and expresses the intention of the substance to evaporate from aqueous solutions. It has the dimension of Pa.m3.mol-1.
3.3. Physical condition, colour and odour
The physical state, colour and odour are given at 20 ° C and 101,3 kPa.)
3.4. Absorption spectrum (UV / VIS, IR, NMR) and mass spectrum, molar extinction at corresponding wavelength, if relevant
The absorption spectrum in ultraviolet (UV), visible (VIS) and nuclear mass spectrometry (NMR) and mass spectrum shall be determined for the pure substance and shall allow for the determination of impurities in the substance if necessary.
3.5. Water solubility, including pH (5 to 9) and solubility temperatures, if relevant
The data must be provided for the pure substance and determined at a temperature close to 20 ° C. For a substance whose solubility depends on temperature, the solubility shall be indicated at 10 ° C and 30 ° C if relevant. Solubility is not determined when the substance is hydrolysed in an aqueous solution. Data such as "insoluble in water 'are not sufficient. However, it may be noted, for example, that solubility is lower than analytical sensitivity, if the method and the indication of sensitivity are given. If the low stability of the substance in water does not allow the determination of solubility, evidence must be provided on the basis of experimental data. It must also be stated if, for example, the production of gel.
3.6. Distribution coefficient n-octanol / water, including pH (5 to 9) and temperature
It is given for the pure substance. If the low stability of the substance in water does not permit the determination of the partition coefficient, evidence must be provided on the basis of experimental data. For substances that are extremely soluble in one of the media, a limit value shall be established, where appropriate using data on individual solubility in n-octanol and water. If the test cannot be performed, calculation methods may be used, if appropriate.
3.7. Temperature stability, identification of significant fissile products
Temperature stability to melting, sublimation or decomposition. Where possible, breakdown products shall be determined taking into account, in particular, the possibility of hazardous substances being produced.
3.8. Flammability, including spontaneity and identification of burning products
Determination of combustivity by methods A.10 (Flammability of solids), A.11. (Flammability of gases) and A.12 (Flammability of substances responding to water for the development of flammable gases) and pyrophoric properties according to method A.13 (Pyrophoric properties of solids and liquids) 2.
Very low melting point substances (< 50 ° C) are generally tested by method A.15 (Temperature of ignition of liquids and gases) or A.16 (Relative ignition temperature of rigid bodies) and the test may be completed at 400 ° C.
3.9. Flash Point
The flash point shall be determined for liquids whose vapours can be ignited. The determination is usually carried out by method A.9.2)
3.10. Surface tension
The surface measurement shall be carried out with an aqueous solution of sufficient concentration, i.e. 90% saturation (concentration must be indicated) to a maximum concentration of 1 g / l (if viscosity permits).
3.11. Explosive properties
An explosive test need not be conducted if thermodynamic information on the substance (merging or decomposing heat) is available or there are no specific reaction groups present and there are reasonable doubts that the substance is capable of decomposition under very rapid development of gases and heat.
3.12. Oxidation properties
The test shall be performed on solids as a general rule according to method A.172) and on liquid substances as a general rule according to the method set out in the Recommendations on the Transport Dangerous Goods publication. Manual of Tests and Criteria. Tests and criteria), 3rd edition, US 1999.
The test is not necessary if the analysis of the structure of the substance shows reasonable doubt that the substance is able to react exothermically with flammable material. If the test is not carried out, this shall be justified.
3.13. Reactivity with packaging material
Corrosion resistant packaging materials which do not react with the substance and materials which must not be used as packaging shall be reported. The chemical properties of the substance (e.g. pH, impurities) and storage conditions (e.g. temperature, pressure) should be considered. Information may be based on practical knowledge and on the chemical structure of the substance.
4. ANALYTICAL METHODS FOR THE DETECTION AND IDENTIFICATION OF THE SUBSTANCE
4.1. Analytical methods
Information on analytical methods for the determination of the substance, including its degradation products, isomers and impurities and additives (such as stabilisers), if they are toxicologically or ecotoxicologically relevant (i.e. relevant for the risk assessment) or present at concentrations of ≥ 1 g / kg of active substance.
The description of the methods shall include a description of the preliminary modifications to the sample, details of the equipment and materials used, data on interference of other substances, calibration curve, sensitivity limit, and other information necessary for the use of the analytical method.
An explanation shall be provided for any interference that causes a measurement deviation greater than ± 3 per cent.
The calibration range shall include the lowest and highest concentration of the pure active substance in the analysed solution. The protocol shall contain an equation of the calibration curve, correlation coefficient and evidence of analysis (e.g. chromatogram).
Five findings of the active substance shall be made and a standard deviation (%) shall be provided.
4.2. Analytical methods for the determination of the active substance and its residues in soil, air, water and body fluids and tissues
For soil sensitivity determination the method shall not be less than 0,05 mg / kg.
Determination of the substance in the air only applies to volatile substances, i.e. substances whose vapour tension ≥ 0,01 Pa or which are used as spray. The sensitivity of the method must correspond to the hygiene limits of substances in the atmosphere of workplaces laid down by specific legislationm3).
The sensitivity of the method of determination in water shall comply with the requirements for permissible values in drinking water.
If a substance is classified as toxic or highly toxic, the sensitivity of the method shall be consistent with the concentration of the substance at which the substance does not cause any harmful effects.
5. EFFICIENCY FOR TARGET ORGANISMS AND INTENDED USE
5.1. Effect
For example, fungicide, rodenticide, insecticide, bactericide.
5.2. Target organism (s) and products, organisms or objects to be protected
The general name and scientific name of the target organism shall be given and, where relevant and appropriate, the gender and stage of development. A warning shall also be provided as to where the target organism is present and which organisms are to be protected.
5.3. Effects on the target organism and the appropriate concentration at which the active substance will be used
Description of the effect on the target organism in different applications if the effect varies. Depending on the effect on the concentration of active substances. Recommended concentration at different routes of application if different. The recommended concentration should be the minimum effective concentration, taking into account the conditions that could affect efficacy.
5.4. Mode of action (including time delay)
Specify the biochemical and physiological principle of action of the substance. If known, whether the substance or its metabolites, degradation products or chemical reactions are active. These metabolites, degradation products or chemical reactions shall be reported if available, i.e. chemical name, empirical and structural formula, molecular weight, CAS number, mechanism and chemical transformation reactions, conversion rate and effects affecting the extent and rate of transformation. It shall also be stated whether efficacy is the result of multiple substances.
5.5. Field of intended use
Specify the areas of use including the product-type for which the substance is intended and a description of the method of use.
5.6. User: Professional, unprofessional
The professional user is the manufacturer and user who uses the product professionally in their business activities (e.g. wood impregnation, cooling equipment production, extermination). Other users are non-professional users.
5.7. Information on the occurrence or possible development of resistance (resistance) and appropriate strategies to face it
5.8. Likely quantity to be marketed per year (tonnes)
6. TOXICOLOGICAL AND METABOLIC STUDIES
6.1. Acute toxicity
Acute toxicity tests shall be carried out for at least two types of administration; One of them should be given per person. The choice of the second route of administration depends on the properties of the substance and the most likely route of entry at exposure to the human organism. Gases and volatile liquids are administered via the inhalation route.
6.1.1. Oral
For substances with low toxicity, a 2000 mg / kg limit test should be sufficient.
6.1.2. Dermal
For substances with low toxicity, a 2000 mg / kg limit test should be sufficient.
6.1.3. Inhalation
Inhalation toxicity is determined if the active substance is a gaseous or volatile liquid (vapour pressure > 10-2 Pa at 20 ° C), or powder with a significant proportion of particles with a mean mass aerodynamic diameter (MMAD) < 50 μm (i.e. > 1% by weight), or is to be part of a powder preparation or preparation applied as aerosol in the form of dust parts or drops with MMAD < 50 μm. Substances classified as corrosive shall not be tested in this way.
6.1.4. Skin and eye irritation
This test is not performed on substances that are corrosive. As a rule, method B.404 shall be used for the determination of corrosivity. No eye irritation test is performed on substances that strongly irritate the skin.
6.1.5. Skin sensitisation
This test is not necessary if the substance is classified as sensitising under a specific legal regulation (5) or is known to be sensitising (e.g. from data on effects on the human organism).
6.2. A metabolism study in mammals. Basic toxickinetics including skin absorption study
A single application with two different doses (low and high dose) and a repeated dose study with the use of the rat as a test animal is usually sufficient.
6.3. Toxicity at short-term repeated dose (28 days)
Preferential administration of the pens is preferred. For substances with low toxicity, a 1000 mg / kg per dose limit test may be sufficient. The dermal route of administration of the substance is chosen when significant skin exposure is expected, or if the effect of the substance is known to differ significantly from that of another route after skin penetration. Inhalation route administration is chosen for volatile substances (vapour tension > 10-2 Pa), or for significant inhalation exposure, in particular for aerosol applications. These studies are not required when a subchronic toxicity study in rodents is submitted.
6.4. Subchronic 90-day study, two species
The test is performed on two species, one of which is rodent. Non-rodents need not be tested if scientifically justified and if residue of the substance has not been found in the food chain. For substances with low toxicity, a 1000 mg / kg per dose limit test may be sufficient. A rat is usually chosen as a rodent and a dog as a second species for the per-os test. If a 90-day study indicates that the dog is significantly more sensitive and the data obtained can be better extrapolated to humans. it may be appropriate to supplement the study with a 12-month dog test. This test may also replace the 90-day test. The dermal route of administration of the substance is chosen when significant skin exposure is expected, or if the effect of the substance is known to differ significantly from that of another route after skin penetration. This test is not performed if the substance had no toxic effects in the 28-day test using the limit dose. Inhalation route administration is chosen for volatile substances (vapour tension > 10-2 Pa), or for significant inhalation exposure, in particular for aerosol applications.
6.5. Chronic toxicity
The test shall be carried out on rodents, preferably on rats. Based on the results of the rodent testing, it is decided whether testing on another species of animal is still necessary. A chronic toxicity test is not necessary when this results from subchronic toxicity tests, in particular from demonstrated reversibility of the effects of the substance. Chronic toxicity and carcinogenicity testing may be performed in one test.
6.6. Mutagenicity study
6.6.1. Detection of gene mutations on micro-organisms with in vitro metabolic activation
6.6.2. Detection of cytogenetic (clastogenic) effects (chromosome aberrations) in mammalian cells in vitro with metabolic activation
6.6.3. Detection of mammalian cell gene mutations with metabolic activation in vitro
6.6.4. If the studies referred to in paragraph 6.6.1, 6.6.2 or 6.6.3 are positive, an in vivo mutagenicity study (chromosomal damage test in the bone marrow or micronucleus test) is required.
6.6.5. If the studies referred to in section 6.6.4 are negative but in vitro positive, the results of the second in vivo study shall be submitted to determine whether mutagenicity or DNA damage can be demonstrated in tissues other than bone marrow.
6.6.6. If the studies referred to in paragraph 6.6.4 are positive, a test may be required to assess possible effects on germ cells
6.7. Carcinogenicity study
Two species - one rodent and another mammalian species. These studies may be combined with the test referred to in paragraph 6.5. If it is declared in exceptional circumstances that such a test is not necessary, this declaration shall be fully justified, for example, on the basis of the results of other tests carried out, the nature of the substance or the literary data.
6.8. Reproduction toxicity
If, in exceptional circumstances, it is declared that such a test is not necessary, this declaration shall be fully justified, for example, on the basis of the results of the other tests carried out, the nature of the substance or the data published in the technical litarature.
6.8.1. Teratogenicity test - rabbit and one rodent species
For substances with low toxicity, a 1000 mg / kg limit test is sufficient preferably using the rabbit as a test animal.
6.8.2. Fertility study - at least two generations, one species, male and female (rat)
6.9. Medical data in anonymous form
6.9.1. Data from medical supervision of factory workers where available
6.9.2. Direct observations such as clinical cases, cases of poisoning, if available
The source of this data is usually specialized literature.
6.9.3. Health records of workers from both industry and other available sources, if available
6.9.4. Epidemiological studies of the population where available
6.9.5. Diagnosis of poisoning including specific signs of poisoning and clinical trials if available
6.9.6. Observation of sensitisation and allergies when available
6.9.7. Specific approaches in the event of an accident or poisoning: emergency assistance, antibodies and medical treatment, if known
6.9.8. Prognosa after poisoning
6.10. Summary of mammalian toxicology and conclusions, including dose value without observed adverse effect (NOAEL), dose value without observed effect (NOEL), overall assessment with regard to all toxicological data and all other information concerning the active substance. Where possible, all measures to protect workers should be included
7. ECOTOXIOLOGICAL PARTICULARS
7.1. Acute toxicity to fish
7.2. Acute toxicity to the Daphne magna
7.3. Algae growth inhibition test
7.4. Inhibition of microbiological activity
7.5. Bioconcentration
The determination of the bioconcentration factor of the substance (ratio of the concentration of the substance in the organism to the concentration of the substance in the aquatic environment, as a rule, by OECD Method 305 (Flow-through Fish Test; OECD Guidelines for the Testing of Chemicals, Section 3) and assessment of the bioconcentration potential of the substance in the aquatic environment based on the physical and chemical properties of the substance (e.g. the partition coefficient n-octanol / water). Particular attention should be paid to the bioconcentration potential of surfactants (surface tension below 50 mN / m) and dissociating or inorganic substances such as metals. This is based on toxickinetic studies (including metabolism), residue studies and data from the monitoring of aquatic organisms (data from residues in tissues of aquatic organisms and environmental concentrations).
7.6. Displaceability
7.6.1. Biotic
A minimum biodegradability test shall be carried out. This test shall always be carried out for organic compounds unless a simulation test is carried out. If the substance is not readily degradable, a simulation test or one of the tests shall be carried out, as a general rule, in accordance with Method IX or XII6). Priority is given to the simulation test.
7.6.2. Abiotic
Substances whose hydrolysis is less than 10% per 5 days at 50 ° C are considered stable against hydrolysis and need not be further tested. Identification of breakdown products shall be required if at any sampling time the loss of the substance is greater than 10% of the original quantity.
7.7. Screening adsorption / desorption test
Where this results from this test, the test referred to in Annex 5, paragraph 7.1.2 or 7.2.2 shall be required.
7.8. Summary of ecotoxicological effects, fate and behaviour of the substance in the environment
8. MEASURES NOT AVAILABLE FOR HUMAN PROTECTION, ANIMAL AND ENVIRONMENT
8.1. Recommended treatment and health protection measures for the treatment, use and transport of the substance
Measures minimising the risk of exposure to the human organism and the environment, including specification of technical measures and personal protective equipment. Consideration shall be given to characteristics such as flammable, oxidising properties and below. Data relating to the possible reactions of certain substances with the active substance in the development of toxic gases, acid-abasic aggressiveness, dust explosion and such shall also be reported.
8.2. In case of fire, the nature of the reaction products, the resulting gases and such.
Devices suitable and not suitable for extinguishing fire and data on gaseous combustion products, in particular the identification of hazardous substances, based on experiments, practical knowledge or chemical structure of the substance.
8.3. Measures in the event of an accident
First aid measures for people and environmental protection measures
8.4. Potential for decomposition or decontamination after leakage into air, water and soil
Procedures for neutralising, decomposing and removing the substance after leakage into air, water or soil due to an accident.
8.5. Waste management procedures for professional users
Disposal of the substance and packaging.
8.5.1. Recovery or recycling options
8.5.2. Potential for neutralising effects
Description of the method of neutralisation, such as alkali in the leakage of the substance, possibilities for large and small quantities, evaluation of the products produced and the possibility of disposal.
8.5.3. Conditions for placing in a landfill or discharge into water
The storage conditions at the landfill shall include an indication of the composition of the leases. When discharges into water after a large dilution are possible, the recommended dilution must be specified specifically.)
8.5.4. Combustion conditions
Combustion products and recommended combustion conditions shall be specified.
8.6. Monitoring for undesirable or unintended side effects on non-target organisms
Data on observed or predicted effects of a substance on useful and other non-target organisms shall be provided.
9. GENERAL CLASSIFICATION AND LABELLING
9.1. Classification 7)
9.2. Text of packaging marking
9.3. Safety data sheet 8)
10. SUMMARY AND EVALUATION OF THE DATA REFERRED TO IN POINT 2 TO 9
(The assessment of data from individual chapters shall be carried out in terms of risk to humans, animals and the environment.)
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Regulation Information
| Citation | Decree of the Ministry of Health No. 305 / 2002 Coll. |
|---|---|
| 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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