305/2002 Sb.



DECREE



The Ministry of health



of 24 July 2003. June 2002,



laying down the content of the request and the detailed specifications of the data

submitted prior to the placing of the biocidal product or active substance on

market



Change: 382/2007 Sb.



The Ministry of health (hereinafter referred to as "the Ministry") determined in accordance with paragraph 4 of

paragraph. 7 of law No 120/2002 Coll., on conditions for the placing of biocidal

products and active substances on the market and amending some related

laws (hereinafter referred to as the "Act"):



§ 1



(1) this Decree incorporates the relevant provisions of the European

Community ^ 1) and modifies the contents of an application for authorisation to place the product

of the biocidal product on the market, and a detailed specification of the data concerning the biocidal

the preparation and the active substance.



(2) an application for authorisation for placing the biocidal product with chemical

an active substance on the market in accordance with § 4 para. 3 of the law provides the basic data

referred to in annexes 1 and 2.



(3) an application for authorisation for placing the biocidal product for which an effective

substance is a micro-organism in accordance with § 4 para. 3 of the Act contains

the basic data referred to in annexes 3 and 4.



(4) an application for authorization to place a low-risk biocidal product

on the market in accordance with § 4 para. 4 of the Act contains the basic data referred to in

Annex # 7.



(5) an application for authorisation for placing the biocidal product with the framework

composition on the market pursuant to § 4 paragraph 2. 4 of the Act contains the basic data

listed in annex No. 8.



(6) the application for inclusion of an active substance to the list of active substances, list of

the low-risk active substances or to the list of basic substances by

§ 12 para. 1 of the law provides the basic information listed in annex 1,

in the case of chemical active substance, or in annex No. 3, if

Active micro-organism. Furthermore, the proposal contains basic information

listed in annex No. 2 for the biocidal product with proposed chemical

the active ingredient or the basic information listed in annex No. 4 for the biocidal

a product whose active ingredient is the proposed micro-organism, and

additional data for the active substance referred to in annex 5, in the case of

chemical substance.



(7) the notification for the placing on the market of active substances according to § 8 para. 1 of the law

contains the basic information listed in annex No. 1, in the case of chemical

the active ingredient, or in annex No. 3, if the active substance

the micro-organism.



§ 2



This Decree shall take effect on the date of publication.



Minister:



Prof. MUDr. Fiser, CSc. v. r.



Č. 1



The basic data for the active substance (chemical)



1. Identification of the applicant and manufacturer



1.1. Identification of the applicant



Name, surname, permanent residence and place of business of the applicant, if

the applicant is a natural person; the name or business name and address, if

the applicant legal person, telephone and fax numbers, e-mail address,

Identification number, if one has been assigned.



1.2. manufacturer of the active substance identification data, unless the applicant



Name, surname, permanent residence and place of business of the manufacturer of the biocidal

product and the manufacturer of the active substance, if the producer is a natural person; the name of the

or business name and registered office of the manufacturer is a legal person, the country

production, telephone and fax numbers, email address, identification number, if one has been

granted, the address of the site.



2. identification of the active substance



2.1. name and synonyms



Enter the name of the ISO (International Standards Organisation

International Organization for Standardization), business name, other generally

used names and synonyms.



2.2. Chemical name



Chemical name according to IUPAC nomenclature (International Union for Pure and

Applied Chemistry-International Union of pure and applied chemistry).

For substances that may be present such as isomers, the correct

designation of the isomer, if possible. For substances with an undefined or

variable composition shall be indicated the identification and the proportion of compounds in a reaction

the mixture.



2.3. Code number of the substance, if the manufacturer is used



2.4. CAS and EC



CAS number means Chemical Abstract Services number. Number Of The EC

means a number against a list of EINECS, ELINCS or NLP ^ 1). For a mixture

isomers with CAS number and the number of the EC for a mixture of both, so for each

isomers, if it is available.



2.5. Molecular and structural formula and molecular weight



The molecular formula is stated according to the Hill, and if different, even according to the CAS. U

substances with an undefined or variable composition shall indicate an empirical

formula. In polymers, shall indicate the average molecular mass, and

characteristics of distribution of molecular weight.



2.6. the manufacturing process



Describe briefly how the synthesis, chemical reactions in progress, to the default

the substance and the substance. Also, by specifying the method of isolation of the substance.

Chemical-engineering data is required. If the data subject

the laboratory or pilot plant production, after achieving full

the production.



2.7. The purity



Enter the average purity and the upper and lower boundaries of the purity of the commercial

products in g/kg or g/l, whichever is more convenient. For substances with

undefined variable in composition or purity is given as a 100% minus the

unreacted starting materials. If the figures quoted apply to

laboratory or pilot plant production, after achieving full

the production.



2.8. Identity of impurities and additives



If possible, include the following information for each of the dirt and

the ingredients, including the by-products of synthesis, optical isomers,

products of degradation etc.: generic and chemical name, mutatis mutandis, as shown

in point 2.1 and 2.2, the CAS and EC numbers (if available), chemical and

structural formula and molecular weight, average concentration and range

concentrations.



2.9. The origin of the natural active substance or the precursor of active substances



The origin of the substance must be described with sufficient precision; so for example, extract

of the plants it is necessary to give the scientific name of the species, the generic name and gender

plants.



2.10. Exposure data



The information provided must provide a fair basis for the evaluation of possible

the exposure of workers in the production process and users, risk assessment

threats to the environment during the manufacture of the substance, its use and

at its disposal. Details of the production process that are

commercially sensitive, is not required. For substances manufactured outside the United

States and of the European communities, the particulars, building on the

the manufacturing process. Estimation of the exposure levels shall also include possible

the worst situation, with the exception of accidental exposure, and cases of abuse of the substance.

Exposure levels or concentration must be derived from the respective

the results of measurements, measurement of the model or a qualified estimate.



3. physical, chemical and technical properties



3.1. Melting point, boiling point, relative density



If the melting or boiling point of the active substance could not be established, it should

be measured temperature sublimation or decomposition. Determination of boiling point and point

melting is carried out in a 360 ° C, if not earlier. The determination of the

the boiling point is done at normal atmospheric pressure, unless there has been

the decomposition. In that case, you can use the determination at a reduced pressure.

It usually provides for the freezing point of liquids, if the over-20 degrees C To

viscous liquids can be used to indicate the point of liquefaction. Gas density is determined from the

molecular weight using the ideal gas equation.



3.1.1. The melting point



3.1.2. Boiling point



3.1.3. Relative density



3.2. Vapour pressure



Vapour pressure is determined at 20 ° C and 25 ° C, or in the form of the curve tension

par. Vapour pressure is expressed in pascals (Pa). If the vapor pressure is lower

than 10-5 Pa, the vapour pressure of the vapour pressure curve determination does not

should be carried out if the melting point of a substance is greater than 300 degrees C for solid and

liquid substances must be indicated Henry's law constant, if it can be

calculate. This constant depends on the water solubility and the

vapour pressure of the substance and expresses the substance of the effort evaporate aqueous solutions.

Has the dimension of URPa.M3.mol-1.



3.3. Physical State, colour and odour



Physical state, colour and odour are given at 20 ° C and 101.3 kPa).



3.4. Absorption Spectra (UV/VIS, IR, NMR), and mass spectrum, molar

extinction at relevant wavelengths, where relevant



Absorption spectra in the ultraviolet (UV), visible (VIS)

and from the nuclear mass spectrometry (NMR), and mass spectra must

to be determined for a clean cloth and allow the determination of impurities in the

the substance, if it is necessary.



3.5. Solubility in water including effect of pH (5 to 9) and temperature on

solubility, where relevant



Data must be placed for the pure substance and set at a nearby

20 degrees C for the substance, whose solubility depends on the temperature shall be indicated

solubility at 10 ° C and 30 ° C, if it is significant. Solubility

does it determine if the substance is hydrolyzed in aqueous solution. Information, such as

"insoluble in water" is not sufficient. However, you can specify, for example, that

solubility is below the analytical sensitivity if the method and

an indication of the sensitivity. In the event that the low stability of the substance in water

does not allow determination of solubility, evidence must be provided on the basis of

experimental data shall be indicated if, for example,

the formation of the gel.



3.6. Partition coefficient n-octanol/water including, depending on the pH (5

to 9) and temperature



It is for the pure substance. In the event that the low stability of the substance in water


does not allow for the determination of the partition coefficient, proof must be provided

based on experimental data. For substances which are extremely

soluble in one of the media outlets octanol and water. The test cannot be

made, the calculation methods may be used, if appropriate.



3.7. Temperature stability, identification of relevant fissile products



Data on the thermal stability to the point of melting, sublimation or decomposition. If

It is possible, the decomposition products in particular to the possibility of

the formation of hazardous substances.



3.8. Flammability including auto-flammability, and identification of the products

burning



The flammability and methods usually 10. (Flammability of solids)

And 11 (Flammability of gases), and 12 (Flammability of substances reacting with water

development of flammable gases) and pyrophoric properties as methods and 13.

(Pyrophoric properties of solids and liquids) 2.



Substances with very low melting point (50 C