Decree of the Ministry of Health No. 250 / 1998 Coll.
Decree of the Ministry of Health on the Registration of Chemicals
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Order
Effective from 01.01.1999
Contents
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250
DECLARATION
Ministry of Health
of 16 October 1998
on the registration of chemicals
The Ministry of Health (hereinafter referred to as "the Ministry ') provides, pursuant to § 6 (2) (e) and § 3, § 7 (2) and § 8 (6) of Act No. 157 / 1998 Coll., on Chemicals and Chemical Products and amending certain other laws (hereinafter referred to as" the Act'):
BASIC PROVISIONS
Preliminary provisions
This decree provides
(a) details of the content of the application for registration of chemicals and the manner in which it is processed;
(b) the procedure for carrying out the registration of chemicals;
(c) the extent of the additional data;
(d) the extent of the supporting documents submitted by the manufacturer or importer of the chemical (hereinafter referred to as the substance) to the application for registration and to the application for an extension of the period for placing on the market of substances not subject to registration pursuant to Article 6 (2) (e) of the Act.
Application for registration
(1) The application for registration shall contain the information set out in Annex 1 and shall be accompanied by a certificate of payment of the administrative fee. 1) The other supporting documents referred to in paragraph 2 shall be attached by the manufacturer or importer to the application in a sealed package with a marked "Registration. Don't open it." This packaging is only authorised to be opened by the personnel of the workplace carrying out the registration of substances (hereinafter referred to as the "registration site ').
(2) The manufacturer or importer shall attach the following supporting documents to the application:
(a) basic data on the substance as set out in Annex No 2;
(b) reports of tests carried out on the substance;
(c) the safety data sheet of the dangerous substance.
BASIC DATA ON THE MATTER
(1) The methods of numbering and labelling of basic data on the substance and their sequence, including further details and technical descriptions, are set out in Annex 2.
(2) If the information given in the model application is not taken into account, the entry "not to be entered 'shall be entered in the relevant box.
(3) Where some data are not detectable experimentally, or in specialised literature, databases or other sources of information, the word "undetected 'shall be written. In that case, the manufacturer or importer shall state the justification in the note to the relevant point.
(4) Where a manufacturer or importer applies for the registration of a substance which has already been registered and whose registration has expired for at least 10 years, the application may not include previously submitted data corresponding to the provisions of Sections 4 (f) and (k), 5 (a) (3) to (7) and (b) (3) and (4), 6 and 7.
Basic data on the substance shall mean:
(a) substance identification data, including data on the nature and concentration of the excipients, impurities and breakdown products, where manufacturers or importers are known:
1. the chemical name of the substance according to the International Union of Pure and Applied Chemistry System (IUPAC), in the case of polymers, also the chemical names of the monomers used for synthesis,
2. the other names of the substance, in particular the common name, the trade name, the group name, the abbreviations if used;
3. name and CAS identification number (according to Chemical Abstracts Service), if assigned to the substance,
4. the summary and structural formula; in the case of polymers, the number average of the molecular weight, the name and content of the starting monomers and substances bound in the polymer, the end-group information and the name and frequency of the functional groups;
5. information on the purity of the substance, including the possible variation in that purity, taking into account the form in which the substance is placed on the market;
6. information on the nature and concentration (% by weight) of the excipients, the results of the determination of the type and concentration (% by weight) of the major and other impurities and degradation products of the substance, if known to the manufacturer or importer, information on the CAS numbers of the major impurities, if any; in the case of polymers, the results of the determination of molecular weight distribution and information on the names and content (by weight) of unreacted monomers;
7. spectrum data, where appropriate for the identification of the substance; spectrum information includes spectrum obtained in ultraviolet, visible and infrared radiation areas and results obtained by magnetic resonance and mass spectroscopy;
8. the results of HPLC or gas chromatography;
(b) methods of detection and determination of the substance: a complete description of the methods used or applicable to determine the characteristics of the substance referred to in (a) (1) to (7) or the corresponding literary references;
(c) analytical methods for determining the substance and its transformation products in relation to the environment and direct human exposure;
(d) information on production and applications where manufacturers or importers are known:
1. information on the technological processes used in production;
2. information on the level of exposure to the substance at the workplace in its production and the level of emissions of the substance to the environment (reported only for the production of the substance in the Czech Republic),
3. information on the purpose of use, including a detailed description of the action of the substance and the desired effects;
4. information on the technological processes in which the substance will be used;
5. information on the level of exposure to the substance at the workplace and the level of emissions of the substance to the environment when using the substance;
6. information on the form in which the substance is placed on the market, i.e. whether as a substance or chemical preparation,
7. Information on the concentration of the substance in the chemical preparation,
8. information on areas of application with approximate mass distribution between industry, agriculture and the public;
9. Information on the quantity and composition of waste resulting from the use of the substance in the intended manner;
(e) a statement of the harmful effects of the substance on humans and the environment when used in the intended manner;
(f) information on the toxickinetic behaviour of the substance, using information and results from the testing of physico-chemical, toxicological and ecotoxicological properties and other relevant information;
(g) the draft classification, packaging and labelling of the substance;
(h) health and safety measures in the use of the substance and in the event of an accident recommended by the manufacturer or importer:
1. measures for safety and health in the handling, storage and transport of the substance;
2. information on possible fire hazards, recommended means of extinguishing and information on products produced during burning or pyrolysis;
3. information on other potential hazards, in particular chemical reactions in contact with water,
4. information on the explosive of the substance, if it can be found in the form of dust;
5. Measures in case of uncontrolled leakage of the substance,
6. measures in the event of persons being affected;
(i) details of the quantity of substance to be placed on the market or imported during the calendar year:
1. the estimated total quantity of the substance produced or imported in the first year and in the following years;
2. the expected distribution of the quantity of substance produced or imported in the first year and subsequent years according to the purpose of use and the area of use;
(j) information on the possibility of disposal, separately for business activities and other areas, i.e. in particular:
1. reuse;
2. the elimination of adverse reactions,
3. controlled storage in landfills,
4. burning,
5. waste water treatment;
6. other options;
(k) the results of the test of the substance:
1. physical, chemical and physico-chemical properties: the state of the substance at 20 ° C and 101,3 kPa; determination of: melting point, boiling point, relative density, vapour pressure, surface tension, water solubility, n-octanol / water partition coefficient, flash point, flammable, explosive, ignition temperature and oxidative properties; the determination of particle size (granulometry) for substances placed on the market in a form that presents a risk of inhalation exposure; in the case of polymers, the results of water leaching and, where appropriate, analysis of eluates;
2. Acute toxicity: results of acute toxicity tests in rodents, principally in oral administration and at least one other route of administration (dermal, inhalation) depending on the nature of the substance and the expected potential for human exposure; in the case of volatile substances, oral and inhalation administration, in the case of gases only inhalation administration,
3. mutagenicity: one bacterial test for the indication of gene mutations and one non-bacterial in vitro test for the indication of chromosomal aberrations,
4. reproductive toxicity: only if information is available relating to the potential effects of the substance on reproduction,
5. irritability and corrosivity: irritability to skin and eyes;
6. sensitisation: skin sensitisation,
7. subacute toxicity: testing for subacute toxicity in rodents for at least 28 days; the route of administration is chosen depending on the most likely route of human exposure, acute toxicity and the nature of the substance. Priority is given to oral administration unless there are serious reasons against this form of administration,
8. Biodegradability and abiotic degradability: testing of biodegradability by micro-organisms for a maximum period of 28 days and abiotic degradability testing if the substance is not readily biodegradable or if an abiotic degradability test is necessary for the evaluation of the substance;
9. Toxicity to aquatic organisms at short-term exposure: tests carried out on fish for 96 hours, Daphne tests for 48 hours or, in exceptional cases where justified, for 24 hours;
10. inhibition of algae growth,
11. bacterial inhibition: the test is carried out before the biodegradability test is carried out where biodegradability can be affected by the inhibition of the substance on bacteria,
12. adsorption and desorption.
In the cases provided for in Section 6 (3) of the Act, the manufacturer or importer shall submit the following basic data on the substance:
(a) where the quantity of substance placed on the market is less than 1 000 kg per year but more than 100 kg per year
1. the data referred to in Articles 4 (a) to (c), (e), (g), (i) and (k) (5) and (6);
2. the data referred to in Article 4 (d) (1) to (9) and (h) (1) to (3), (5) and (6);
3. test results: state of the substance at 20 ° C and 101,3 kPa, melting point, boiling point, vapour pressure, water solubility, n-octanol / water partition coefficient, flash point, flammable and, in the case of polymers, water leaching,
4. results of acute toxicity testing in rodents in one route of administration, usually oral. Gases are tested during inhalation administration,
5. results of bacterial gene mutation test; if the bacterial test is not suitable for testing the substance, an in vitro mammalian cell test shall be performed;
6. results of biodegradability testing using micro-organisms for a maximum period of 28 days;
7. results of toxicity tests for Daphne for 48 hours;
(b) where the quantity of substance placed on the market is equal to or less than 100 kg per year,
1. the data referred to in § 4 (a) to (c), (e), (g) and (i);
2. the data referred to in § 4 (d) (1) to (9) (h) (1) to (3), (5) and (6);
3. the results of the determination: the state of the substance at 20 ° C and 101,3 kPa, the flash point and the combustible point,
4. results of acute toxicity testing in rodents in one route of administration, usually oral. Gases should be tested during inhalation administration.
ADDITIONAL DATA
Additional grade I data
Additional grade I data means the results:
(a) testing for the physical, chemical and physico-chemical properties of a substance where necessary in the light of the results of the basic tests (e.g. new analytical methods enabling the determination of the substance, its transformation products or its thermal degradation products);
(b) testing for sub-chronic or chronic toxicity (one species of animals, males and females, the most appropriate route of administration of the substance) if further testing is necessary with regard to the results of the baseline test (e.g. findings of serious or irreversible damage, very low or undetectable level without observed adverse effect (NOAEL), the chemical structure of the substance is similar to another, demonstrably dangerous substance);
(c) testing the effect of the substance on fertility (one animal species, one generation, males and females, the most appropriate route of administration); if the results are not clear, the impact on fertility must be tested in the second generation;
(d) testing of teratogenicity (one animal species, most appropriate route of administration); This test shall only be performed if the teratogenic effect has not been observed in the tests under (c);
(e) other mutagenicity tests (if both tests were negative in the basic test of the substance, further tests shall be carried out taking into account the specific properties of the substance and the intended purpose of use; if both tests were positive in the background test of the substance, other in vivo test methods shall be used to confirm or refute the previous results),
(f) testing the basic toxickinetic properties of the substance;
(g) testing of potential biodegradability and abiotic degradability, unless sufficient degradation of the substance has been detected in the basic test of the substance;
(h) further studies of adsorption and desorption, to the extent necessary in the light of the results of the basic examination;
(i) bioaccumulation testing carried out on fish, if possible;
(j) testing for at least 21 days for the effects of the substance on fertility and mortality of Singapore magna;
(k) toxicity testing for fish for at least 14 days;
(l) testing the effect of the substance on higher plants and one species of earthworms.
Additional grade II data
Additional grade II data means the results:
(a) testing of toxickinetic properties including biotransformation properties;
(b) chronic toxicity testing;
(c) testing for carcinogenic properties in long-term animal tests;
(d) fertility testing in a two-generation study;
(e) testing the effect of the substance on animal development for species not tested in accordance with § 6 (d);
(f) testing for the effects of the substance at the perinatal and postnatal stages of development;
(g) testing of the specific organ and systemic toxicity of the substance;
(h) testing the mobility of the substance in water, soil and air, in particular carrying out further adsorption and desorption tests;
(i) other abiotic and biodegradability tests;
(j) other bioaccumulation tests;
(k) long-term testing of toxicity to fish, including effects on reproduction;
(l) testing the toxicity of the substance to birds, including effects on reproduction;
(m) testing for other properties of a substance which, by themselves or in conjunction with other properties, pose a risk to the environment.
PROTOCOLS AND SECURITY LIST
Protocols of tests carried out
Protocols for the performance tests carried out shall be accompanied by a copy of the certificate of good laboratory practice as an annex to the application for marketing authorisation.
Safety data sheet
(1) The safety data sheet of the substance is attached as an annex to the application for registration if the substance is classified as dangerous within the meaning of Section 2 (8) of the Act.
(2) The safety data sheets of dangerous substances and chemical products provided to the Ministry pursuant to Article 14 (1) of the Act are sent to the registration point by the manufacturer or importer before being placed on the market in paper form, where appropriate in agreement with the registration point in electronic form. The registration site shall be prepared without delay by safety data sheets for the needs of the Toxicological Information Centre.
(3) If, for reasons of commercial secrecy, the manufacturer or importer does not indicate the exact name and CAS number of a substance in the safety data sheet, the manufacturer or importer shall communicate this exact information to the registration site separately when the safety data sheet is sent.
SUBSTANCES TO APPEAR ON THE MARKET FOR THE NEED FOR APPLIED RESEARCH AND DEVELOPMENT
The application for an extension of a period of 1 year pursuant to Paragraph 6 (6) of the Act contains:
(a) the particulars referred to in Annex 1;
(b) the reasons for the request;
(c) the date of first delivery of the substance;
(d) a list of customers;
(e) a brief description of the research or development programme for which the substance is intended, including the planned starting and ending date and the quantity of the substance used;
(f) a declaration by the customer that the substance or chemical product in which the substance is contained will be handled only by the customer's employees under controllable conditions and will not be made available to other persons or in the form of a chemical product;
(g) substance data:
1. the data referred to in Article 4 (a) (1) to (5) and (7);
2. the type and content (%) of the excipients, the main and other impurities and degradation products, to the extent known to the manufacturer or importer,
3. an indication of the expected quantity of the substance produced or imported per year,
4. the information referred to in Article 4 (d) (3) to (6) and (9);
5. in the case of a dangerous substance, the information referred to in § 4 (h) (1) to (3), (5) and (6);
6. in the case of a substance that is highly toxic, toxic, carcinogenic, toxic for reproduction or mutagenic, toxicological data if available to manufacturers or importers,
7. Classification and labelling of the substance.
FINAL PROVISIONS
This Decree shall take effect on 1 January 1999.
Minister:
Dr. David, CSc.
Příloha č. 1
Annex No 1 to Decree No. 250 / 1998 Coll.
Model of application for registration of a substance
Příloha č. 2
Annex No 2 to Decree No. 250 / 1998 Coll.
Model of application for registration of a substance - basic data on the substance 1 and draft classification of the substance
1. IDENTIFICATION OF THE SUBSTANCE
1.1. Name
1.1.1. Chemical name by IUPAC2 nomenclature
1.1.2 Business name 3
1.1.3. Other names 4 or abbreviations when used
Number CAS5
1.1.5. Chemical name according to CAS6
1.2. Formula
Total Sample 7
Total formula according to CAS7
1.2.3 Structural Sample
1.2.4. Molecular mass of the substance
Additive composition
1.3.1. Degree of cleans9
1.3.2. Pollutant specification 10
1.3.3. Concentration of significant pollutants
1.3.4. Concentration of stabilisers, inhibitors or other additives as a percentage or ppm
1.3.5 Spectral data 12
1.3.6.
Contents
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Regulation Information
| Citation | Decree of the Ministry of Health No. 250 / 1998 Coll., on Registration of Chemicals |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 02.11.1998 |
|---|---|
| Effective from | 01.01.1999 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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