Decree No. 426 / 2004 Coll.
Ordinance on the Registration of Chemicals
Valid
Order
Effective from 01.08.2004
Zobrazeno prvních 200 z celkem 814 ustanovení tohoto předpisu.
Zobrazit celý předpis →
Pro stažení celého znění použijte tlačítko Stáhnout výše.
426
DECLARATION
of 2 July 2004
on the registration of chemicals
According to § 10 (11) of Act No. 356 / 2003 Coll., on Chemicals and Chemicals, and on the amendment of certain laws, hereinafter "the Act ', the Ministry of Health provides:
Subject matter
This decree implements the regulations of the European Community1) and lays down the
(a) applications for full registration of a chemical (hereinafter referred to as the substance) pursuant to Article 12 (1) of the Act;
(b) additional tests or studies referred to in Article 12 (2);
(c) applications for restricted registration of a substance under Article 13 (1) of the Act;
(d) applications for restricted registration of a substance under Article 13 (2) of the Act;
(e) applications for registration of a polymer pursuant to Article 18 of the Act;
(f) a request for consent to submit a limited range of information (hereinafter referred to as "limited set of tests") for the registration of an intermediate product pursuant to Article 12 (5) of the Act;
(g) applications for registration of an intermediate product with a limited set of examinations pursuant to Article 12 (1) and (5) of the Act;
(h) additional tests or studies when registering an intermediate product under Section 12 (2) of the Act.
Full registration of the substance and registration of the substance as an intermediate with a limited set of tests
The particulars of the application for full registration pursuant to Article 12 (1) of the Act and the particulars of the application for registration of a substance as an intermediate product with a limited set of tests provided for in Article 12 (1) and (5) of the Act, as evidenced by a legal person or an undertaking natural person (hereinafter referred to as "the entrepreneur ') at the latest before the marketing of 1 tonne of substance per calendar year or 5 tonnes of total quantity of substance from one manufacturer, are set out in Annex 1 to this Decree.
Restricted substance registration
(1) The requirements of the application for a restricted registration of a substance provided for in Article 13 (1) of the Act, as evidenced by the entrepreneur, where it places on the market at least 100 kg and less than 1 tonne of substance per calendar year from one producer, are set out in Annex 2 to this Decree.
(2) The requirements of the application for a restricted registration of a substance under Paragraph 13 (2) of the Act, which are evidenced by an entrepreneur when he places on the market less than 100 kg of a substance per calendar year or in total less than 500 kg per manufacturer, are set out in Annex 3 to this Decree.
Registration of polymer
(1) The particulars of the application for registration of a polymer provided for in Article 18 of the Act, as evidenced by the entrepreneur, if the anticipated quantity of polymer placed on the market is at least 1 tonne per calendar year or a total quantity of at least 5 tonnes per manufacturer, are set out in Annex 4 to this Decree, unless it is the case referred to in paragraph 4.
(2) The particulars of the application for registration of a polymer provided for in Article 18 of the Act, as evidenced by the entrepreneur if the anticipated quantity of polymer placed on the market is at least 100 kg and less than 1 tonne per calendar year or the total quantity of less than 5 tonnes per manufacturer, are given in Annex 5 to this Decree, unless it is a case referred to in paragraph 3 or 5.
(3) The particulars of the application for registration of a polymer provided for in Article 18 of the Act, as evidenced by the entrepreneur, if the anticipated quantity of polymer placed on the market is less than 100 kg per calendar year or the total quantity less than 500 kg per manufacturer, are set out in Annex 6 to this Decree, except in the case referred to in paragraph 5.
(4) The requirements of the application for registration of a polymer provided for in Article 18 of the Act, which is evidenced by an entrepreneur when placing on the market a polymer which is not readily degradable, has a high mean molecular weight, leaching capacity (extractable) in water of less than 10 mg of substances other than additives and impurities per litre of leaching, contain less than 1% of the components with a molecular weight of less than 1000 including monomers excluding additives and impurities, and the expected quantity of polymer placed on the market is at least 1 tonne per calendar year or the total quantity is at least 5 tonnes per manufacturer, are set out in Annex 7 to this Decree. Where compliance with those requirements cannot be demonstrated by means of the prescribed tests, the applicant shall demonstrate compliance with them by other means of proof. In such cases, the Ministry of Health (hereinafter referred to as the Ministry) may require toxicological and ecotoxicological tests in accordance with Annex 7, points 4 and 5.
(5) The requirements of the application for registration of a polymer provided for in Article 18 of the Act, which is evidenced by the entrepreneur when placing on the market a polymer which is not readily degradable, has a high mean molecular weight, water leaching capacity of less than 10 mg of substances other than additives and impurities per litre of leaching and the expected quantity of polymer placed on the market is less than 1 tonne per calendar year or the total quantity is less than 5 tonnes per manufacturer, are set out in Annex 8 to this Regulation. Where compliance with those requirements can not be demonstrated by the prescribed tests, the applicant shall demonstrate compliance with them by other means of proof.
Requirements for additional tests and studies
(1) The additional tests or studies which the Ministry may require to be carried out if the conditions laid down in Section 12 (2) (a) of the Act are fulfilled are set out in Annex 9 as stage 1. All additional examinations or studies of stage 1 require the Ministry if the conditions laid down in Section 12 (2) (b) of the Act are met.
(2) Additional examinations or studies required by the Ministry to be carried out if the conditions laid down in Section 12 (2) (c) of the Act are fulfilled are listed in Annex 9 as stage 2.
Details of the application for the registration of a substance, the registration of a substance as an intermediate with a limited set of tests or the registration of a polymer
(1) The person requesting the registration of a substance, a substance as an intermediate product with a limited set of tests or a polymer registration shall, together with the application, forward to the Ministry in five copies:
(a) information on a substance the extent (individual items) of which, including the results of additional tests or studies depending on the quantity of the substance placed on the market, is set out in Annexes 1 to 3 and 9;
(b) a declaration that:
1. the substance, when it is not a monomer, is manufactured exclusively for chemical treatment, consumed or used; in processing, the substance is transformed into chemically different molecules, not a polymer;
2. the substance is treated at no more than two additional processing sites, i.e. that the substance produced in one undertaking can be transported to one or two other processing undertakings,
3. delivery to the place where the intermediate product is further processed must be made directly by the person requesting registration, not through another supplier;
4. the substance must be strictly sealed throughout the life cycle, that is in the manufacture, transport, purification, cleaning and maintenance of equipment, sampling, analysis, filling and emptying of apparatus or containers, storage or treatment of waste and storage. All functional elements, such as filling holes, emptying devices, shall be included in the relevant process either as a closed design type with a secured leak or as a closed design type with an integrated exhaust system,
5. where exposure may occur, operational and control technologies that minimise emissions shall be available;
6. special procedures, such as rinsing and washing, shall be used for cleaning and maintenance before opening or entering the system,
7. in the event of an accident and where waste treatment, cleaning and maintenance occurs and environmental exposure is likely to occur, operational and control technologies which minimise emissions and resulting exposure shall be used in all cases;
8. There is an internal regulation setting out the task of each employee at work;
9. on the packaging of the substance, the label shall be accompanied by the following text: "Caution - the substance is not yet fully tested,"
10. the whole life cycle of the intermediate product shall be controlled at all places where the intermediate product is treated.
(c) information on a polymer the size of which, depending on the quantity and chemical characteristics of the polymer placed on the market, is set out in Annexes 4 to 8;
(d) reports of tests carried out on a substance or polymer, including the name and address of the institution or institutions which carried out the tests in accordance with the principles of good laboratory practice;
(e) a copy of the certificate of compliance with the principles of good laboratory practice in laboratories carrying out tests under Section 9 of the Act;
(f) a copy of the certificate of compliance with the principles of good laboratory practice in laboratories carrying out testing in accordance with Article 9 of the Act and a copy of the accreditation decision, if experimenting on animals (2);
(g) a copy of the administrative fee certificate according to the Administrative Charge3).
(2) When applying for registration of related polymers (homopolymers or copolymers), the results of tests or studies may be submitted with representative samples. The Ministry may request additional testing of additional representative samples.
(3) A group of related polymers is a group of polymers (either homopolymers or copolymers) with different average molecular weights or a different composition resulting from different ratios of monomer units. The difference in the mean molecular weight or composition is not determined by random effects in the production process, but by deliberate changes in the conditions of production, while the production process itself remains the same.
(4) Homopolymer is a polymer consisting of only one type of monomer units. Copolymer is a polymer consisting of more than one type of monomer units.
(5) The information on a substance or polymer referred to in paragraph 1 (a) or (c) shall be provided by the applicant to the Ministry, in addition to paper form, by electronic means using the Data Entry Screens (DES) programme for Windows.
(6) If some of the information required under paragraph 1 (a) or (c) does not have real meaning, taking into account the nature of the substance or polymer, the person shall enter "not to be entered" under the relevant heading.
(7) Where any of the information required under paragraph 1 (a) or (c) is not detectable, taking into account the nature of the substance or polymer, the person shall enter "not detected 'under the appropriate heading and briefly state the reasons for which the information could not be established.
Repeal
It shall be repealed:
1. Decree No. 250 / 1998 Coll., on the Registration of Chemicals,
2nd Decree No. 50 / 2001 Coll., amending the Decree of the Ministry of Health No. 250 / 1998 Coll., on the Registration of Chemicals.
Efficacy
This Decree shall take effect on 1 August 2004.
Minister:
Dr. Kubinyi, Ph.D. v. r.
Příloha č. 1
Annex No 1 to Decree No 426 / 2004 Coll.
Forms of application for full registration of a substance and registration of a substance as an intermediate product with a limited set of tests pursuant to Article 2 of the Decree (quantity of substance placed on the market is at least 1 tonne per calendar year or total quantity of substance placed on the market is greater than or equal to 5 tonnes)
0. IDENTIFICATION OF THE MANUFACTURER AND THE PERSONS REQUEST FOR MARKETING AUTHORISATION
PLACE OF PRODUCTION
For substances manufactured outside the Community for which the applicant has been designated as the sole representative of the manufacturer for the purposes of registration, the identification and addresses of all importers who will import the substance into the Community should be provided.
1 IDENTIFICATION OF THE SUBSTANCE
1.1. Name
1.1.1. Chemical name according to IUPAC2 nomenclature)
1.1.2 Other names (trade name3), shortcuts 4)
(if applicable)
1.2 Summary6) and Structural 7) Formula
Chemical composition
1.3.1. Purity level (%) 8)
1.3.2. Nature of impurities including isomers and by-products9)
1.3.3. Percentage of significant impurities (10)
1.3.4 Specifications for stabilisers, inhibitors or other additives (11) - species and concentration (a)................ ppm, (b)................% in order of quantity
1.3.5 Spectral data (UV13), IR14, NMR15) or mass spectrum)
1.3.6 Chromatography (HPLC, GC)
1.4 Methods of detection and determination
A full description of the methods used or relevant references to the literature should be provided.
In addition to detection and determination methods, information on analytical methods known to the applicant and allowing the detection of the substance and its products in the environment, including the determination of direct human exposure, shall be provided.
2. PRODUCT INFORMATION
2.0 Production
The information referred to in this Section shall be sufficient to permit an approximate but realistic estimation of human exposure and the environment in connection with the production process. The exact details of the production process are not required, in particular data which may be considered as a subject of business secrecy.
2.0.1. Technological procedure used in production16)
2.0.2 Production exposure estimates 17)
- working environment
- environment
2.1 Expected uses
The information referred to in this Section shall be sufficient to permit an approximate but realistic estimation of human exposure and the environment to the substances concerned in connection with the proposed or expected use.
2.1.1 Types of use with description of use and description of desired effects
Examples of areas of use, including codes, are given in Table 1 of this Annex. If no description of the area of use listed in the Annex is appropriate for the registered substance, code 999 shall be used and the description of the intended area of use shall be given.
Examples of the purpose of use, including codes, are given in Table 2 of this Annex. If no description of the purpose of the use set out in the Annex is appropriate for the registered substance, code 999 shall be used and the intended purpose of use shall be described.
2.1.1.1 Technological procedure (s) concerning the use of the substance (if known) 18
2.1.1.2. Estimates of exposure in use (if known) 19
- working environment
- environment
2.1.1.3. Form in which the substance is placed on the market 20)
2.1.1.4. Concentration of the substance in products placed on the market
2.1.2 Estimation of the use of the substance in individual areas21)
- industry
- agriculture and business
- public
2.1.3 Identification of the subscribers of the substance (if known)
2.1.4. Quantity and composition of waste generated by the proposed use (if known)
2.2 Estimates of production and / or imports into the Czech Republic for each of the intended types of use or areas of use
2.2.1. Total production and / or imports in tonnes per calendar year
- first calendar year
- the following calendar years
For substances manufactured outside the Community for which the applicant has been designated as the sole representative of the manufacturer for registration purposes, this information shall be provided for each importer referred to in point 0.
2.2.2 Production and / or imports, broken down by points 2.1.1 and 2.1.2, expressed as a percentage
- first calendar year
- the following calendar years
2.3 Recommended methods and precautions concerning
2.3.1 Manipulation22)
2.3.2 Storage 23)
2.3.3 Transport 24)
2.3.4 Fire (nature of flue-gases or pyrolysis if the proposed method of use so justifies) 25
2.3.5 Other hazards, in particular chemical reactions with water26)
2.3.6 Information on the susceptibility of the substance to explosion if it is in the form of dust, if relevant)
2.4. Measures in the event of accidental leakage 28)
2.5. Measures in case of contact with persons (e.g. poisoning) 29)
2.6 Packing 30)
3. PHYSICAL-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.0 at 20 ° C and 101,3 kPa31)
3.1 Thaw point 32)
3.2 Warning point 33)
3.3 Hustota34)
3.4 Tension par35)
3.5 Surface voltage 36)
3.6 Solubility in water37)
3.7 Distribution coefficient n-octanol / water38)
3.8 Fire point 39)
3.9 Flammability
3.10 Explosion40)
3.11 Incineration temperature
3.12 Oxidation properties
3.13 Granulatrie41)
For substances that may be placed on the market in a form presenting a risk of inhalation exposure, a test should be performed to determine the particle size distribution of the substance in the form in which it will be marketed.
4. TOXICOLOGICAL STUDIES
4.1 Acute toxic42)
For the tests referred to in paragraphs 4.1.1 to 4.1.3, substances, except gases, shall be applied in at least two ways, one of which shall be oral. The choice of the second method depends on the nature of the substance and the anticipated human exposure. Gases and volatile liquids should be inhaled.
4.1.1 Oral application43)
4.1.2 Inhalation application44)
4.1.3 Dermal application45)
4.1.4 Skin irritation46)
4.1.5 Eye irritation47)
4.1.6 Skin sensitisation 48)
4.2 Repeated dose
The method of administration must be as appropriate due to the likely route of human exposure, acute toxicity and nature of the substance. In the absence of contraindications, the oral method is usually preferred.
4.2.1 Repeated dose toxicity (28 days)
4.3 Other effects
4.3.1 Mutagenita49)
The substance is tested in two ways. One test must be carried out on bacteria (reverse mutation) with or without metabolic activation. The second test shall be non-bacteriological to detect changes or damage to chromosomes. In the absence of contraindications, this test is usually performed in vitro with or without metabolic activation. In the case of a positive result of one or the other test, further testing according to § 8 (5) of Act 356 / 2003 Coll.
4.3.2 Reproductive toxicity (resulting data must be recorded) 50
4.3.3 Evaluation of the toxickinetic behaviour of a substance to the extent that can be derived from a basic set of data and other related information (e.g. from expert literature) 51)
5. ECOTOXICOLOGICAL STUDIES
5.1 Effects on organisms 52)
5.1.1 Acute toxicity to fish 53)
5.1.2 Acute toxicity for dafnie54)
5.1.3. Inhibition of algae growth 55)
5.1.4 Inhibition of bacteries56)
In cases where biodegradation may be affected by the inhibition effect of the substance on bacteria, a bacterial inhibition test should be performed prior to biodegradation.
5.2 Displaceability
- biotic
- abiotic.
If the substance is not readily biodegradable, the need for the following test should be considered: hydrolysis as a pH function.
5.3 Screening Absorption / Desorption Test
6. POTENTIAL DISEASES
In this chapter, it is necessary to distinguish between business and others. Examples of standard sentences for disposal procedures are given in Table 3 of this Annex.
6.1 Business area
6.1.1 Recycling possibility 57)
6.1.2 The possibility of neutralising adverse reactions 58)
6.1.3 Possible disposal 59)
- controlled landfill
- combustion 60)
- waste water treatment 61)
- other procedures
6.2 Other areas
6.2.1 Recycling possibility 57)
6.2.2 The possibility of neutralising adverse reactions 58)
6.2.3 Possible disposal 59)
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree No. 426 / 2004 Coll., on the Registration of Chemicals |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 21.07.2004 |
|---|---|
| Effective from | 01.08.2004 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
Comments 0