Decree No. 220 / 2004 Coll.
Order setting out the formalities for notification and keeping records of hazardous chemicals
Valid
Order
Effective from 01.05.2004
Text versions:
01.05.2004
29.04.2004
220
DECLARATION
of 14 April 2004
laying down the formalities for the notification and registration of hazardous chemicals
The Ministry of the Environment (hereinafter referred to as "the Ministry ') provides, pursuant to § 28 (14) of Act No. 356 / 2003 Coll., on Chemicals and Chemical Products and amending certain acts (hereinafter referred to as" the Act'):
The manufacturer or importer of a dangerous chemical (hereinafter referred to as "the substance ') placed on the market either alone or as part of a chemical preparation (hereinafter referred to as" the preparation') in a concentration higher than that specified in Annex 1 to the Act shall keep a register of that substance as set out in Annex 1 to this Decree. The registration of a substance or preparation shall be kept separately for each substance or preparation and for each establishment of the manufacturer or importer separately.
(1) The manufacturer who produces and the importer who imports the dangerous substance on its own or contained in the preparation and places it on the market in quantities greater than 1000 tonnes per calendar year shall notify the Ministry of the identification of the dangerous substance and the data on its quantity and properties as set out in Annex 2 to this Decree.
(2) The manufacturer who produces and the importer who imports the dangerous substance on its own or contained in the preparation and places it on the market in quantities greater than 10 tonnes and less than or equal to 1 000 tonnes per calendar year shall notify the Ministry of the type and quantity of the dangerous substance referred to in points 1 and 2 of Annex 2 to this Decree.
(3) The manufacturer and importer only notify data on the properties of the substance on the first notification of the substance. Information which the manufacturer and importer may obtain without additional testing shall be reported, either from specialised literature or from other professional sources. When notifying an identical substance in subsequent years, only changes and additions to the data already notified shall be reported.
(4) The data referred to in paragraphs 1 and 2 shall be reported in the form of a computer data file in the HEDSET format. The HEDSET programme, including the User's Guide and Methodology Guidance, shall be provided by the Ministry to the manufacturer and importers free of charge upon request.
(5) The notification referred to in paragraphs 1 and 2 shall be made separately for each type of substance and each establishment of the manufacturer or importer.
The following shall be deleted:
1. Decree No. 302 / 1998 Coll., laying down the detailed conditions of professional competence and the procedure for its verification, the procedure for demonstrating medical fitness, the procedure for granting and withdrawing authorisations, the list of selected hazardous substances and preparations, the import and export of which is only possible with the consent of the Ministry of the Environment, the content of the application for import and export and the manner and details of keeping records and notification of dangerous chemicals and preparations.
2. Decree No. 391 / 2000 Coll., amending Decree No. 302 / 1998 Coll., laying down the detailed conditions of professional competence and the procedure for its verification, the procedure for demonstrating medical fitness, the procedure for granting and withdrawing authorisation, the list of selected hazardous substances and preparations whose import and export is only possible with the consent of the Ministry of the Environment, the content of the application for import and export and the manner and details of keeping records and notification of dangerous chemicals and preparations.
This decree shall take effect on the date of the entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Minister:
RNDr. Ambrozek v. r.
Příloha č. 1
Annex No 1 to Decree No. 220 / 2004 Coll.
1. Registration of dangerous substances shall include:
(a) Identification of the substance
- chemical name according to the list of mandatory hazardous substances (hereinafter referred to as the list); if the substance is not listed in the List, the Czech name must be used according to internationally recognised nomenclature,
- CAS number according to Chemical Abstract Service,
- EC number according to Einecs, Elincs or Nlp.
(b) Identification of impurities
- chemical name according to the List; if the substance is not listed in the List, the name shall be used according to the internationally recognised nomenclature,
- CAS number according to Chemical Abstract Service,
- EC number according to Einecs, Elincs or Nlp,
- the concentration of the impurity substance by weight.
(c) Identification of ingredients
- chemical name according to the List; if the substance is not listed in the List, the name shall be used according to internationally recognised nomenclature,
- CAS number according to Chemical Abstract Service,
- EC number according to Einecs, Elincs or Nlp,
- the concentration of the substance forming the ingredient by weight.
d) Classification of the substance
- the letter marking of dangerous properties in accordance with Section 20 (4) (c) of the Act,
- standard risk phrases (R-phrases) pursuant to Section 20 (4) (d) of the Act,
- for the manufacturer, the quantity of the substance produced and the importer, the quantity of the substance imported (always in mass units).
If the substance does not contain additives or impurities, the data shall not be provided.
2. Continuous registration of dangerous substances in preparations shall include:
(a) Identification of product
- trade name,
(b) Identification of the ingredients of the preparation
- chemical name according to the List; if the substance is not listed in the List, the name shall be used according to internationally recognised nomenclature,
- CAS number according to Chemical Abstract Service,
- EC number according to Einecs, Elincs or Nlp,
- concentration by weight.
c) Classification
- the letter marking of dangerous properties in accordance with Section 20 (5) (d) of the Act,
- standard risk phrases (R-phrases) according to § 20 (5) (e) of the Act,
- the quantity of the product imported (in units of weight).
Příloha č. 2
Annex No 2 to Decree No 220 / 2004 Coll.
Notification of the production and import of dangerous substances
The notification of the production and import of dangerous substances shall include:
1. Basic data on producers and importers
1.1. Business name or name as registered in the Commercial Register or in the Commercial Register,
1.2 IČO (business identification number),
1.3. Business address, i.e. street, location and postal code,
1.4 the code of the district in whose territory is the registered office of the entrepreneur, according to the code list of the counties of the Czech Republic,
1.5. Name of establishment, i.e. the name used in the address next to the business firm,
1.6. Address of separate establishment, i.e. street, location and postal code,
1.7 code of the district in whose territory the establishment is located, according to the code list of the counties of the Czech Republic,
1.8 the code ZUJ, i.e. the code of the municipality in whose territory the establishment is located,
1.9. Name of responsible staff member,
1.10 Telephone / fax to the responsible staff member.
2. Basic data on the substance
2.1. Chemical name according to the list of mandatory classification of hazardous substances (hereinafter referred to as the list); if the substance is not listed in the List, the name shall be used according to the internationally recognised nomenclature,
CAS number 2.2 according to Chemical Abstract Service,
2.3 the EC number in the Einecs, Elinks or Nlp list,
2.4. Sumoral (molecular) formula,
2.5. Structural formula,
2.6 group of substances (only for petroleum substances),
2.7 type of substance broken down: inorganic, organic, organo-metallic, element, natural substance, petroleum product,
2.8 molecular mass,
2.9 at 20 ° C and 101,3 kPa,
2.10 the quantity of substance produced or imported for the reporting year, expressed in tonnes,
2.11 degree of purity (% m / m) and accuracy of determination,
2.12 common name or trade name or abbreviation, as appropriate;
2.13. The identification of impurities - the identification details of the substance constituting the impurity are the chemical name according to the List, CAS number, EC number according to the Einecs, Elinks or Nlp list,
2.14. Identification of ingredients - Identification data on the substance forming the ingredient are chemical name according to the List, CAS number, EC number according to the Einecs, Elinks or Nlp list,
2.15 letter marking of dangerous properties according to § 20 (4) (c) of the Act,
2.16 the standard risk phrases (R - sentences) according to § 20 (4) (d) of the Act,
2.17 standard precautionary guidance (S - sentences) according to § 20 (4) (e) of the Act,
2.18 method of use broken down: to a limited extent, to a large extent, to a closed system, to be incorporated into the product,
2.19 kind of use.
3. Physical-chemical properties
3.1. Melting point,
3.2 boiling point,
3.3. Specific mass,
3.4 vapour pressure,
3.5. Distribution coefficient (log Pow),
3.6 solubility in water,
3.7 flash point,
3.8. Self-ignition,
3.9 flammable,
3.10 Explosivity,
3.11 oxidation properties,
3.12 additional data and comments.
4. Fate and transport of substances in the environment
4.1 Stability,
4.1.1 photodegradation,
4.1.2. Stability in water,
4.1.3 soil stability,
4.2 environmental monitoring data,
4.3 transport and distribution between environmental components,
4.4 method of decomposition,
4.5 Biodegradability,
4.6 BSK5 and COD,
4.7 bioaccumulation,
4.8 additional data and comments.
5. Ecotoxicity
5.1 Acute toxicity to fish,
5.2 acute toxicity to aquatic invertebrates,
5.3 inhibition of algae growth,
5.4 inhibition of bacterial growth,
5.5. Chronic toxicity to fish
5.6. Chronic toxicity to aquatic invertebrates;
5.7. Toxicity to soil organisms
5.8 toxicity to terrestrial plants,
5.9 toxicity to terrestrial animals other than mammals;
5.10 monitoring of biological effects,
5.11 biotransformation and kinetics,
5.12 additional data and comments.
6. Toxicity
6.1 Acute toxicity,
6.1.1 acute oral toxicity,
Acute toxicity of inhalation,
6.1.3. Acute dermal toxicity,
6.1.4 acute toxicity (other),
6.2. Corrosion and irritation,
6.2.1 skin irritation,
6.2.2 eye irritation,
6.3 sensitisation,
repeated dose toxicity,
6.5 in vitro mutagenicity,
6.6 in vivo mutagenicity,
6.7 carcinogenicity,
toxicity to reproduction,
6.9 developmental toxicity,
6.10 other important information,
6.11 human exposure experience.
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Regulation Information
| Citation | Decree No. 220 / 2004 Coll., laying down the formalities for notification and registration of hazardous chemicals |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.04.2004 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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