Decree No 231 / 2004 Coll.
Order setting out the detailed contents of the safety data sheet for the hazardous chemical and chemical preparation
Valid
Order
Effective from 01.05.2004
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231
DECLARATION
of 20 April 2004
laying down the detailed content of the safety data sheet for the hazardous chemical and chemical preparation
According to Article 23 (8) of Act No. 356 / 2003 Coll., on Chemicals and Chemicals and on the Amendment of Certain Acts (hereinafter referred to as "the Act"), the Ministry of Industry and Trade provides:
The detailed content of the safety data sheet (1) to the hazardous chemical (hereinafter referred to as the substance) and the chemical preparation (hereinafter referred to as the preparation) is set out in the Annex to this Decree.
Decree No. 27 / 1999 Coll., on the form and content of the safety data sheet for hazardous chemical and preparation, is hereby repealed.
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:
Ing. Urban v. r.
Annex to Decree No 231 / 2004 Coll.
Detailed contents of the safety data sheet
The information shall be provided for each dangerous property. A clear distinction shall be made between cases where the classifier has no information and cases where negative test results are available. If information on certain properties is irrelevant or technically impossible to provide, it is necessary to justify this at that point.
The date of issue shall be indicated on the first page of the safety data sheet.
1. Identification of the substance or preparation and manufacturer, importer, first distributor or distributor
1.1 Identification of the substance or preparation
The name of the substance or preparation shall be indicated identical to that indicated on the label on the packaging. Other names of the substance or preparation may also be provided.
1.2. Use of the substance or preparation
Specify the intended or recommended uses of the substance or preparation, if known. Where more than one possible use exists, only the most important or common shall be indicated. A brief description of the function of the substance or preparation shall be given (e.g. extinguishing agent, antioxidant, etc.).
1.3. Identification of the manufacturer, importer, first distributor or distributor
For the manufacturer, importer, first distributor or distributor, the name or, where applicable, the name, surname, business name, place of business and telephone number, if any, if it is a natural person authorised to do business, or name or business name, legal form, seat and telephone number, if it is a legal person. In the case of a substance or preparation transported on the territory of the Czech Republic from another Member State of the European Communities, the first distributor shall provide the identification details of his person and the manufacturer, importer or distributor established in the territory of another Member State of the European Communities (Section 23 (2) of the Act).
1.4. Emergency telephone number
Enter the company's or advisory body's telephone number for the provision of emergency information (e.g. accident, life and health hazards) related to the substance or preparation.
2. Information on the composition of the product
The information provided shall enable the recipient to easily identify the hazardous properties of the constituents of the preparation. The dangerous properties of the product itself shall be indicated in point 3 of the Safety Data Sheet.
2.1 It is not necessary to indicate the complete composition of the preparation, a general description of the hazardous components and their concentration may be given.
2.2 For dangerous preparations classified under Section 2 (5) of the Act, the following substances shall be listed together with their concentrations or concentration ranges:
- substances which present a health or environmental hazard if they are contained in concentrations equal to or greater than those specified in Annex 1 to the Act, provided that there are no lower limits in the specific legislation (4), (5),
- substances for which exposure limits are allowed (6) and are no longer included among substances posing a health or environmental hazard.
Note: Substances present in a dangerous preparation and classified exclusively as:
- irritating, with the exception of substances assigned to the sentence R 41, or irritating in conjunction with one or more of the following characteristics: explosive, oxidising, extremely flammable, highly flammable, flammable, hazardous to the environment, or
- harmful or harmful health in combination with one or more of the following: explosive, oxidising, extremely flammable, highly flammable, flammable, irritating, hazardous to the environment, representing acute lethal effects,
In accordance with Section 20 (8) of the Act, names identifying the most important functional groups or their alternative names may be used instead of the names of these substances. 7) This procedure cannot be used if an exposure limit for the substance is established. 6)
2.3 For preparations which are not classified as hazardous under the law, the following substances shall be listed together with their concentrations or concentration ranges if they are contained in an individual concentration ≥ 1% by weight for preparations other than gaseous and ≥ 0,2% by volume for gaseous products:
- substances presenting a risk to health or the environment,
- substances for which exposure limits are allowed (6).
Note: Where the person placing these products on the market can demonstrate that the identification of a substance is exclusively classified as:
- irritant, with the exception of substances assigned to the sentence R 41, or irritant in conjunction with one or more of the following characteristics: explosive, oxidizing, extremely flammable, highly flammable, flammable, hazardous to the environment, or
- harmful to one or more of the following characteristics: explosive, oxidising, extremely flammable, highly flammable, flammable, irritating, dangerous to the environment, representing acute lethal effects alone,
in the Safety Data Sheet, the subject of a trade secret under Section 17 of the Act may indicate the name identifying the most important chemical functional groups or its alternative names7). This procedure cannot be used if an exposure limit for the substance is established. 6)
2.4 The classification of the constituents of the preparation referred to in points 2.2 and 2.3, including the letter marking of dangerous properties and R- phrases, which are assigned on the basis of their physical-chemical, hazardous to health and hazardous to the environment, shall be provided. The full version of the R-phrases shall not be required; reference shall be made to point 16 of the safety data sheet indicating the full text of each relevant R-phrases.
2.5. The names of the substances referred to in points 2.2 and 2.3 shall be given in the form of one of the names listed in the list of mandatory classified hazardous substances (hereinafter referred to as the list). If a substance is not listed in the List, the name of the substance shall be indicated in accordance with internationally recognised nomenclature. In addition, their EC number according to Einecs8), Elincs9) or Nlp8) shall be indicated. It is appropriate to specify their CAS number (Chemical Abstracts Service number). For substances listed under a group name in accordance with the notes referred to in paragraphs 2.2 and 2.3, precise chemical identification is not necessary.
2.6 Where the confidentiality of data is to be maintained in accordance with the notes referred to in paragraphs 2.2 and 2.3, the chemical nature of those substances shall be described in order to ensure that they are handled safely. The name used shall be the same as that derived from the established procedures (7).
3. Data on the hazards of the substance or preparation
3.1 The classification of the substance or preparation shall be provided according to the law. The risks posed by the substance or preparation to humans and the environment shall be clearly and briefly described.
A clear distinction shall be made between products that are classified as dangerous under the law and products that are not classified as dangerous under the law.
3.2 The most important adverse physico-chemical effects, health and environmental effects and the symptoms associated with the use and possible inappropriate use of the substance or preparation that can be predicted shall be described.
3.3 Other risks, such as dust, nitrites, frostbite hazards, or environmental effects, such as hazards to soil organisms, etc., which do not affect classification but contribute to the overall hazard of the material shall be identified.
3.4 The information on the packaging shall be given in point 15.
4. Instructions for first aid
It shall first be determined whether immediate medical assistance is needed.
Instructions for first aid shall be given, which shall be concise and easily understandable to the disabled, the persons present and the workers providing first aid. Briefly summarise the symptoms and effects. The instructions shall indicate what needs to be done in the event of an on-site accident and whether delayed effects can be expected after exposure.
The information shall be divided into sub-paragraphs by individual exposure routes, i.e. exposure by inhalation, skin and eye contact and ingestion.
It shall be indicated whether professional assistance by a physician is needed or recommended.
For certain substances or preparations it shall be noted that special means must be available at the workplace to ensure specific and immediate treatment.
5. Measures for emergency intervention
The requirements for extinguishing the fire in the event of a fire caused by a substance or a preparation or produced in or around the substance shall be indicated, indicating:
- suitable fireplaces,
- fireplaces which cannot be used for safety reasons,
- specific hazards caused by exposure to the substance or preparation itself, burning products or resulting gases,
- special protective equipment for firefighters.
6. Measures in case of accidental leakage of a substance or preparation
According to the type of substance or preparation:
- preventive measures to protect persons such as the removal of ignition sources, measures for adequate ventilation and protection of the respiratory organs, reduction of dust, avoidance of contact with skin and eyes,
- preventive measures to protect the environment, such as prevention of sewerage, surface water, groundwater and soil, possible need to warn the environment,
- cleaning methods such as the use of absorbent materials such as sand, quartz, acid absorbers, universal absorbent, sawdust, etc., reduction of gas or vapour content by water, dilution.
Warning may be given, such as "never use...," "neutralize using...."
Where appropriate, reference shall be made to points 8 and 13 of the Safety Data Sheet.
7. Instructions for the treatment of the substance or preparation and storage of the substance or preparation
7.1 Treatment
7.1.1. Precautions for the safe handling of the substance or preparation shall be provided, including instructions for technical measures such as safety zone, local and general ventilation, measures to prevent aerosol and dust formation, fire prevention measures.
7.1.2. Specify the required preventive measures to protect the environment, such as the use of filters or separators at the outlet of the ventilation system, use in a enclosed area, measures for the capture and disposal of leaks, etc.
7.1.3. All specific requirements or rules relating to the substance or preparation (e.g. prohibited or recommended procedures and equipment) shall be reported, preferably with a brief description.
7.2 Storage
7.2.1. Specify the conditions for safe storage, such as specific requirements for storage areas or containers (including storage walls and ventilation), incompatible materials, storage conditions (temperature and humidity limits / ranges, lighting, inert gas, etc.), special electrical equipment and prevention of static electricity.
7.2.2. Where appropriate, quantitative limits shall be indicated under the storage conditions in question. In particular, all special requirements, such as the type of material used for packaging and packaging of the substance or preparation, shall be indicated.
7.3 Specific (specific) use
For finished products intended for specific use, detailed operational recommendations for the intended purpose (s) of use shall be provided. Reference may be made to specific approved industrial or sectoral operational procedures.
8. Restriction of exposure by substance or preparation and protection of persons
8.1 Exposure limits
Indicate the permissible exposure limit values (6) or limit values for biological exposure tests10). Information on recommended monitoring procedures shall be provided. For products, the values for those components of the preparation, as specified in the safety data sheet in point 2, shall be given.
8.2 Exposure limitation
For the purposes of the safety data sheet, the total set of specific protective and preventive measures to be taken to minimise exposure to workers and the environment when using substances and preparations shall be considered as a restriction of exposure.
8.2.1 Limitation of worker exposure
The information referred to in this point shall be used by the employer to assess the risk posed by the substance or preparation for the health and safety of workers under the specific legislation10).
Information shall be provided on appropriate working practices and technical regulatory measures, the use of appropriate equipment and materials, the application of collective protection measures and the use of individual protective measures such as the use of personal protective equipment. This information shall be supplemented by the information already referred to in point 7.1.
Where necessary, the protection of persons shall be specified precisely which equipment provides adequate and appropriate protection. The requirements of the Specific Legislation (11) shall be taken into account and reference shall be made to the relevant technical standards.
8.2.1.1 Respiratory protection
In the case of hazardous gases, vapours or dust, the type of personal protective equipment such as breathing apparatus, appropriate masks and filters shall be specified.
8.2.1.2. Hand protection
The type of gloves to be used for the handling of the substance or preparation shall be clearly specified, including:
- the type of material,
- the penetration times of the glove material with regard to the intensity and duration of the skin exposure.
If necessary, any additional measures to protect hands shall be indicated.
8.2.1.3 Eye protection
Specify the required type of personal eye protection device, such as goggles, safety goggles, facial shield.
8.2.1.4 Skin protection
Where it is necessary to protect parts of the body other than the hands, the type and characteristics of the required personal protective equipment, such as apron, shoes and overall protective clothing shall be specified. If necessary, any other skin protection measures and specific hygiene measures shall be indicated.
8.2.2 Limitation of environmental exposure
Information required by the employer to fulfil obligations under environmental legislation (12) shall be provided.
9. Information on the physical and chemical properties of the substance or preparation
All relevant information on the substance or preparation shall be provided, in particular the information referred to in point 9.2, in order to take appropriate protective measures.
9.1 General information
Appearance - state (solid, liquid, gas) and colour of the substance or preparation in the state in which it is supplied.
The odour or odour - if identifiable, shall be briefly written.
9.2 Important information on health, safety and the environment
The following shall be indicated:
- the pH of the substance or preparation as supplied or in an aqueous solution; in the case of an aqueous solution, indicate its concentration;
- boiling point or boiling range,
- flash point,
- flammable (solids, gases),
- explosive properties,
- oxidation properties,
- tenze par,
- density,
- solubility
in water,
in fats (specify solvent - oil),
- partition coefficient n-octanol / water,
- viscosity,
- vapour density,
- evaporation rate.
9.3. Further information
Additional safety-relevant properties such as mixing, conductivity, melting point or melting range, gas class, ignition temperature, etc.
The determination of these characteristics shall be carried out in accordance with the law.
For products, information on the properties of the product itself shall be provided. A clear distinction shall be made between cases where the classifier has no information and cases where negative test results are available. Where information on the characteristics of each component is provided, it shall be clearly indicated that this information relates to the constituents of the preparation.
10. Information on the stability and reactivity of the substance or preparation
Data shall be provided on the stability of the substance or preparation and on the possibility of hazardous reactions under certain conditions of use as well as on release into the environment.
10.1 Conditions to be avoided
An overview of conditions such as temperature, pressure, light, impact, etc., which may cause a dangerous reaction, and a brief description thereof, shall be provided.
10.2 Materials that cannot be used
An overview of materials such as water, air, acids, bases, oxidising agents or any other specific substances which may cause a dangerous reaction and a brief description thereof shall be provided.
10.3 Dangerous degradation products
A list of hazardous materials arising during decomposition in hazardous quantities shall be provided. In particular:
- the need and presence of stabilisers,
- the possibility of a dangerous exothermic reaction,
- the possible importance of changing the physical state of the substance or preparation for safety,
- any hazardous degradation products arising from contact with water,
- the possibility of decomposition into unstable products.
11. Information on the toxicological properties of the substance or preparation
A brief but complete and understandable description of the various toxicological effects (effects on health) which may occur in contact with the user of the substance or preparation shall be provided.
11.1 Indicate the health effects arising from exposure to the substance or preparation, based on both experience and conclusions of scientific experiments. Information on different routes of exposure (inhalation, ingestion, skin and eye contact) shall be provided and the symptoms associated with physical, chemical and toxicological properties shall be described.
11.2 Known long-term and immediate effects as well as chronic effects resulting from both short-term and long-term exposure, such as sensitisation, narcotic effects, carcinogenicity, mutagenicity and toxicity to reproduction (developmental and fertility effects) shall be reported. In the light of the information already provided in point 2 of the Safety Data Sheet, references to the specific health effects of certain constituents of the products may also be made.
12. Environmental information on the substance or preparation
The potential effects, behaviour and fate of the substance or preparation in air, water or soil and the corresponding test results, if available, e.g. LC50, fish shall be indicated. The most important properties likely to affect the environment shall be described, given the nature of the substance or preparation and the likely use methods. Information of the same species shall be provided for dangerous products arising from the degradation of substances and preparations. This is the following information:
12.1 Ecotoxicity
Appropriate available data on aquatic toxicity, acute and chronic toxicity to fish, Daphne, algae and other aquatic plants shall be provided. Where available, toxicity data for soil micro-organisms and macro-organisms and other environmental relevant organisms such as birds, bees and plants shall be provided. If the substance or preparation has inhibitory effects on the activity of micro-organisms, the potential impact on sewage treatment plants shall be reported.
12.2 Mobility
Data shall be provided on the ability of the substance or individual components of the preparation to penetrate groundwater or disperse over a long distance in case of leakage into the environment.
Important data include:
- known or expected distribution to environmental compartments,
- surface tension,
- absorption or desorption.
Other physicochemical properties are already listed in point 9.
12.3 Persistence and degradability
Data shall be provided on the ability of the substance or the relevant constituents of the preparation to decompose in the relevant environmental compartments either by biological degradation or by other processes such as oxidation or hydrolysis. If available, half-lives shall be indicated. The ability of the substance or the relevant components of the preparation to decompose in sewage treatment plants shall also be indicated.
12.4 Bioaccumulation potential
Data shall be provided on the ability of the substance or the relevant components of the preparation to accumulate in the biota and to pass through the food chain, referring to the Kow and BCF values if available.
12.5 Other adverse effects
Where available, information shall be provided on any other adverse effects on the environment, such as ozone depletion, photochemical ozone generation or global warming potential.
Information relevant to the environment shall also be provided at other points of the safety data sheet, in particular guidance on controlled discharges, accidental release, transport and disposal measures, shall be given in points 6, 7, 13, 14 and 15 of the safety data sheet.
13. Instructions for disposal of the substance or preparation
13.1. Where the disposal of a substance or preparation (surpluses or waste resulting from the intended use) presents a danger, information on the safe handling of the substance or preparation shall be provided.
13.2 Appropriate methods of disposal of the substance or preparation and all contaminated packaging (e.g. incineration, recycling, landfill, etc.) shall be provided.
13.3. The waste legislation shall be provided.
14. Information for the transport of a substance or preparation
14.1 Any special precautions to be taken by the user shall be indicated and observed when transporting or transporting inside or outside the undertaking.
14.2. The corresponding information concerning the transport classification for each mode of transport shall be provided:
- road transport: ADR13),
- rail transport: RID14),
- air transport: ICAO / IATA15),
- sea transport: IMDG16).
This information shall include in particular:
- UN number,
- hazard class,
- the names of the substances transported,
- packaging group,
- a marine pollutant,
- other applicable data.
15. Information on legislation regarding the substance or preparation
15.1. Information relating to health, safety and environment protection shall be provided, which must be provided by law on the packaging of the substance or preparation.
15.2 Where the substance or preparation included in the safety data sheet is subject to specific provisions concerning the protection of persons or the environment at European Community level (e.g. restrictions on placing on the market and use), they shall be indicated.
15.3. Legislation containing specific provisions on the protection of persons or the environment (e.g. restrictions on marketing and use) shall be provided.
16. Further information on the substance or preparation
Any other information deemed relevant by the manufacturer, importer or first distributor for the protection of the health and safety of the user and for the protection of the environment, such as:
- the list of relevant R- phrases; the full text of all the R phrases referred to in points 2 and 3 of the safety data sheet shall be given,
- training instructions,
- recommended restrictions on use (i.e. non-binding recommendations from the manufacturer or importer),
- further information (written references or contact point for the provision of technical information),
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Regulation Information
| Citation | Decree No 231 / 2004 Coll. |
|---|---|
| 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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