Decree No. 402 / 2011 Coll.
Ordinance on the evaluation of dangerous properties of chemicals and chemical mixtures and the packaging and labelling of dangerous chemical mixtures
Valid
Order
Effective from 01.01.2012
Text versions:
01.01.2012
16.12.2011
Zobrazeno prvních 200 z celkem 1944 ustanovení tohoto předpisu.
Zobrazit celý předpis →
Pro stažení celého znění použijte tlačítko Stáhnout výše.
402
DECLARATION
of 8 December 2011
on the evaluation of the dangerous properties of chemicals and chemical mixtures and the packaging and labelling of dangerous chemical mixtures
The Ministry of Industry and Trade provides, pursuant to Sections 6 (3), 11 (3) and 12 (6) of Act No. 350 / 2011 Coll., on Chemicals and Chemical Mixtures and on the amendment of certain laws (Chemical Act), hereinafter referred to as "the Act":
Subject matter
This decree implements the relevant European Unionregulations (1) and also follows the directly applicable European UnionRegulations (2) and provides:
(a) general procedures for assessing the hazardous properties of the substance [§ 1 (a) of the Act] and mixtures [§ 1 (a) of the Act] and labelling of the mixture,
(b) conventional calculation methods for assessing the hazardous properties of the mixture on the basis of those of health and environmental hazards;
(c) other elements of packaging of dangerous mixtures intended for sale to the consumer;
(d) mixtures which may present a specific health or environmental hazard;
(e) the particulars of the labelling of a dangerous mixture and mixture which may constitute a specific risk to health or the environment;
(f) warning symbols and letters of dangerous physicochemical properties and of a mixture dangerous to health or the environment;
(g) standard phrases indicating the specific risk of the substance or mixture (R-phrases);
(h) standard instructions for the safe handling of the substance or mixture (S-phrases).
Determination of procedures and methods for assessing hazardous properties of substances and mixtures and labelling of mixtures
(1) The general procedures for assessing the hazardous properties of the substance and the mixture and the labelling of the mixture are set out in Annex 1 to this Decree.
(2) Conventional calculation methods for assessing the hazardous properties of the mixture based on those of health and environmental hazards are set out in Annex 2 to this Decree.
Labelling of certain groups of hazardous mixtures
(1) In addition to the data contained in the Act, dangerous mixtures
(a) intended for sale to the consumer;
(b) intended for use by spraying or spraying;
(c) containing a substance with an assigned phrase R 33,
(d) containing a substance associated with the sentence R 64,
(e) gaseous when transported in gas cylinders;
(f) containing deorified propane, butane or liquefied petroleum gas (LPG) in gas containers;
(g) alloys, mixtures containing polymers and mixtures containing elastomers;
(h) classified as R 65,
indicate in accordance with Annex 3 to this Decree.
(2) The mixtures which may constitute a specific health or environmental hazard are set out in Annex 4 to this Decree. In addition to the information provided for in § 12 (1) and (2) of the Act, these mixtures shall also be identified in the manner set out in Annex 4 to this Decree.
Forms of packaging of dangerous mixtures intended for sale to the consumer ensuring increased protection of children and the blind
(1) The packaging for a dangerous mixture, which is provided in accordance with § 11 (2) of the Act by a tangible warning for the blind, must also be provided with a child-resistant closure, if it contains a dangerous mixture which:
(a) presents a risk of lung damage (Xn, R 65) and is classified and labelled in accordance with Annex 1, paragraph 3.2.3 of this Decree, if not a mixture placed on the market in aerosol dispenser (3) or in a package equipped with an inseparably connected spray device;
(b) contains methanol (CAS No 67- 56-1, EC No 200- 659- 6) at a concentration equal to or greater than 3%;
(c) contains dichloromethane (CAS No 75- 09-2, EC No 200- 838- 9) at a concentration equal to or greater than 1%.
(2) The packaging of a dangerous mixture intended for sale to the consumer, which is fitted with a child-resistant cap or a closure with a palpable warning for the blind, must also comply with the requirements of the relevant Czech technical standard governing child-resistant packaging or with a palpable warning for the nevidomain 4).
Dimensions of the marking
The dimensions of the label or packaging surface to indicate the dangerous mixture are:
(a) at least 52 x 74 mm if the volume of packaging does not exceed 3 l,
(b) at least 74 x 105 mm if the packaging volume is more than 3 l and does not exceed 50 l,
(c) at least 105 x 148 mm if the packaging volume is more than 50 l and does not exceed 500 l,
(d) at least 148 x 210 mm if the packaging volume is more than 500 l.
Names of dangerous substances in dangerous mixtures
The chemical name of the dangerous substance or substances present in the dangerous mixture shall be indicated in accordance with the following rules:
(a) for a mixture classified as highly toxic, toxic and harmful, the names of substances of very toxic, toxic and harmful health present at concentrations equal to or greater than the lowest limit (Xn limit) given for each of them in the list (Section 4 (2) of the Act), or, where the limits are not included in the list, the limits set out in Annex 2, Part 1, Section B, Tables I, IA, II, IIA or III, IIIA of this Decree shall apply;
(b) for a mixture classified as corrosive, the names of the corrosive substances present at concentrations equal to or greater than the lowest limit (Xi limit) given for each of them in the list or, in the absence of limits in the list, the limits set out in Annex 2, Part 1, Section B, Table IV and IVA of this Decree shall apply;
(c) the name of the dangerous substances which justify the classification of the mixture in one or more of the following groups and categories of hazards shall be indicated on the labelling of the dangerous mixture:
1. carcinogenic category 1, 2 or 3,
2. mutagenic category 1, 2 or 3,
3. toxic for reproduction category 1, 2 or 3,
4. Highly toxic, toxic or harmful to non-lethal effects following single exposure,
5. toxic or harmful to health due to serious effects following repeated or long-term exposure,
6. sensitising,
(d) the name of the dangerous substance for which the mixture is classified as explosive, oxidising, extremely flammable, highly flammable, flammable, irritating or hazardous to the environment need not be indicated if the name of the substance does not need to be given for the reasons set out in (a), (b) or (c);
(e) it is sufficient, as a general rule, to identify dangerous substances which present the main risks to health to indicate the names of a maximum of four of them.
Select the warning symbol
(1) The warning symbols and letters of the dangerous properties of the mixture are given in Annex 5 to this Decree.
(2) The warning symbol includes a graphic symbol in the form of a pictogram and a verbal expression of danger.
(3) The dangerous properties referred to in § 5 (1) (e), (k), (l), (m) or (n) of the Act do not have separate warning symbols and letters of dangerous properties.
(4) The warning symbols shall be assigned to dangerous mixtures according to the criteria set out in Annexes 1 and 2 to this Regulation.
(5) Where dangerous mixtures are assigned multiple warning symbols and unless otherwise specified in the list, the following shall apply:
(a) when assigning the warning symbol "T +" or "T" simultaneously with the warning symbols "Xn," "Xi" or "C" the symbols "Xn," "Xi" and "C" need not be used;
(b) when assigning the warning symbol "C" simultaneously with the warning symbols "Xn" or "Xi" the warning symbols "Xn" and "Xi" need not be used;
(c) when assigning the warning symbol "E" simultaneously with the warning symbols "F +," "F" or "O", the warning symbols "F +," "F" and "O" need not be used;
(d) the warning symbol "Xn" together with the warning symbol "Xi" need not be assigned.
(6) Each graphic symbol shall cover at least one tenth of the area of the label. Where the area for marking is less than 10 cm2, each graphic symbol shall cover at least 1 cm2. The graphic symbol is made in black on yellow and orange background.
Choice of R-phrases
(1) The list of R phrases is set out in Annex 6 to this Decree.
(2) In the designation of the mixture, the R-phrases shall be given in accordance with Annex 6 to this Decree.
(3) The dangerous substances listed in Section 4 (2) of the Act shall be assigned the R-phrases listed therein.
(4) Hazardous substances not listed and dangerous mixtures are assigned R-phrases according to the criteria set out in Annexes 1 and 2 to this Decree. If a hazardous substance not listed or a hazardous mixture has more dangerous properties, the R-phrases corresponding to all these properties are assigned.
(5) As a rule, six R phrases are sufficient to describe risks. When a mixture is classified in more than one hazard group, the R-phrases on the label shall cover all major risks associated with the mixture.
(6) In the case of a mixture dangerous to health, the labelling shall indicate:
(a) R-phrases corresponding to the hazard group for which the warning symbol is provided. The R-phrases assigned to the component (s) of the mixture which cause the mixture to be classified in the relevant hazard group shall be provided in accordance with the tables set out in Annex No 2, Part 1, B to this Decree,
(b) R-phrases corresponding to other hazard groups of ingredients for which no warning symbol is provided under Section 7 (4) of this Decree.
(7) In the case of a mixture whose hazards result from physicochemical properties, the labelling shall always indicate the R-phrases according to the criteria referred to in paragraph 6. This does not apply to the R-phrases "extremely flammable" or "highly flammable" which need not be mentioned if the wording from the verbal expression of danger given in the warning symbol is repeated.
(8) In the case of a mixture hazardous to the environment, the labelling shall indicate:
(a) R- or R- phrases corresponding to the classification "hazardous to the environment,"
(b) the sentence R 50 / 53 where, in addition to the sentence R 51 / 53 or R 52 / 53 or R 53, the sentence R 50 has been assigned.
Sv Choice
(1) The list of Swords is set out in Annex 7 to this Decree.
(2) In the designation of the mixture, the S-phrases shall be given in accordance with Annex 7 to this Decree.
(3) Hazardous mixtures shall be assigned S-phrases according to the criteria set out in Annex 1 to this Decree and their final selection shall be made according to the following criteria:
(a) if the S-phrases are related to disposal, one S-sentence shall be indicated if the removal of material and packaging presents a risk to health or the environment;
(b) The phrases corresponding to the R-phrases shall be indicated on the label only if the purpose of the marking is to highlight a specific warning;
(c) Swords are chosen taking into account the intended conditions of use of a dangerous mixture (e.g. spraying or aerosol dispensers);
(d) the sentences S 1, S 2 and S 45 must appear on the labelling of all toxic and corrosive mixtures sold to consumers;
(e) the sentences S 2 and S 46 must be indicated in the labelling of other hazardous mixtures sold to consumers, except for mixtures classified only as hazardous to the environment.
(4) Where the choice of S-phrases made in accordance with the criteria set out in point 6.2 of Annex No 1 to this Regulation results in an excess or ambiguity of the precautionary statements, or where certain S-phrases are clearly not necessary in respect of a specific product or packaging, the designation of the mixture shall not appear.
Efficacy
1. This Decree shall take effect on 1 January 2012.
2. The Decree expires on 31 May 2015.
Minister:
MUDr. Cuba v. r.
Příloha č. 1
Annex No. 1 to Decree No. 402 / 2011 Coll.
General procedures for evaluation of hazardous properties of the substance and mixture and labelling of the mixture
1. GENERAL INTRODUCTION
1.1. Sources of required data for classification and labelling
1.2. Application of criteria for the assessment of hazardous properties
2. GENERAL CLASSIFICATION ON THE BASIS OF PHYSICAL - CHEMICAL PROPERTIES
2.1. Criteria for classification, selection of warning symbols, hazard marking and selection of risk phrases
2.1.1 Explosive
2.1.2 Oxidising
2.1.3 Extremely flammable
2.1.4 Highly flammable
2.1.5 Flammable
2.1.6 Other physicochemical properties
2.2. Remarks
3. GENERAL CLASSIFICATION ON THE BASIS OF HEALTH HAZARDS
3.1 General procedures
3.2 Criteria for classification, selection of warning symbols, hazard marking and selection of risk-specific standard phrases
3.2.1 Very toxic
3.2.2 Toxic
3.2.3 Harmful
3.2.4 Notes for use of sentence R 48
3.2.5
3.2.6.
3.2.7 Sensitising
3.2.8 Other health hazards
4. GENERAL CLASSIFICATION ON THE BASIS OF SPECIFIC HEALTH EFFECTS
4.1 Criteria for classification, hazard marking and selection of risk-specific standard phrases
4.1.1 Carcinogenic
4.1.2. Mutagenic
4.1.3 Toxic to reproduction
4.2. Classification procedure for specific health effects
5. GENERAL CLASSIFICATION FOR ENVIRONMENTAL EFFECTS
5.1 General procedures
5.2 Criteria for classification, hazard marking and selection of risk-specific standard phrases
5.2.1 Water environment
5.2.2. Other environment
5.3 Note
6. OPENING STANDARD GUIDELINES FOR SAFETY TREATMENT (WORLD)
6.1 Preliminary remarks
6.2 Standard guidance on safe handling of mixtures
7. SPECIFIC CASES: Mixtures
7.1. Gas mixtures
7.2 Organic peroxides
1. GENERAL INTRODUCTION
1.1. Sources of required data for classification and labelling
1.1.1. For the classification of substances:
(a) for substances for which the information specified in Annexes VI, VII and VIII to the directly applicable European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (5) is required, most of the data required for classification and labelling are included in the technical dossier. This classification and labelling shall be reviewed where necessary, where additional data are available in accordance with Annexes IX and X to the directly applicable European Union Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (5);
(b) for other substances, i.e. substances not subject to registration under the directly applicable European Union Regulation (5), data may be obtained for classification and labelling from different sources, in particular from:
- the results of earlier tests,
- information required under international rules on the transport of dangerous substances,
- information obtained from quoted works and literature, or
- information derived from practical experience.
Verified results of relationships structure-effect and expert opinions can also be used.
1.1.2. For classification and labelling of mixtures:
(a) physico-chemical data can be obtained using methods according to the directly applicable European Union Regulation (6). This also applies to plant protection products under other legislation7) unless another legislation7) provides for other methods. For gaseous mixtures, the calculation methods referred to in paragraph 7.1 of this Annex may be used for oxidising and flammable properties. For mixtures other than gaseous ones containing organic peroxides, the calculation method may be used for oxidation properties;
(b) health data may be obtained:
- the use of methods according to the directly applicable European Union Regulation (6). This applies to plant protection products where other legislation7) does not provide for other assessment methods,
- or by applying the conventional calculation method set out in Annex 2, Part One, to this decree,
- in the case of sentence R 65, by applying the rules set out in paragraph 3.2.3 of this Annex,
- in the case of the evaluation of the properties of carcinogenic, mutagenic and toxic for reproduction, using the conventional calculation method set out in Annex 2, Part One, to this decree;
(c) data on ecotoxicological properties may be obtained:
1. for aquatic toxicity:
- the application of methods according to the directly applicable European Union Regulation (6), depending on the conditions set out in Annex No 2, Part Two, C to this Decree. This applies to plant protection products where other legislation7) does not provide for other assessment methods; or
- by applying the conventional calculation method set out in Annex 2, Part Two, to this decree,
2. to evaluate the potential of bioaccumulation (or for actual bioaccumulation) by determination of log Pow (or BCF)
Note:
log Pow = logarithm of octanol / water partition coefficient
BCF = bioconcentration factor
3. for the evaluation of biological degradation by using the conventional calculation method set out in Annex 2, Part Two, to this Decree,
4. for the evaluation of the hazard to the ozone layer by using the conventional calculation method set out in Part Two of Annex 2 to this Decree.
1.1.3. Note on animal testing
Tests on animals are subject to other legislation8).
1.1.4. Note to physicochemical properties
For organic peroxides and mixtures containing organic peroxides, data can be obtained using the calculation method (see paragraph 7.2). For gaseous mixtures, the calculation method may be used to determine flammable and oxidising properties (see paragraph 7.1).
1.2. Application of criteria for the assessment of hazardous properties
The classification of the substance and mixture shall be carried out according to this point (1.2) on the basis of the criteria set out in points 2 to 5 (substances) and points 2, 3, 4.2 and 5 (mixtures) of this Annex. All kinds of hazards must be considered.
The choice of the warning symbol (s) and the standard risk phrases (s) shall be made on the basis of the classification to ensure that the designation indicates the specific nature of the potential hazard identified in the classification.
Notwithstanding the criteria set out in points 2.1.3, 2.1.4 and 2.1.5, substances and mixtures in the form of aerosols shall be subject to the requirements of another legislation4).
1.2.1. Application of evaluation criteria for the substance
The assessment criteria set out in this Annex may be applied directly if the relevant data have been obtained by test methods comparable to those directly applicable to the European Union6). In other cases, the available data shall be evaluated by comparing the test methods used with those specified in the directly applicable European Union Regulation (6) and the criteria specified in this Annex for determining the relevant classification.
1.2.1.1. Classification of a substance containing impurities, additives or individual constituents
Where impurities, components or components of a substance are identified, they shall be taken into account if their concentration is greater than or equal to the limit concentrations referred to in Article 4 (2) of the Act.
1.2.2. Application of assessment criteria for the mixture
The assessment criteria set out in this Annex may be applied directly if the data concerned have been obtained using test methods comparable to those in accordance with the directly applicable European Union Regulation (6), with the exception of the criteria in point 4, for which only the conventional calculation method referred to in Annex 2, Part One, to this Decree may be used. The conventional calculation method shall also be applicable in relation to the criteria set out in point 5, except for aquatic toxicity, depending on the conditions set out in Annex 2, Part Two, Section C to this Decree. For plant protection products (7), data obtained by other internationally accepted methods may also be used for classification and labelling (see the specific provision in point 1.2 of this Annex). In other cases, data shall be evaluated by comparing the test methods used with those according to the directly applicable European Union Regulation (6) and the criteria set out in this Annex for determining the relevant classification and labelling.
If the hazard for health and the environment is assessed using the conventional calculation method provided for in Sections 8 and 9 of the Act and Annex 2 to this Decree, the individual concentration limits used are either:
(1) in the list; or
2) in Annex 2 to this Decree, if the substance or substances are not listed or are listed without concentration limits:
- for health hazards (Annex No 2, Part One of this Decree):
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree No. 402 / 2011 Coll., on the evaluation of hazardous properties of chemicals and chemical mixtures and the packaging and labelling of dangerous chemical mixtures |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 16.12.2011 |
|---|---|
| Effective from | 01.01.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0