232
The Decree
of 20 April 2004
implementing some provisions of the Act on Chemical Substances and Chemical Preparations and on
Amendments to some Acts concerning the classification, packaging and labelling of dangerous chemical
substances and chemical preparations
The Ministry of Industry and Trade, pursuant to Article 3(7), Article 19(3) and Article 20(7) of the Act
No. 356/5003 Coll., on Chemical Substances and Chemical Preparations and on Amendments to some Acts
(hereinafter referred to as “Act”) stipulates as follows:
Article 1
Subject of the regulation
a)
b)
c)
d)
e)
f)
g)
h)
1
This Regulation, in accordance with the law of the European Community 1), stipulates for:
A list of chemical substances mandatorily classified as dangerous (hereinafter referred to as "List”),
and the manner of their use,
A general methodology for the evaluation and labelling of the properties of dangerous chemical
substances (hereinafter referred to as "Substance”) and chemical preparations (hereinafter referred to
as "Preparation”),
Conventional calculation methods for the evaluation of dangerous properties of preparations based
on their physical and chemical properties, health hazards, and environmental hazards,
Other particulars of the packaging of dangerous preparations to be sold to consumers,
Particulars for the labelling of dangerous substances, dangerous preparations and preparations that
may pose a specific hazard to human health or the environment,
Warning symbols and alphabetical labelling identifying hazardous physical and chemical properties
and properties hazardous to human health or the environment,
Standard R-phrases (risk phrases) identifying special risks,
Standard S-phrases (safety phrases) to provide information on safe handling.
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative
provisions relating to the classification, packaging and labelling of dangerous substances as last amended by
Council Regulation (EC) No 807/2003 of 14 April 2003 adapting to Decision 1999/468/EC the provisions
relating to committees which assist the Commission in the exercise of its implementing powers laid down in
Council instruments adopted in accordance with the consultation procedure (unanimity).
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the
approximation of the laws, regulations and administrative provisions of the Member States relating to the
classification, packaging and labelling of dangerous preparations as last amended by Regulation (EC) No
1882/2003 of the European Parliament and of the Council of 29 September 2003 adapting to Council
Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of
its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the
EC Treaty.
Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and
administrative provisions of the Member States relating to restrictions on the marketing and use of certain
dangerous substances and preparations as last amended by the Commission Directive 2004/21/EC (thirteenth
adaptation to technical progress of Council Directive 76/769/EEC).
Article 2
Definition of the List and the manner of its utilization,
of the general methodology and of the conventional calculation methods
(1) The List and the manner of the utilization are specified in Annex 1 hereto.
(2) The general methodology for the evaluation and labelling of the properties of dangerous chemical
substances and chemical preparations are specified in Annex 2 hereto.
(3) The conventional calculation methods for the evaluation of dangerous properties of preparations based
on their physical and chemical properties, health hazards, and environmental hazards are specified in Annex 3
hereto.
Article 3
Additional properties of the packaging of dangerous preparations
to be sold to consumers
(1) In addition to the requirements stipulated by the Act, the packaging of dangerous preparations to be sold
to customers shall meet the following requirements:
a) A packaging containing a dangerous preparation dangerous to the lungs (Xn, R65) and classified
and labelled according to Annex 2 hereto shall have a seal resistant to opening by a child, except for
preparations marketed in spray packaging2) or in a packaging fitted with non-detachably connected
spray fixture;
b) A packaging containing a dangerous preparation, which contains at least one of the following
substances:
1. Methanol (CAS No. 67-56-1, ES No. 200-659-6) in a concentration equal or higher than 3 %,
2. Dichloromethane (CAS No. 75-09-2, ES No. 200-838-9) in a concentration equal or higher
than 1 %,
shall have a seal resistant to opening by children.
(2) Seals resistant to opening by children are deemed compliant with Article 19(2)(a) of the Act provided
that they conform to relevant technical standards.3)
(3) Palpable embossed symbols for blind persons are deemed compliant with Article 19(2)(a) and (b) of the
Act provided that they conform to relevant technical standards. 4)
Particulars for the labelling of dangerous substances
and dangerous preparations
Article 4
Names of dangerous substances present in dangerous preparations
(1) The chemical name/s of a dangerous substance or substances present in a dangerous preparation shall be
rendered in accordance with the following principles:
a) For a preparation classified as highly toxic, toxic and hazardous to health, the names shall be given
of highly toxic, toxic and harmful to health substances present in concentrations equal to or higher
than relevant minimum limit (Xn limit) specified for each of the substances in the List, or, in case
2
Government´s Regulation No. 194/2001 Coll., laying down technical specifications for aerosol sprays.
3
Czech standard CSN EN 28317+AC (77 0410) “Children-safe packaging. Requirements and test procedures
for resealable packaging.”
Czech standard CSN EN 862 (77 0411) “Packaging – Children-Safe Packaging - Requirements and test
procedures for non-resealable packaging for other than pharmaceutical products”.
4
Czech standard CSN EN ISO 11683 (77 4001) “Packaging –Embossed Palpable Warnings – Requirements”
and Errata No. 1.
when no limits are specified in the list, relevant limits shall be used, which are specified in Tables I,
II or III of Section B contained in Annex 3 hereto.
b) For a preparation classified as caustic, the names shall be given of caustic substances present in
concentrations equal to or higher than relevant minimum limit (Xi limit) specified for each of the
substances in the List, or, in case when no limits are specified in the list, relevant limits shall be
used, which are specified in Table IV of Section B Part 2 in Annex 3 hereto.
c) For a dangerous preparation, the labelling shall give the names of dangerous substances, which
render the preparation dangerous according to one or more of the following hazard groups and
categories:
1. Class 1, 2 or 3 carcinogens,
2. Class 1, 2 or 3 mutagens,
3. Toxic to reproduction, Class 1, 2 or 3,
4. Highly toxic, toxic or harmful to health due to non-lethal effects of a single exposure,
5. Toxic or harmful to health due to serious health effects of repeated or chronic exposure,
6. Sensibilising,
d) The labelling of a dangerous preparation shall give the name of the dangerous substance, which
render the preparation explosive, oxidizer, extremely flammable, highly flammable, flammable,
irritating or hazardous to the environment only if such name must be given for reasons under a), b)
or c),
e) To identify dangerous substances posing major hazard to health, usually the names of no more than
four such substances are sufficient.
(2) To label dangerous preparations containing only substances classified as:
a) Irritating, except for substances assigned R41 phrase pursuant to Annex 5 hereto or irritating and
displaying at the same time one or more of the following properties:
1. Explosive,
2. Oxidizing,
3. Extremely flammable,
4. Highly flammable,
5. Flammable,
6. Hazardous to the environment,
or
b)
Harmful to health and displaying at the same time one or more of the following properties:
1. Explosive,
2. Oxidizing,
3. Extremely flammable,
4. Highly flammable,
5. Irritating,
6. Hazardous to the environment, causing acute lethal effects,
the names identifying the most important functional groups of such ingredients or alternative names 5) thereof
may be used in line with Article 20(8) of the Act instead of their chemical names.
Article 5
Choice of warning symbols
(1) Warning symbols and alphabetical codes for hazardous properties are listed in Annex 4 hereto.
(2) The warning symbol comprises a graphic symbol of relevant in the form of a pictogram (icon) and a
description of the hazard.
(3) Hazardous properties of substances and preparations may also be expressed in words.
(4) Warning symbols and relevant worded expression of hazardous properties are not stipulated for
hazardous properties listed in Article 2(5)(e), (k), (l), (m) or (n) of the Act.
(5) Dangerous substances listed in the List shall be assigned relevant warning symbols given in the same.
(6) Dangerous substances not listed in the List and dangerous preparation shall be assigned relevant
warning symbols according to criteria specified in Annexes 2 and 3 hereto.
5
Article 20(8) of the Act No. 356/2003 Coll., on Chemical Substances and Chemical Preparations and on
Amendments to some Acts.
(7) If a dangerous substance or dangerous preparation is assigned more warning symbols and unless he List
stipulates otherwise, then
a) If the hazard symbol for “T” or “T+” is assigned together with symbols for “Xn”, “Xi” or for “C”,
the symbols for “Xn”, “Xi” or for “C” do not have to be used,
b) If the hazard symbol for “C” is assigned together with symbols for “Xn” or “Xi”, the symbols for
“Xn” and “Xi” do not have to be used,
c) If the hazard symbol for “E” is assigned together with symbols for “F+”, “F” or for “O”, the
symbols for “F+”, “F” or for “O” do not have to be used,
d) If the hazard symbol for “Xn” is assigned together with symbols for “Xi”, the symbol for “Xi” does
not have to be used.
(8) Each symbol shall cover at least one tenth (1/10) of the area of the label but not less than 1 cm2. The
warning symbol shall be executed in black colour on a yellow-orange background.
Article 6
Choice of R-phrases
(1) A list of R-phrases is given in Annex 5 hereto.
(2) R-phrases given in the List shall be used to identify hazards on the label.
(3) Dangerous substances specified in the List shall be assigned R-phrases given in the same.
(4) Dangerous substances not included in the List and dangerous preparations shall be assigned relevant
R-phrases according to criteria given in Annex 2 and 3 hereto. If a dangerous substance not included on the List
or a dangerous preparation displays more dangerous properties, R-phrases relevant to all such properties shall be
listed on the label.
(5) Typically six R-phrases are sufficient to identify hazards. If a preparation falls into more than one
hazard group, relevant R-phrases on its label shall identify all the main hazards of the preparation.
(6) The label of substances hazardous to human health and not included on the List shall give the following:
a) R-phrases relevant to hazard groups for which hazard symbols are prescribed,
b) R-phrases relevant to other hazard groups with no hazard symbol assigned.
(7) In case of dangerous substances not included on the List posing hazards due to their physical and/or
chemical properties, their label shall give R-phrases, for which hazard symbols are prescribed.
(8) In case of substances hazardous to the environment and not included on the List, their label shall give
R-phrase (R-phrases) relevant to its/their “hazardous to the environment” classification.
(9) In case of substances hazardous to human health, their label shall give the following:
a) R-phrases relevant to hazard group for which hazard symbol is prescribed. The same shall give Rphrases assigned to the ingredient of ingredients due to which the preparations fall into relevant
hazard group as listed in B section of Annex 3 hereto.
b) R-phrases relevant to other hazard groups of ingredients with no hazard symbol assigned pursuant to
Article 5(4).
(10) In case of preparations posing hazard due to their physical and chemical properties, their label shall give
R-phrases according to criteria given in paragraph 9. This does not apply to the R-phrases “extremely
flammable” or “highly flammable”, which R-phrases do not have to be on the label if they repeat the words
given on relevant hazard symbol.
(11) The label of preparations hazardous to the environment shall give the following:
a) R-phrase (R-phrases) identifying the “hazardous to the environment” classification,
b) R50/53 R-phrase, if R50 phrase has been assigned to such preparations in addition to R51/53 or
R52/53 or R53.
Article 7
Choice of S-phrases
(1) A list of S-phrases is given in Annex 6 hereto.
(2) S-phrases given in the List shall be used to identify hazards on the label.
(3) Dangerous substances specified in the List shall be assigned S-phrases given in the same. If substances
on the List have no S-phrase or S-phrases assigned, the manufacturer or importer may assign them any suitable
S-phrase or S-phrases.
(4) Dangerous substances not included on the List and dangerous preparations shall be assigned S-phrases
according to criteria given in Annex 2, the final selection of relevant S-phrases being made according to the
following criteria:
a) In case of S-phrases pertinent to the disposal of relevant substance/preparation, one S-phrases shall
be given if the disposal of the material or its packaging poses is hazardous to human health or the
environment,
b) S-phrases identifying the same hazard/s as R-phrases shall only be used on the label if such Sphrases are supposed to point out a specific warning/hazard,
c) Such S-phrases should be selected for the label, which are compatible with intended manner of the
use or application of dangerous substances and dangerous preparations (e.g. spray application or
spray-can packaging),
d) S-phrases S1, S2 and S45 shall be given on the labels of all highly toxic, toxic or caustic substances
and preparations sold to customers,
e) S-phrases S2 and S46 shall be given on the labels of all other dangerous substances and dangerous
preparations sold to customers, except for substances and preparations classified as “hazardous to
the environment” only.
Article 8
Labelling of some groups of dangerous substances and dangerous preparations
(1) In addition to information stipulated for in the Act, dangerous preparations
a) to be sold to customers,
b) to be applied by spraying or in the form of an aerosol,
c) containing a substance with R33 phrase assigned,
d) containing a substance with R64 phrase assigned,
shall be labelled according to Annex 7 hereto.
(2) Products containing asbestos shall – in addition to information stipulated for in the Act– also be labelled
according to Annex 8 hereto.
(3) The following shall apply to dangerous substances and dangerous preparations in packaging with a
volume not exceeding 125 ml:
a) In case of substances classified as highly flammable, flammable, oxidizing, or irritating, their labels
do not have to give R-phrases and S-phrases. This also applies for the labelling of substances
classified as “hazardous to human health”, unless they are intended to be sold to consumers,
b) In case of preparations classified as highly flammable, flammable, oxidizing, or irritating, except for
preparations with R41 phrase assigned or hazardous to the environment with “N” symbol assigned,
their labels do not have to give R-phrases and S-phrases. This also applies for the labelling of
substances classified as “hazardous to human health”, unless they are intended to be sold to
consumers,
c) In case of preparations classified as flammable or hazardous to the environment but with no “N”
symbol assigned, their labels shall give R-phrases, but S-phrases are not mandatory,
(4) Dangerous substances
a) gases in general, if transported in cylinders dedicated for gas transportation,
b) propane, butane or liquefied petroleum gas (LPG) in gas cylinders,
c) pure metals in solid form,
d) substances classified (characterised) by R65 phrase,
shall be labelled according to Annex 9 hereto.
(5) Dangerous preparations
a) gaseous preparations (gas mixtures) if transported in cylinders dedicated for gas transportation,
b) preparations containing odorised propane, butane or liquefied petroleum gas (LPG) in gas cylinders,
c) alloys, preparations containing polymers and preparations containing elastomers,
d) preparations characterised by R65 phrase,
shall be labelled according to Annex 9 hereto.
Article 9
Label dimensions
(1) The dimensions of a label or an area on the packaging of a dangerous substance or preparation shall be
the following:
a) At least 52 x 74 mm for packaging with a volume not exceeding 3 L,
b) At least 74 x 105 mm for packaging with a volume over 3 L but not exceeding 50 L,
c) At least 105 x 148 mm for packaging with a volume over 50 L but not exceeding 500 L,
d) At least 148 x 210 mm for packaging with a volume exceeding 500 L.
Article 10
Preparations with specific hazard to human health or the environment
The labels of preparations with specific hazard to human health or the environment shall – in addition
to providing for information stipulated for in Article 20(3) of the Act – also be marked in the manner given in
Annex 10 hereto.
Article 11
Abrogating provisions
The Regulation No. 26/1999 Coll., on the manner of the execution and labelling the packaging of
dangerous chemical substances and preparations.
Article 12
Effect
This Regulation shall be applied as from the entry into force of the Treaty of Accession of the Czech
Republic to the European Union.
Minister:
Ing. Urban (mp)