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"B COMMISSION DIRECTIVE 98/98/EC
of 15 December 1998
adapting to technical progress for the 25 time Council Directive 67/548/EEC on the approximation of the
laws, regulations and administrative provisions relating to the classification, packaging and labelling of
dangerous substances
(Text with EEA relevance)
(OJ L 355, 30.12.1998, p. 1)
Amended by:
Official Journal
No page date
"M1 Commission Decision 2000/368/EC of 19 May 2000 L 136 108 8.6.2000
Corrected by:
"C1 Corrigendum, OJ L 293, 15.11.1999, p. 1 (98/98/EC)1998L0098 — EN — 08.06.2000 — 001.001 — 1
COMMISSION DIRECTIVE 98/98/EC
of 15 December 1998
adapting to technical progress for the 25 time Council Directive
67/548/EEC on the approximation of the laws, regulations and adminis-trative provisions relating to the classification, packaging and labelling of
dangerous substances
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,Having regard to Council Directive 67/548/EEC of 27 June 1967 on the
approximation of the laws, regulations and administrative provisions relatingto the classification, packaging and labelling of dangerous substances (
1), as
last amended by Commission Directive 98/73/EC (2), and in particular Article
28 thereof,
Whereas Annex I to Directive 67/548/EEC contains a list of dangerous
substances, together with particulars of the classification and labelling
procedures in respect of each substance; whereas present scientific andtechnical knowledge has shown that the list of dangerous substances in that
Annex should be adapted; whereas in consequence it is necessary to amend
the foreword to Annex I so as to include changes in nomenclature, format ofentries, notes relating to the identification, classification and labelling ofsubstances and notes relating to the labelling of preparations; whereas the list
of dangerous substances in Annex I contains substances for which specific
temporary classification and labelling derogations have been granted toAustria and Sweden by the Act of Accession of Austria, Finland and Sweden;whereas the Act of Accession provides for the review of the classification and
labelling requirements of those substances; whereas that review leads to the
adaptation of classifications for a number of such substances;
Whereas Annex III to Directive 67/548/EEC contains a list of phrases
indicating the nature of special risks attributed to dangerous substances andpreparations; whereas it is necessary to introduce new phrases indicating the
danger to health of certain substances and preparations;
Whereas Annex IV to Directive 67/548/EEC contains a list of the phrases
indicating the safety advice concerning dangerous substances and prepara-
tions; whereas it is necessary to revise certain safety advice phrases related tothe dangers to health and for the environment; whereas it is necessary tointroduce certain safety advice phrases related to the dangers to health;
whereas it is also necessary to introduce certain combined phrases relating to
the use of dangerous substances and preparations;
Whereas Annex VI to Directive 67/548/EEC contains a guide to the
classification and labelling of dangerous substances and preparations;whereas it is necessary to amend this guide;
Whereas the measures provided for in this Directive are in accordance with
the opinion of the Committee on the Adaptation to Technical Progress of the
Directives for the Elimination of Technical Barriers to Trade in Dangerous
Substances and Preparations,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 67/548/EEC is amended as follows.
1. Annex I is amended as follows:
(a) the text in Annex 1A to this Directive replaces the corresponding text
in the Foreword;
(b) the entries in Annex 1B to this Directive replace the corresponding
entries;!B
(1) OJ L 196, 16.8.1967, p. 1.
(2) OJ L 305, 16.11.1998, p. 1.1998L0098 —EN—08.06.2000 —001.001 —2
(c) the entries in Annex 1C to this Directive are inserted;
(d) the entries in Annex 1D to this Directive are deleted.
2. Annex 2 to this Directive is inserted in Annex III.3. Annex IV is amended as follows:
(a) the phrases in Annex 3A to this Directive replace the corresponding
phrases;
(b) the phrases in Annex 3B to this Directive are inserted;
(c) the combined phrases in Annex 3C to this Directive are inserted.
4. Annex VI is amended as set out in Annex 4 to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive by 1 July
2000 at the latest. They shall forthwith inform the Commission thereof.
When Member States adopt those provisions, they shall contain a reference to
this Directive or be accompanied by such a reference on the occasion of their
official publication. Member States shall determine how such reference is tobe made.
2. Member States shall communicate to the Commission the main
provisions of national law which they adopt in the field covered by thisDirective and a correlation table between this Directive and the national
provisions adopted.
Article 3
This Directive shall enter into force on the third day following its publication
in the Official Journal of the European Communities.
Article 4
This Directive is addressed to the Member States.!B1998L0098 —EN—08.06.2000 —001.001 —3
ANNEX 1A
‘FOREWORD TO ANNEX I
Introduction
Annex I is an index of dangerous substances for which harmonised classification and
labelling have been agreed at Community level in accordance with the procedure laid
down in Article 4(3) of this Directive.
Numbering of entries
Entries in Annex I are listed according to the atomic number of the element most
characteristic of the substance’ s properties. A list of the chemical elements, arranged
according to atomic number is shown in Table A. Organic substances, because of their
variety, have been placed in the usual classes, as shown in Table B.
The Index number for each substance is in the form of a digit sequence of the type
ABC-RST -VW-Y , where:
— ABC is either the atomic number of the most characteristic chemical element
(preceded by one or two zeros to make up the sequence) or the usual class numberfor organic substances,
— RST is the consecutive number of the substance in the series ABC,— VW denotes the form in which the substance is produced or placed on the market,
— Y is the check-digit calculated in accordance with the ISBN (International
Standard Book Number) method.
As an example, the index number for sodium chlorate is 017-005-00-9.For dangerous substances in the European inventory of existing commercial chemical
substance (Einecs, OJ C 146 A, 15.6.1990) the Einecs number is included. This numberis a seven-digit system of the type XXX-XXX-X which starts at 200-001-8.
For dangerous substances notified under the provisions of this Directive, the number of
the substance in the European list of notified substance (Elincs) is included. This
number is a seven-digit system of the type XXX-XXX-X which starts at 400-010-9.
For dangerous substances in the list of “No-longer polymers’’ (document of the Office
for Official Publications of the European Communities, 1997, ISBN 92-827-8995-0),the “No-longer-polymer’’ number is included. This number is a seven-digit system ofthe type XXX-XXX-X which starts at 500-001-0.
The Chemical Abstracts Service (Cas) number is also included to assist identification of
the entry. It should be noted that the Einecs number includes both anhydrous and
hydrated forms of a substance, and there are frequently different Cas numbers foranhydrous and hydrated forms. The Cas number included is for the anhydrous formonly, and therefore the Cas number shown does not always describe the entry asaccurately as the Einecs number.
Einecs, Elincs, “No-longer-polymer’’ or Cas numbers are not usually included for
entries which comprise more than four individual substances.
Nomenclature
Wherever possible dangerous substances are designated by their Einecs, Elincs or “No-
longer-polymer’’ names. Other substances not listed in Einecs, Elincs or the list of “No-longer-polymers’’ are designatedusing an internationally recognised chemical name
(e.g. ISO, IUPAC). An additional common name is included in some cases.
Impurities, additives and minor components are normally not mentioned unless they
contribute significantly to the classification of the substance.
Some substances are described as a mixture of A and B. These entries refer to one
specific mixture. In some cases where it is necessary to characterise the substance puton the market, the proportions of the main substances in the mixture are specified.
Some substances are described with a specific percentage purity. Substances containing
a higher content of active material (e.g. an organic peroxide) are not included in the
Annex I entry and may have other hazardous properties (e.g. explosive). Where specificconcentration limits are shown, these apply to the substance or substances shown in theentry. In particular, in the case of entries which are mixtures of substances or substancesdescribed with a specific percentage purity, the limits apply to the substance asdescribed in Annex I and not the pure substance.
Article 23(2)(a) requires that for substances appearing in Annex I, the name of the
substance to be used on the label should be one of the designations given in the Annex.For certain substances, additional information has been added in square brackets in!
B1998L0098 — EN — 08.06.2000 — 001.001 — 4
order to help identify the substance. This additional information need not be included
on the label.
Certain entries contain a reference to impurities. An example is index No 607-190-00-
X: methyl acrylamidomethoxyacetate (containing 50,1 % acrylamide). In these cases
the reference in brackets forms part of the name, and must be included on the label.
Certain entries refer to groups of substances. An example is index No 006-007-00-5:
“hydrogen cyanide (salts of …) with exception of complex cyanides such asferrocyanides, ferricyanides and mercuric oxycyanide’’. For individual substances
covered by these entries, the Einecs name or another internationally recognised name
must be used.
Format of entries
The following information is given for each substance in Annex I:
(a) the classification:
(i) the process of classification consists of placing a substance in one or
more categories of danger (as defined in Article 2(2) of Directive 92/32/EEC) and assigning the qualifying risk phrase or phrases. Theclassification has consequences not only for labelling but also for otherlegislation and regulatory measures on dangerous substances;
(ii) the classification for each category of danger is shown in separate boxes.
The classification is normally presented in the form of an abbreviationrepresenting the category of danger together with the appropriate risk
phrase or phrases. However, in some cases (i.e. substances classified as
flammable, sensitising and some substances classified as dangerous forthe environment) the risk phrase alone is used;
(iii) the abbreviation for each of the categories of danger is shown below:
— explosive: E— oxidising: O— extremely flammable: F +— highly flammable: F— flammable: R 10— very toxic: T +— toxic: T— harmful: Xn— corrosive: C— irritant: Xi— sensitising: R 42 and/or R 43
— carcinogenic: Carc. Cat. (
1)
— mutagenic: Muta. Cat. (1)
— toxic for reproduction: Repr. Cat. (1)
— dangerous for the environment: N and/or R 52, R 53, R 59;
(iv) additional risk phrases which have been assigned to describe other
properties (see sections 2.2.6 and 3.2.8 of the labelling guide) are shown
in separate boxes on the same line although they are not formally part ofthe classification.
(b) the label, including:
(i) the letter assigned to the substance in accordance with Annex II (see
Article 23(2)(c)). This acts as an abbreviation for the symbol (ifassigned) and the indication of danger;
(ii) the risk phrases, denoted as a series of numbers preceded by the letter R
indicating the nature of the special risks, in accordance with Annex III
(see Article 23(2)(d)). The numbers are separated by either:
— a dash (-) to denote separate statements concerning special risks
(R), or!
B
(1) The category of carcinogen, mutagen or toxic for reproduction (i.e. 1, 2 or 3) is
shown as appropriate.1998L0098 — EN — 08.06.2000 — 001.001 — 5
— an oblique stroke (/) to denote a combined statement, in a single
sentence, of the special risks as set out in Annex III;
(iii) the safety phrases denoted as a series of numbers preceded by the letter S
indicating the recommended safety precautions, in accordance withAnnex IV (see Article 23(2)(e)). Again the numbers are separated byeither a dash or an oblique stroke; the significance of recommended
safety precautions are set out in Annex IV . The safety phrases shown
apply only to substances; for preparations, phrases are selectedaccording to the usual rules.
Note that for certain dangerous substances and preparations sold to the
general public certain S phrases are mandatory.
S 1, S 2 and S 45 are obligatory for all very toxic, toxic and corrosive
substances and preparations sold to the general public.
S 2 and S 46 are obligatory for all other dangerous substances and
preparations sold to the general public other than those that have only
been classified as dangerous for the environment.
Safety phrases S 1 and S 2 are shown in brackets in Annex I and can only
be omitted from the label when the substance or preparation is sold forindustrial use only;
(c) the concentration limits and associated classifications necessary to classify
dangerous preparations containing the substance in accordance withDirective 88/379/EEC .
Unless otherwise shown, the concentration limits are a percentage by weight
of the substance calculated with reference to the total weight of thepreparation.
Where no concentration limits are given, the concentration limits to be used
when applying the conventional method of assessing health hazards are thosein Annex I of Directive 88/379/EEC.
General explanatory notes
Groups of substances
A number of group entries are included in Annex I. In these cases, the classification and
labelling requirements will apply to all substances covered by the description if they areplaced on the market, insofar as they are listed in Einecs or Elincs. Where a substancethat is covered by a group entry occurs as an impurity in another substance, theclassification and labelling requirements described in the group entry shall be taken into
account in the labelling of the substance.
In some cases, there are classification and labelling requirements for specific
substances that would be covered by the group entry. In such cases a specific AnnexI entry will be present for the substance and the group entry will be annotated with the
phrase “except those specified elsewhere in this Annex’’.
In some cases, individual substances may be covered by more than one group entry.
Lead oxalate (Einecs No 212-413-5) is for instance covered by the entry for leadcompounds (index No 082-001-00-6) as well as for salts of oxalic acid (607-007-00-3).
In these cases, the labelling of the substance reflects the labelling for each of the two
group entries. In cases where different classifications for the same hazard are given, theclassification leading to the more severe classification is used for the label of theparticular substance (see section on Note A below).
Entries in Annex I for salts (under any denomination) cover both anhydrous and hydrous
forms unless specifically specified otherwise.
Substances with an Elincs number
In Annex I, substances with an Elincs number have been notified under the provisions
of this Directive. A producer or importer who has not previously notified thesesubstances must refer to the provisions of this Directive if he intends to place thesesubstances on the market.
Explanation of the notes relating to the identification, classification and labelling of
substances
Note A:
The name of the substance must appear on the label in the form of one of the
designations given in Annex I (see Article 23(2)(a)).!
B1998L0098 — EN — 08.06.2000 — 001.001 — 6
In Annex I, use is sometimes made of a general description such as “… compounds’’ or
“… salts’’. In this case, the manufacturer or any other person who markets such asubstance is required to state on the label the correct name, due account being taken ofthe chapter entitled “Nomenclature’’ of the Foreword:
Example: for BeCl
2(Einecs No 232-116-4): beryllium chloride.
The Directive also requires that the symbols, indications of danger, R and S phrases to
be used for each substance shall be those shown in Annex I (Article 23(2)(c), (d) and(e)).
For substances belonging to one particular group of substances included in Annex I, the
symbols, indications of danger, R and S phrases to be used for each substance shall bethose shown in the appropriate entry in Annex I.
For substances belonging to more than one group of substances included in Annex I, the
symbols, indications of danger, R and S phrases to be used for each substance shall bethose shown in both the appropriate entries given in Annex I. In cases where twodifferent classifications are given in the two entries for the same hazard, theclassification reflecting the more severe hazard classification is used.
Example:
Group entry 1 clas-
sification:Repr. Cat. 1; R 61
R3 3Repr. Cat. 3; R 62
N; R 50-53Xn; R 20/22
Group entry 2 clas-
sification:Carc. Cat. 1; R 45 T; R 23/25 N; R 51-53
Substance classifi-
cation:Carc. Cat. 1; R 45
T; R 23/25Repr. Cat. 1; R 61
R3 3Repr. Cat. 3; R 62
N; R 50-53
Note B:
Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at
various concentrations and therefore require different labelling since the hazards vary atdifferent concentrations.
In Annex I entries with Note B have a general designation of the following type: “… %
nitric acid’’.
In this case the manufacturer or any other person who markets such a substance must
state the percentage concentration of the solution on the label.
Example: 45 % nitric acid.Unless otherwise stated, it is assumed that the percentage concentration is calculated on
a weight/weight basis.
The use of additional data (e.g. specific gravity, degrees Baumé) or descriptive phrases
(e.g. fuming or glacial) is permissible.
Note C:
Some organic substances may be marketed either in a specific isomeric form or as a
mixture of several isomers.
In Annex I, a general designation of the following type is sometimes used: “xylenol’’.
In this case the manufacturer or any other person who markets such a substance must
state on the label whether the substance is a specific isomer (a) or a mixture of isomers
(b).
Example: (a) 2,4-dimethylphenol
(b) xylenol (mixture of isomers).
Note D:
Certain substances which are susceptible to spontaneous polymerisation or decomposi-
tion are generally placed on the market in a stabilised form. It is in this form that theyare listed in Annex I to this Directive.
However, such substances are sometimes placed on the market in a non-stabilised form.
In this case, the manufacturer or any person who places such a substance on the marketmust state on the label the name of the substance followed by the words non-stabilised.
Example: methacrylic acid (non-stabilised).
Note E:
Substances with specific effects on human health (see Chapter 4 of Annex VI) that are
classified as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2are ascribed Note E if they are also classified as very toxic (T +), toxic (T) or harmful
(Xn). For these substances, the risk phrases R 20, R 21, R 22, R 23, R 24, R 25, R 26, R
27, R 28, R 39, R 40, R 48 and R 65 and all combinations of these risk phrases shall bepreceded by the word “Also’’.!
B1998L0098 — EN — 08.06.2000 — 001.001 — 7
Examples: R 45-23 “May cause cancer. Also toxic by inhalation’’
R 46-27/28 “May cause heritable genetic damage. Also very
toxic in contact with skin and if swallowed’’.
Note F:
This substance may contain a stabiliser. If the stabiliser changes the dangerous
properties of the substance, as indicated by the label in Annex I, a label should beprovided in accordance with the rules for the labelling of dangerous preparations.
Note G:
This substance may be marketed in an explosive form in which case it must be evaluated
using the appropriate test methods and a label should be provided reflecting its
explosive property.
Note H:
The classification and label shown for this substance applies to the dangerous
property(ies) indicated by the risk phrase(s) in combination with the category(ies) ofdanger shown. The requirements of Article 6 of this Directive on manufacturers,
distributors and importers of this substance apply to all other aspects of classification
and labelling. The final label shall follow the requirements of section 7 of Annex VI ofthis Directive.
This note applies to certain coal- and oil-derived substances and to certain entries for
groups of substances in Annex I.
Note J:
The classification as a carcinogen need not apply if it can be shown that the substance
contains less than 0,1 % w/w benzene (Einecs No 200-753-7). This note applies only tocertain complex coal- and oil-derived substances in Annex I.
Note K:
The classification as a carcinogen need not apply if it can be shown that the substance
contains less than 0,1 % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance isnot classified as a carcinogen, at least the S phrases (2-)9-16 should apply. This noteapplies only to certain complex oil-derived substances in Annex I.
Note L:
The classification as a carcinogen need not apply if it can be shown that the substance
contains less than 3 % DMSO extract as measured by IP 346. This note applies only tocertain complex oil-derived substances in Annex I.
Note M:
The classification as a carcinogen need not apply if it can be shown that the substance
contains less than 0,005 % w/w benzo[a]-pyrene (Einecs No 200-028-5). This noteapplies only to certain complex coal-derived substances in Annex I.
Note N:
The classification as a carcinogen need not apply if the full refining history is known
and it can be shown that the substance from which it is produced is not a carcinogen.
This note applies only to certain complex oil-derived substances in Annex I.
Note P:
The classification as a carcinogen need not apply if it can be shown that the substance
contains less than 0,1 % w/w benzene (Einecs No 200-753-7).
When the substance is classified as a carcinogen, Note E shall also apply.
When the substance is not classified as a carcinogen at least the S phrases (2-)23-24-62
shall apply.
This note applies only to certain complex oil-derived substances in Annex I.
Note Q:
The classification as a carcinogen need not apply if it can be shown that the substance
fulfils one of the following conditions:
— a short term biopersistence test by inhalation has shown that the fibres longer than
20 µm have a weighted half-life of less than 10 days, or
— a short term biopersistence test by intratracheal instillation has shown that the
fibres longer than 20 µm have a weighted half-life of less than 40 days, or!
B1998L0098 — EN — 08.06.2000 — 001.001 — 8
— an appropriate intra-peritoneal test has shown no evidence of excess carcinogeni-
city, or
— absence of relevant pathogenicity or neoplastic changes in a suitable long term
inhalation test.
Note R:
The classification as a carcinogen need not apply to fibres with a length weighted
geometric mean diameter less two standard errors greater than 6 µm.
Note S:
This substance may not require a label according to Article 23 (see section 8 of Annex
VI).
Explanation of the notes relating to the labelling of preparations
The significance of the notes that appear to the right of the concentration limits is as
follows:
Note 1:
The concentration stated or, in the absence of such concentrations, the general
concentrations of Directive 88/379/EEC are the percentages by weight of the metallicelement calculated with reference to the total weight of the preparation.
Note 2:
The concentration of isocyanate stated is the percentage by weight of the free monomer
calculated with reference to the total weight of the preparation.
Note 3:
The concentration stated is the percentage by weight of chromate ions dissolved in
water calculated with reference to the total weight of the preparation.
Note 4:
Preparations containing these substances have to be classified as harmful with R 65 if
they meet the criteria in section 3.2.3 in Annex VI.
Note 5:
The concentration limits for gaseous preparations are expressed as volume per volume
percentage.
Note 6:
Preparations containing these substances have to be assigned R 67 if they meet the
criteria in section 3.2.8 in Annex VI.’!
B1998L0098 — EN — 08.06.2000 — 001.001 — 9
ANEXO IB — BILAG IB — ANHANG IB — ΠΑΡΑΡΤΗΜΑ IB — ANNEX IB — ANNEXE IB — ALLEGATO IB —
BIJLAGE IB — ANEXO IB — LIITE IB — BILAGA IB
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1998L0098 — EN — 08.06.2000 — 001.001 — 400
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ANEXO IC — BILAG IC — ANHANG IC — ΠΑΡΑΡΤΗΜΑ IC — ANNEX IC — ANNEXE IC — ALLEGATO IC —
BIJLAGE IC — ANEXO IC — LIITE IC — BILAGA IC
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1998L0098 — EN — 08.06.2000 — 001.001 — 426
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!B
1998L0098 — EN — 08.06.2000 — 001.001 — 428
!B1998L0098 — EN — 08.06.2000 — 001.001 — 429
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!B1998L0098 — EN — 08.06.2000 — 001.001 — 435
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 436
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1998L0098 — EN — 08.06.2000 — 001.001 — 437
!B1998L0098 — EN — 08.06.2000 — 001.001 — 438
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1998L0098 — EN — 08.06.2000 — 001.001 — 445
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1998L0098 — EN — 08.06.2000 — 001.001 — 446
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1998L0098 — EN — 08.06.2000 — 001.001 — 447
!B1998L0098 — EN — 08.06.2000 — 001.001 — 448
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!B1998L0098 — EN — 08.06.2000 — 001.001 — 487
!B1998L0098 — EN — 08.06.2000 — 001.001 — 488
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 489
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 490
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 491
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 492
!B1998L0098 — EN — 08.06.2000 — 001.001 — 493
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!B1998L0098 — EN — 08.06.2000 — 001.001 — 496
!B1998L0098 — EN — 08.06.2000 — 001.001 — 497
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 498
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 499
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 500
!B1998L0098 — EN — 08.06.2000 — 001.001 — 501
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1998L0098 — EN — 08.06.2000 — 001.001 — 522
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1998L0098 — EN — 08.06.2000 — 001.001 — 523
!B1998L0098 — EN — 08.06.2000 — 001.001 — 524
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1998L0098 — EN — 08.06.2000 — 001.001 — 525
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 526
!B1998L0098 — EN — 08.06.2000 — 001.001 — 527
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1998L0098 — EN — 08.06.2000 — 001.001 — 533
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1998L0098 — EN — 08.06.2000 — 001.001 — 534
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1998L0098 — EN — 08.06.2000 — 001.001 — 535
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 536
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 537
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 538
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1998L0098 — EN — 08.06.2000 — 001.001 — 539
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 540
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 541
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 542
!B1998L0098 — EN — 08.06.2000 — 001.001 — 543
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!B1998L0098 — EN — 08.06.2000 — 001.001 — 545
!B1998L0098 — EN — 08.06.2000 — 001.001 — 546
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 547
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 548
!B1998L0098 — EN — 08.06.2000 — 001.001 — 549
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!B1998L0098 — EN — 08.06.2000 — 001.001 — 567
!B1998L0098 — EN — 08.06.2000 — 001.001 — 568
!B1998L0098 — EN — 08.06.2000 — 001.001 — 569
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 570
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 571
!B1998L0098 — EN — 08.06.2000 — 001.001 — 572
!B1998L0098 — EN — 08.06.2000 — 001.001 — 573
!B1998L0098 — EN — 08.06.2000 — 001.001 — 574
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 575
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 576
!B1998L0098 — EN — 08.06.2000 — 001.001 — 577
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!B1998L0098 — EN — 08.06.2000 — 001.001 — 580
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!B1998L0098 — EN — 08.06.2000 — 001.001 — 585
!B1998L0098 — EN — 08.06.2000 — 001.001 — 586
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 587
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 588
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 589
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 590
!B1998L0098 — EN — 08.06.2000 — 001.001 — 591
!C1
1998L0098 — EN — 08.06.2000 — 001.001 — 592
!B
1998L0098 — EN — 08.06.2000 — 001.001 — 593
!B1998L0098 — EN — 08.06.2000 — 001.001 — 594
!B1998L0098 — EN — 08.06.2000 — 001.001 — 595
ANEXO 1D — BILAG 1D — ANHANG 1D — ΠΑΡΑΡΤΗΜΑ 1 D — ANNEX 1D —
ANNEXE 1D — ALLEGATO 1D — BIJLAGE 1D — ANEXO 1D — LIITE 1D —
BILAGA 1D
006-075-00-6
007-005-00-7603-017-00-7
606-008-00-6
606-015-00-4607-193-00-6
607-202-00-3
609-014-00-7
613-005-00-3
613-055-00-6615-005-01-6!
B1998L0098 — EN — 08.06.2000 — 001.001 — 596
ANEXO 2 — BILAG 2 — ANHANG 2 — ΠΑΡΑΡΤΗΜΑ 2 — ANNEX 2 —
ANNEXE 2 — ALLEGATO 2 — BIJLAGE 2 — ANEXO 2 — LIITE 2 — BILAGA 2
R6 6
ES: La exposición repetida puede provocar sequedad o formación de grietas en la
piel
DA: Gentagen udsættelse kan give tør eller revnet hudDE: Wiederholter Kontakt kann zu spröder oder rissiger Haut führenEL: Παρατεταµένη έκθεση µπ/omikronρεί να πρ/omikronκαλέσει /ksiηρ/omikronacuteτητα δέρµατ/omikronς ή
σκάσιµ/omikron
EN: Repeated exposure may cause skin dryness or crackingFR: L ’exposition répétée peut provoquer dessèchement ou gerçures de la peauIT: L ’esposizione ai vapori può provocare secchezza e screpolature della pelleNL: Herhaalde blootstelling kan een droge of een gebarsten huid veroorzakenPT: Pode provocar secura da pele ou fissuras, por exposição repetidaFI: Toistuva altistus voi aiheuttaa ihon kuivumista tai halkeiluaSV: Upprepad kontakt kan ge torr hud eller hudsprickor
R6 7
ES: La inhalación de vapores puede provocar somnolencia y vértigo
DA: Dampe kan give sløvhed og svimmelhedDE: Dämpfe können Schläfrigkeit und Benommenheit verursachenEL: Η εισπ/omikronνή ατµών µπ/omikronρεί να πρ/omikronκαλέσει υπνηλία και /dzetaάλη
EN: Vapours may cause drowsiness and dizziness
FR: L ’inhalation de vapeurs peut provoquer somnolence et vertiges
IT: L ’inalazione dei vapori può provocare sonnolenza e vertiginiNL: Dampen kunnen slaperigheid en duizeligheid veroorzakenPT: Pode provocar sonolência e vertigens, por inalação dos vaporesFI: Höyryt voivat aiheuttaa uneliaisuutta ja huimaustaSV: Ångor kan göra att man blir dåsig och omtöcknad!
B1998L0098 — EN — 08.06.2000 — 001.001 — 597
ANEXO 3A — BILAG 3A — ANHANG 3A — ΠΑΡΑΡΤΗΜΑ 3 A — ANNEX 3A —
ANNEXE 3A — ALLEGATO 3A — BIJLAGE 3A — ANEXO 3A — LIITE 3A —
BILAGA 3A
S2 3
FR: Ne pas respirer les gaz/fumées/vapeurs/aérosols
S2 9
ES: No tirar los residuos por el desagüe
DA: Må ikke tømmes i kloakafløbDE: Nicht in die Kanalisation gelangen lassenEL: Μην αδειά/dzetaετε τ/omikron υπ/omikronacuteλ/omikronιπ/omikron τ/omikronυ περιε/khi/omikronµέν/omikronυ στην απ/omikron/khiέτευση
EN: Do not empty into drainsFR: Ne pas jeter les résidus à l’égoutIT: Non gettare i residui nelle fognatureNL: Afval niet in de gootsteen werpenPT: Não deitar os resíduos no esgotoFI: Ei saa tyhjentää viemäriinSV: Töm ej i avloppet!
B1998L0098 — EN — 08.06.2000 — 001.001 — 598
ANEXO 3B — BILAG 3B — ANHANG 3B — ΠΑΡΑΡΤΗΜΑ 3 B — ANNEX 3B —
ANNEXE 3B — ALLEGATO 3B — BIJLAGE 3B — ANEXO 3B — LIITE 3B —
BILAGA 3B
S6 3
ES: En caso de accidente por inhalación, alejar a la víctima fuera de la zona
contaminada y mantenerla en reposo
DA: Ved ulykkestilfælde ved indånding bringes tilskadekomne ud i frisk luft og
holdes i ro
DE: Bei Unfall durch Einatmen: Verunfallten an die frische Luft bringen und
ruhigstellen
EL: Σε περίπτωσηατυ/khiήµατ/omikronςλ/omikronacuteγωεισπ/omikronνής:απ/omikronµακρύνετε τ/omikronθύµααπ/omikronacute
τ/omikron µ/omikronλυσµέν/omikron /khiώρ/omikron και αφήστε τ/omikron να ηρεµήσει
EN: In case of accident by inhalation: remove casualty to fresh air and keep at restFR: En cas d’accident par inhalation, transporter la victime hors de la zone
contaminée et la garder au repos
IT: In caso di incidente per inalazione, allontanare l’infortunato dalla zona
contaminata e mantenerlo a riposo
NL: Bij een ongeval door inademing: slachtoffer in de frisse lucht brengen en
laten rusten
PT: Em caso de inalação acidental, remover a vítima da zona contaminada e
mantê-la em repouso
FI: Jos ainetta on onnettomuuden sattuessa hengitetty: siirrä henkilö raittiiseen
ilmaan ja pidä hänet levossa
SV: Vid olycksfall via inandning, flytta den drabbade till frisk luft och låt vila
S6 4
ES: En caso de ingestión, lavar la boca con agua (solamente si la persona está
consciente)
DA: Ved indtagelse, skyl munden med vand (kun hvis personen er ved bevisthed)DE: Bei Verschlucken Mund mit Wasser ausspülen (nur wenn Verunfallter bei
Bewußtsein ist)
EL: Σε περίπτωση κατάπ/omikronσης, /ksiεπλύνετε τ/omikron στ/omikronacuteµα µε νερ/omikronacute (µ/omikronacuteν/omikron εφ/omikronacuteσ/omikronν
τ/omikron θύµα διατηρεί τις αισθήσεις τ/omikronυ)
EN: If swallowed, rinse mouth with water (only if the person is conscious)FR: En cas d’ingestion, rincer la bouche avec de l’eau (seulement si la personne
est consciente)
IT: In caso di ingestione, sciacquare la bocca con acqua (solamente se
l’infortunato è cosciente)
NL: Bij inslikken, mond met water spoelen (alleen als de persoon bij bewustzijn
is)
PT: Em caso de ingestão, lavar repetidamente a boca com água (apenas se a
vítima estiver consciente)
FI: Jos ainetta on nielty, huuhtele suu vedellä (vain jos henkilö on tajuissaan)SV: Vid förtäring, skölj munnen med vatten (endast om personen är vid
medvetande)!
B1998L0098 — EN — 08.06.2000 — 001.001 — 599
ANEXO 3C — BILAG 3C — ANHANG 3C — ΠΑΡΑΡΤΗΜΑ 3 C — ANNEX 3C —
ANNEXE 3C — ALLEGATO 3C — BIJLAGE 3C — ANEXO 3C — LIITE 3C —
BILAGA 3C
S 27/28
ES: Después del contacto con la piel, quítese inmediatamente toda la ropa
manchada o salpicada y lávese inmediata y abundantemente con …(productos a especificar por el fabricante )
DA: Kommer stof på huden, tages tilsmudset tøj straks af og der vaskes med store
mængder … angives af fabrikanten
DE: Bei Berührung mit der Haut beschmutzte Kleidung sofort ausziehen und
sofort abwaschen mit viel … vom Hersteller anzugeben
EL: Σε περίπτωση επαφής µε τ/omikron δέρµα, αφαιρέστε αµέσως /omikronacuteλα τα
µ/omikronλυσµένα ρ/omikronύ/khiα και πλύνετε αµέσως µε άφθ/omikronν/omikron … τ/omikron είδ/omikronς τ/omikronυ
υγρ/omikronύ καθ/omikronρί/dzetaεται απ/omikronacute τ/omikronν παραγωγ/omikronacute
EN: After contact with skin, take off immediately all contaminated clothing, and
wash immediately with plenty of … to be specified by the manufacturer
FR Après contact avec la peau, enlever immédiatement tout vêtement souillé ou
éclaboussé et se laver immédiatement et abondamment avec … produits
appropriés à indiquer par le fabricant
IT: In caso di contatto con la pelle, togliersi di dosso immediatamente gli
indumenti contaminati e lavarsi immediatamente e abbondantemente con …prodotti idonei da indicarsi da parte del fabbricante
NL: Na contact met de huid, alle besmette kleding onmiddellijk uittrekken en de
huid onmiddellijk wassen met veel … aan te geven door de fabrikant
PT: Em caso de contacto com a pele, retirar imediatamente toda a roupa
contaminada e lavar imediata e abundantemente com … produto adequado a
indicar pelo produtor
FI: Ihokosketuksen jälkeen, saastunut vaatetus on riisuttava välittömästi ja
roiskeet huuhdeltava välittömästi runsaalla määrällä … aineen ilmoittaa
valmistaja/maahantuoja
SV: Vid kontakt med huden, tag genast av alla nedstänkta kläder och tvätta genast
med mycket … anges av tillverkaren
S 29/35
ES: No tirar los residuos por el desagüe; elimínense los residuos del producto y
sus recipientes con todas las precauciones posibles
DA: Må ikke tømmes i kloakafløb; stoffet og emballagen skal bortskaffes på en
sikker måde
DE: Nicht in die Kanalisation gelangen lassen; Abfälle und Behälter müssen in
gesicherter Weise beseitigt werden
EL: Μην αδειά/dzetaετε τ/omikron υπ/omikronacuteλ/omikronιπ/omikron τ/omikronυ περιε/khi/omikronµέν/omikronυ στην απ/omikron/khiέτευση.
διαθέστε αυτ/omikronacute τ/omikron υλικ/omikronacute και τ/omikronν περιέκτη τ/omikronυ κατά ασφαλή τρ/omikronacuteπ/omikron
EN: Do not empty into drains; dispose of this material and its container in a safe
way
FR: Ne pas jeter les résidus à l’égout; ne se débarrasser de ce produit et de son
récipient qu’en prenant toutes les précautions d’usage
IT: Non gettare i residui nelle fognature; non disfarsi del prodotto e del
recipiente se non con le dovute precauzioni
NL: Afval niet in de gootsteen werpen; stof en verpakking op veilige wijze
afvoeren
PT: Não deitar os resíduos no esgoto; não eliminar o produto e o seu recipiente
sem tomar as precauções de segurança devidas
FI: Ei saa tyhjentää viemäriin; hävitä tämä aine ja sen pakkaus turvallisestiSV: Töm ej i avloppet, oskadliggör produkt och förpackning på säkert sätt!
B1998L0098 — EN — 08.06.2000 — 001.001 — 600
ANNEX 4
1.6. For substances, the data required for classification and labelling may be
obtained:
(a) as regards substances for which the information specified in Annex VII
is required, most of the necessary data for classification and labelling
appear in the base set. This classification and labelling must be reviewed,if necessary, when further information is available (Annex VIII);
(b) as regards other substances (e.g. those referred to in section 1.5), the data
required for classification and labelling may, if necessary, be obtainedfrom a number of different sources, for example the results of previoustests, information required by international rules on the transport ofdangerous substances, information taken from reference works and theliterature or information derived from practical experience. The resultsof validated structure-activity relationships and expert judgement may
also be taken into account where appropriate.
For preparations, the data required for classification and labelling may be
obtained:
(a) if it concerns physicochemical data, by the application of the methods
specified in Annex V . For gaseous preparations, a calculation methodmay be used for flammable and oxidising properties (see Chapter 9);
(b) if it concerns data on health effects:
— by the application of the methods specified in Annex V and/or by
the application of the conventional method referred to in Article3(5)(a) to (i) of Directive 88/379/EEC, or, in the case of R 65, by theapplication of the rules under 3.2.3,
— however, if it concerns the evaluation of the carcinogenic,
mutagenic and reproductive properties, by the application of theconventional method referred to in Article 3(5)(j) to (q) of Directive88/379/EEC.
Note concerning the performance of animal testsThe performance of animal tests to establish experimental data is subject to
the provisions of Directive 86/609/EEC regarding the protection of animalsused for experimental purposes.
1.7.2. Application of the guide criteria for substances
The guidance criteria set out in this Annex are directly applicable when the
data in question have been obtained from test methods comparable with those
described in Annex V . In other cases, the available data must be evaluated bycomparing the test methods employed with those indicated in Annex V andthe rules specified in this Annex for determining the appropriate classificationand labelling.
In some cases there may be doubt over the application of the relevant criteria,
especially where these require the use of expert judgement. In such cases the
manufacturer, distributor or importer should provisionally classify and labelthe substance on the basis of an assessment of the evidence by a competentperson.
Without prejudice to Article 6, where the above procedure has been followed
and there is concern over possible inconsistencies then a proposal may besubmitted for the entry of the provisional classification into Annex I. The
proposal should be made to one of the Member States and should be
accompanied by appropriate scientific data (see also section 4.1).
A similar procedure may be followed when information is identified which
gives cause for concern over the accuracy of an existing entry in Annex I.
2.2.2.1. R e m a r k s c o n c e r n i n g p e r o x i d e s
For the explosive properties, an organic peroxide or preparation thereof in the
form in which it is placed on the market is classified according to the criteriain section 2.2.1 on the basis of tests carried out in accordance with themethods given in Annex V .
For the oxidising properties the existing methods in Annex V cannot be
applied to organic peroxides.
For substances, organic peroxides not already classified as explosive are
classified as dangerous on the basis of their structure (e.g. R-O-O-H; R
1-O-O-
R2).!M11998L0098 — EN — 08.06.2000 — 001.001 — 601
Preparations not already classified as explosive shall be classified using the
calculation method based on the percentage of active oxygen shown in section9.5.
Any organic peroxide or preparation thereof not already classified as
explosive is classified as oxidising, if the peroxide or its formulation contains:
— more than 5 % of organic peroxides or,
— more than 0,5 % available oxygen from the organic peroxides, and more
than 5 % hydrogen peroxide.
3.2.3. Harmful
Substances and preparations shall be classified as harmful and assigned the
symbol ‘Xn’ and the indication of danger ‘harmful’ in accordance with thecriteria specified below. Risk phrases shall be assigned in accordance with thefollowing criteria:
R 22 Harmful if swallowed
Acute toxicity results:—L D
50per oral, rat: 200 5LD 5042 000 mg/kg,
— discriminating dose, oral, rat 50, mg/kg: 100 % survival but evident
toxicity,
— less than 100 % survival at 500 mg/kg, rat oral by the fixed dose
procedure. Refer to the evaluation table in the test method Bl(a) of
Annex V .
R 21 Harmful in contact with skin
Acute toxicity results:
—L D 50dermal, rat or rabbit: 400 5LD 5042 000 mg/kg.
R 20 Harmful by inhalation
Acute toxicity results:
—L C 50inhalation, rat, for aerosols or particulates: 1 5LC5045 mg/litre/
4h r ,
—L C 50inhalation, rat, for gases or vapours: 2 5LC50420 mg/litre/4 hr.
R 65 Harmful: may cause lung damage if swallowed
Liquid substances and preparations presenting an aspiration hazard in humans
because of their low viscosity
(a) For substances and preparations containing aliphatic, alicyclic and
aromatic hydrocarbons in a total concentration equal to or greater than10 % and having either:
— a flow time of less than 30 seconds in a 3 mm ISO cup according to
ISO 2431, or
— a kinematic viscosity measured by a calibrated glass capillary
viscometer in accordance with ISO 3104/3105 of less than 7 × 10
−
6m2/sec at 40 °C, or
— a kinematic viscosity derived from measurements of rotational
viscometry in accordance with ISO 3129 of less than 7 × 10−6m2/
sec at 40 °C.
Note that substances and preparations meeting these criteria need not be
classified if they have a mean surface tension greater than 33 mN/m at 25 °C as measured by the du Nouy tensiometer or by the testmethods shown in Annex V Part A(5);
(b) For substances and preparations, based on practical experience in
humans.
R 40 Possible risk of irreversible effects
— strong evidence that irreversible damage other than the effects referred to
in Chapter 4 is likely to be caused by a single exposure by an appropriateroute, generally in the abovementioned dose range.
In order to indicate route of administration/exposure one of the following
combinations shall be used: R 40/20, R 40/21, R 40/22, R 40/20/21, R 40/20/22, R 40/21/22, R 40/20/21/22.
R 48 Danger of serious damage to health by prolonged exposure!
M11998L0098 — EN — 08.06.2000 — 001.001 — 602
— serious damage (clear functional disturbance or morphological change
which has toxicological significance) is likely to be caused by repeatedor prolonged exposure by an appropriate route.
Substances and preparations are classified at least as harmful when these
effects are observed at levels of the order of:
— oral, rat 450 mg/kg (body weight)/day,
— dermal, rat or rabbit 4100 mg/kg (body weight)/day,
— inhalation, rat 40,25 mg/l, 6 h/day.
These guide values can apply directly when severe lesions have been observed
in a subchronic (90 days) toxicity test. When interpreting the results of a
subacute (28 days) toxicity test these figures should be increasedapproximately three fold. If a chronic (two years) toxicity test is available itshould be evaluated on a case-by-case basis. If results of studies of more thanone duration are available, then those from the study of the longest durationshould normally be used.
In order to indicate route of administration/exposure one of the following
combinations shall be used: R 48/20, R 48/21, R 48/22, R 48/20/21, R 48/20/22, R 48/21/22, R 48/20/21/22.
3.2.3.1. C o m m e n t s r e g a r d i n g v o l a t i l e s u b s t a n c e s
For certain substances with a high saturated vapour concentration, evidence
may be available to indicate effects that give cause for concern. Such
substances may not be classified under the criteria for health effects in this
guide (3.2.3) or not covered by Section 3.2.8. However, where there isappropriate evidence that such substances may present a risk in normalhandling and use, then classification on a case-by-case basis in Annex I maybe necessary.
3.2.6.1. I n f l a m m a t i o n o f t h e s k i n
The following risk phrase shall be assigned in accordance with the criteria
given:
R 38 Irritating to skin
— substances and preparations which cause significant inflammation of the
skin which persists for at least 24 hours after an exposure period of up tofour hours determined on the rabbit according to the cutaneous irritationtest method cited in Annex V .
Inflammation of the skin is significant if:
(a) the mean value of the scores for either erythema and eschar
formation or oedema formation, calculated over all the animals
tested, is two or more;
(b) or, in the case where the Annex V test has been completed using
three animals, either erythema and eschar formation or oedemaformation equivalent to a mean value of two or more calculated for
each animal separately has been observed in two or more animals.
In both cases all scores at each of the reading times (24, 48 and 72 hours)
for an effect should be used in calculating respective mean values.
Inflammation of the skin is also significant if it persists in at least two
animals at the end of the observation time. Particular effects, forexample, hyperplasia, scaling, discoloration, fissures, scabs and alopeciashould be taken into account.
Relevant data may also be available from non-acute animal studies (see
comments on R 48, section 2(d)). These are considered significant if theeffects seen are comparable to those described above;
— substances and preparations which cause significant inflammation of the
skin, based on practical observations in humans on immediate, prolonged
or repeated contact;
— organic peroxides, except where evidence to the contrary is available.
Paresthesia: Paresthesia caused in humans by skin contact with pyrethroid
pesticides is not regarded as an irritant effect justifying classification as Xi; R38. The S-phrase S 24 should however be applied for substances seen to causethis effect.!
M11998L0098 — EN — 08.06.2000 — 001.001 — 603
3.2.8. Other toxicological properties
Additional risk phrases shall be assigned in accordance with the following
criteria (based on experience obtained during compilation of Annex I) tosubstances and preparations classified by virtue of 2.2.1 to 3.2.7 above and/orChapters 4 and 5:
R 29 Contact with water liberates toxic gas
For substances and preparations which in contact with water or damp air,
evolve very toxic or toxic gases in potentially dangerous amounts, forexample, aluminium phosphide, phosphorus pentasulphide.
R 31 Contact with acids liberates toxic gas
For substances and preparations which react with acids to evolve toxic gases
in dangerous amounts, for example, sodium hypochlorite, barium poly-sulphide. For substances used by members of the general public, the use of S
50 (do not mix with … (to be specified by the manufacturer)) would be more
suitable.
R 32 Contact with acids liberates very toxic gas
For substances and preparations which react with acids to evolve very toxic
gases in dangerous amounts; e.g. salts of hydrogen cyanide, sodium azide. Forsubstances used by members of the general public, the use of S 50 (do not mixwith … (to be specified by the manufacturer)) would be more suitable.
R 33 Danger of cumulative effects
For substances and preparations when accumulation in the human body is
likely and may cause some concern which, however, is not sufficient to justifythe use of R 48.
R 64 May cause harm to breastfed babies
For substances and preparations which are absorbed by women and may
interfere with lactation or which may be present (including metabolites) in
breast milk in amounts sufficient to cause concern for the health of a
breastfed child.
For comments on the use and this R-phrase (and in some cases R 33) see
section 4.2.3.3.
R 66 Repeated exposure may cause skin dryness or cracking
For substances and preparations which may cause concern as a result of skin
dryness, flaking or cracking but which do not meet the criteria for R 38:
based on either:— practical observation after normal handling and use, or
— relevant evidence concerning their predicted effects on the skin.
See also sections 1.6 and 1.7.
R 67 Vapours may cause drowsiness and dizziness
For volatile substances and preparations containing such substances which
cause clear symptoms of central nervous system depression by inhalation andwhich are not already classified with respect to acute inhalation toxicity (R20, R 23, R 26, R 40/20, R 39/23 or R 39/26).
The following evidence may be used:
(a) data from animal studies showing clear signs of CNS depression such as
narcotic effects, lethargy, lack of coordination (including loss of rightingreflex) and ataxia either:
— at concentrations/exposure times not exceeding 20 mg/l/4 h or,— for which the ratio of the effect concentration at 44ht ot h e
saturated vapour concentration (SVC) at 20 °C is 41/10;
b) practical experience in humans (e.g. narcosis, drowsiness, reduced
alertness, loss of reflexes, lack of coordination, vertigo) from welldocumented reports under comparable exposure conditions to the effectsspecified above for animals.
See also sections 1.6 and 1.7.For other supplementary risk phrases see section 2.2.6.
4.1.2. If a manufacturer, distributor or importer has information available which
indicates that a substance should be classified and labelled in accordance withthe criteria given in section 4.2.1, 4.2.2 or 4.2.3, he shall provisionally label!
M11998L0098 — EN — 08.06.2000 — 001.001 — 604
the substance in accordance with these criteria, on the basis of the assessment
of the evidence by a competent person.
4.1.3. The manufacturer, distributor or importer shall submit as soon as possible a
document summarising all relevant information to one Member State in which
the substance is placed on the market. This summary document should
include a bibliography containing all relevant references, including anyrelevant unpublished data.
4.1.4. Furthermore, a manufacturer, distributor or importer who has new data which
are relevant to the classification and labelling of a substance in accordancewith the criteria given in section 4.2.1, 4.2.2 or 4.2.3, shall submit this data as
soon as possible to one Member State in which the substance in placed on the
market.
5.2.2. Non-aquatic environment
5.2.2.1. Substances shall be classified as dangerous for the environment and assigned
the symbol ‘N’ and the appropriate indication of danger, and assigned risk
phrases in accordance with the following criteria:
R 54: Toxic to flora
R 55: Toxic to faunaR 56: Toxic to soil organismsR 57: Toxic to beesR 58: May cause long term adverse effects on the environment
Substances which on the basis of the available evidence concerning their
properties, persistence, potential to accumulate and predicted or observedenvironmental fate and behaviour may present a danger, immediate or long-term and/or delayed, to the structure and/or functioning of natural ecosystemsother than those covered under 5.2.1. Detailed criteria will be elaborated later.
5.2.2.2. Substances shall be classified as dangerous for the environment and assigned
the symbol ‘N’ and the appropriate indication of danger, and assigned riskphrases in accordance with the following criteria:
R 59: Dangerous for the ozone layer
Substances which on the basis of the available evidence concerning their
properties and their predicted or observed environmental fate and behaviourmay present a danger to the structure and/or functioning of the stratospheric
ozone layer. This includes the substances which are listed in Annex I to
Council Regulation (EC) No 3093/94 on substances that deplete the ozonelayer (OJ L 333, 22.12.1994, p. 1) and its subsequent amendments.
6.2. Safety phrases for substances and preparations.
S 1 Keep locked up
— Applicability:
— very toxic, toxic and corrosive substances and preparations,
— Criteria for use:
— obligatory for those substances and preparations mentioned above if
sold to the general public.
S 2 Keep out of the reach of children
— Applicability:
— all dangerous substances and preparations,
— Criteria for use:
— obligatory for all dangerous substances and preparations sold to the
general public, except for those only classified as dangerous for theenvironment.
S 3 Keep in a cool place
— Applicability:
— organic peroxides,
— other dangerous substances and preparations having a boiling point
440 °C,!
M11998L0098 — EN — 08.06.2000 — 001.001 — 605
— Criteria for use:
— obligatory for organic peroxides unless S 47 is used,— recommended for other dangerous substances and preparations
having a boiling point 440 °C.
S 4 Keep away from living quarters
— Applicability:
— very toxic and toxic substances and preparations,
— Criteria for use:
— normally limited to very toxic and toxic substances and preparations
when desirable to supplement S 13; for example when there is aninhalation risk and the substance or preparation should be stored
away from living quarters. The advice is not intended to preclude
proper use of the substance or preparation in living quarters.
S 5 Keep contents under … (appropriate liquid to be specified by the
manufacturer)
— Applicability:
— spontaneously flammable solid substances and preparations,
— Criteria for use:
— normally limited to special cases, for example, sodium, potassium
or white phosphorous.
S 6 Keep under … (inert gas to be specified by the manufacturer)
— Applicability:
— dangerous substances and preparations which must be kept under an
inert atmosphere,
— Criteria for use:
— normally limited to special cases, for example, certain organome-
tallic compounds.
S 7 Keep container tightly closed
— Applicability:
— organic peroxides,— substances and preparations which can give off very toxic, toxic,
harmful or extremely flammable gases,
— substances and preparations which in contact with moisture give off
extremely flammable gases,
— highly flammable solids,
— Criteria for use:
— obligatory for organic peroxides,— recommended for the other fields of application mentioned above.
S 8 Keep container dry
— Applicability:
— substances and preparations which may react violently with water,— substances and preparations which on contact with water liberate
extremely flammable gases,
— substances and preparations which on contact with water liberate
very toxic or toxic gases,
— Criteria for use:
— normally limited to the fields of application mentioned above when
necessary to reinforce warnings given by R 14, R 15 in particular,and R 29.
S 9 Keep container in a well-ventilated place
— Applicability:
— volatile substances and preparations which may give off very toxic,
toxic or harmful vapours,!
M11998L0098 — EN — 08.06.2000 — 001.001 — 606
— extremely flammable or highly flammable liquids and extremely
flammable gases,
— Criteria for use:
— recommended for volatile substances and preparations which may
give off very toxic, toxic or harmful vapours,
— recommended for extremely flammable or highly flammable liquids
or extremely flammable gases.
S 12 Do not keep the container sealed
— Applicability:
— substances and preparations which will by giving off gases or
vapours be liable to burst the container,
— Criteria for use:
— normally limited to the special cases mentioned above.
S 13 Keep away from food, drink and animal feedingstuffs
— Applicability:
— very toxic, toxic and harmful substances and preparations,
— Criteria for use:
— recommended when such substances and preparations are likely to
be used by the general public.
S 14 Keep away from … (incompatible materials to be indicated by the
manufacturer)
— Applicability:
— organic peroxides,
— Criteria for use:
— obligatory for and normally limited to organic peroxides. However,
may be useful in exceptional cases when incompatibility is likely to
produce a particular risk.
S 15 Keep away from heat
— Applicability:
— substances and preparations which may decompose or which may
react spontaneously under the effect of heat,
— Criteria for use:
— normally limited to special cases, for example monomers, but not
assigned if risk phrases R 2, R 3 and/or R 5 have already beenapplied.
S 16 Keep away from sources of ignition — no smoking
— Applicability:
— extremely flammable or highly flammable liquids and extremely
flammable gases,
— Criteria for use:
— recommended for the substances and preparations mentioned above
but not assigned if risk phrases R 2, R 3 and/or R 5 have alreadybeen applied.
S 17 Keep away from combustible material
— Applicability:
— substances and preparations which may form explosive or
spontaneously flammable mixtures with combustible material,
— Criteria for use:
— available for use in special cases, for example to emphasise R 8 and
R9 .
S 18 Handle and open container with care
— Applicability:
— substances and preparations liable to produce an overpressure in the
container,!
M11998L0098 — EN — 08.06.2000 — 001.001 — 607
— substances and preparations which may form explosive peroxides,
— Criteria for use:
— normally limited to the abovementioned cases when there is risk of
damage to the eyes and/or when the substances and preparations arelikely to be used by the general public.
S 20 When using do not eat or drink
— Applicability:
— very toxic, toxic and corrosive substances and preparations,
— Criteria for use:
— normally limited to special cases (for example arsenic and arsenic
compounds; (fluoracetates) in particular when any of these are
likely to be used by the general public.
S 21 When using do not smoke
— Applicability:
— substances and preparations which produce toxic products on
combustion.
— Criteria for use:
— normally limited to special cases (e.g. halogenated compounds).
S 22 Do not breathe dust
— Applicability:
— all solid substances and preparations dangerous for health,
— Criteria for use:
— obligatory for those substances and preparations mentioned above
to which R 42 is assigned,
— recommended for those substances and preparations mentioned
above which are supplied in the form of an inhalable dust and forwhich the health hazards following inhalation are not known.
S 23 Do not breathe gas/fumes/vapour/spray (appropriate wording to be
specified by the manufacturer)
— Applicability:
— all liquid or gaseous substances and preparations dangerous to
health,
— Criteria for use:
— obligatory for those substances and preparations mentioned above
to which R 42 is assigned,
— obligatory for substances and preparations intended for use by
spraying. Either S 38 or S 51 must be ascribed in addition,
— recommended when it is necessary to draw the attention of the user
to inhalation risks not mentioned in the risk phrases which have tobe ascribed.
S 24 Avoid contact with skin
— Applicability:
— all substances and preparations dangerous for health,
— Criteria for use:
— obligatory for those substances and preparations to which R 43 has
been ascribed, unless S 36 has also been ascribed,
— recommended when it is necessary to draw the attention of the user
to skin contact risks not mentioned in the risk phrases (e.g.paresthesia) which have to be ascribed. However, may be used toemphasise such risk phrases.
S 25 Avoid contact with eyes
— Applicability:
— all substances and preparations dangerous to health,!
M11998L0098 — EN — 08.06.2000 — 001.001 — 608
— Criteria for use:
— recommended when it is necessary to draw the attention of the user
to eye contact risks not mentioned in the risk phrases which have tobe applied. However, may be used to emphasise such risk phrases,
— recommended for substances ascribed R 34, R 35, R 36 or R 41
which are likely to be used by the general public.
S 26 In case of contact with eyes, rinse immediately with plenty of water
and seek medical advice
— Applicability:
— corrosive or irritant substances and preparations,
— Criteria forr use:
— obligatory for corrosive substances and preparations and those to
which R 41 has already been ascribed,
— recommended for irritant substances and preparations to which the
risk phrase R 36 has already been ascribed.
S 27 Take off all contaminated clothing immediately
— Applicability:
— very toxic, toxic or corrosive substances and preparations,
— Criteria for use:
— obligatory for very toxic substances and preparations to which R 27
has been ascribed and which are likely to be used by the generalpublic.
— recommended for very toxic substances and preparations to which
R 27 has been ascribed used in industry. However, this safety phraseshould not be used if S 36 has been ascribed.
— recommended for toxic substances and preparations to which R 24
has been ascribed as well as corrosive substances and preparationswhich are likely to be used by the general public.
S 28 After contact with skin, wash immediately with plenty of … (to be
specified by the manufacturer).
— Applicability:
— very toxic, toxic or corrosive substances and preparations,
— Criteria for use:
— obligatory for very toxic substances and preparations,
— recommended for the other substances and preparations mentioned
above, in particular when water is not the most appropriate rinsingfluid,
— recommended for corrosive substances and preparations which are
likely to be used by the general public.
S 29 Do not empty into drains
— Applicability:
— extremely or highly flammable liquids immiscible with water,
— very toxic and toxic substances and preparations,— substances dangerous for the environment,
— Criteria for use:
— obligatory for substances dangerous for the environment and
assigned the symbol ‘N’, which are likely to be used by the generalpublic, unless this is the intended use.
— recommended for other substances and preparations mentioned
above which are likely to be used by the general public, unless this
is the intended use.
S 30 Never add water to this product
— Applicability:
— substances and preparations which react violently with water,!
M11998L0098 — EN — 08.06.2000 — 001.001 — 609
— Criteria for use:
— normally limited to special cases (e.g. sulphuric acid) and may be
used, as appropriate, to give the clearest possible information, either
to emphasise R 14 or as an alternative to R 14.
S 33 Take precautionary measures against static discharges
— Applicability:
— extremely or highly flammable substances and preparations,
— Criteria for use:
— recommended for substances and preparations used in industry
which do not absorb moisture. Virtually never used for substances
and preparations as placed on the market for use by the generalpublic.
S 35 This material and its container must be disposed of in a safe way.
— Applicability:
— all dangerous substances and preparations,
— Criteria for use:
— recommended for substances and preparations where special
guidance is needed to ensure proper disposal.
S 36 Wear suitable protective clothing
— Applicability:
— organic peroxides,
— very toxic, toxic or harmful substances and preparations,— corrosive substances and preparations,
— Criteria for use:
— obligatory for very toxic and corrosive substances and preparations,— obligatory for those substances and preparations to which either R
21 or R 24 has been ascribed,
— obligatory for category 3 carcinogens, mutagens and substances
toxic to reproduction unless the effects are produced solely by
inhalation of the substance or preparation,
— obligatory for organic peroxides,
— recommended for toxic substances and preparations if the LD
50
dermal value is unknown but the substance or preparation is likely
to be toxic through skin contact,
— recommended for substances and preparations used in industry
which are liable to damage health by prolonged exposure.
S 37 Wear suitable gloves
— Applicability:
— very toxic, toxic, harmful or corrosive substances and preparations,
— organic peroxides,
— substances and preparations irritating to the skin or causing
sensitisation by skin contact,
— Criteria for use:
— obligatory for very toxic and corrosive substances and preparations,
— obligatory for those substances and preparations to which either R
21, R 24 or R 43 has been ascribed,
— obligatory for category 3 carcinogens, mutagens and substances
toxic to reproduction unless the effects are produced solely byinhalation of the substances and preparations,
— obligatory for organic peroxides,
— recommended for toxic substances and preparations if the LD
50
dermal value is unknown but the substance or preparation is likely
to be harmful by skin contact,
— recommended for substances and preparations irritating to the skin.!M11998L0098 — EN — 08.06.2000 — 001.001 — 610
S 38 In case of insufficient ventilation, wear suitable respiratory
equipment
— Applicability:
— very toxic or toxic substances and preparations,
— Criteria for use:
— normally limited to special cases involving the use of very toxic or
toxic substances and preparations in industry or in agriculture.
S 39 Wear eye/face protection
— Applicability:
— organic peroxides,
— corrosive substances and preparations, including irritants which
give rise to risk of serious damage to the eyes.
— very toxic and toxic substances and preparations,
— Criteria for use:
— obligatory for those substances and preparations to which R 34, R
35 or R 41 have been ascribed,
— obligatory for organic peroxides,— recommended when it is necessary to draw the attention of the user
to eye contact risks not mentioned in the risk phrases which have tobe ascribed,
— normally limited to exceptional cases for very toxic and toxic
substances and preparations, where there is a risk of splashing andthey are likely to be easily absorbed by the skin.
S 40 To clean the floor and all objects contaminated by this material use
… (to be specified by the manufacturer)
— Applicability:
— all dangerous substances and preparations,
— Criteria for use:
— normally limited to those dangerous substances and preparations for
which water is not considered to be a suitable cleansing agent (e.g.where absorption by powdered material, dissolution by solvent, etc.is necessary) and where it is important for health and/or safetyreasons to provide a warning on the label.
S 41 In case of fire and/or explosion do not breathe fumes
— Applicability:
— dangerous substances and preparations which on combustion give
off very toxic or toxic gases,
— Criteria for use:
— normally limited to special cases.
S 42 During fumigation/spraying wear suitable respiratory equipment
(appropriate wording to be specified by the manufacturer)
— Applicability:
— substances and preparations intended for such use but which may
endanger the health and safety of the user unless proper precautionsare taken,
— Criteria for use:
— normally limited to special cases.
S 43 In case of fire use … (indicate in the space the precise type of fire-
fighting equipment. If water increases the risk add: Never use
water)
— Applicability:
— extremely flammable, highly flammable and flammable substances
and preparations,
— Criteria for use:
— obligatory for substances and preparations which, in contact with
water or damp air, evolve extremely flammable gases,!
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— recommended for extremely flammable, highly flammable and
flammable substances and preparations, particularly when they areimmiscible with water.
S 45 In case of accident or if you feel unwell seek medical advice
immediately (show the label where possible).
— Applicability:
— very toxic substances and preparations,
— toxic and corrosive substances and preparations,
— substances and preparations causing sensitisation by inhalation,
— Criteria for use:
— obligatory for the substances and preparations mentioned above.
S 46 If swallowed, seek medical advice immediately and show this
container or label
— Applicability
— all dangerous substances and preparations other than those which
are very toxic, toxic, corrosive or dangerous to the environment,
— Criteria for use:
— obligatory for all dangerous substances and preparations mentioned
above which are likely to be used by the general public, unless there
is no reason for fear any danger from swallowing, particularly by
children.
S 47 Keep at temperature not exceeding … °C (to be specified by the
manufacturer)
— Applicability:
— substances and preparations which become unstable at a certain
temperature,
— Criteria for use:
— normally limited to special cases (e.g. certain organic peroxides).
S 48 Keep wetted with … (appropriate material to be specified by the
manufacturer)
— Applicability:
— substances and preparations which may become very sensitive to
sparks, friction or impact if allowed to dry out,
— Criteria for use:
— normally limited to special cases, for example nitrocelluloses.
S 49 Keep only in the original container
— Applicability:
— substances and preparations sensitive to catalytic decomposition,
— Criteria for use:
— substances and preparations sensitive to catalytic decomposition,
for example certain organic peroxides.
S 50 Do not mix with … (to be specified by the manufacturer)
— Applicability:
— substances and preparations which may react with the specified
product to evolve very toxic or toxic gases,
— organic peroxides,
— Criteria for use
— recommended for substances and preparations mentioned above
which are likely to be used by the general public, when it is a better
alternative to R 31 or R 32,
— obligatory with certain peroxides which may give violent reaction
with accelerators or promoters.!
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S 51 Use only in well-ventilated areas
— Applicability:
— substances and preparations likely to or intended to produce
vapours, dusts, sprays, fumes, mists, etc. which give rise toinhalation risks or to a fire or explosion risk,
— Criteria for use:
— recommended when use of S 38 would not be appropriate. Thus
important when such substances and preparations are likely to beused by the general public.
S 52 Not recommended for interior use on large surface areas
— Applicability:
— volatile, very toxic, toxic and harmful substances and preparations
containing them,
— Criteria for use:
— recommended when damage to health is likely to be caused by
prolonged exposure to these substances by reason of theirvolatilisation from large treated surfaces in the home or other
enclosed places where persons congregate.
S 53 Avoid exposure — Obtain special instructions before use
— Applicability:
— substances and preparations that are carcinogenic, mutagenic and/or
toxic to reproduction,
— Criteria for use:
— obligatory for the abovementioned substances and preparations to
which at least one of the following R-phrases has been assigned: R45, R 46, R 49, R 60 or R 61.
S 56 Dispose of this material and its container to hazardous or special
waste collection point
— Applicability:
— all dangerous substances and preparations,
— Criteria for use:
— recommended for all dangerous substances and preparations likely
to be used by the general public for which special disposal isrequired.
S 57 Use appropriate containment to avoid environmental contamination
— Applicability:
— substances which have been assigned the symbol ‘N’,
— Criteria for use:
— normally limited to substances not likely to be used by the general
public.
S 59 Refer to manufacturer/supplier for information on recovery/
recycling
— Applicability:
— all dangerous substances and preparations,
— Criteria for use:
— obligatory for substances dangerous for the ozone layer,
— recommended for other substances and preparations for which
recovery/recycling is recommended.
S 60 This material and its container must be disposed of as hazardous
waste
— Applicability:
— all dangerous substances and preparations,
— Criteria for use:
— recommended for substances and preparations not likely to be used
by the general public and where S 35 is not assigned.!
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S 61 Avoid release to the environment. Refer to special instructions/safety
data sheet
— Applicability:
— substances dangerous for the environment,
— Criteria for use:
— normally used for substances which have been assigned the symbol
‘N’,
— recommended for all substances classified dangerous for the
environment not covered above.
S 62 If swallowed, do not induce vomiting: seek medical advice
immediately and show this container or label.
— Applicability:
— substances and preparations classified as harmful with R 65 in
accordance with the criteria in section 3.2.3,
— not applicable to substances and preparations which are placed on
the market in aerosol containers (or in containers fitted with asealed spray attachment), see sections 8 and 9,
— Criteria for use:
— obligatory for substances and preparations metioned above, if sold
to, or likely to be used by the general public, except when S 45 or S46 are obligatory,
— recommended for the substances and preparations mentioned above
when used in industry, except where S 45 or S 46 are obligatory,
S 63 In case of accident by inhalation: remove casualty to fresh air and
keep at rest
— Applicability:
— very toxic and toxic substances and preparations (gases, vapours,
particulates, volatile liquids),
— substances and preparations causing respiratory sensitisation,
— Criteria for use:
— obligatory for substances and preparation to which R 26, R 23 or R
42 has been assigned which are likely to be used by the general
public in a way which could result in inhalation
S 64 If swallowed, rinse mouth with water, (only if the person is
conscious).
— Applicability:
— corrosive or irritant substances and preparations,
— Criteria for use:
— recommended for the above substances and preparations which are
likely to be used by the general public and where the abovetreatment is suitable.
7.5.2. Choice of safety phrases
The final choice of safety phrases must have regard to the risk phrases
indicated on the label and to the intended use of the substance or preparation:
— as a general rule, a maximum of four S-phrases shall suffice to formulate
the most appropriate safety advice; for this purpose the combinedphrases listed in Annex IV shall be regarded as single phrases,
— in the case of S-phrases concerning disposal, one S-phrase shall be used,
unless it is clear that disposal of the material and its container does notpresent a danger for human health or the environment. In particular,advice on safe disposal is important for substances and preparations soldto the general public,
— some R-phrases become superfluous if a careful selection is made of S-
phrases and vice versa; S-phrases which obviously correspond to R-phrases will appear on the label only if it is intended to emphasise aspecific warning,
— particular attention must be given, in the choice of safety phrases, to the
foreseen conditions of use of certain substances and preparations, for!
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example spraying or other aerosol effects. Phrases should be chosen with
the intended use in view,
— the safety phrases S 1, S 2 and S 45 are obligatory for all very toxic, toxic
and corrosive substances and preparations sold to the general public,
— the safety phrases S 2 and S 46 are obligatory for all other dangerous
substances and preparations (except those only classified as dangerous to
the environment) sold to the general public.
Where the phrases selected according to the strict criteria in 6.2 result in
redundancy or ambiguity or are clearly unnecessary given the specific
product/package then some phrases may be deleted.
8. SPECIAL CASES: SUBSTANCES
8.1. Mobile gas cylinders
For mobile gas cylinders the requirements concerning labelling are considered
to be satisfied when they are in agreement with Article 23 or Article 24(6)b.
However, by way of derogation from Article 24(1) and 82), one of the
following alternatives can be used for gas cylinders with a water capacity of
less than or equal to 150 litres:
— the format and dimensions of the label can follow the prescriptions of the
ISO standard ISO/DP 7225,
— the information specified in Article 23(2) may be provided on a durable
information disc or label held captive on the cylinder.
8.2. Gas containers intended for propane, butane or liquefied petroleum gas
(LPG)
These substances are classified in Annex I. Although classified in accordance
with Article 2, they do not present a danger to human health when they areplaced on the market in closed refillable cylinders or in non-refillablecartridges within the scope of EN 417 as fuel gases which are only released
for combustion.
These cylinders or cartridges must be labelled with the appropriate symbol
and the R- and S-phrases concerning flammability. No informationconcerning the effects on human health is required on the label. However,the information concerning effects on human health which should haveappeared on the label shall be transmitted to the professional user by the
person responsible for placing the substance on the market in the format
foreseen in Article 27 of the Directive. For the consumer, sufficientinformation shall be transmitted to enable them to take all necessarymeasures for health and safety as foreseen in Article 1(3) of Directive 91/155/EEC, as modified by Directive 93/112/EEC.
8.3. Metals in massive form
These substances are classified in Annex I or shall be classified in accordance
with Article 6. However, some of these substances, although classified inaccordance with Article 2 do not present a danger to human health byinhalation, ingestion or contact with skin or to the aquatic environment in theform in which they are placed on the market. Such substances do not require a
label according to Article 23. However, all the information which should have
appeared on the label shall be transmitted to the user by the personresponsible for placing the metal on the market, in a format foreseen inArticle 27.
8.4. Substances classified with R 65
Substances classified as harmful on the basis of an aspiration hazard need not
be labelled as harmful with R 65 when placed on the market in aerosolcontainers or in containers fitted with a sealed spray attachment.!
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