S.I. No. 116/2003 - European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations 2003

• (c) European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) (No. 2) Regulations, 1998 ( S.I. No. 513 of 1998 ),

• (d) European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) (Amendment) Regulations, 1999 ( S.I. No. 363 of 1999 ), and

• (e) European Communities (Classification, Packaging, Labelling and Notification of Dangerous Substances) Regulations, 2000 ( S.I. No. 393 of 2000 ),

are revoked.

SCHEDULE 1 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 Directive 67/548/EEC.

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 number for 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 No. C 146A, 15.6.1990) the Einecs number is included. This number is 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, 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 of the 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 for anhydrous and hydrated forms. The CAS number included is for the anhydrous form only, and therefore the CAS number shown does not always describe the entry as accurately 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 designated using 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 put on 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 specific concentration limits are shown, these apply to the substance or substances shown in the entry. In particular, in the case of entries which are mixtures of substances or substances described with a specific percentage purity, the limits apply to the substance as described in Annex I and not the pure substance.

Article 23 (2)(a) of Directive 67/548/EEC⁶⁰ 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 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 ≥ 0,1 % 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 as ferrocyanides, 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/EEC⁶¹ ) and assigning the qualifying risk phrase or phrases. The classification has consequences not only for labelling but also for other legislation and regulatory measures on dangerous substances;

• (ii) the classification for each category of danger is normally presented in the form of an abbreviation representing 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 for the 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: R10

• very toxic: T+

• toxic: T

• harmful: Xn

• corrosive: C

• irritant: Xi

• sensitising: R42 and/or R43

• carcinogenic: Carc. Cat.⁶²

• mutagenic: Muta. Cat.⁶²

• toxic for reproduction: Repr. Cat.⁶²

• dangerous for the environment: N or/and R52, R53, R59;

• (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 although they are not formally part of the classification.

• (b) the label, including:

• (i) the letter assigned to the substance in accordance with Annex II (see Article 23(2)(c) of Directive 67/548/EEC). This acts as an abbreviation for the symbol and for the indication of danger (if these are assigned);

• (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) of Directive 67/548/EEC). The numbers are separated by either:

• a dash (-) to denote separate statements concerning special risks (R), or

• 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 with Annex IV (see Article 23(2)(e) of Directive 67/548/EEC). Again the numbers are separated by either 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 selected according to the usual rules.

Note that for certain dangerous substances and preparations sold to the general public certain S-phrases are mandatory.

S1, S2 and S45 are obligatory for all very toxic, toxic and corrosive substances and preparations sold to the general public.

S2 and S46 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 S1 and S2 are shown in brackets in Annex I and can only be omitted from the label when the substance or preparation is sold for industrial use only.

• (c) the concentration limits and associated classifications necessary to classify dangerous preparations containing the substance in accordance with Directive 1999/45/EC.

Unless otherwise shown, the concentration limits are a percentage by weight of the substance calculated with reference to the total weight of the preparation.

Where no concentration limits are given, the concentration limits to be used when applying the conventional method of assessing health hazards are those in Annex II, and when applying the conventional method of assessing environmental hazards are those in Annex III of Directive 1999/45/EC.

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 are placed on the market, insofar as they are listed in Einecs or ELINCS. Where a substance that is covered by a group entry occurs as an impurity in another substance, the classification 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 Annex I 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 lead compounds (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, the classification leading to the more severe classification is used for the label of the particular 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 these substances must refer to the provisions of this Directive if he intends to place these substances 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)).

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 a substance is required to state on the label the correct name, due account being taken of the chapter entitled “Nomenclature” of the Foreword:

Example: for BeC12 (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 be those 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 be those shown in both the appropriate entries given in Annex I. In cases where two different classifications are given in the two entries for the same hazard the classification reflecting the more severe hazard classification is used.

Example:

for substance AB - no individual entry in Annex I:

Annex I group entry for compounds of A:

Repr. Cat. 1; R61 Repr. Cat. 3; R62 Xn; R20/22 R33 N; R50-53

Annex I group entry for compounds of B:

Carc. Cat. 1; R45 T; R23/25 N; R51-53

Classification of substance AB thus becomes:

Carc. Cat. 1; R45 Repr. Cat. 1; R61 Repr. Cat. 3; R62 T; R23/25 R33 N; R50-53

Note B:

Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and therefore, these solutions require different labelling since the hazards vary at different 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 in aqueous solution must state the percentage concentration of the solution on the label.

Example: nitric acid 45%.

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 decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Annex I to Directive 67/548/EEC.

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 market must 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 2 are ascribed Note E if they are also classified as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22 R23, R24, R25, R26, R27, R28, R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the word “Also”.

Examples:	R45-23 “May cause cancer. Also toxic by inhalation”
R46-27/28 “May cause heritable genetic damage. Also very toxic in contact with skin and if swallowed”.	R46-27/28 “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 be provided 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) of danger shown. The requirements of Article 6⁶³ of Directive 67/548/EEC 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 of this 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 to certain 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 is not classified as a carcinogen, at least the S-phrases (2-)9-16 should apply. This note applies 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 to certain 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 note applies 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 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 less than 40 days, or

• an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity, 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 geometric errors greater than 6µm.

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 1999/45/EC are the percentages by weight of the metallic element 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 R65 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 R67 if they meet the criteria in Section 3.2.8 in Annex VI.

This Note will no longer apply from the date on which the criteria for the use of R67 provided for in Directive 1999/45/EC enter into force.

TABLE A

List of chemical elements listed according to their atomic number [Z]

Z	Symbol	Element	Z	Symbol	Element	Z	Symbol	Element
1	H	Hydrogen	19	K	Potassium	37	Rb	Rubidium
2	He	Helium	20	Ca	Calcium	38	Sr	Strontium
3	Li	Lithium	21	Sc	Scandium	39	Y	Yttrium
4	Be	Berllium	22	Ti	Titanium	40	Zr	Zirconium
5	B	Boron	23	V	Vanadium	41	Nb	Nicobium
6	C	Carbon	24	Cr	Chromium	42	Mo	Molybdenum
7	N	Nitrogen	25	Mn	Manganese	43	Tc	Technetium
8	O	Oxygen	26	Fe	Iron	44	Ru	Ruthenium
9	F	Fluoride	27	Co	Cobalt	45	Rh	Rhodium
10	Ne	Neon	28	Ni	Nickel	46	Pd	Palladium
11	Na	Sodium	29	Cu	Copper	47	Ag	Silver
12	Mg	Magnesium	30	Zn	Zinc	48	Cd	Cadmium
13	Al	Aluminium	31	Ga	Gallium	49	In	Indium
14	Si	Silicon	32	Ge	Germanium	50	Sn	Tin
15	P	Phosphorus	33	As	Arsenic	51	Sb	Antimony
16	S	Sulphur	34	Se	Selenium	52	Te	Tellurium
17	Cl	Chlorine	35	Br	Bromine	53	I	Iodine
18	Ar	Argon	36	Kr	Krypton	54	Xe	Xenon
55	Cs	Caesium	72	Hf	Hafnium	89	Ac	Actinium
56	Ba	Barium	73	Ta	Tantalum	90	Th	Thorium
57	La	Lanthanum	74	W	Tungsten	91	Pa	Protactinium
58	Ce	Cerium	75	Re	Rhenium	92	U	Uranium
59	Pr	Praseodymium	76	Os	Osmium	93	Np	Neptunium
60	Nd	Neodymium	77	Ir	Iridium	94	Pu	Plutonium
61	Pm	Promethium	78	Pt	Platinum	95	Am	Americium
62	Sm	Samarium	79	Au	Gold	96	Cm	Curium
63	Eu	Europium	80	Hg	Mercury	97	Bk	Berkelium
64	Gd	Gadolinium	81	Tl	Thallium	98	Cf	Californium
65	Tb	Terbium	82	Pb	Lead	99	Es	Einsteinium
66	Dy	Dysprosium	83	Bi	Bismuth	100	Fm	Fermium
67	Ho	Holmium	84	Po	Polonium	101	Md	Mendelevium
68	Er	Erbium	85	At	Astatine	102	No	Nobelium
69	Tm	Thulium	86	Rn	Radon	103	Lw	Lawrencium
70	Yb	Ytterbium	87	Fr	Francium
71	Lu	Lutetium	88	Ra	Radium

TABLE B

SPECIAL CLASSIFICATION FOR ORGANIC SUBSTANCES	SPECIAL CLASSIFICATION FOR ORGANIC SUBSTANCES	SPECIAL CLASSIFICATION FOR ORGANIC SUBSTANCES	SPECIAL CLASSIFICATION FOR ORGANIC SUBSTANCES
601	Hydrocarbons	606	Ketones and their derivatives
602	Halogenated hydrocarbons	607	Organic acids and their derivatives
603	Alcohols and their derivatives	608	Nitriles
604	Phenols and their derivatives	609	Nitro compounds
605	Aldehydes and their derivatives	610	Chloronitro compounds
611	Azoxy-and azo compounds	616	Amides and their derivatives
612	Amine compounds	617	Organic Peroxides
613	Heterocyclic bases and their derivatives	647	Enzymes
614	Glycosides and alkaloids	648	Complex substances derived from coal
615	Cyanates and isocyanates	649	Complex substances derived from petroleum
650	Miscellandous substances

SCHEDULE 2 ANNEX II

SYMBOLS AND INDICATIONS OF DANGER FOR DANGEROUS SUBSTANCES AND PREPARATIONS

Note: The letters E, O, F, F+, T, T+, C, Xn, Xi and N do not form part of the symbol.	Note: The letters E, O, F, F+, T, T+, C, Xn, Xi and N do not form part of the symbol.
E [image omitted] Explosive	O [image omitted] Oxidizing
F [image omitted] Highly flammable	F+ [image omitted] Extremely flammable
T [image omitted] Toxic	T+ [image omitted] Very Toxic
C [image omitted] Corrosive	Xn [image omitted] Harmful
Xi [image omitted] Irritant	N [image omitted] Dangerous for the environment

SCHEDULE 3 ANNEX III

NATURE OF SPECIAL RISKS ATTRIBUTED TO DANGEROUS SUBSTANCES AND PREPARATIONS

R1

Explosive when dry

R2

Risk of explosion by shock, fire or other sources of ignition

R3

Extreme risk of explosion by shock, friction, fire or other sources of ignition

R4

Forms very sensitive explosive metallic compounds

R5

Heating may cause an explosion

R6

Explosive with or without contact with air

R7

May cause fire

R8

Contact with combustible material may cause fire

R9

Explosive when mixed with combustible materials

R10

Flammable

R11

Highly flammable

R12

Extremely flammable

R14

Reacts violently with water

R15

Contact with water liberates highly flammable gases

R16

Explosive when mixed with oxidizing substances

R17

Spontaneously flammable in air

R18

In use, may form flammable/explosive vapour-air mixture

R19

May form explosive peroxides

R20

Harmful by inhalation

R21

Harmful in contact with skin

R22

Harmful if swallowed

R23

Toxic by inhalation

R24

Toxic in contact with skin

R25

Toxic if swallowed

R26

Very toxic by inhalation

R27

Very toxic in contact with skin

R28

Very toxic if swallowed

R29

Contact with water liberates toxic gas

R30

Can become highly flammable in use

R31

Contact with acids liberates toxic gas

R32

Contact with acids liberates very toxic gas

R33

Danger of cumulative effects

R34

Causes burns

R35

Causes severe burns

R36

Irritating to eyes

R37

Irritating to respiratory system

R38

Irritating to skin.

R39

Danger of very serious irreversible effects

R40

Limited evidence of a carcinogenic effect

R41

Risk of serious damage to eyes

R42

May cause sensitisation by inhalation

R43

May cause sensitisation by skin contact

R44

Risk of explosion if heated under confinement

R45

May cause cancer

R46

May cause heritable genetic damage

R48

Danger of serious damage to health by prolonged exposure

R49

May cause cancer by inhalation

R50

Very toxic to aquatic organisms

R51

Toxic to aquatic organisms

R52

Harmful to aquatic organisms

R53

May cause long-term adverse effects in the aquatic environment

R54

Toxic to flora

R55

Toxic to fauna

R56

Toxic to soil organisms

R57

Toxic to bees

R58

May cause long-term adverse effects in the environment

R59

Dangerous for the ozone layer

R60

May impair fertility

R61

May cause harm to the unborn child

R62

Possible risk of impaired fertility

R63

Possible risk of harm to the unborn child

R64

May cause harm to breastfed babies

R65

Harmful: May cause lung damage if swallowed

R66

Repeated exposure may cause skin dryness or cracking

R67

Vapours may cause drowsiness and dizziness

R68

Possible risk of irreversible effects

COMBINATION OF R-PHRASES

R14/15

Reacts violently with water, liberating highly flammable gases

R15/29

Contact with water liberates toxic, highly flammable gas

R20/21

Harmful by inhalation and in contact with skin

R20/22

Harmful by inhalation and if swallowed

R20/21/22

Harmful by inhalation, in contact with skin and if swallowed

R21/22

Harmful in contact with skin and if swallowed

R23/24

Toxic by inhalation and in contact with skin

R23/25

Toxic by inhalation and if swallowed

R23/24/25

Toxic by inhalation, in contact with skin and if swallowed

R24/25

Toxic in contact with skin and if swallowed

R26/27

Very toxic by inhalation and in contact with skin

R26/28

Very toxic by inhalation and if swallowed

R26/27/28

Very toxic by inhalation and in contact with skin and if swallowed

R27/28

Very toxic in contact with skin and if swallowed

R36/37

Irritating to eyes and respiratory system

R36/38

Irritating to eyes and skin

R36/37/38

Irritating to eyes, respiratory system and skin

R37/38

Irritating to respiratory system and skin

R39/23

Toxic: danger of very serious irreversible effects through inhalation

R39/24

Toxic: danger of very serious irreversible effects in contact with skin

R39/25

Toxic: danger of very serious irreversible effects if swallowed

R39/23/24

Toxic: danger of very serious irreversible effects through inhalation and in contact with skin

R39/23/25

Toxic: danger of very serious irreversible effects through inhalation and if swallowed

R39/24/25

Toxic: danger of very serious irreversible effects in contact with skin and if swallowed

R39/23/24/25

Toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed

R39/26

Very toxic: danger of very serious irreversible effects through inhalation

R39/27

Very toxic: danger of very serious irreversible effects in contact with skin

R39/28

Very toxic: danger of very serious irreversible effects if swallowed

R39/26/27

Very toxic: danger of very serious irreversible effects through inhalation and in contact with skin

R39/26/28

Very toxic: danger of very serious irreversible effects through inhalation and if swallowed

R39/27/28

Very toxic: danger of very serious irreversible effects in contact with skin and if swallowed

R39/26/27/28

Very toxic: danger of very serious irreversible effects through inhalation, in contact with skin and if swallowed

R68/20

Harmful: possible risk of irreversible effects through inhalation

R68/21

Harmful: possible risk of irreversible effects in contact with skin

R68/22

Harmful: possible risk of irreversible effects if swallowed

R68/20/21

Harmful: possible risk of irreversible effects through inhalation and in contact with skin

R68/20/22

Harmful: possible risk of irreversible effects through inhalation and if swallowed

R68/21/22

Harmful: possible risk of irreversible effects in contact with skin and if swallowed

R68/20/21/22

Harmful: possible risk of irreversible effects through inhalation, in contact with skin and if swallowed

R42/43

May cause sensitisation by inhalation and skin contact

R48/20

Harmful: danger of serious damage to health by prolonged exposure through inhalation

R48/21

Harmful: danger of serious damage to health by prolonged exposure in contact with skin

R48/22

Harmful: danger of serious damage to health by prolonged exposure if swallowed

R48/20/21

Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin

R48/20/22

Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed

R48/21/22

Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed

R48/20/21/22

Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed

R48/23

Toxic: danger of serious damage to health by prolonged exposure through inhalation

R48/24

Toxic: danger of serious damage to health by prolonged exposure in contact with skin

R48/25

Toxic: danger of serious damage to health by prolonged exposure if swallowed

R48/23/24

Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin

R48/23/25

Toxic: danger of serious damage to health by prolonged exposure through inhalation and if swallowed

R48/24/25

Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed

R48/23/24/25

Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed

R50/53

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment

R51/53

Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment

R52/53

Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment

SCHEDULE 4 ANNEX IV

SAFETY ADVICE CONCERNING DANGEROUS SUBSTANCES AND PREPARATIONS

S 1

Keep locked up.

S 2

Keep out of the reach of children.

S 3

Keep in a cool place.

S 4

Keep away from living quarters.

S 5

Keep contents under … (appropriate liquid to be specified by the manufacturer).

S 6

Keep under … (inert gas to be specified by the manufacturer).

S 7

Keep container tightly closed.

S 8

Keep container dry.

S 9

Keep container in a well-ventilated place.

S 12

Do not keep the container sealed.

S 13

Keep away from food, drink and animal feedingstuffs.

S 14

Keep away from … (incompatible materials to be indicated by the manufacturer).

S 15

Keep away from heat.

S 16

Keep away from sources of ignition - No smoking.

S 17

Keep away from combustible material.

S 18

Handle and open container with care.

S 20

When using do not eat or drink.

S 21

When using do not smoke.

S 22

Do not breathe dust.

S 23

Do not breathe gas/fumes/vapour/spray (appropriate wording to be specified by the manufacturer).

S 24

Avoid contact with skin.

S 25

Avoid contact with eyes.

S 26

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

S 27

Take off immediately all contaminated clothing.

S 28

After contact with skin, wash immediately with plenty of … (to be specified by the manufacturer).

S 29

Do not empty into drains.

S 30

Never add water to this product.

S 33

Take precautionary measures against static discharges.

S 35

This material and its container must be disposed of in a safe way.

S 36

Wear suitable protective clothing.

S 37

Wear suitable gloves.

S 38

In case of insufficient ventilation, wear suitable respiratory equipment.

S 39

Wear eye/face protection.

S 40

To clean the floor and all objects contaminated by this material, use … (to be specified by the manufacturer).

S 41

In case of fire and/or explosion do not breathe fumes.

S 42

During fumigation/spraying wear suitable respiratory equipment (appropriate wording to be specified by the manufacturer).

S 43

In case of fire, use … (indicate in the space the precise type of fire-fighting equipment. If water increases risk, add - ‘Never use water’).

S 45

In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).

S 46

If swallowed, seek medical advice immediately and show this container or label.

S 47

Keep at temperature not exceeding … °C (to be specified by the manufacturer).

S 48

Keep wetted with … (appropriate material to be specified by the manufacturer).

S 49

Keep only in the original container.

S 50

Do not mix with … (to be specified by the manufacturer).

S 51

Use only in well-ventilated areas.

S 52

Not recommended for interior use on large surface areas.

S 53

Avoid exposure - obtain special instructions before use.

S 56

Dispose of this material and its container at hazardous or special waste collection point.

S 57

Use appropriate containment to avoid environmental contamination.

S 59

Refer to manufacturer/supplier for information on recovery/recycling.

S 60

This material and its container must be disposed of as hazardous waste.

S 61

Avoid release to the environment. Refer to special instructions/Safety data sheets.

S 62

If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label.

S 63

In case of accident by inhalation: remove casualty to fresh air and keep at rest.

S 64

If swallowed, rinse mouth with water (only if the person is conscious).

Combination of S-phrases

S 1/2

Keep locked up and out of reach of children.

S 3/7

Keep container tightly closed in a cool place.

S 3/9/14

Keep in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).

S 3/9/14/49

Keep only in the original container in a cool, well-ventilated place away from … (incompatible materials to be indicated by the manufacturer).

S 3/9/49

Keep only in the original container in a cool, well-ventilated place.

S 3/14

Keep in a cool place away from … (incompatible materials to be indicated by the manufacturer).

S 7/8

Keep container tightly closed and dry.

S 7/9

Keep container tightly closed and in a well-ventilated place.

S 7/47

Keep container tightly closed and at a temperature not exceeding … °C (to be specified by the manufacturer).

S 20/21

When using do not eat, drink or smoke.

S 24/25

Avoid contact with skin and eyes.

S 27/28

After contact with skin, take off immediately all contaminated clothing and wash immediately with plenty of … (to be specified by the manufacturer).

S 29/35

Do not empty into drains; dispose of this material and its container in a safe way.

S 29/56

Do not empty into drains, dispose of this material and its container to hazardous or special waste collection point.

S 36/37

Wear suitable protective clothing and gloves.

S 36/37/39

Wear suitable protective clothing, gloves and eye/face protection.

S 36/39

Wear suitable protective clothing and eye/face protection.

S 37/39

Wear suitable gloves and eye/face protection.

S 47/49

Keep only in the original container at a temperature not exceeding … °C (to be specified by the manufacturer).

SCHEDULE 5 ANNEX VI

GENERAL CLASSIFICATION AND LABELLING REQUIREMENTS FOR DANGEROUS SUBSTANCES AND PREPARATIONS

CONTENTS

1.	GENERAL INTRODUCTION
2.	CLASSIFICATION ON THE BASIS OF PHYSICOCHEMICAL PROPERTIES
2.1.	Introduction
2.2.	Criteria for classification, choice of symbols, indication of danger, choice of risk phrases
2.2.1.	Explosive
2.2.2.	Oxidising
2.2.3.	Extremely flammable
2.2.4.	Highly flammable
2.2.5.	Flammable
2.2.6.	Other physicochemical properties
3.	CLASSIFICATION ON THE BASIS OF TOXICOLOGICAL PROPERTIES
3.1.	Introduction
3.2.	Criteria for classification, choice of symbols, indication of danger, choice of risk phrases
3.2.1.	Very toxic
3.2.2.	Toxic
3.2.3.	Harmful
3.2.4.	Comments regarding the use of R48
3.2.5.	Corrosive
3.2.6.	Irritant
3.2.7.	Sensitisation
3.2.8.	Other toxicological properties
4.	CLASSIFICATION ON THE BASIS OF SPECIFIC EFFECTS ON HUMAN HEALTH
4.1.	Introduction
4.2.	Criteria for classification, indication of danger, choice of risk phrases
4.2.1.	Carcinogenic substances
4.2.2.	Mutagenic substances
4.2.3.	Substances toxic to reproduction
4.2.4.	Procedure for the classification of preparations concerning specific effects on health
5.	CLASSIFICATION ON THE BASIS OF ENVIRONMENTAL EFFECTS
5.1.	Introduction
5.2.	Criteria for classification, indication of danger, choice of risk phrases
5.2.1.	Aquatic environment
5.2.2.	Non-aquatic environment
6.	CHOICE OF SAFETY ADVICE PHRASES
6.1.	Introduction
6.2.	Safety phrases for substances and preparations
7.	LABELLING
8.	SPECIAL CASES: Substances
8.1.	Mobile gas cylinders
8.2.	Gas containers intended for propane, butane or liquefied petroleum gas (LPG)
8.3.	Metals in massive form
8.4.	Substances classified with R65
9.	SPECIAL CASES: Preparations
9.1.	Gaseous preparations (gas mixtures)
9.2.	Gas containers intended for preparations containing stenched propane, butane or liquefied petroleum gas (LPG)
9.3.	Alloys, preparations containing polymers, preparations containing elastomers
9.4.	Preparations classified with R65
9.5.	Organic peroxides
9.6.	Additional labelling requirements for certain preparations
COMMISSION STATEMENT	COMMISSION STATEMENT

1.1. The object of classification is to identify all the physicochemical, toxicological and ecotoxicological properties of substances and preparations which may constitute a risk during normal handling or use. Having identified any hazardous properties the substance or preparation must then be labelled to indicate the hazard(s) in order to protect the user, the general public and the environment.

1.2. This Annex sets out the general principles governing the classification and labelling of substances and preparations referred to in Article 4⁶⁴ of Directive 67/548/EEC and in Article 4 of Directive 1999/45/EC and other relevant Directives on dangerous preparations.

It is addressed to all those concerned (manufacturers, importers, national authorities) with methods of classifying and labelling dangerous substances and preparations.

1.3. The requirements of Directive 67/548/EEC and of Directive 1999/45/EC are intended to provide a primary means by which the general public and persons at work are given essential information about dangerous substances and preparations. The label draws the attention of persons handling or using substances and preparations to the inherent danger of certain such materials.

The label may also serve to draw attention to more comprehensive product information on safety and use available in other forms.

1.4. The label takes account of all potential hazards which are likely to be faced in the normal handling and use of dangerous substances and preparations when in the form in which they are placed on the market, but not necessarily in any different form in which they may finally be used, e.g. diluted. The most severe hazards are highlighted by symbols, such hazards and those arising from other dangerous properties are specified in standard risk phrases, and safety phrases give advice on necessary precautions.

In the case of substances, the information is completed by the name of the substance under an internationally recognised chemical nomenclature, the preferred name being the one used in the European Inventory of Existing Commercial Chemical Substances (Einecs), or in the European List of Notified Chemical Substances (ELINCS), the EC number and the name address and telephone number of the person established in the Community who is responsible for placing the substance on the market.

In the case of preparations, the information in accordance with Article 10.2. of Directive 1999/45/EC, is completed by:

• the trade name or the designation of the preparation;

• the chemical name of the substance or substances present in the preparation; and

• the name, full address and telephone number of the person established in the Community who is responsible for placing the preparation on the market.

1.5. Article 6⁶⁵ of Directive 67/548/EEC requires that manufacturers, distributors and importers of dangerous substances which appear in the Einecs but which have not yet been introduced into Annex I shall be obliged to carry out an investigation to make themselves aware of the relevant and accessible data which exist concerning the properties of such substances. On the basis of this information, they shall package and provisionally label these substances according to the rules laid down in Articles 22 to 25⁶⁶ and the criteria in this Annex.

1.6. Data required for classification and labelling

1.6.1. For substances the data required for classification and labelling may be obtained:

• (a) as regards substances for which the information specified in Annex VII⁶⁷ , 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 above), the data required for classification and labelling may, if necessary, be obtained from a number of different sources, for example:

• the results of previous tests;

• information required by international rules on the transport of dangerous substances;

• information taken from reference works and the literature; or

• information derived from practical experience.

The results of validated structure-activity relationships and expert judgement may also be taken into account where appropriate.

1.6.2. For preparations, normally 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. This applies also to preparations covered by Directive 91/414/EEC unless other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC (Article 5. 5. of Directive 1999/45/EC). For gaseous preparations a calculation method may be used for flammable and oxidising properties (see 9.1.1.1 and 9.1.1.2). For non-gaseous preparations containing organic peroxides a calculation method may be used for oxidising properties (see 2.2.2.1).

• (b) if it concerns data on health effects:

• by the application of the methods specified in Annex V, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC (Article 6. 1. (b) of Directive 1999/45/EC),

• and/or by the application of a conventional method referred to in Article 6 and Annex II, Parts A 1 - 6 and B 1 - 5 of Directive 1999/45/EC, or,

• in the case of R65, by the application of the rules under 3.2.3

• however, if it concerns the evaluation of the carcinogenic, mutagenic and reproductive toxicity properties, by the application of a conventional method referred to in Article 6 and Annex II, Parts A 7 - 9 and B 6 of Directive 1999/45/EC.

• (c) if it concerns data on ecotoxicological properties

• (i) for aquatic toxicity only:

• by the application of the methods specified in Annex V, subject to the conditions referred to in Annex III Part C of Directive 1999/45/EC, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC (Article 7. 1. (b) of Directive 1999/45/EC), or

• by application of a conventional method referred to in Article 7 and Annex III, Parts A and B, of Directive 1999/45/EC.

• (ii) for the evaluation of the potential for (or actual) bioaccumulation through the determination of log Pow (or BCF), or the evaluation of degradability, by application of a conventional method referred to in Article 7 and Annex III Parts A and B, of Directive 1999/45/EC.

• (iii) for dangers of the ozone layer by application of a conventional method referred to in Article 7 and Annex III, Parts A and B, of Directive 1999/45/EC.

Note concerning the performance of animal tests:

The performance of animal tests to establish experimental data is subject to the provisions of Directive 86/609/EEC regarding the protection of animals used for experimental purposes.

Note concerning physicochemical properties:

For organic peroxides and organic peroxide preparations data may be derived from the calculation method set out in Chapter 9.5. For gaseous preparations a calculation method may be used for flammable and oxidising properties (see chapter 9).

1.7. Application of the guide criteria

Classification must cover the physicochemical, toxicological and ecotoxicological properties of substances and preparations.

Classification of substances and preparations is made according to Chapter 1.6, on the basis of the criteria in Chapters 2 to 5 (substances) and Chapters 2, 3, 4.2.4 and 5 of this Annex. All types of hazard must be considered. For instance, classification under 3.2.1 does not imply that the sections such as 3.2.2 or 3.2.4 can be ignored.

The choice of symbol(s) and risk phrase(s) is made on the basis of the classification in order to ensure that the specific nature of the potential dangers identified in classification is expressed on the label.

Notwithstanding the criteria given under 2.2.3, 2.2.4 and 2.2.5, substances and preparations in the form of aerosols shall be subject to the provisions of Directive 75/324/EEC as amended and adapted to technical progress.

1.7.1. Definitions

‘Substances’ means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the product, and any impurity deriving from the production process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

A substance may be chemically very well defined (e.g. acetone) or a complex mixture of constituents of variable composition (e.g. aromatic distillates). For certain complex substances, some individual constituents have been identified.

‘Preparations’ means mixtures or solutions composed of two or more substances.

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 by comparing the test methods employed with those indicated in Annex V and the rules specified in this Annex for determining the appropriate classification and 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 label the substance on the basis of an assessment of the evidence by a competent person.

Without prejudice to Article 6, where the above procedure has been followed and there is concern over possible inconsistencies then a proposal may be submitted 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.

1.7.2.1. Classification of substances containing impurities, additives or individual constituents

Where impurities, additives or individual constituents of substances have been identified, they shall be taken into account if their concentration is greater than or equal to the limits specified

• 0,1 % for substances classified as very toxic, toxic, carcinogenic (category 1 or 2) mutagenic (category 1 or 2), toxic to reproduction (category 1 or 2), or dangerous for the environment (assigned the symbol ‘N’ for the aquatic environment, dangerous for the ozone layer)

• 1% for substances classified as harmful, corrosive, irritant sensitising, carcinogenic (category 3), mutagenic (category 3), toxic to reproduction (category 3), or dangerous for the environment (not assigned the symbol ‘N’, i.e. harmful to aquatic organisms, may cause long-term adverse effects)

unless lower values have been specified in Annex I.

With the exception of substances listed specifically in Annex I, classification should be carried out according to the requirements of Articles 5, 6 and 7 of Council Directive 1999/45/EC.

In the case of asbestos (650-013-00-6) this general rule does not apply until a concentration limit has been fixed in Annex I. Substances in which asbestos is present must be classified and labelled according to the principles in Article 6.

1.7.3. Application of the guide criteria for preparations

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 with the exception of the criteria of Chapter 4 for which only the conventional method is applicable. A conventional method is also applicable in relation to the criteria of Chapter 5, with the exception of aquatic toxicity, subject to the conditions referred to in Annex III Part C of Directive 1999/45/EC. For preparations covered by Directive 91/414/EEC data for classification and labelling are also acceptable from other internationally recognised methods (see special provisions in Section 1.6 of this Annex). In other cases, the available data must be evaluated by comparing the test methods employed with those indicated in Annex V and the rules specified in this Annex for determining the appropriate classification and labelling.

Where the health and environmental hazards are assessed by applying a conventional method referred to in Articles 6 and 7 and Annexes II and III of Directive 1999/45/EC the individual concentration limits to be used are those set out either:

• in Annex I to Directive 67/548/EEC, or

• in Annex II Part B and/or Annex III Part B of Directive 1999/45/EC where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

In the case of preparations containing mixtures of gases, classification with respect to the health and environmental effects will be established by the calculation method on the basis of the individual concentration limits from Annex I to Directive 67/548/EEC or when these limits are not in Annex I on the basis of the criteria of Annexes II and III of Directive 1999/45/EC.

1.7.3.1. Preparations or substances described in Section 1.7.2.1 used as constituents of another preparation

The labelling of such preparations must be in conformity with the provisions of Article 10 according to the principles set out in Articles 3 and 4 of Directive 1999/45/EC. However, in certain cases, the information on the label of the preparation or substance described in Section 1.7.2.1 is insufficient to enable other manufacturers who wish to use it as a constituent of their own preparation(s) to carry out the classification and labelling of their preparation(s correctly.

In these cases, the person established within the Community responsible for placing the original preparation or substance described in Section 1.7.2.1 on the market, whether it be the manufacturer, the importer or the distributor shall supply upon justified request and as soon as possible all necessary data concerning the dangerous substances present to enable correct classification and labelling of the new preparation. This data is also necessary to enable the person responsible for placing the new preparation on the market to comply with other requirements of Directive 1999/45/EC.

2.1. Introduction

The test methods relating to explosive, oxidising and flammable properties included in Annex V serve to give specific meaning to the general definitions given in Article 2 (2) (a) to (e) of Directive 67/548/EEC⁶⁸ . Criteria follow directly from the test methods in Annex V as far as they are mentioned.

If adequate information is available to demonstrate in practice that the physicochemical properties of substances and preparations (apart from organic peroxides) are different from those revealed by the test methods given in Annex V, then such substances and preparations should be classified according to the hazard they present, if any, to those handling the substances and preparations or to other persons.

2.2. Criteria for classification, choice of symbols, indication of danger and choice of risk phrases

In the case of preparations, the criteria referred to in Article 5 of Directive 1999/45/EC need to be taken into consideration.

2.2.1. Explosive

Substances and preparations shall be classified as explosive and assigned the symbol ‘E’ and the indication of danger ‘explosive’ in accordance with the results of the tests given in Annex V and in so far as the substances and preparations are explosive as placed on the market. One risk phrase is obligatory, it is to be specified on the basis of the following:

R2 Risk of explosion by shock, friction, fire or other sources of ignition

• substances and preparations except those set out below.

R3 Extreme risk of explosion by shock, friction, fire or other source of ignition

• substances and preparations which are particularly sensitive such as picric acid salts or PETN.

2.2.2. Oxidising

Substances and preparations shall be classified as oxidising and assigned the symbol ‘O’ and the indication of danger ‘oxidising’ in accordance with the results of the tests given in Annex V. One risk phrase is obligatory, it is to be specified on the basis of the test results but subject to the following:

R7 May cause fire

• organic peroxides which have flammable properties even when not in contact with other combustible material.

R8 Contact with combustible material may cause fire

• other oxidising substances and preparations, including inorganic peroxides, which may cause fire or enhance the risk of fire when in contact with combustible material.

R9 Explosive when mixed with combustible material

• other substances and preparations, including inorganic peroxides, which become explosive when mixed with combustible materials, e.g. certain chlorates.

2.2.2.1. Remarks concerning peroxides

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 criteria in section 2.2.1. on the basis of tests carried out in accordance with the methods 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; R1-O-O-R2).

Preparations not already classified as explosive shall be classified using the calculation method based on the percentage of active oxygen shown in Section 9.5.

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.

2.2.3. Extremely flammable

Substances and preparations shall be classified as extremely flammable and assigned the symbol ‘F+’ and the indication of danger ‘extremely flammable’ in accordance with the results of the tests given in Annex V. The risk phrase shall be assigned in accordance with the following criteria:

R12 Extremely flammable

• Liquid substances and preparations which have a flash point lower than 0 °C and a boiling point (or in case of a boiling range the initial boiling point) lower than or equal to 35 °C.

• Gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure.

2.2.4. Highly flammable

Substances and preparations shall be classified as highly flammable and assigned the symbol ‘F’ and the indication of danger ‘highly flammable’ in accordance with the results of the tests given in Annex V. Risk phrases shall be assigned in accordance with the following criteria:

R11 Highly flammable

• Solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition.

• Liquid substances and preparations having a flash point below 21 °C but which are not extremely flammable.

R15 Contact with water liberates extremely flammable gases

• Substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities, at a minimum rate of one litre per kilogram per hour.

R17 Spontaneously flammable in air

• Substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any input of energy.

2.2.5. Flammable

Substances and preparations shall be classified as flammable in accordance with the results of the tests given in Annex V. The risk phrase shall be assigned in accordance with the criteria mentioned below.

R10 Flammable

• Liquid substances and preparations having a flash point equal to or greater than 21 °C, and less than or equal to 55 °C.

However, in practice it has been shown that a preparation having a flash point equal to or greater than 21 °C and less than or equal to 55 °C need not be classified as flammable if the preparation could not in any way support combustion and only so long as there is no reason to fear risks to those handling these preparations or to other persons.

2.2.6. Other physicochemical properties

Additional risk phrases shall be assigned to substances and preparations which have been classified by virtue of Sections 2.2.1 to 2.2.5 above or by Chapter 3, 4 and 5 below, in accordance with the following criteria (based on experience obtained during compilation of Annex I):

R1 Explosive when dry

For explosive substances and preparations put on the market in solution or in a wetted form e.g. nitrocellulose with more than 12.6% nitrogen.

R4 Forms very sensitive explosive metallic compounds

For substances and preparations which may form sensitive explosive metallic derivatives e.g. picric acid, styphnic acid.

R5 Heating may cause an explosion

For thermally unstable substances and preparations not classified as explosive, e.g. perchloric acid > 50%.

R6 Explosive with or without contact with air

For substances and preparations which are unstable at ambient temperatures, e.g. acetylene.

R7 May cause fire

For reactive substances and preparations, e.g. fluorine, sodium hydrosulphite.

R14 Reacts violently with water

For substances and preparations which react violently with water, e.g. acetyl chloride alkali metals, titanium tetrachloride.

R16 Explosive when mixed with oxidising substances

For substances and preparations which react explosively with an oxidising agent, e.g. red phosphorus.

R18 In use, may form flammable/explosive vapour-air mixture

For preparations not in themselves classified as flammable, which contain volatile components which are flammable in air.

R19 May form explosive peroxides

For substances and preparations which may form explosive peroxides during storage e.g. diethyl ether, 1,4-dioxan.

R30 Can become highly flammable in use

For preparations not in themselves classified as flammable, which may become flammable due to the loss of non-flammable volatile components.

R44 Risk of explosion if heated under confinement

For substances and preparations not in themselves classified as explosive in accordance with Section 2.2.1 above but which may nevertheless display explosive properties in practice if heated under sufficient confinement. For example, certain substances which would decompose explosively if heated in a steel drum do not show this effect if heated in less-strong containers.

For other additional risk phrases see Section 3.2.8.

3.1. Introduction

3.1.1. Classification is concerned with both the acute and long-term effects of substances and preparations, whether resulting from a single instance of exposure or repeated or prolonged exposure.

Where it can be demonstrated by epidemiological studies, by scientifically valid case studies as specified in this Annex or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases, that toxicological effects on man differ from those suggested by the application of the methods outlined in Section 1.6 of this Annex, then the substance or preparation shall be classified according to its effects on man. However, tests on man should be discouraged and should not normally be used to negate positive animal data.

Directive 86/609/EEC seeks to protect animals used for experimental and other scientific purposes. For several endpoints there are validated in vitro test methods in Annex V of Directive 67/548/EEC and these tests should be used where appropriate.

3.1.2. The classification of substances must be made on the basis of the experimental data available in accordance with the following criteria which take into account the magnitude of these effects:

• (a) for acute toxicity (lethal and irreversible effects after a single exposure), the criteria under Sections 3.2.1 to 3.2.3 are to be used,

• (b) for sub-acute, sub-chronic or chronic toxicity the criteria under Sections 3.2.2 to 3.2.4 are to be used,

• (c) for corrosive and irritant effects the criteria under Sections 3.2.5 and 3.2.6 are to be used,

• (d) for sensitising effects the criteria under Section 3.2.7 are to be used,

• (e) for specific effects on health (carcinogenicity, mutagenicity and reproductive toxicity) the criteria in Chapter 4 are to be used.

3.1.3. For preparations, the classification relating to dangerous for health is carried out:

• (a) on the basis of a conventional method referred to in Article 6 and Annex II of Directive 1999/45/EC in the absence of experimental data. In this case, the classification is based on the individual concentration limits:

• either taken from Annex I to Directive 67/548/EEC, or

• from Annex II, Part B of Directive 1999/45/EC where the substance or substances do not appear in Annex I of Directive 67/548/EEC or appear in it without concentration limits.