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

Animal studies

Positive results from appropriate animal tests are:

in the case of the adjuvant type test method for skin sensitisation detailed in Annex V or in the case of other adjuvant-type test methods, a response of at least 30% of the animals is considered as positive. For any other test method a response of at least 15% of the animals is considered positive.

3.2.7.3. Immunological contact urticaria

Some substances which meet the criteria for R42 may in addition cause immunological contact urticaria. In these cases, information concerning contact urticaria should be included by the use of appropriate S-phrases, usually S24 and S36/37, and in the Safety Data Sheet.

For substances or preparations, which produce signs of immunological contact urticaria which do not fulfil the criteria for R42, consideration should be given to classification with R43.

There is no recognised animal model available to identify substances which cause immunological contact urticaria. Therefore, classification will normally be based on human evidence which will be similar to that for skin sensitisation (R43).

3.2.7.4. Note that if the symbol ‘Xn’ and the indication of danger ‘Harmful’ are assigned, the symbol ‘Xi’ and indication of danger ‘Irritant’ are optional

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) to substances and preparations classified by virtue of 2.2.1 to 3.2.7 above and/or chapters 4 and 5:

R29 Contact with water liberates toxic gas

For substances and preparations which in contact with water or damp air, evolve very toxic/toxic gases in potentially dangerous amounts, e.g. aluminium phosphide, phosphorus pentasulphide.

R31 Contact with acids liberates toxic gas

For substances and preparations which react with acids to evolve toxic gases in dangerous amounts, e.g. sodium hypochlorite, barium polysulphide. For substances used by members of the general public, the use of S50 (do not mix with … (to be specified by the manufacturer)) would be more suitable.

R32 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. For substances used by members of the general public, the use of S50 (do not mix with … (to be specified by the manufacturer)) would be more suitable.

R33 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 justify the use of R48.

R64 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 of this R-phrase (and in some cases R33) see Section 4.2.3.3.

R66 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 R38:

based on either:

• practical observation after normal handling and use, or

• relevant evidence concerning their predicted effects on the skin.

See also paragraphs 1.6 and 1.7.

R67 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 and which are not already classified with respect to acute inhalation toxicity (R20, R23, R26, R40/20, R39/23 or R39/26).

The following evidence may be used:

• (a) Data from animal studies showing clear signs of CNS depression such as narcotic effects, lethargy, lack of co-ordination (including loss of righting reflex) and ataxia either:

• at concentrations/exposure times not exceeding 20 mg/1/4h or,

• for which the ratio of the effect concentration at ≤ 4 h to the saturated vapour concentration (SVC) at 20°C is ≤ 1/10.

See also paragraphs 1.6 and 1.7.

For other supplementary risk phrases see Section 2.2.6.

4. CLASSIFICATION ON THE BASIS OF SPECIFIC EFFECTS ON HUMAN HEALTH

4.1. Introduction

4.1.1. This Section sets out the procedure for the classification of substances which may have the effects mentioned below.

4.1.2. If a manufacturer, distributor or importer has information available which indicates that a substance should be classified and labelled in accordance with the criteria given in Section 4.2.1, 4.2.2 or 4.2.3, he shall provisionally label 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 any relevant 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 accordance with 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 is placed on the market.

4.1.5. In order to obtain as quickly as possible a harmonized classification for the Community by the procedure defined in Article 28 of Directive 67/548/EEC, Member States which have relevant information available justifying the classification of a substance in one of these categories, whether submitted by the manufacturer or not, should forward such information together with suggestions for classification and labelling, to the Commission as soon as possible.

The Commission will forward to the other Member States the classification and labelling proposal that it receives. Any Member State may ask the Commission for the information it has received.

Any Member State which has good reason to believe that the suggested classification and labelling is inappropriate as far as the carcinogenic, mutagenic or reproductive toxicity effects are concerned shall notify the Commission thereof.

4.2. Criteria for classification, indication of danger, choice of risk phrases

4.2.1. Carcinogenic substances

For the purpose of classification and labelling, and having regard to the current state of knowledge, such substances are divided into three categories:

Category 1

Substances known to be carcinogenic to man. There is sufficient evidence to establish a causal association between human exposure to a substance and the development of cancer.

Category 2

Substances which should be regarded as if they are carcinogenic to man. There is sufficient evidence to provide a strong presumption that human exposure to a substance may result in the development of cancer, generally on the basis of:

• appropriate long-term animal studies,

• other relevant information.

Category 3

Substances which cause concern for man owing to possible carcinogenic effects but in respect of which the available information is not adequate for making a satisfactory assessment. There is some evidence from appropriate animal studies, but this is insufficient to place the substance in Category 2.

4.2.1.1. The following symbols and specific risk phrases apply:

Categories 1 and 2:

T; R45 May cause cancer

However for substances and preparations which present a carcinogenic risk only when inhaled, for example, as dust, vapour or fumes, (other routes of exposure e.g. by swallowing or in contact with skin do not present any carcinogenic risk), the following symbol and specific risk phrase should be used:

T; R49 May cause cancer by inhalation

Category 3:

Xn; R40 Possible risk of irreversible effects

4.2.1.2. Comments regarding the categorisation of carcinogenic substances

The placing of a substance into Category 1 is done on the basis of epidemiological data; placing into Categories 2 and 3 is based primarily on animal experiments.

For classification as a Category 2 carcinogen either positive results in two animal species should be available or clear positive evidence in one species, together with supporting evidence such as genotoxicity data, metabolic or biochemical studies, induction of benign tumours, structural relationship with other known carcinogens, or data from epidemiological studies suggesting an association.

Category 3 actually comprises 2 sub-categories:

• (a) substances which are well investigated but for which the evidence of a tumour-inducing effect is insufficient for classification in Category 2. Additional experiments would not be expected to yield further relevant information with respect to classification;

• (b) substances which are insufficiently investigated. The available data are inadequate, but they raise concern for man. This classification is provisional; further experiments are necessary before a final decision can be made.

For a distinction between Categories 2 and 3 the arguments listed below are relevant which reduce the significance of experimental tumour induction in view of possible human exposure. These arguments, especially in combination, would lead in most cases to classification in Category 3, even though tumours have been induced in animals:

• carcinogenic effects only at very high dose levels exceeding the ‘maximal tolerated dose’. The maximal tolerated dose is characterized by toxic effects which, although not yet reducing lifespan, go along with physical changes such as about 10 % retardation in weight gain:

• appearance of tumours, especially at high dose levels, only in particular organs of certain species known to be susceptible to a high spontaneous tumour formation;

• appearance of tumours, only at the site of application, in very sensitive test systems (e.g. i.p. or s.c. application of certain locally active compounds), if the particular target is not relevant to man;

• lack of genotoxicity in short-term tests in vivo and in vitro,

• existence of a secondary mechanism of action with the implication of a practical threshold above a certain dose level (e.g., hormonal effects on target organs or on mechanisms of physiological regulation, chronic stimulation of cell proliferation),

• existence of a species - specific mechanism of tumour formation (e.g. by specific metabolic pathways) irrelevant for man.

For a distinction between Category 3 and no classification arguments are relevant which exclude a concern for man:

• a substance should not be classified in any of the categories if the mechanism of experimental tumour formation is clearly identified, with good evidence that this process cannot be extrapolated to man;

• if the only available tumour data are liver tumours in certain sensitive strains of mice, without any other supplementary evidence, the substance may not be classified in any of the categories;

• particular attention should be paid to cases where the only available tumour data are the occurrence of neoplasms at sites and in strains where they are well known to occur spontaneously with a high incidence.

4.2.2. Mutagenic substances

4.2.2.1 For the purposes of classification and labelling, and having regard to the current state of knowledge, such substances are divided into three categories:

Category 1

Substances known to be mutagenic to man.

There is sufficient evidence to establish a causal association between human exposure to a substance and heritable genetic damage.

Category 2

Substances which should be regarded as if they are mutagenic to man.

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in the development of heritable genetic damage, generally on the basis of:

• appropriate animal studies,

• other relevant information.

Category 3

Substances which cause concern for man owing to possible mutagenic effects. There is evidence from appropriate mutagenicity studies, but this is insufficient to place the substance in Category 2.

4.2.2.2. The following symbols and specific risk phrases apply:

Category 1:

T; R46 May cause heritable genetic damage

Category 2:

T; R46 May cause heritable genetic damage

Category 3:

Xn; R40Possible risk of irreversible effects

4.2.2.3. Comments regarding the categorisation of mutagenic substances

Definition of terms:

A mutation is a permanent change in the amount or structure of the genetic material in an organism, resulting in a change of the phenotypic characteristics of the organism. The alterations may involve a single gene, a block of genes, or a whole chromosome. Effects involving single genes may be a consequence of effects on single DNA bases (point mutations) or of large changes, including deletions, within the gene. Effects on whole chromosomes may involve structural or numerical changes. A mutation in the germ cells in sexually reproducing organisms may be transmitted to the offspring. A mutagen is an agent that gives rise to an enhanced occurrence of mutations.

It should be noted that substances are classified as mutagens with specific reference to inherited genetic damage. However, the type of results leading to classification of chemicals in Category 3: ‘induction of genetically relevant events in somatic cells’, is generally also regarded as an alert for possible carcinogenic activity.

Method development for mutagenicity testing is an ongoing process. For many new tests no standardized protocols and evaluation criteria are presently available. For the evaluation of mutagenicity data the quality of the test performance and the degree of validation of the test method have to be considered.

Category 1

To place a substance in Category 1, positive evidence from human mutation epidemiology studies will be needed. Examples of such substances are not known to date. It is recognized that it is extremely difficult to obtain reliable information from studies on the incidence of mutations in human populations, or on possible increases in their frequencies.

Category 2

To place a substance in Category 2, positive results are needed from assays showing (a) mutagenic effects, or (b) other cellular interactions relevant to mutagenicity, in germ cells of mammals in vivo, or (c) mutagenic effects in somatic cells of mammals in vivo in combination with clear evidence that the substance or a relevant metabolite reaches the germ cells.

With respect to placement in Category 2, at present the following methods are appropriate:

2 (a) in vivo germ cell mutagenicity assays:

• specific locus mutation test,

• heritable translocation test,

• dominant lethal mutation test.

These assays actually demonstrate the appearance of affected progeny or a defect in the developing embryo.

2 (b.) in vivo assays showing relevant interaction with germ cells (usually DNA):

• assays for chromosomal abnormalities, as detected by cytogenetic analysis, including aneuploidy, caused by malsegregation of chromosomes,

• test for sister chromatid exchanges (SCEs),

• test for unscheduled DNA synthesis (UDS),

• assay of (covalent) binding of mutagen to germ cell DNA,

• assaying other kinds of DNA damage.

These assays provide evidence of a more or less indirect nature. Positive results in these assays would normally be supported by positive results from in vivo somatic cell mutagenicity assays, in mammals or in man (see under Category 3, preferably methods as under 3 (a)).

2 (c.) in vivo assays showing mutagenic effects in somatic cells of mammals (see under 3 (a)), in combination with toxicokinetic methods, or other methodologies capable of demonstrating that the compound or a relevant metabolite reaches the germ cells.

For 2 (b) and 2 (c), positive results from host-mediated assays or the demonstration of unequivocal effects in in vitro assays can be considered as supporting evidence.

Category 3

To place a substance in Category 3, positive results are needed in assays showing (a) mutagenic effects or (b) other cellular interaction relevant to mutagenicity, in somatic cells in mammals in vivo. The latter especially would normally be supported by positive results from in vitro mutagenicity assays.

For effects in somatic cells in vivo at present the following methods are appropriate:

3 (a) in vivo somatic cell mutagenicity assays:

• bone marrow micronucleus test or metaphase analysis,

• metaphase analysis of peripheral lymphocytes,

• mouse coat colour spot test.

3 (b) in vivo somatic cell DNA interaction assays:

• test for SCEs in somatic cells,

• test for UDS in somatic cells,

• assay for the (covalent) binding of mutagen to somatic cell DNA,

• assay for DNA damage, e.g. by alkaline elution, in somatic cells.

Substances showing positive results only in one or more in vitro mutagenicity assays should normally not be classified. Their further investigation using in vivo assays, however, is strongly indicated. In exceptional cases, e.g. for a substance showing pronounced responses in several in vitro assays, for which no relevant in vivo data are available, and which shows resemblance to known mutagens/carcinogens, classification in Category 3 could be considered.

4.2.3. Substances toxic to reproduction

4.2.3.1. For the purposes of classification and labelling and having regard to the present state of knowledge, such substances are divided into 3 categories:

Category 1:

Substances known to impair fertility in humans

There is sufficient evidence to establish a causal relationship between human exposure to the substance and impaired fertility.

Substances known to cause developmental toxicity in humans

There is sufficient evidence to establish a causal relationship between human exposure to the substance and subsequent developmental toxic effects in the progeny.

Category 2

Substances which should be regarded as if they impair fertility in humans:

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in impaired fertility on the basis of:

• clear evidence in animal studies of impaired fertility in the absence of toxic effects, or, evidence of impaired fertility occurring at around the same dose levels as other toxic effects but which is not a secondary non-specific consequence of the other toxic effects,

• other relevant information.

Substances which should be regarded as if they cause developmental toxicity to humans:

There is sufficient evidence to provide a strong presumption that human exposure to the substance may result in developmental toxicity, generally on the basis of:

• Clear results in appropriate animal studies where effects have been observed in the absence of signs of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the other toxic effects,

• Other relevant information.

Category 3

Substances which cause concern for human fertility

Generally on the basis of:

• Results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of impaired fertility in the absence of toxic effects, or evidence of impaired fertility occurring at around the same dose levels as other toxic effects, but which is not a secondary non-specific consequence of the other toxic effects, but where the evidence is insufficient to place the substance in Category 2.

• other relevant information.

Substances which cause concern for humans owing to possible developmental toxic effects

Generally on the basis of:

• Results in appropriate animal studies which provide sufficient evidence to cause a strong suspicion of developmental toxicity in the absence of signs of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not a secondary non-specific consequence of the other toxic effects, but where the evidence is insufficient to place the substance in Category 2,

• Other relevant information.

4.2.3.2. The following symbols and specific risk phrases apply:

Category 1:

For substances that impair fertility in humans:

T; R60: May impair fertility

For substances that cause developmental toxicity:

T; R61: May cause harm to the unborn child

Category 2:

For substances that should be regarded as if they impair fertility in humans:

T; R60: May impair fertility

For substances that should be regarded as if they cause developmental toxicity in humans:

T; R61: May cause harm to the unborn child.

Category 3:

For substances which cause concern for human fertility:

Xn; R62: Possible risk of impaired fertility

For substances which cause concern for humans owing to possible developmental toxic effects:

Xn; R63: Possible risk of harm to the unborn child.

4.2.3.3. Comments regarding the categorization of substances toxic to reproduction

Reproductive toxicity includes impairment of male and female reproductive functions or capacity and the induction of non-inheritable harmful effects on the progeny. This may be classified under two main headings of 1). Effects on male or female fertility; 2). Developmental toxicity.

1) Effects on male or female fertility, includes adverse effects on libido, sexual behaviour, any aspect of spermatogenesis or oogenesis, or on hormonal activity or physiological response which would interfere with the capacity to fertilise, fertilisation itself or the development of the fertilised ovum up to and including implantation.

2) Developmental toxicity, is taken in its widest sense to include any effect interfering with normal development, both before and after birth. It includes effects induced or manifested prenatally as well as those manifested postnatally. This includes embrytoxic/fetotoxic effects such as reduced body weight, growth and developmental retardation, organ toxicity, death, abortion, structural defects (teratogenic effects), functional defects, peri-postnatal defects, and impaired postnatal mental or physical development up to and including normal pubertal development.

Classification of chemicals as toxic to reproduction is intended to be used for chemicals which have an intrinsic or specific property to produce such toxic effects. Chemicals should not be classified as toxic to reproduction where such effects are solely produced as a non-specific secondary consequence of other toxic effects. Chemicals of most concern are those which are toxic to reproduction at exposure levels which do not produce other signs of toxicity.

The placing of a compound in Category 1 for effects on Fertility and/or Developmental toxicity is done on the basis of epidemiological data. Placing into Categories 2 or 3 is done primarily on the basis of animal data. Data from in vitro studies, or studies on avian eggs, are regarded as ‘supportive evidence’ and would only exceptionally lead to classification in the absence of in vivo data.

In common with most other types of toxic effect, substances demonstrating reproductive toxicity will be expected to have a threshold below which adverse effects would not be demonstrated. Even when clear effects have been demonstrated in animal studies the relevance for humans may be doubtful because of the doses administered, for example, where effects have been demonstrated only at high doses, or where marked toxicokinetic differences exist, or the route of administration is inappropriate. For these or similar reasons it may be that classification in Category 3, or even no classification, will be warranted.

Annex V to the Directive specifies a limit test in the case of substances of low toxicity. If a dose level of at least 1000 mg/kg orally produces no evidence of effects toxic to reproduction, studies at other dose levels may not be considered necessary. If data are available from studies carried out with doses higher than the above limit dose, this data must be evaluated together with other relevant data. Under normal circumstances it is considered that effects seen only at doses in excess of the limit dose would not necessarily lead to classification as ‘Toxic to reproduction’.

EFFECTS ON FERTILITY

For the classification of a substance into Category 2 for impaired fertility, there should normally be clear evidence in one animal species, with supporting evidence on mechanism of action or site of action, or chemical relationship to other known anti-fertility agents or other information from humans which would lead to the conclusion that effects would be likely to be seen in humans. Where there are studies in only one species without other relevant supporting evidence then classification in Category 3 may be appropriate.

Since impaired fertility may occur as a non-specific accompaniment to severe generalized toxicity or where there is severe inanition, classification into Category 2 should only be made where there is evidence that there is some degree of specificity of toxicity for the reproductive system. If it was demonstrated that impaired fertility in animal studies was due to failure to mate, then for classification into Category 2, it would normally be necessary to have evidence on the mechanism of action in order to interpret whether any adverse effect such as alteration in pattern of hormonal release would be likely to occur in humans.

DEVELOPMENTAL TOXICITY

For classification into Category 2 there should be clear evidence of adverse effects in well conducted studies in one or more species. Since adverse effects in pregnancy or postnatally may result as a secondary consequence of maternal toxicity, reduced food or water intake, maternal stress, lack of maternal care, specific dietary deficiencies, poor animal husbandry, intercurrent infections, and so on, it is important that the effects observed should occur in well conducted studies and at dose levels which are not associated with marked maternal toxicity. The route of exposure is also important. In particular, the injection of irritant material intraperitoneally may result in local damage to the uterus and its contents, and the results of such studies must be interpreted with caution and on their own would not normally lead to classification.

Classification into Category 3 is based on similar criteria as for Category 2 but may be used where the experimental design has deficiencies which make the conclusions less convincing, or where the possibility that the effects may have been due to non-specific influences such as generalised toxicity cannot be excluded.

In general, classification in Category 3 or no category would be assigned on an ad hoc basis where the only effects recorded are small changes in the incidences of spontaneous defects, small changes in the proportions of common variants such as are observed in skeletal examinations, or small differences in postnatal developmental assessments.

Effects during lactation

Substances which are classified as toxic to reproduction and which also cause concern due to their effects on lactation should in addition be labelled with R64 (see criteria in Section 3.2.8.).

For the purpose of classification, toxic effects on offspring resulting only from exposure via the breast milk, or toxic effects resulting from direct exposure of children will not be regarded as ‘Toxic to reproduction’, unless such effects result in impaired development of the offspring.

Substances which are not classified as toxic to reproduction but which cause concern due to toxicity when transferred to the baby during the period of lactation should be labelled with R64 (see criteria in Section 3.2.8.). This R-phrase may also be appropriate for substances which affect the quantity or quality of the milk.

R64 would normally be assigned on the basis of:

• (a) toxicokinetic studies that would indicate the likelihood that the substance would be present in potentially toxic levels in breast milk; and/or

• (b) on the basis of results of one or two generation studies in animals which indicate the presence of adverse effects on the offspring due to transfer in the milk; and/or

• (c) on the basis of evidence in humans indicating a risk to babies during the lactational period.

Substances which are known to accumulate in the body and which subsequently may be released into milk during lactation may be labelled with R33 and R64.

4.2.4. Procedure for the classification of preparations concerning specific effects on health

If a preparation contains one or more substances classified with respect to the criteria laid out above, it must be classified according to the criteria referred to in Article 3(5) items j) to q) of Directive 88/379/EEC (the concentration limits are either in Annex I of Directive 67/548/EEC, or in Annex I to Directive 88/379/EEC where the substance or substances under consideration do not appear in Annex I or appear in it without concentration limits).

5. CLASSIFICATION ON THE BASIS OF ENVIRONMENTAL EFFECTS

5.1. Introduction

The primary objective of classifying substances dangerous for the environment is to alert the user to the hazards these substances present to ecosystems. Although the present criteria refer to aquatic ecosystems it is recognised that certain substances and preparations may simultaneously or alternatively affect other ecosystems whose constituents may range from soil microflora and microfauna to primates.

The criteria set out below follow directly from the test methods set out in Annex V in so far as they are mentioned. The test methods required for the ‘base set’ referred to in Annex VII are limited and the information derived from them may be insufficient for an appropriate classification. Classification may require additional data derived from Level I (Annex VIII) or other equivalent studies. Furthermore, classified substances may be subject to review in the light of other new data.

For the purposes of classification and labelling and having regard to the current state of knowledge such substances and preparations are divided into two groups according to their acute and/or long-term effects in aquatic systems or their acute and/or long-term effects in non-aquatic systems.

5.2 Criteria for classification, indication of danger, choice of risk phrases

5.2.1 Aquatic environment

5.2.1.1. 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:

R50: Very toxic to aquatic organisms

and

R53: May cause long-term adverse effects in the aquatic environment

	Acute toxicity:		96 hr LC50 (for fish)	≤ 1 mg/l
		or	48 hr EC50 (for Daphnia)	≤ 1 mg/l
		or	72 hr IC50 (for algae)	≤ 1 mg/l

and the substance is not readily degradable

or the log Pow (log octanol/water partition coefficient) ≥ 3,0 (unless the experimentally determined BCF ≤ 100)

R50: Very toxic to aquatic organisms

	Acute toxicity:		96 hr LC50 (for fish)	≤ 1 mg/l
		or	48 hr EC50 (for Daphnia)	≤ 1 mg/l
		or	72 hr IC50 (for algae)	≤ 1 mg/l

R51: Toxic to aquatic organisms

and

R53: May cause long-term adverse effects in the aquatic environment

	Acute toxicity:		96 hr LC50 (for fish)	1 mg/l < LC50 ≤ 10 mg/l
		or	48 hr EC50 (for Daphnia)	1 mg/l < EC50 ≤ 10 mg/l
		or	72 hr IC50 (for algae)	1 mg/l < EC50 ≤ 10 mg/l

and the substance is not readily degradable

or the log Pow ≥ 3.0 (unless the experimentally determined BCF ≤ 100)

5.2.1.2 Substances shall be classified as dangerous for the environment in accordance with the criteria set out below. Risk phrases shall also be assigned in accordance with the following criteria

R52: Harmful to aquatic organisms

and

R53: May cause long-term adverse effects in the aquatic environment

	Acute toxicity:	96 hr LC50 (for fish)	10 mg/l < LC50 ≤ 100 mg/l
	or	48 hr EC50 (for Daphnia)	10 mg/l < EC50 ≤ 100 mg/l
	or	72 hr IC50 (for algae)	10 mg/l < IC50 ≤ 100 mg/l

and the substance is not readily degradable

This criterion applies unless there exists additional scientific evidence concerning degradation and/or toxicity sufficient to provide an adequate assurance that neither the substance nor its degradation products will constitute a potential long-term and/or delayed danger to the aquatic environment. Such additional scientific evidence should normally be based on the studies required at Level l (Annex VIII), or studies of equivalent value, and could include:

• (i) a proven potential to degrade rapidly in the aquatic environment.

• (ii) in absence of chronic toxicity effects at a concentration of 1.0 mg/litre, e.g. a no-observed effect concentration of greater than 1.0 mg/litre determined in a prolonged toxicity study with fish or Daphnia.

R52: Harmful to aquatic organisms

Substances not falling under the criteria listed above in this section, but which on the basis of the available evidence concerning their toxicity may nevertheless present a danger to the structure and/or functioning of aquatic ecosystems.

R53: May cause long-term adverse effects in the aquatic environment

Substances not falling under the criteria listed above in this section, but which, on the basis of the available evidence concerning their persistence, potential to accumulate, and predicted or observed environmental fate and behaviour may nevertheless present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems.

For example, poorly water-soluble substances, i.e. substances with a solubility of less than 1 mg/l will be covered by this criterion if:

• (a) they are not readily degradable; and

• (b) the log Pow ≥ 3.0 (unless the experimentally determined BCF ≤ 100)

This criterion applies unless there exists additional scientific evidence concerning degradation and/or toxicity sufficient to provide an adequate assurance that neither the substance nor its degradation products will constitute a potential long-term and/or delayed danger to the aquatic environment.

Such additional scientific evidence should normally be based on the studies required at Level l (Annex VIII), or studies of equivalent value, and could include

• (i) a proven potential to degrade rapidly in the aquatic environment;

• (ii) in absence of chronic toxicity effects at the solubility limit e.g. a no-observed effect concentration of greater than the solubility limit determined in a prolonged toxicity study with fish or Daphnia.

5.2.1.3 Comments on the determination of IC50 for algae and of degradability

• Where it can be demonstrated in the case of highly coloured substances and preparations that algal growth is inhibited solely as a result of a reduction in light intensity, then the 72h IC50 for algae should not be used as a basis for classification.

• Substances are considered readily degradable if the following criteria hold true.

• (a) If in 28-day biodegradation studies the following levels of degradation are achieved:

• in tests based upon dissolved organic carbon: 70%,

• in tests based upon oxygen depletion or carbon dioxide generation: 60% of the theoretical maxima.

These levels of biodegradation must be achieved within 10 days of the start of degradation, which point is taken as the time when 10% of the substance has been degraded.

or

• (b) If in those cases where only COD and BOD5, data are available when the ratio of BOD5/COD is greater than or equal to 0.5;

or

• (c) If other convincing scientific evidence is available to demonstrate that the substance can be degraded (biotically and/or abiotically) in the aquatic environment to a level of > 70% within a 28-day period.

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:

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

Substances which on the basis of the available evidence concerning their toxicity, persistence, potential to accumulate and predicted or observed environmental fate and behaviour may present a danger, immediate or long-term and/or delayed, to the structure and/or functioning of natural ecosystems other than those covered under 5.2.1 above. 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 risk phrases in accordance with the following criteria:

R59: 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 behaviour may present a danger to the structure and/or the functioning of the stratospheric ozone layer. This includes the substances which are listed in Annex l to Council Regulation (EC) No 3093/94 on substances that deplete the ozone layer (OJ No L 333, 22. 12. 1994, p.l) and its subsequent amendments.

6 CHOICE OF SAFETY ADVICE PHRASES

6.1 Introduction

Safety advice phrases (S-phrases) shall be assigned to dangerous substances and preparations in accordance with the following general criteria. In addition, for certain preparations, the safety advice listed in Annex II of Directive 88/379/EEC is mandatory.

Whenever the manufacturer is mentioned in Chapter 6 it refers to the person responsible for placing the substance or preparation on the market.

6.2 Safety phrases for substances and preparations

SI 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.

S2 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 the environment.

S3 Keep in a cool place

• Applicability:

• organic peroxides,

• other dangerous substances and preparations having a boiling point ≤ 40° C.

• Criteria for use:

• obligatory for organic peroxides unless S47 is used,

• recommended for other dangerous substances and preparations having a boiling point ≤ 40°C.

S4 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 S13; for example when there is an inhalation 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

S5 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, e.g. sodium, potassium or white phosphorous.

S6 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, e.g. certain organo-metallic compounds.

S7 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.

S8 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 R14, R15 in particular, and R29.

S9 Keep container in a well-ventilated place

• Applicability:

• volatile substances and preparations which may give off very toxic, toxic or harmful vapours,

• 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.

S12 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.

S13 Keep away from food, drink and animal feeding stuffs

• 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.

S14 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 product a particular risk

S15 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, e.g. monomers, but not assigned if risk phrases R2, R3 and/or R5 have already been applied.

S16 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 R2, R3 and/or R5 have already been applied.

S17 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, e.g. to emphasize R8 and R9.

S18 Handle and open container with care

• Applicability:

• Substances and preparations liable to produce an overpressure in the container,

• Substances and preparations which may form explosive peroxides.

• Criteria for use:

• normally limited to the above-mentioned cases when there is risk of damage to the eyes and/or when the substances and preparations are likely to be used by the general public.

S20 When using do not eat or drink

• Applicability:

• very toxic, toxic and corrosive substances and preparations.

• Criteria for use:

• normally limited to special cases (e.g. arsenic and arsenic compounds; fluoracetates) in particular when any of these are likely to be used by the general public.

S21 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).

S22 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 R42 is assigned,

• recommended for those substances and preparations mentioned above which are supplied in the form of an inhalable dust and for which the health hazards following inhalation are not known.

S23 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 R42 is assigned,

• obligatory for those substances and preparations intended for use by spraying. Either S38 or S51 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 to be ascribed.

S24 Avoid contact with skin

• Applicability:

• all substances and preparations dangerous for health.

• Criteria for use:

• obligatory for those substances and preparations to which R43 has been ascribed, unless S36 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 to emphasise such risk phrases.

S25 Avoid contact with eyes

• Applicability:

• all substances and preparations dangerous to health.

• 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 to be applied. However, may be used to emphasis such risk phrases.

• recommended for substances ascribed R34, R35, R36 or R41 which are likely to be used by the general public.

S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice

• Applicability:

• corrosive or irritant substances and preparations.

• Criteria for use:

• obligatory for corrosive substances and preparations and those to which R41 has already been ascribed,

• recommended for irritant substances and preparations to which the risk phrase R36 has already been ascribed.

S27 Take off immediately all contaminated clothing.

• Applicability:

• very toxic, toxic or corrosive substances and preparations.

• Criteria for use:

• obligatory for very toxic substances and preparations to which R27 has been ascribed and which are likely to be used by the general public.

• recommended for very toxic substances and preparations to which R27 has been ascribed used in industry. However, this safety phrase should not be used if S36 has been ascribed.

• recommended for toxic substances and preparations to which R24 has been ascribed as well as corrosive substances and preparations which are likely to be used by the general public.

S28 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 rinsing fluid.

• recommended for corrosive substances and preparations which are likely to be used by the general public.

S29 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 general public, 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.

S30 Never add water to this product

• Applicability:

• substances and preparations which react violently with water.

• 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 emphasize R14 or as an alternative to R 14.

S33 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 general public.

S35 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.

S36 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 R21 or R24 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 LD50 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.

S37 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 R21, R24 or R43 has been ascribed

• obligatory for Category 3 carcinogens, mutagens and substances toxic to reproduction unless the effects are produced solely by inhalation of the substances and preparations

• obligatory for organic peroxides

• recommended for toxic substances and preparations if the LD50 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.

S38 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.

S39 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 R34, R35 or R41 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 to be ascribed,

• normally limited to exceptional cases for very toxic and toxic substances and preparations, where there is a risk of splashing and they are likely to be easily absorbed by the skin.

S40 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 safety reasons to provide a warning on the label.

S41 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

S42 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 precautions are taken.

• Criteria for use:

• normally limited to special cases.

S43 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 or evolve extremely flammable gases,

• recommended for extremely flammable, highly flammable and flammable substances and preparations, particularly when they are immiscible with water.

S45 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.

S46 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 to fear any danger from swallowing, particularly by children.

S47 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).

S48 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, e.g. nitrocelluloses.

S49 Keep only in the original container

• Applicability:

• substances and preparations sensitive to catalytic decomposition.

• Criteria for use:

• substances and preparations sensitive to catalytic decomposition e.g. certain organic peroxides.

S50 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 R31 or R32.

• obligatory with certain peroxides which may give violent reaction with accelerators or promoters.

S51 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 to inhalation risks or to a fire or explosion risk

• Criteria for use:

• recommended when use of S38 would not be appropriate. Thus important when such substances and preparations are likely to be used by the general public.

S52 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 their volatilization from large treated surfaces in the home or other enclosed places where persons congregate.

S53 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 above mentioned substances and preparations to which at least one of the following R-phrases has been assigned : R45, R46, R49, R60 or R61.

S56 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 is required.

S57 Use appropriate containment to avoid environmental contamination

• Applicability:

• substances and preparations which have been assigned the symbol ‘N’.

• Criteria for use:

• Normally limited to substances and preparations not likely to be used by the general public.

S59 Refer to manufacturer for information on recovery/recycling

• Applicability:

• all dangerous substances and preparations.

• Criteria for use:

• obligatory for substances and preparations dangerous for the ozone layer,

• recommended for other substances and preparations for which recovery/recycling is recommended.

S60 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 S35 is not assigned.

S61 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.

S62 If swallowed, do not induce vomiting: seek medical advice immediately and show this container or label.

• Applicability:

• substances and preparations classified as harmful with R65 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 a sealed spray attachment), see sections 8 and 9.

• Criteria for use:

• obligatory for substances and preparations mentioned above, if sold to, or likely to be used by the general public, except when S45 or S46 are obligatory.

• recommended for the substances and preparations mentioned above when used in industry, except where S45 or S46 are obligatory.

S63 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 preparations to which R26, R23 or R42 has been assigned which are likely to be used by the general public in a way which could result in inhalation

S64 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 above treatment is suitable.

7 LABELLING

7.1 When a substance or preparation has been classified the appropriate label is determined with reference to the requirements of Article 23 of Directive 67/548/EEC and Article 7 of Directive 88/379/EEC for substances and preparations respectively. This section explains how the label is determined and, in particular, gives guidance on how to choose the appropriate risk and safety phrases.

The label contains the following information:

• (a) name or names of the substances which will appear on the label;

• (b) the name, address and telephone number of the manufacturer/importer;

• (c) the symbols and indication of danger;

• (d) phrases indicating particular risks (risk phrases);

• (e) phrases indicating safety advice (safety phrases);

• (f) for substances, the EC number.

7.1.1 For substances appearing in Annex I of Directive 67/548/EEC, the label also includes the words ‘EC label’.

7.1.2 Final choice of risk and safety phrases

Although the final choice of the most appropriate risk and safety phrases is primarily governed by the need to give all necessary information, consideration should also be given in the clarity and impact of the label. With clarity in mind, the necessary information should be expressed in a minimum number of phrases.

In the case of irritant, highly flammable, flammable and oxidising substances and preparations, an indication of risk phrases and safety phrases need not be given where the package does not contain more than 125ml. This shall also apply in the case of the same volume of harmful substances not retailed to the general public.

7.1.3. Indications such as ‘non-toxic’, ‘non-harmful’, or any other similar indications must not appear on the label or packaging of substances or preparations subject to these Regulations or Directive 88/379/EEC.

7.1.4. For certain preparations, Annex II of Directive 88/379/EEC has special provisions concerning the labelling.

7.2. Chemical name(s) to be displayed on the label:

7.2.1. For substances listed in Annex I of Directive 67/548/EEC the label shall show the name of the substances under one of the designations given in Annex I.

For substances not listed in Annex I, the name is established according to an internationally recognised chemical nomenclature as defined in Section 1.4 above.

7.2.2 For preparations, the choice of names to be displayed on the label follows the rules of Article 7. (1) (C) of Directive 88/379/EEC.

Note:

In the case of concentrate preparations which are intended for the perfume industry:

• the person responsible for placing them on the market may identify merely the one sensitising substance judged by him to be primarily responsible for the sensitisation hazard.

• in the case of a natural substance, the chemical name may be of the type: ‘essential oil of …’ ‘extract of …’, rather than the name of the constituents of that essential oil or extract

7.3 Choice of danger symbols

The design of the danger symbols and the wording of the indications of danger shall comply with those laid down in Annex II⁴² . The symbol shall be printed in black on an orange-yellow background.

7.3.1 For substances appearing in Annex I the danger symbols and indications of danger shall be those shown in the Annex.

7.3.2. For dangerous substances not yet appearing in Annex I and for preparations, the danger symbols and indications of danger shall be assigned according to the rules laid down in this Annex.

Where more than one danger symbol is assigned to a substance:

• the obligation to indicate the symbol T makes the symbols X and C optional,

• the obligation to indicate the symbol C makes the symbol X optional,

• the obligation to indicate the symbol E makes the symbols F and O optional.

7.4 Choice of Risk phrases

The wording of the risk phrases shall comply with that laid down in Annex III⁴³ . The combined risk phrases in Annex III shall be used where applicable.

7.4.1. For substances appearing in Annex I, the risk phrases shall be those shown in the Annex.

7.4.2. For substances not appearing in Annex I, risk phrases will be selected according to the following criteria and priorities:

• (a) in the case of dangers which give rise to health effects:

• (i) risk phrases corresponding to the category of danger illustrated by a symbol must appear on the label;

• (ii) risk phrases corresponding to other categories of danger which are not illustrated by a symbol by virtue of Article 23 of Directive 67/548/EEC

• (b) in the case of dangers arising from physico-chemical properties:

• the criteria described under 7.4.2 (a) above are applicable, except that the risk phrases ‘extremely flammable’ or ‘highly flammable’ need not be indicated where they repeat the wording of the indication of danger used with a symbol;

• the risk phrase corresponding to the classification category ‘dangerous for the environment’ must appear on the label.

7.4.3. For preparations, risk phrases will be selected according to the following criteria and priorities:

• (a) in the case of dangers which give rise to health effects:

• (i) risk phrases which correspond to the category of danger illustrated by a symbol. In certain cases the risk phrases must be adopted according to the tables of Annex I to Directive 88/379/EEC. More specifically, the risk phrases of the constituent(s) which are responsible for the assignment of the preparation to a danger category must appear on the label.

• (ii) risk phrases which correspond to other categories of danger which have been attributed to the constituents but which are not illustrated by a symbol by virtue of Article 7 (d) of Directive 88/379/EEC;

• (b) in the case of dangers arising from physico-chemical properties:

• the criteria described under 7.4.3 (a) are applicable, except that the risk phrases ‘extremely flammable’ or ‘highly flammable’ need not be indicated where they repeat the wording of the indication of danger used with a symbol.

As a general rule, for preparations a maximum of four risk phrases shall suffice to describe the risk; for this purpose the combined phrases listed in Annex 3 shall be regarded as single phrases. However, the standard phrases must cover all the principal hazards associated with the preparation.

However, if the manufacturer feels that there is a need to identify environmental hazards, additional risk phrases shall be added as required.

7.5. Safety phrases

The wording of safety phrases shall comply with that laid down in Annex IV⁴⁴ .

The combined safety phrases in Schedule 4 shall be used where applicable.

7.5.1. For substances appearing in Annex I, the safety phrases shall be those shown in the Annex. Where no safety phrases are shown, the manufacturer/importer may include any appropriate safety phrase(s).

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 combined phrases 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 not present a danger for human health or the environment. In particular, advice on safe disposal is important for substances and preparations sold to 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 risk phrases will appear on the label only if it is intended to emphasize a specific warning,

• particular attention must be given, in the choice of safety phrases, to the foreseen conditions of use of certain substances and preparations, e.g. spraying or other aerosol effects. Phrases should be chosen with the intended use in view,

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

• the safety phrases S2 and S46 are obligatory for all other dangerous substances and preparations (except those only classified as dangerous for 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.

7.6. The EC number

If a substance named on the label is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS) or in the European List of Notified Substances (ELINCS), the EINECS or ELINCS number of the substances shall be shown on the Label. This requirement does not apply to preparations.

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)b⁴⁵ of Directive 67/548/EEC

However, by way of derogation from Article 24(1) and (2) of Directive 67/548/EEC 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) of Directive 67/548/EEC 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 2⁴⁶ of Directive 67/548/EEC, they do not present a danger to human health when they are placed on the market in closed refillable cylinders or in non-refillable cartridges 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 risk and safety phrases concerning flammability. No information concerning the effects on human health is required on the label. However, the information concerning effects on human health which should have appeared 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 27⁴⁷ of Directive 67/548/EEC. For the consumer, sufficient information shall be transmitted to enable them to take all necessary measures for health and safety as foreseen in Article I paragraph 3 of Directive 91/155/EEC, as modified by Directive 93/112/EEC.

8.3 Metals in massive form