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

• 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 feedingstuffs

• Applicability:

• very toxic, toxic and harmful substances and preparations.

• Criteria for use:

• recommended when such substances and preparations are likely to be used by the general public.

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 produce 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 emphasise 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 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 emphasise 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 and preparations dangerous for the environment.

• Criteria for use:

• obligatory for substances and preparations 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 emphasise R14 or as an alternative to R14.

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 air 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 and preparations by reason of their volatilisation 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 and preparations dangerous for the environment.

• Criteria for use:

• normally used for substances and preparations which have been assigned the symbol ‘N’,

• recommended for all substances and preparations 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.

7.1. When a substance or preparation has been classified the appropriate label is determined with reference to the requirements of Article 23 and Article 10 of Directive 1999/45/EC 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) for preparations the trade name or designation;

• (b) for substances the name of the substance and for preparations the names of the substances present in the preparations in accordance with the rules set out in Article 10.2.3. of Directive 1999/45/EC;

• (c) the name, full address and telephone number of the person responsible for placing the substance or preparation on the market, whether manufacturer, importer or distributor;

• (d) the symbol(s) and indication(s) of danger;

• (e) phrases indicating particular hazards (R-phrases);

• (f) phrases indicating safety advice (S-phrases);

• (g) for substances, the EC number, and in addition for substances appearing in Annex I, the word ‘EC label’;

• (h) for preparations offered or sold to the general public the nominal quantity of the contents unless specified elsewhere on the package.

Note

For certain preparations there are additional labelling requirements set out in Article 10.1.2. and Annex V of Directive 1999/45/EC and in Article 20 of Directive 98/8/EC.

7.1.1. 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 substances which are irritant, highly flammable, flammable and oxidising, an indication of R-phrases and S-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.

For preparations, if the contents of the package do not exceed 125 ml:

• if classified as highly flammable, oxidising, irritant, with the exception of those assigned R41, or dangerous for the environment and assigned the ‘N’ symbol it shall not be necessary to indicate the R-phrases or the S-phrases,

• if classified as flammable or dangerous to the environment and not assigned the ‘N’ symbol it shall be necessary to indicate the R-phrases but it shall not be necessary to indicate the S-phrases.

7.1.2. Without prejudice to Article 16.4. of Directive 91/414/EEC and to Directive 98/8/EC indications such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’, ‘ecological’ or any other statement indicating that the substance or preparation is not dangerous or likely to lead to underestimation of the dangers of the substance or preparation in question shall not appear on the label or packaging of substances or preparations subject to this Directive or to Directive 1999/45/EC.

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

7.2.1. For substances listed in Annex I 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 10.2.3. of Directive 1999/45/EC.

Note:

Subject to Annex V, B. 9. of Directive 1999/45/EC,

• the name of the sensitising substance must be chosen in accordance with Section 7.2.1 of this Annex,

• 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 II⁷⁰ . 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 or preparation:

• the obligation to indicate the symbol ‘E’ makes the symbols ‘F+’, ‘F’ and ‘O’ optional,

• the obligation to indicate the symbol ‘T+’ or ‘T’ makes the symbols ‘Xn’, ‘Xi’ and ‘C’ optional,

• the obligation to indicate the symbol ‘C’ makes the symbols ‘Xn’ and ‘Xi’ optional,

• if the symbol ‘Xn’ is assigned, the symbol ‘Xi’ is optional.

7.4. Choice of Risk-phrases

The wording of the R-phrases shall comply with that laid down in Annex III⁷¹ .

The combined R-phrases in Annex III shall be used where applicable.

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

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

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

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

• (ii) R-phrases corresponding to other categories of danger which are not illustrated by a symbol by virtue of Article 23;

• (b) in the case of dangers arising from physicochemical properties:

• R-phrases corresponding to the category of danger illustrated by a symbol must appear on the label;

• (c) in the case of dangers for the environment:

• the R-phrase(s) corresponding to the classification category ‘dangerous for the environment’ must appear on the label.

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

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

• (i) R-phrases which correspond to the category of danger illustrated by a symbol. In certain cases the R-phrases must be adopted according to the tables of Annex II, Part B of Directive 1999/45/EC. More specifically, the R-phrases of the constituent(s which are responsible for the assignment of the preparation to a danger category must appear on the label.

• (ii) R-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 10.2.4. of Directive 1999/45/EC;

• (b) in the case of dangers arising from physicochemical 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.

• (c) in the case of dangers for the environment

• (i) the R-phrase(s) corresponding to the classification category ‘dangerous for the environment’ must appear on the label;

• (ii) where the R-phrase R50 has been assigned in addition to a combined R-phrase R51/53 or R52/53 or to the R-phrase 53 alone, the combined R-phrase R50/53 shall be used.

As a general rule, for preparations a maximum of six R-phrases shall suffice to describe the risk; for this purpose the combined phrases listed in Annex III shall be regarded as single phrases. However, if the preparation falls within more than one danger category, those standard phrases shall cover all the principal hazards associated with the preparation. In some cases, more than six R-phrases may be necessary.

7.5. Safety phrases

The wording of S-phrases shall comply with that laid down in Annex IV⁷² .3e

The combined S-phrases in Annex IV shall be used where applicable.

7.5.1. For substances appearing in Annex I, the S-phrases shall be those shown in the Annex. Where no S-phrases are shown, the manufacturer/importer may include any appropriate S-phrase(s). For substances not in Annex I and for preparations, the manufacturer shall include S-phrases in accordance with the criteria given in Chapter 6 of this Annex.

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 six 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 R phrases will appear on the label only if it is intended to emphasise 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.

7.7. Dimensions of the label for preparations

The dimensions of the label shall be as follows:

Capacity of the package	Dimensions (in millimetres)
- not exceeding 3 litres:	if possible, at least 52 × 74
- greater than 3 litres but not exceeding 50 litres:	at least 74 × 105
- greater than 50 litres but not exceeding 500 litres:	at least 105 × 148
- greater than 500 litres:	at least 148 × 210

Each symbol shall cover at least one-tenth of the surface area of the label but shall not be less than 1cm2. The label shall be firmly affixed to one or more surfaces of the packaging immediately containing the preparation.

The information required on the label shall stand out clearly from its background and shall be of such size and spacing as to be easily read.

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) b⁷³ of Directive 67/548/EEC

However, by way of derogation from Article 24 (1) and (2), 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 (1994 edition) relating to ‘Gas cylinders - Precautionary labels’,

the information specified in Article 23 (2) may be provided on a durable information disc or label held captive on the cylinder.

8.2. Gas containers intended for propane, butane or liquefied petroleum gas (LPG)

These substances are classified in Annex I. Although classified in accordance with Article 2 they do not present a danger to human health when they 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 (EN 417, September 1992 edition, relating to ‘Non-refillable metallic gas cartridges for liquefied petroleum gases, with or without a valve, for use with portable appliances; construction, inspection, testing and marking’).

These cylinders or cartridges must be labelled with the appropriate symbol and the R- and S-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 27⁷⁴ 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 1 (3) of Directive 91/155/EEC, as modified by Directive 93/112/EEC and Directive 2001/58/EC.

8.3. Metals in massive form

These substances are classified in Annex I or shall be classified in accordance with Article 6. However, some of these substances, although classified in accordance with Article 2 do not present a danger to human health by inhalation, ingestion or contact with skin or to the aquatic environment in the form in which they are placed on the market. Such substances do not require a label according to Article 23. However, all the information which should have appeared on the label shall be transmitted to the user by the person responsible for placing the metal on the market, in a format foreseen in Article 27.

8.4. Substances classified with R65

Substances classified as harmful on the basis of an aspiration hazard need not be labelled as harmful with R65 when placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

9.1. Gaseous preparations (gas mixtures)

For gaseous preparations, consideration must be given to:

the evaluation of the physicochemical properties,

• the evaluation of health hazards,

• the evaluation of the environmental hazards.

9.1.1. Evaluation of physicochemical properties

9.1.1.1 Flammability

The flammable properties of these preparations are determined in accordance with Article 5 of Directive 1999/45/EC according to the methods specified in Part A of Annex V to Directive 67/548/EEC.

These preparations will be classified according to the results of the tests carried out and with respect to the criteria of Annex V and to the criteria of the labelling guide.

However, by derogation, in the case where gaseous preparations are produced to order in small amounts, the flammability of these gaseous mixtures can be evaluated by the following calculation method:

the expression of the gaseous mixture

A1F1 +… + AiFi + …AnFn + BiIi + … + BpIp

where: Ai and Bi are the molar fractions

Fi flammable gas

Ii inert gas

n number of flammable gases

p number of inert gases

can be transformed in a form where all the Ii (inert gases) are expressed by a nitrogen equivalent using a coefficient Ki and where the equivalent content of inflammable gas A'i is expressed as follows:

A'i=Ai × (100 / (Ai+KiBi))

By using the value of the maximum content of flammable gas which, in a mixture with nitrogen, gives a composition which is not flammable in air (Tci), the following expression can be obtained:

ΣiA'i/Tci ≤ 1

The gas mixture is flammable if the value of the above expression is greater than one. The preparation is classified extremely flammable and, the phrase R12 is assigned.

Coefficients of equivalency (Ki)

The values of the coefficients of equivalency Ki, between the inert gases and nitrogen and the values of the maximum contents of flammable gas (Tci) may be found in tables 1 and 2 of the ISO Standard ISO 10156 edition 15. 12. 1990 (new: 1996 edition) relating to ‘Gases and gas mixtures - Determination of fire potential and oxidising ability for the selection of cylinder valve outlets’.

Maximum content of flammable gas (Tci)

The value of the maximum content of flammable gas (Tci) may be found in table 2 of the ISO Standard ISO 10156 edition 15. 12. 1990 (new: 1996 edition) relating to ‘Gases and gas mixtures - Determination of fire potential and oxidising ability for the selection of cylinder valve outlets’.

When a Tci value for a flammable gas does not appear in the above standard, the corresponding lower explosivity limit (LEL) will be used. If no LEL value exists, the value of Tci will be set at 1 % by volume.

Remarks

• The expression above can be used to allow an appropriate labelling of gaseous preparations, however, it should not be regarded as a method for replacing experimentation for the determination of technical safety parameters.

• Furthermore, this expression gives no information as to whether a mixture containing oxidising gases can be prepared safely. When estimating flammability these oxidising gases are not taken into account.

• The expression above will give reliable results only if the flammable gases do not influence each other as far as their flammability is concerned. This has to be considered e.g. with halogenated hydrocarbons.

9.1.1.2 Oxidising properties

Given the fact that Annex V to Directive 67/548/EEC does not contain a method to determine the oxidising properties of gaseous mixtures, the evaluation of these properties must be realised according to the following estimation method.

The principle of the method is comparison of the oxidising potential of gases in a mixture with that of the oxidising potential of oxygen in air. The concentrations of gases in the mixture are expressed in % vol.

It is considered that the gas mixture is as oxidant as or more oxidant than air, if the following condition is verified:

ΣixiCi ≥ 21

where: xi is the concentration of gas i in % vol,

Ci is the coefficient of oxygen equivalency.

In this case, the preparation is classified as oxidising and the phrase R8 will be assigned.

Coefficients of equivalency between oxidising gases and oxygen

The coefficients used in the calculation to determine the oxidising capacity of certain gases in a mixture with respect to the oxidising capacity of oxygen in air, listed under 5.2. in the ISO Standard ISO 10156 edition 15. 12. 1990 (new: 1996 edition) relating to ‘Gases and gas mixtures - Determination of fire potential and oxidising ability for the selection of cylinder valve outlets’, are the following.

O2	1
N2O	0,6

When no value for the Ci coefficient exists for a gas in the cited standard a value of 40 is attributed to this coefficient.

9.1.2 Labelling

For mobile gas containers the requirements concerning labelling are considered to be satisfied when they are in agreement with Article 11. 6. (b) of Directive 1999/45/EC.

However, by way of derogation from Articles 11. 1. and 11. 2., for gas containers 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 7225 (1994 edition) relating to ‘Gas cylinders - Precautionary labels’. In this case, the label can bear the generic name or industrial/commercial name of the preparation provided that the dangerous component substances of the preparation are shown on the body of the gas cylinder in a clear and indelible way.

The information specified in Article 10 may be provided on a durable information disc or label held captive on the containers.

9.2. Gas containers intended for preparations containing stenched propane, butane or liquefied petroleum gas (LPG)

Propane, butane and liquefied petroleum gas are classified in Annex I. Although preparations containing these substances are classified in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, they do not present a danger to human health when they are placed on the market in closed refillable cylinders or non-refillable cartridges within the scope on EN 417 as fuel gases which are only released for combustion (EN 417, September 1992 edition, relating to ‘Non-refillable metallic gas cartridges for liquefied petroleum gases, with or without a valve for use with portable appliances; construction, inspection, testing and marking’).

These cylinders and cartridges must be labelled with the appropriate symbol and the R- and S- 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 14 of Directive 1999/45/EC. For the consumer, sufficient information shall be transmitted to enable them to take all necessary measures for health and safety as foreseen in Article 1 (3) of Directive 91/155/EEC.

9.3. Alloys, preparations containing polymers, preparations containing elastomers

These preparations shall be classified according to the requirements of Articles 5, 6 and 7 and labelled according to the requirements of Article 10 of Directive 1999/45/EC.

However some of these preparations although classified in accordance with Articles 6 and 7 do not present a danger to human health by inhalation, ingestion or contact with the skin or to the aquatic environment in the form in which they are placed on the market. Such preparations do not require a label according to Article 10 or according to Annex V B. 9. However, all the information which would have appeared on the label shall be transmitted to the professional user by means of an information system in a format foreseen in Article 14 of the above-mentioned Directive.

9.4. Preparations classified with R65

Preparations classified as harmful on the basis of an aspiration hazard need not be labelled as harmful with R65 when placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

9.5. Organic peroxides

Organic peroxides combine the properties of an oxidiser and a combustible substance in one molecule: when an organic peroxide decomposes, the oxidising part of the molecule reacts exothermically with the combustible (oxidisable) part. For the oxidising properties the existing methods in Annex V cannot be applied to the organic peroxides.

The following calculation method based on the presence of active oxygen must be used.

The available oxygen content (%) of an organic peroxide preparation is given by the formula:

16 × Σ (ni × ci/mi)

where:

ni=number of peroxygen groups per molecule of organic peroxide i,

ci=concentration (mass %) of organic peroxide i,

mi=molecular mass of organic peroxide i.

9.6. Additional labelling requirements for certain preparations

For certain preparations there are additional labelling requirements set out in Article 10.1.2. and Annex V of Directive 1999/45/EC and Article 20 of Directive 98/8/EC.

COMMISSION STATEMENT

With regard to Section 4.1.5. and in particular to the last paragraph of Section 4.1.5., the Commission states that, should it envisage making use of the procedure of Article 28 of Directive 67/548/EEC, it is prepared to consult in advance appropriate experts designated by Members States and having special qualifications with respect to either carcinogenicity mutagenicity or reproductive toxicity.

This consultation will take place in the framework of the normal consultation procedure with national experts and/or in the framework of existing committees. The same will be the case when substances already included in Annex I must be reclassified in respect of their carcinogenic, mutagenic effects, or effects toxic to reproduction.

SCHEDULE 6 ANNEX VII. A

INFORMATION REQUIRED FOR THE TECHNICAL DOSSIER (“BASE SET”) REFERRED TO IN ARTICLE 7 (1)

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authority.

The name of the body or bodies responsible for carrying out the studies shall be mentioned.

For intermediates with limited exposure the provisions under point 7 apply.

0.	IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: LOCATION OF THE PRODUCTION SITE
	For substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, the identity and the addresses of the importers who will be bringing the substance into the Community.
1.	IDENTITY OF THE SUBSTANCE
1.1	Name
1.1.1.	Names in the IUPAC nomenclature
1.1.2.	Other names (usual name, trade name, abbreviation)
1.1.3.	CAS number and CAS name (if available)
1.2.	Molecular and structural formula
1.3.	Composition of the substance
1.3.1.	Degree of purity (%)
1.3.2.	Nature of impurities, including isomers and by-products
1.3.3.	Percentage of (significant) main impurities
1.3.4.	If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature order of magnitude: .................... ppm, .................... %
1.3.5.	Spectral data (UV, IR, NMR or mass spectrum)
1.3.6.	HPLC, GC
1.4.	Methods of detection and determination
	A full description of the methods used or the appropriate bibliographical references Apart from methods of detection and determination, information shall be given on analytical methods which are known to the notifier and allows detection of a substance and its transformation products after discharge into the environment as well as determination of the direct exposure of humans.
2	INFORMATION ON THE SUBSTANCE
2.0..	Production Information given in the section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure associated with the production process. Precise details of the production process, particularly those of a commercially sensitive nature are not required.
2.0.1.	Technological process used in production
2.0.2.	Exposure estimates related to production: - working environment - environment
2.1.	Proposed uses Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure to the substances as associated with the proposed/expected uses.
2.1.1.	Types of use: description of the function and the desired effects
2.1.1.1	Technological process(es) related to the use of the substance (where known)
2.1.1.2	Exposure estimate(s) related to use (where known): - working environment - environment
2.1.1.3	Form under which the substance is marketed: substance, preparation, product
2.1.1.4	Concentration of the substance in marketing preparations and products (where known)
2.1.2.	Fields of application with approximate breakdown: - industries - farmers and skilled trades - use by the public at large
2.1.3.	Where known and where appropriate, the identity of the recipients of the substance
2.1.4.	Waste quantities and composition of waste resulting from the proposed uses (where known)
2.2.	Estimated production and/or imports for each of the anticipated uses or fields of application
2.2.1.	Overall production and/or imports in tonnes per year: - the first calendar year - the following calendar years For the substances manufactured outside the Community and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, this information must be given for each of the importers identified under section 0 above.
2.2.2.	Production and/or imports, broken down in accordance with 2.1.1 and 2.1.2 expressed as a percentage: - the first calendar year - the following calendar years
2.3.	Recommended methods and precautions concerning:
2.3.1.	Handling
2.3.2.	Storage
2.3.3.	Transport
2.3.4.	Fire (nature of combustion gases or pyrolysis, where proposed uses justify this)
2.3.5.	Other dangers, particularly chemical reaction with water
2.3.6.	If relevant, information concerning the susceptibility of the substance to explode when presented in the form of a dust
2.4.	Emergency measures in the case of accidental spillage
2.5.	Emergency measures in the case of injury to persons (e.g. poisoning)
2.6.	Packaging
3.	PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE
3.0.	State of the substance at 20 °C and 101,3 kPA
3.1.	Melting-point
3.2.	Boiling-point
3.3.	Relative density
3.4.	Vapour pressure
3.5.	Surface tension
3.6.	Water solubility
3.8.	Partition coefficient n/octanol/water
3.9.	Flash-point
3.10.	Flammability
3.11.	Explosive properties
3.12.	Self-ignition temperature
3.13.	Oxidizing properties
3.15.	Granulometry: For those substances which may be marketed in a form which gives rise to the danger of exposure by the inhalatory route, a test should be conducted to determine the particle size distribution of the substance as it will be marketed.
4.	TOXICOLOGICAL STUDIES
4.1.	Acute toxicity For tests 4.1.1 to 4.1.3, substances other than gases shall be administered via at least two routes, one of which should be the oral route. The choice of the second route will depend on the nature of the substance and the likely route of human exposure. Gases and volatile liquids should be administered by the inhalation route.
4.1.1.	Administered orally
4.1.2.	Administered by inhalation
4.1.3.	Administered cutaneously
4.1.5.	Skin irritation
4.1.6.	Eye irritation
4.1.7.	Skin sensitization
4.2.	Repeated dose The route of administration should be the most appropriate having regard to the likely route of human exposure, the acute toxicity and the nature of the substance. In the absence of contra-indications the oral route is usually the preferred one.
4.2.1.	Repeated dose toxicity (28 days)
4.3.	Other effects
4.3.1.	Mutagenicity The substance shall be examined in two tests. One shall be a bacteriological (reverse mutation) test, with and without metabolic activation. The second shall be a non-bacteriological test to detect chromosome aberrations or damage. In the absence of contra-indications, this test should normally be conducted in vitro, both with and without metabolic activation. In the event of a positive result in either test, further testing according to the strategy described in Annex V should be carried out.
4.3.2.	Screening for toxicity related to reproduction (for the record)
4.3.3.	Assessment of the toxicokinetic behaviour of a substance to the extent that can be derived from base set data and other relevant information
5.	ECOTOXICOLOGICAL STUDIES
5.1.	Effects on organisms
5.1.1.	Acute toxicity for fish
5.1.2.	Acute toxicity for daphnia
5.1.3.	Growth-inhibitor test on algae
5.1.6.	Bacterial inhibitionIn those cases where biodegradation may be affected by the inhibitory effect of a substance on the bacteria, a test for bacterial inhibition should be carried out prior to undertaking the biodegradation.
5.2.	Degradation -biotic -antibiotic: If the substance is not readily biodegradable then consideration should be given to the need to carry out the following tests: hydrolysis as a function of pH.
5.3.	Absorption/desorption screening test
6.	POSSIBILITY OF RENDERING THE SUBSTANCE HARMLESS
6.1.	For industry/skilled trades
6.1.1.	Possibility of recycling
6.1.2.	Possibility of neutralization of unfavourable effects
6.1.3.	Possibility of destruction: - controlled discharge - incineration - water purification station - others
6.2.	For the public at large
6.2.1.	Possibility of recycling
6.2.2.	Possibility of neutralization of unfavourable effects
6.2.3.	Possibility of destruction: - controlled discharge - incineration - water purification station - others

7 REDUCED TEST PACKAGE FOR INTERMEDIATES AT QUANTITIES □ 1 TONNE / ANNUM

“Intermediate” is a chemical substance that is solely manufactured for and consumed in or used for chemical processing in order to be transformed into another chemical substance(s);

“Emission” concerns the release of a substance from a system, for example when a system is breached. To guarantee a maximum level of protection for workers and the environment minimisation of emission through rigorous containment of the process must therefore be the primary aim;

“Exposure” is concerned with what happens to a substance after it has been emitted, whether this is into the wider environment or whether the substance can be potentially inhaled or come in contact with the skin of a member of the workforce. If emissions can be anticipated to occur, rigorous exposure control must be achieved by appropriate techniques, noting the need to adopt the precautionary principle in that physicochemical, toxicological and ecotoxicological properties which had not been tested shall be assumed as being hazardous;

“Integrated exhaust ventilation system” is an exhaust ventilation system of closed type which is used in combination with locks, enclosures, housings, containers etc. in order to restrict the chemical agents to the inner part of the closed functional unit. Process-related openings must be as small as possible. The power of extraction and the air ducting must be designed so that there is sufficient underpressure within the extraction unit to ensure that all of the gases, vapours and/or dusts that occur are fully captured and carried away. Back-flow of the extracted hazardous substances into the working area must be prevented. This means that hazardous substances are prevented from escaping from the closed functional unit into the working area;

“Highly effective exhaust ventilation” is an exhaust ventilation system of open and semi-open type which is dimensioned in such a way that chemical agents remain within the catchment area. This means that the occurrence of chemical agents in the workplace atmosphere can practically be excluded;

“Effective exhaust ventilation system” is an exhaust ventilation system of open and semi-open type which is dimensioned in such a way that the chemical agents remain within the catchment area, i.e., the occurrence of chemical agents in the workplace atmosphere can be largely excluded or proof of adherence to the limit value is furnished;

“Other exhaust ventilation system” is an exhaust ventilation system of open and semi-open type which is dimensioned in such a way that the occurrence of chemical agents in the workplace atmosphere cannot be excluded;

“Low-emission forms of use” are, for example:

• expendable packaging, i.e. the hazardous substance is enclosed in appropriate packaging and, without opening the packaging, is introduced into a reaction system together with this packaging.

• change in consistency, i.e., the substance is used, for example, in the form of a paste or a granulate instead of in powder form.

• master batch; this means that the hazardous substance is surrounded by a plastic matrix which prevents direct contact with the hazardous substance. The plastic matrix itself is not a hazardous substance. Abrasion of the plastic matrix and therefore of the hazardous substance is, however, possible.

“Emission-free forms of use” are, for example, master batches without abrasion, i.e., the plastic matrix is so resistant to abrasion that no hazardous substance can be released;

“Technically leakproof” is applied to a sub unit if a leak is not discernible during testing, monitoring or checking for leakproofness, e.g. using foaming agents or leak searching / indicating equipment performed for the particular use. Systems, sub systems and functional elements are technically leakproof, if the Rate of leakage is < 0.00001 mbar 1 s^-1;

The notifier must demonstrate to the satisfaction of the competent authority where the substance is notified that the following conditions are fulfilled.

A notifier requesting an RTP for a substance must supply the following technical dossier to the competent authority for all production and user sites:

Where emissions may lead to exposure, the means by which these are controlled must be described in sufficient detail to enable the competent authority to make a decision whether to accept the statement or to calculate an emission rate according to the EU Technical Guidance Document.

Annex VII. B plus the following tests from this Annex:

• vapour pressure (3.4)

• explosive properties (3.11)

• self-ignition temperature (3.12)

• oxidising properties (3.13)

• granulometry (3.15)

• acute toxicity for daphnia (5.1.2)

The notifier must also include other relevant information to enable the competent authority to make an informed decision and to enable proper controls to be put in place by the user at the intermediate processing site. For example, if supplementary physicochemical and/or toxicological information and/or information about the environmental behaviour is available this data must also be submitted. Additionally, the notifier must review the available toxicity and ecotoxicity data on substances having close structural relationship to the notified substance. If relevant data are available, especially on chronic and reproductive toxicity and carcinogenicity, then a summary of these data must be provided.

5.1 Use

An assessment index is used in the assessment of the plant. The assessment index classifies the handling of the substance and the resultant process-related exposure potential. The notifier shall examine the plant or plant unit is in order to determine the assessment index. Each individual functional element must be assessed.

Systems are regarded as closed if the assessment of all of the available functional elements corresponds to the assessment index 0.5 and if only functional elements are involved which are of closed type with assured leakproofness and/or equipped with integrated exhaust ventilation. In addition, direct skin contact must be excluded.

In the collection of examples relevant functional elements are indicated by 0.5 in bold type.

Functional elements of partially open type with highly effective exhaust ventilation (also indicated by the assessment index 0.5, but in normal type) are not regarded as closed according to the meaning of this rule.

In the case of functional elements assigned the assessment index 1, the safe adherence to the limit value on a permanent basis is not always assured. Such functional elements are

1 - closed type, leakproofness not assured

1 - partially open type with effective exhaust ventilation.

In the case of functional elements assigned the assessment indices 2 and 4 the adherence to the limit values is not always assured. Such functional elements are

2 - of a partially open type, opening as intended with simple exhaust ventilation

2 - open with simple exhaust ventilation

4 - open type or partially open type

4 - natural ventilation

The catalogue of examples in Table 1 of Annex VIIA to Directive 67/548/EEC facilitates the classification of the functional elements. Functional elements which are not included in the collection of examples can be classified by means of conclusions drawn by analogy. The plant or plant unit is then classified using the index value of the functional element which has received the highest assessment index.

5.2 Checking

Use of this criterion requires adherence to the process parameters which have been laid down as well as the performance of the checks cited in the collection of examples (e.g. inspection and maintenance).

If the competent authority accepts the notifier's application for a RTP, then information from the tests and/or studies set out in point 7.4 above shall be required for the technical dossier referred to in Article 7 of Directive 67/548/EEC⁷⁷ . Note that for quantities below 1 tonne/annum the usual Annex VIIB/VIIC testing requirements apply.

ANNEX VII. B

INFORMATION REQUIRED FOR THE TECHNICAL DOSSIER (“BASE SET”) REFERRED TO IN ARTICLE 8 (1) AND (3)

If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and subject to acceptance by the competent authority.

The name of the body or bodies responsible for carrying out the studies shall be mentioned.

In addition to the information requested below, Member States may, if they consider it necessary for the risk assessment, require that the notifier provides the following additional information: - vapour pressure, - daphnia acute toxicity test.