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S.I. No. 62/2004 - European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations 2004

Type Statutory Instrument
Publication 2004-02-19
Last updated 2015-05-19
State Repealed superseded text
Text As published
Source Irish Statute Book
articles 24

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

5 amending acts · 2015-05-19, S.I. No. 196/2015 - European Communities (Classification, Packaging and Labelling) (Revoc…

Reform history JSON API

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:

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

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

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 oxidizing gases can be prepared safely. When estimating flammability these oxidizing 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.

SCHEDULE 3 CONVENTIONAL METHOD FOR THE EVALUATION OF HEALTH HAZARDS OF PREPARATIONS

Introduction

An assessment must be made for all the health effects corresponding to the health effects of substances contained in a preparation. This conventional method described in Parts A and B of this Schedule is a calculation method which is applicable to all preparations and which takes into consideration all the health hazards of substances contained in the preparation. For that purpose the dangerous health effects have been subdivided into:

1.

acute lethal effects;

2.

non-lethal irreversible effects after a single exposure;

3.

severe effects after repeated or prolonged exposure;

4.

corrosive effects, irritant effects;

5.

sensitising effects;

6.

carcinogenic effects, mutagenic effects, toxic effects for reproduction.

The health effects of a preparation are to be assessed in accordance with Regulation 9 by the conventional method described in Parts A and B of this Schedule using individual concentration limits:

The procedure for classification is set out in Part A of this Schedule.

The classification of the substance(s) and the resulting classification of the preparation are expressed:

— either by a symbol and one or more risk phrases, or

— by categories (category 1, category 2 or category 3) also assigned risk phrases when substances and preparations are shown to be carcinogenic, mutagenic or toxic for reproduction. Therefore it is important to consider, in addition to the symbol, all the phrases denoting specific risks which are assigned to each substance under consideration.

Note: In the case of combined risk phrases where the second phrase denotes route of exposure only, then only the risk phrase denoting special risks needs to be taken into account for classification purposes, i.e., the route of exposure does not contribute to the additivity.

The systematic assessment of all the dangerous health effects is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of the substance.

Where they are not given in Annex I, the concentration limits to be taken into account for the application of this conventional method are those set out in Part B of this Schedule.

PART A — PROCEDURE FOR EVALUATION OF HEALTH HAZARDS

The evaluation proceeds stepwise as follows:

1. Very Toxic due to Acute Lethal Effects

1.1. Preparations should be classified as very toxic, assigned the corresponding symbol ‘T+’ with the indication of danger ‘very toxic’ and the appropriate risk phrases (R26, R27 or R28) in accordance with the following criteria:

1.1.1. preparations containing one or more substances classified as very toxic that produce such effects, in individual concentrations equal to or greater than:

1.1.2. preparations containing more than one substance classified as very toxic in lower individual concentrations than the limits specified under 1.1.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PT+ is the percentage by weight or by volume of each very toxic substance in the preparation,

LT+ is the lower concentration limit defined for the substance for classifying the preparation as very toxic (as per Table 1= 7% by weight). For gaseous preparations the lower concentration limits in Table 1A shall apply.

1.2. Toxic due to non-lethal irreversible effects after a single exposure

Preparations should be classified as very toxic, assigned the symbol ‘T+’, the indication of danger ‘very toxic’ and the risk phrase R39/route of exposure when they contain at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:

2. Toxic due to acute lethal effects

2.1. Preparations should be classified as toxic and assigned the symbol ‘T’ the indication of danger ‘toxic’ and the risk phrases R23, R24 or R25 in accordance with the following criteria:

2.1.1. preparations containing one or more substances classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than:

2.1.2. preparations containing more than one substance classified as very toxic or toxic in lower individual concentrations than the limits specified under 2.1.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PT+ is the percentage by weight or by volume of each very toxic substance in the preparation,

PT is the percentage by weight or by volume of each toxic substance in the preparation,

LT and LT+ are the lower concentration limits defined for each substance for classifying the preparation as toxic (as per Table 1 = 1% by weight for T+ substances and 25% by weight for T substances). For gaseous preparations the lower concentration limits in Table 1A shall apply.

2.2. Non-lethal irreversible effects

Preparations should be classified as toxic, assigned the symbol ‘T’ the indication of danger ‘toxic’ and the risk phrase R39/route of exposure if they contain at least one dangerous substance classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than:

2.3. Severe effects after repeated or prolonged exposure

Preparations should be classified as toxic, assigned the symbol ‘T’, the indication of danger ‘toxic’ and the risk phrase R48/route of exposure if they contain at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:

3. Harmful due to acute lethal effects

3.1. Preparations should be classified as harmful, assigned the symbol ‘Xn’ and the indication of danger ‘harmful’ and the risk phrases R20, R21 or R22 in accordance with the following criteria;

3.1.1. preparations containing one or more substances classified as very toxic, toxic or harmful and that produce such effects in individual concentrations equal to or greater than:

3.1.2. preparations containing more than one substance classified as very toxic, toxic or harmful in lower individual concentrations than the limits specified under 3.1.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PT+ is the percentage by weight or by volume of each very toxic substance in the preparation,

PT is the percentage by weight or by volume of each toxic substance in the preparation,

PXn is the percentage by weight or by volume of each harmful substance in the preparation,

LT+, LT and LXn are the lower concentration limits defined for each substance for classifying the preparation as harmful (as per Table 1 = 0.1% by weight for T+ substances, 3% by weight for T substances and 25% by weight for Xn substances). For gaseous preparations the lower concentration limits in Table 1A shall apply.

3.2. Acute effects to the lungs if swallowed

Preparations should be classified as harmful, assigned the symbol ‘Xn’, and the indication of danger ‘harmful’ and the risk phrase R65 in accordance with the criteria specified in paragraph 3.2.3 of Annex VI. In applying the conventional method according to the above paragraph 3.1 no account shall be taken of the classification of a substance as R65.

3.3. Non-lethal irreversible effects after a single exposure

Preparations should be classified as harmful, assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase R68/route of exposure if they contain at least one dangerous substance classified as very toxic, toxic or harmful that produces such effects in individual concentrations equal to or greater than:

3.4. Severe effects after repeated or prolonged exposure

Preparations should be classified as harmful, assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase R48/route of exposure if they contain at least one dangerous substance classified as toxic or harmful that produces such effects in individual concentrations equal to or greater than:

4 Corrosive

4.1. Preparations should be classified as corrosive, assigned the symbol ‘C’, the indication of danger ‘corrosive’ and the risk phrase R35 in accordance with the following criteria:

4.1.1. preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 in individual concentrations equal to or greater than:

4.1.2. preparations containing more than one substance classified as corrosive to which is assigned phrase R35 in lower individual concentrations than the limits specified under 4.1.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PC, R35 is the percentage by weight or by volume of each corrosive substance which is assigned phrase R35 in the reparation,

LC, R35 is the lower concentration limit defined for the substance for classifying the preparation as corrosive with R35 (as per Table IV = 10% by weight). For gaseous preparations the lower concentration limits in Table IVA shall apply.

4.2. and assigned the symbol ‘C’, the indication of danger ‘corrosive’ and the risk phrase R34;

4.2.1. preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 or R34 in individual concentrations equal to or greater than:

4.2.2. preparations containing more than one of the substances classified as corrosive to which is assigned the phrase R35 or R34 in lower individual concentrations than the limits specified under 4.2.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PC, R35 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation

PC, R34 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation

LC, R35 and LC, R34 are the lower concentration limits defined for each substance for classifying the preparation as corrosive with R34 (as per Table IV = 5% and 10% by weight respectively). For gaseous preparations the lower concentration limits in Table IVA shall apply.

5 Irritants:

5.1. Risk of serious damage to eyes

Preparations should be classified as irritant, assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R41 in accordance with the following criteria:

5.1.1 preparations containing one or more substances classified as irritant to which is assigned phrase R41 in individual concentrations equal to or greater than:

5.1.2. preparations containing more than one of the substances classified as irritant and to which is assigned phrase R41, or classified as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified under 5.1.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PC, R35 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R41 is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,

LC, R35, LC, R34, and LXi, R41 are the lower concentration limits defined for each substance for classifying the preparation as Irritant with risk phrase R41 (as per Table IV = 5%, 10% and 10% by weight respectively). For gaseous preparations the lower concentration limits in Table IVA shall apply.

5.2. Irritating to eyes

Preparations should be classified as irritant, assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R36 in accordance with the following criteria:

5.2.1. preparations containing one or more substances classified as corrosive to which is assigned phrase R35 or R34 or as irritant and to which is assigned phrase R41 or R36 in individual concentrations equal to or greater than:

5.2.2. preparations containing more than one substance classified as irritant to which is assigned phrase R41 or R36, or as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified under 5.2.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PC, R35 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R41 is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,

PXi, R36 is the percentage by weight or by volume of each irritant substance to which is assigned phrase R36 in the preparation,

LC, R35, LC, R34, and LXi, R41, LXi, R36 are the lower concentration limits defined for each substance for classifying the preparation as Irritant with risk phrase R36 (as per Table IV = 1%, 5%, 5% and 20% by weight respectively). For gaseous preparations the lower concentration limits in Table IVA shall apply.

5.3 Irritating to skin

Preparations should be classified as irritant, assigned the symbol ‘XI’, the indication of danger ‘irritant’ and the risk phrase R38 in accordance with the following criteria:

5.3.1 preparations containing one or more substances classified as irritant and to which is assigned phrase R38 or as corrosive and to which is assigned phrase R35 or R34 in individual concentrations equal to or greater than:

5.3.2 preparations containing more than one of the substances classified as irritant and to which is assigned phrase R38, or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified under 5.3.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PC, R35 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R38 is the percentage by weight or by volume of each irritant substance to which is assigned phrase R38 in the preparation,

LC, R35, LC, R34, and LXi, R38 are the lower concentration limits defined for each substance for classifying the preparation as Irritant with risk phrase R38 (as per Table IV = 1%, 5% and 20% by weight respectively). For gaseous preparations the lower concentration limits in Table IVA shall apply.

5.4 Irritating to respiratory system

Preparations should be classified as irritant, assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R37 in accordance with the following criteria:

5.4.1. preparations containing one or more substances classified as irritant and to which is assigned phrase R37 in individual concentrations equal to or greater than:

5.4.2. preparations containing more than one substance classified as irritant and to which is assigned phrase R37 in lower individual concentrations than the limits specified under 5.4.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PXi, R37 is the percentage by weight or by volume of each irritant substance to which is assigned phrase R37 in the preparation,

LXi, R37 is the lower concentration limit defined for the substance for classifying the preparation as Corrosive with risk phrase R37 (as per Table IV = 20%). For gaseous preparations the lower concentration limits in Table IVA shall apply.

5.4.3. gaseous preparations containing more than one of the substances classified as irritant to which is assigned phrase R37 or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified under 5.4.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PC, R35 is the percentage by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 is the percentage by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R37 is the percentage by volume of each irritant substance to which is assigned phrase R37 in the preparation,

LC, R35, LC, R34, and LXi, R37 are the lower concentration limits defined for each gaseous corrosive substance for classifying the preparation as Irritant with risk phrase R37 (as per Table IVA = 0.02%, 0.5% and 5% by weight respectively).

6 Sensitisers:

Skin sensitisers

6.1. Preparations should be classified as irritant, assigned the symbol ‘Xi’, the indication of danger‘irritant’ and the risk phrase R43 if they contain at least one substance classified as sensitising and to which is assigned phrase R43 that produces such effects in individual concentrations equal to or greater than:

Respiratory sensitisers

6.2. Preparations should be classified as harmful, assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase R42 if they contain at least one substance classified as sensitising to which is assigned phrase R42 that produces such effects in individual concentrations equal to or greater than:

7 Carcinogens:

7.1. Preparations should be classified as carcinogens category 1 or 2, assigned the symbol ‘T’ and the phrase R45 or R49 if they contain at least one substance producing such effects, classified as carcinogenic and to which is assigned phrase R45 or R49 which denotes carcinogenic substances in category 1 and category 2, in individual concentrations equal to or greater than:

7.2. Preparations should be classified as carcinogens category 3 which are assigned the symbol ‘Xn’ and the phrase R40 if they contain at least one substance producing such effects classified as carcinogenic and to which is assigned phrase R40 which denotes carcinogenic substances in category 3, in individual concentrations equal to or greater than:

8 Mutagens

8.1. Preparations should be classified as mutagens category 1 or 2 which are assigned the symbol ‘T’ and the phrase R46 if they contain at least one substance producing such effects, classified as mutagenic and to which is assigned phrase R46 which denotes mutagenic substances in category 1 and category 2, in individual concentrations equal to or greater than:

8.2. Preparations should be classified as mutagens category 3 which are assigned the symbol ‘Xn’ and the phrase R68 if they contain at least one substance, producing such effects, classified as mutagenic and to which is assigned phrase R68 which denotes mutagenic substances in category 3, in individual concentrations equal to or greater than:

9 Toxic for Reproduction

Fertility

9.1. Preparations should be classified as toxic for reproduction category 1 or 2 which are assigned the symbol ‘T’ and the phrase R60 (fertility) if they contain at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R60 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than:

9.2. Preparations should be classified as toxic for reproduction category 3 which are assigned the symbol ‘Xn’ and the phrase R62 (fertility) if they contain at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R62 which denotes substances toxic for reproduction of category 3, in individual concentrations equal to or greater than:

Development

9.3. Preparations should be classified as toxic for reproduction category 1 or 2 which are assigned the symbol ‘T’ and the phrase R61 (development) if they contain at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R61 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than:

9.4. Preparations should be classified as toxic for reproduction category 3 which are assigned the symbol ‘Xn’ and the phrase R63 (development) if they contain at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R63 which denotes substances toxic for reproduction of category 3, in individual concentrations equal to or greater than:

PART B — Concentration limits to be used in evaluation of health hazards

For each health effect, the first table (Tables I to VI) sets out the concentration limits (expressed as a weight/weight percentage) to be used for non-gaseous preparations and the second table (Tables IA to VIA) sets out the concentration limits (expressed as a volume/volume percentage) to be used for gaseous preparations. These concentration limits are used in the absence of specific concentration limits for the substance under consideration in Annex I.

1. Acute lethal effects

1.1. Non-gaseous preparations

The concentration limits fixed in Table I, expressed as a weight/weight percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table I
Classification of the substance Classification of the preparation Classification of the preparation Classification of the preparation
T+ T Xn
T^+ with R26, R27, R28 concentration > = 7% 1% = < concentration < 7% 0.1% = < concentration < 1%
T with R23, R24, R25 concentration > = 25% 3% = < concentration < 25%
Xn with R20, R21, R22 concentration > = 25%

The risk phrases denoting risk shall be assigned to the preparation in accordance with the following criteria:

— the label shall include one or more of the above mentioned risk phrases according to the classification used,

— in general, the risk phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.

1.2 Gaseous preparations

The concentration limits expressed as a volume/volume percentage in Table IA below determine the classification of the gaseous preparations in relation to the individual concentration of the gas(es) present whose classification is also shown.

Table IA
Classification of the substance (gas) Classification of the preparation Classification of the preparation Classification of the preparation
T+ T Xn
T^+ with R26, R27, R28 concentration > = 1% 0.2% = < concentration < 1% 0.2% = < concentration < 0.2%
T with R23, R24, R25 concentration > = 5% 0.5% = < concentration < 5%
Xn with R20, R21, R22 concentration > = 5%

The risk phrases denoting risk shall be assigned to the preparation in accordance with the following criteria:

— the label shall include one or more of the above mentioned risk phrases according to the classification used,

— in general, the risk phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.

2. Non-lethal irreversible effects after a single exposure

2.1. Non-gaseous preparations

For substances that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R40/route of exposure), the individual concentration limits specified in Table II, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table II
Classification of the substance (gas) Classification of the preparation Classification of the preparation Classification of the preparation
T+ T Xn
T+ with R39/ route of exposure concentration > = 10% R39 (^*) obligatory 1%=<concentration < 10% R39 (^*) obligatory 0.1% = < concentration < 1% R68 (^*) obligatory
T with R39/ route of exposure concentration > = 10% R39 (^*) obligatory 1% = < concentration < 10% R68 (^*) obligatory
Xn with R68/ route of exposure concentration > = 10% R68 (^*) obligatory
^(* ) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(* ) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(* ) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(* ) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used.

2.2 Gaseous preparations

For gases that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R40/route of exposure), the individual concentration limits specified in Table IIA, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table IIA
Classification of the substance (gas) Classification of the preparation Classification of the preparation Classification of the preparation
T+ T Xn
T+ with R39/ route of exposure concentration > = 1% R39 (^*) obligatory 0.2% =<concentration<1% R39 (^*) obligatory 0.02% = < concentration < 0.2% R68 (^*) obligatory
T with R39/ route of exposure concentration > = 5% R39 (^*) obligatory 0.5% = < concentration < 5% R68 (^*) obligatory
Xn with R68/ route of exposure concentration > = 5% R68 (^*) obligatory
^(* ) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(* ) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(* ) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(* ) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used.

3. Severe effects after repeated or prolonged exposure

3.1 Non-gaseous preparations

For substances that produce severe effects after repeated or prolonged exposure (R48/route of exposure), the individual concentration limits specified in Table III, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table III
Classification of the substance Classification of the preparation Classification of the preparation
T+ Xn
T+ with R48/route of exposure concentration > = 10% R48 (^*) obligatory 1%=<concentration<10% R48 (^*) obligatory
Xn with R48 route of exposure concentration > = 10% R48 (^*) obligatory
^(*) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(*) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(*) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used.

3.2 Gaseous preparations

For gases that produce severe effects after repeated or prolonged exposure (R48/route of exposure), the individual concentration limits specified in Table IIIA below, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table IIIA
Classification of the substance (gas) Classification of the preparation Classification of the preparation
T Xn
T+ with R48/route of exposure concentration > = 5% R48 (^*) obligatory 0.5%=<concentration<5% R48 (^*) obligatory
Xn with R48 route of exposure concentration > = 5% R48 (^*) obligatory
^(*) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(*) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used. ^(*) To indicate the route of administration/exposure (route of exposure) the combined risk phrases listed under paragraphs 3.2.1, 3.2.2, and 3.2.3 of the labelling guide (Annex VI) are to be used.

4 Corrosive and irritant effects including serious damage to the eye

4.1. Non-gaseous preparations

For substances that produce corrosive effects (R34, R35) or irritant effects (R36, R37, R38, R41), the individual concentration limits specified in Table IV, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table IV
Classification of the substance Classification of the preparation Classification of the preparation Classification of the preparation Classification of the preparation
C with R35 C with R34 Xi with R41 Xi with R36, R37, R38
C with R35 concentration > = 10% R35 obligatory 5% = < concentration < 10% R34 obligatory (5%*) 1% = < concentration < 5% R36/38 obligatory
C with R34 concentration > = 10% R34 obligatory (10%*) 5% = < concentration < 10% R36/38 obligatory
Xi with R41 concentration>= 10% R41 obligatory 5% = < concentration < 10% R36 obligatory
Xi with R36, R37, R38 concentration < = 20% R36, R37, R38 are obligatory in the light of the concentration present if they apply to the substances under con- sideration
^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 11(6). ^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 11(6). ^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 11(6). ^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 11(6). ^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 11(6).

4.2. Gaseous preparations

For gases that produce such effects (R34, R35 or R36, R37, R38, R41), the individual concentration limits specified in Table IVA below, expressed as a volume/volume percentage determine, when appropriate, the classification of the preparation.

Table IVA
Classification of the substance (gas) Classification of the preparation Classification of the preparation Classification of the preparation Classification of the preparation
C with R35 C with R35 Xi with R41 Xi with R36, R37, R38
C with R35 concentration > = 1% R35 obligatory 0.2% = < concentration < 1% R34 obligatory 0.2%(^*) 0.02% = < concentration < 0.2% R36/37/38 obligatory
C with R34 concentration > = 5% R34 obligatory 5%(^*) 0.5% = < concentration < 5% R36/37/38 obligatory
Xi with R41 concentration > = 5% R41 obligatory 0.5% = < concentration < 5% R36 obligatory
Xi with R36, R37, R38 concentration < 5% R36, R37, R38 obligatory as appropriate
^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 9(6). ^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 9(6). ^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 9(6). ^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 9(6). ^() According to the labelling guide (Annex VI), corrosive substances assigned risk phrases R35 or R34 must also be considered as being assigned phrase R41. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concentration limits for a classification of the preparation as corrosive, such substances can contribute to a classification of the preparation as irritant with R41 or irritant with R36. Note:* Simple application of the conventional method to preparations containing substances classified as corrosive or irritant may result in under-classification or over-classification of the hazard, if other relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying for corrosivity, consider the advice given in paragraph 3.2.5 of Annex VI and Regulation 9(6).

5 Sensitising effects

5.1 Non-gaseous preparations

Preparations that produce such effects are classified as sensitising and assigned:

— the symbol Xn and phrase R42 if this effect can be produced by inhalation,

— the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.

The individual concentration limits specified in Table V, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

Table V
Classification of the substance Classification of the preparation Classification of the preparation
Classification of the substance Sensitising with R42 Sensitising with R43
Sensitising with R42 concentration > = 1% R42 obligatory
Sensitising with R43 concentration > = 1% R43 obligatory

5.2 Gaseous preparations

Gaseous preparations that produce such effects are classified as sensitising and assigned:

— the symbol Xn and phrase R42 if this effect can be produced by inhalation,

— the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.

The individual concentration limits specified in Table VA below, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table VA
Classification of the substance (gas) Classification of the preparation Classification of the preparation
Classification of the substance (gas) Sensitising with R42 Sensitising with R43
Sensitising with R42 concentration > = 0.2% R42 obligatory
Sensitising with concentration > = 0.2% R43 obligatory

6. Carcinogenic/mutagenic/toxic effects for reproduction

6.1. Non-gaseous preparations

For substances which produce such effects, the concentration limits laid down in Table VI, expressed as a weight/weight percentage, shall determine, where appropriate, the classification of the preparation. The following symbols and risk phrases are assigned:
Carcinogenic categories 1 and 2: T; R45 or R49
Carcinogenic category 3: Xn ; R40
Mutagenic categories 1 and 2: T; R46
Mutagenic category 3: Xn ; R68
Toxic for reproduction fertility categories 1 and 2: T; R60
Toxic for reproduction development categories 1 and 2: T; R61
Toxic for reproduction fertility category 3: Xn ; R62
Toxic for reproduction development category 3: Xn ; R63

Table VI
Classification of the substance Classification of the preparation Classification of the preparation
Classification of the substance Categories 1 and 2 Category 3
carcinogenic substances of category 1 or 2 with R45 or R49 concentration > = 0.1% carcinogenic R45, R49 obligatory as appropriate
carcinogenic substances of category 3 with R40 concentration > = 1% carcinogenic R40 obligatory
mutagenic substances of category 1 or 2 with R46 concentration > = 0.1% mutagenic R46 obligatory
mutagenic substances of category 3 with R68 concentration > = 1% mutagenic R68 obligatory
substances “toxic for reproduction” of category 1 or 2 with R60 (fertility) concentration > = 0.5% toxic for reproduction (fertility) R60 obligatory
substances “toxic for reproduction” of category 3 with R62 (fertility) concentration > = 5% toxic for reproduction (fertility) R62 obligatory
substances “toxic for reproduction” of category 1 or 2 with R61 (development) concentration > = 0.5% toxic for reproduction (development) R61 obligatory
substances “toxic for reproduction” of category 3 with R63 (development) concentration > = 5% toxic for reproduction (development) R63 obligatory
--- ---
Carcinogenic categories 1 and 2: T; R45 or R49
Carcinogenic category 3: Xn ; R40
Mutagenic categories 1 and 2: T; R46
Mutagenic category 3: Xn ; R68
Toxic for reproduction fertility categories 1 and 2: T; R60
Toxic for reproduction development categories 1 and 2: T; R61
Toxic for reproduction fertility category 3: Xn ; R62
Toxic for reproduction development category 3: Xn ; R63

6.2. Gaseous preparations

For gases which produce such effects, the concentration limits laid down in Table VIA, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation. The following symbols and risk phrases are assigned:
Carcinogenic categories 1 and 2: T; R45 or R49
Carcinogenic category 3: Xn ; R40
Mutagenic categories 1 and 2: T; R46
Mutagenic category 3: Xn ; R68
Toxic for reproduction fertility categories 1 and 2: T; R60
Toxic for reproduction development categories 1 and 2: T; R61
Toxic for reproduction fertility category 3: Xn ; R62
Toxic for reproduction development category 3: Xn ; R63

Table VIA
Classification of the substance Classification of the preparation Classification of the preparation
Classification of the substance Categories 1 and 2 Category 3
carcinogenic substances of category 1 or 2 with R45 or R49 concentration > = 0.1% carcinogenic R45, R49 obligatory as appropriate
carcinogenic substances of category 3 with R40 concentration > = 1% carcinogenic R40 obligatory
mutagenic substances of category 1 or 2 with R46 concentration > = 0.1% mutagenic R46 obligatory
mutagenic substances of category 3 with R68 concentration > = 1% mutagenic R68 obligatory
substances “toxic for reproduction” of category 1 or 2 with R60 (fertility) concentration > = 0.2% toxic for reproduction (fertility) R60 obligatory
substances “toxic for reproduction” of category 3 with R62 (fertility) concentration > = 1% toxic for reproduction (fertility) R62 obligatory
substances “toxic for reproduction” of category 1 or 2 with R61 (development) concentration > = 0.2% toxic for reproduction (development) R61 obligatory
substances “toxic for reproduction” of category 3 with R63 (development) concentration = 1% toxic for reproduction (development) R63 obligatory

SCHEDULE 4 CONVENTIONAL METHOD FOR THE EVALUATION OF ENVIRONMENTAL HAZARDS OF PREPARATIONS

METHODS FOR THE EVALUATION OF THE ENVIRONMENTAL HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 7

INTRODUCTION

The systematic assessment of all the dangerous properties for the environment is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of a substance.

Part A gives the calculation procedure according to Regulation 12 (1) and gives the risk phrases to be assigned to the classification of the preparation.

Part B gives the concentration limits to be used when applying the conventional method and relevant symbols and risk phrases for classification.

In accordance with Regulation 12 (1) the environmental hazards of a preparation shall be assessed by the conventional method described in parts A and B of this Schedule, using individual concentration limits.

Part C gives the test methods for the evaluation of the hazards for the aquatic environment.

PART A — Procedure for the evaluation of environmental hazards

I. Conventional method for the evaluation of hazards to the aquatic environment

The conventional method for the evaluation of hazards to the aquatic environment takes into account all the hazards that a preparation may entail for this medium according to the following specifications.

1.

Preparations should be classified as dangerous for the environment, assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrases R50 and R53 (R50-53) in accordance with the following criteria:

1.1. preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-53 in individual concentrations equal to or greater than:

1.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 in lower individual concentrations than the limits specified under 1.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PN, R50-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

LN, R50-53 is the lower concentration limit defined for the substance for classifying the preparation as dangerous for the environment N, R50-53, (as per Table 1 = 25% by weight).

2.

Preparations should be classified as dangerous for the environment, assigned the symbol ‘N’ the indication of danger ‘dangerous for the environment’ and the risk phrases R51 and R53 (R51-53), unless the preparation is already classified according to paragraph 1 above, in accordance with the following criteria:

2.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases R50-53 or R51-53 in individual concentrations equal to or greater than:

2.2. preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases R50-53 or R51-53 in lower individual concentrations than the limits specified under 2.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PN, R50-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

PN, R51-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51-53 in the preparation,

LN, R50-53, LN, R51-53 are the lower concentration limits defined for the substances for classifying the preparations as dangerous for the environment N, R51-53, (as per Table 1 = 2.5% and 25% by weight for N, R50-53 and N, R51-53 substances respectively).

3.

Preparations should be classified as dangerous for the environment and assigned the risk phrases R52 and R53 (R52-53), unless the preparation is already classified according to paragraph 1 or 2 above, in accordance with the following criteria:

3.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases R50-53 or R51-53 or R52-53 in individual concentrations equal to or greater than:

3.2. preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases R51-53 or R50-53 or R52-53 in lower individual concentrations than the limits specified under 3.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PN, R50-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

PN, R51-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51-53 in the preparation,

PR52-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R52-53 in the preparation,

LN, R50-53, LN, R51-53 and LR52-53 are the lower concentration limits defined for the substances for classifying the preparations as dangerous for the environment N, R52-53, (as per Table 1 = 0.25%, 2.5% and 25% by weight for N, R50-53 and N, R51-53, and R52-53 substances respectively).

4.

Preparations should be classified as dangerous for the environment, assigned the symbol ‘N’ the indication of danger ‘dangerous for the environment’ and the risk phrase R50 unless the preparation is already classified according to 1 above:

4.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R50 in individual concentrations equal to or greater than:

4.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R50 in lower individual concentrations than the limits specified under 4.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PN, R50 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

LN, R50 is the lower concentration limit defined for the substance for classifying the preparation as N, R50, (as per Table 2 = 25% by weight).

4.3. preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R50 not meeting the criteria under 4.1 or 4.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PN, R50 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

PN, R50-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

LN, R50, LN, R50-53 are the lower concentration limits defined for the substance for classifying the preparation as dangerous for the environment, N, R50, (as per Table 2 = 25% by weight for both N, R50 and N, R50-53 substances).

5.

Preparations should be classified as dangerous for the environment and assigned the risk phrase R52 unless the preparation is already classified according to paragraphs 1, 2, 3, or 4 according to the following criteria:

5.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R52 in individual concentrations equal to or greater than:

5.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R52 in lower individual concentrations than the limits specified under 5.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PR52 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52 in the preparation,

LR52 is the limit defined for each substance for classifying the preparation dangerous for the environment R52, (as per Table 3 = 25% by weight).

6.

Preparations should be classified as dangerous for the environment and assigned the risk phrase R53 unless the preparation is already classified according to paragraph 1, 2, or 3 above:

6.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R53 in individual concentrations equal to or greater than:

6.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R 53 in lower individual concentrations than the limits specified under 6.1(a) or (b) if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PR53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

LR53 is the limit defined for each substance for classifying the preparation dangerous for the environment R52, (as per Table 4 = 25% by weight).

6.3. preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R53 not meeting the criteria under I.6.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 or R51-53 or R52-53 if the sum of the fractions in the formula below is equal to or greater than 1:

where:

PR53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

PN, R50-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50-53 in the preparation,

PN, R51-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R51-53 in the preparation,

PR52-53 is the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52-53 in the preparation,

LR53, LN, R50-53, LN, R51-53 and LR52-53 = are the lower concentration limits defined for the substances for classifying the preparations as dangerous for the environment R53, (as per Table 4 = 25%, by weight for N, R53, N, R50-53 and N, R51-53, and R52-53 substances respectively).

1. Conventional method for the evaluation of preparations dangerous for the ozone layer

1.1. Preparations should be classified as dangerous for the environment, assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrase R59 if they contain one or more substances classified as dangerous to the environment and to which is assigned the symbol ‘N’ and the risk phrase R59 in individual concentrations equal to or greater than:

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