Annexes to COM(1996)347 - Approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations

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dossier COM(1996)347 - Approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, ...
document COM(1996)347 EN
date May 31, 1999
ANNEX I


METHODS FOR THE EVALUATION OF PHYSICO-CHEMICAL PROPERTIES OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 5

PART A

Exemptions to test methods of Annex V - Part A to Directive 67/548/EEC

See 2.2.5 of Annex VI to Directive 67/548/EEC.

PART B

Alternative calculation methods

B.1. Non-gaseous preparations

1. Method for the determination of oxidising properties of preparations containing organic peroxides.

See point 2.2.2.1 of Annex VI to Directive 67/548/EEC.

B.2. Gaseous preparations

1. Method for the determination of oxidising properties

See 9.1.1.2 of Annex VI to Directive 67/548/EEC.

2. Method for the determination of flammability properties

See 9.1.1.1 of Annex VI to Directive 67/548/EEC.


ANNEX II


METHODS FOR THE EVALUATION OF HEALTH HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 6

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 Annex 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 Article 6(1)(a) by the conventional method described in parts A and B of this Annex using individual concentration limits.

(a) where the dangerous substances listed in Annex I to Directive 67/548/EEC are assigned concentration limits necessary for the application of the method of assessment described in part A of this Annex, these concentration limits must be used;

(b) where the dangerous substances do not appear in Annex I to Directive 67/548/EEC or appear there without the concentration limits necessary for the application of the method of evaluation described in part A of this Annex, the concentration limits must be assigned in accordance with the specifications in part B of this Annex.

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

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.

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 to Directive 67/548/EEC, the concentration limits to be taken into account for the application of this conventional method are those set out in Part B of this Annex.

PART A

Procedure for evaluation of health hazards

The evaluation proceeds stepwise as follows:

1. The following preparations are to be classified as very toxic:

1.1. owing to their acute lethal effects and assigned the symbol "T+", the indication of danger "very toxic" and the risk phrases R26, R27 or R28;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 1 in Part B of this Annex (Table I and I A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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:

>REFERENCE TO A GRAPHIC>

where:

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

LT+= is the very toxic limit specified for each very toxic substance, expressed as a percentage by weight or by volume;

1.2. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol "T+", the indication of danger "very toxic" and the risk phrase R39/route of exposure.

Preparations containing at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 2 in Part B of this Annex (Table II and II A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

2. The following preparations shall be classified as toxic:

2.1. owing to their acute lethal effects and assigned the symbol "T", the indication of danger "toxic" and the risk phrases R23, R24 or R25;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 1 in Part B of this Annex (Table I and I A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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:

>REFERENCE TO A GRAPHIC>

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= is the respective toxic limit specified for each very toxic or toxic substance, expressed as a percentage by weight or by volume;

2.2. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol "T", the indication of danger "toxic" and the risk phrase R39/route of exposure.

Preparations containing at least one dangerous substance classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 2 in Part B of this Annex (Table II and II A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

2.3. owing to their long-term effects and assigned the symbol "T", the indication of danger "toxic" and the risk phrase R48/route of exposure.

Preparations containing at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 3 in Part B of this Annex (Table III and III A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

3. The following preparations shall be classified as harmful:

3.1. owing to their acute lethal effects and assigned the symbol "Xn" and the indication of danger "harmful" and the risk phrases R20, R21 or R22;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 1 in Part B of this Annex (Table I and I A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

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:

>REFERENCE TO A GRAPHIC>

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,

LXn= is the respective harmful limit specified for each very toxic, toxic or harmful substance, expressed as percentage by weight or by volume;

3.2. owing to their acute effects to the lungs if swallowed and assigned the symbol "Xn", and the indication of danger "harmful" and the risk phrase R65.

Preparations classified as harmful according to the criteria specified in paragraph 3.2.3 of Annex VI to Directive 67/548/EEC. 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. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol "Xn", the indication of danger "harmful" and the risk phrase R40/route of exposure.

Preparations containing at least one dangerous substance classified as very toxic, toxic or harmful that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 2 in Part B of this Annex (Table II and II A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

3.4. owing to their long-term effects and assigned the symbol "Xn", the indication of danger "harmful" and the risk phrase R48/route of exposure.

Preparations containing at least one dangerous substance classified as toxic or harmful that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 3 in Part B of this Annex (Table III and III A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

4. The following preparations are to be classified as corrosive

4.1. and assigned the symbol "C", the indication of danger "corrosive" and the risk phrase R35;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

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:

>REFERENCE TO A GRAPHIC>

where:

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

LC, R35= is the corrosive limit R35 specified for each corrosive substance to which is assigned phrase R35, expressed as a percentage by weight or by volume;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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:

>REFERENCE TO A GRAPHIC>

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, R34= is the respective corrosive limit R34 specified for each corrosive substance to which is assigned phrase R35 or R34, expressed as a percentage by weight or by volume.

5. The following preparations are to be classified as irritants:

5.1. liable to cause serious eye damage and assigned the symbol "Xi", the indication of danger "irritant" and the risk phrase R41;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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:

>REFERENCE TO A GRAPHIC>

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,

LXi, R41= is the respective irritant limit R41 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, expressed as percentage by weight or by volume;

5.2. irritant to eyes and assigned the symbol "Xi", the indication of danger "irritant" and the risk phrase R36;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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:

>REFERENCE TO A GRAPHIC>

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,

LXi, R36= is the respective irritant limit R36 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, or R36 expressed as percentage by weight or by volume;

5.3. irritant to skin and assigned the symbol "Xi", the indication of danger "irritant" and the risk phrase R38;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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:

>REFERENCE TO A GRAPHIC>

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, R35= 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,

LXi, R38= is the respective irritant limit R38 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R38, expressed as percentage by weight or by volume;

5.4. irritant to respiratory system and assigned the symbol "Xi", the indication of danger "irritant" and the risk phrase R37;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table IV and IV A) where the substance or the substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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:

>REFERENCE TO A GRAPHIC>

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 irritant limit R37 specified for each irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume;

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:

>REFERENCE TO A GRAPHIC>

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,

LXi, R37= is the respective irritant limit R37 specified for each gaseous corrosive substance to which is assigned phrase R35 or R34 or gaseous irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume.

6. The following preparations are to be classified as sensitising:

6.1. by skin contact and assigned the symbol "Xi", the indication of danger "irritant" and the risk phrase R43.

Preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 5 in Part B of this Annex (Table V and V A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

6.2. by inhalation and assigned the symbol "Xn", the indication of danger "harmful" and the risk phrase R42.

Preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 5 in Part B of this Annex (Table V and V A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

7. The following preparations are to be classified as carcinogenic:

7.1. those of category 1 or 2 which are assigned the symbol "T" and the phrase R45 or R49.

Preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

7.2. those of category 3 which are assigned the symbol "Xn" and the phrase R40.

Preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

8. The following preparations are to be classified as mutagenic:

8.1. those of category 1 or 2 which are assigned the symbol "T" and the phrase R46.

Preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

8.2. those of category 3 which are assigned the symbol "Xn" and the phrase R40.

Preparations containing at least one substance, producing such effects, classified as mutagenic and to which is assigned phrase R40 which denotes mutagenic substances in category 3, in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

9. The following preparations are to be classified as toxic for reproduction:

9.1. those of category 1 or 2 which are assigned the symbol "T" and the phrase R60 (fertility).

Preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

9.2. those of category 3 which are assigned the symbol "Xn" and the phrase R62 (fertility).

Preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

9.3. those of category 1 or 2 which are assigned the symbol "T" and the phrase R61 (development).

Preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

9.4. those of category 3 which are assigned the symbol "Xn" and the phrase R63 (development).

Preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table VI and VI A) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

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 I A to VI A) 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 to Directive 67/548/EEC.

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

>TABLE>

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

- the label shall include one or more of the abovementioned R phrases according to the classification used,

- in general, the R 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 I A 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 I A

>TABLE>

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

- the label shall include one or more of the abovementioned R phrases according to the classification used,

- in general, the R 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

>TABLE>

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 II A, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table II A

>TABLE>

3. Severe effects after repeated or prolonged exposure

3.1. Non-gaseous preparations

For substances that produce severe effects after repeated or prolonged exposure (R 48/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

>TABLE>

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 III A below, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table III A

>TABLE>

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

>TABLE>

4.2. Gaseous preparations

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

Table IV A

>TABLE>

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

>TABLE>

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 V A below, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

Table V A

>TABLE>

6. Carcinogenic/mutagenic/toxic effects for reproduction

6.1. Non-gaseous preparations

>TABLE>

Table VI

>TABLE>

6.2. Gaseous preparations

For gases which produce such effects, the concentration limits laid down in Table VI A, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned:

>TABLE>

Table VI A

>TABLE>


ANNEX III


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 Article 7(1)(a) and gives the R 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 R phrases for classification.

In accordance with Article 7(1)(a) the environmental hazards of a preparation shall be assessed by the conventional method described in parts A and B of this Annex, using individual concentration limits.

(a) Where the dangerous substances listed in Annex 1 to Directive 67/548/EEC are assigned concentration limits necessary for the application of the method of assessment described in Part A of this Annex, these concentration limits must be used.

(b) Where the dangerous substances do not appear in Annex I to Directive 67/548/EEC or appear there without the concentration limits necessary for the application of the method of evaluation described in Part A of this Annex, the concentration limits shall be assigned in accordance with the specification in Part B of this Annex.

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

(a) Aquatic environment

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 substance may entail for this medium according to the following specifications.

The following preparations are to be classified as dangerous for the environment:

1. and assigned the symbol "N", the indication of danger "dangerous for the environment" and the risk phrases R50 and R53 (R50-53):

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified in Part B of this Annex (Table 1) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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 I.1.1(a) or (b) if:

>REFERENCE TO A GRAPHIC>

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 limit R50-53 for each substance dangerous for the environment to which is assigned the phrases R50-53, expressed as percentage by weight

2. and 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 I.1 above;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified in Part B of this Annex (Table 1) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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 I.2. (a) or (b) if:

>REFERENCE TO A GRAPHIC>

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, R51-53= is the respective limit R51-53 for each substance dangerous for the environment to which is assigned phrases R50-53 or R51-53, expressed as percentage by weight

3. and assigned the risk phrases R52 and R53 (R52-53) unless the preparation is already classified according to I.1 or I.2 above;

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified in Part B of this Annex (Table 1) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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 I.3.1(a) or (b) if:

>REFERENCE TO A GRAPHIC>

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,

LR52-53= is the respective limit R52-53 for each substance dangerous for the environment to which is assigned phrases R50-53 or R51-53 or R52-53, expressed as percentage by weight;

4. and 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 I.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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified in Part B of this Annex (Table 2) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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 I.4.1(a) or (b) if:

>REFERENCE TO A GRAPHIC>

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 limit R50 for each substance dangerous for the environment to which is assigned phrase R50, expressed as percentage 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 I.4.1 or I.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:

>REFERENCE TO A GRAPHIC>

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= is the perspective limit R50 for each substance dangerous for the environment to which is assigned phrases R50 or R50-53, expressed as percentage by weight;

5. and assigned the risk phrase R52 unless the preparation is already classified according to I.1, I.2, I.3, or I.4 above:

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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified in Part B of this Annex (Table 3) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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 I.5.1 (a) or (b) if:

>REFERENCE TO A GRAPHIC>

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 R52 for each substance dangerous for the environment to which is assigned phrase R52, expressed as percentage by weight;

6. and assigned the risk phrase R53 unless the preparation is already classified according to I.1, I.2, or I.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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified in Part B of this Annex (Table 4) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

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 I.6.1(a) or (b) if:

>REFERENCE TO A GRAPHIC>

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 R53 for each substance dangerous for the environment to which is assigned phrase R53, expressed as percentage 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:

>REFERENCE TO A GRAPHIC>

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= is the respective limit R53 for each substance dangerous for the environment to which is assigned phrase R53 or R50-53 or R51-53 or R52-53, expressed as percentage by weight.

(b) Non-aquatic environment

(1) OZONE LAYER

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

The following preparations are to classified as dangerous for the environment:

1. and assigned the symbol "N", the indication of danger "dangerous for the environment" and the risk phrase R59;

1.1. preparations containing 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified in Part B of this Annex (Table 5) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

2. and assigned the risk phrase R59:

2.1. preparations containing one or more substances classified as dangerous to the environment and to which is assigned R59 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified in Part B of this Annex (Table 5) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

(2) TERRESTRIAL ENVIRONMENT

I. Evaluation of preparations dangerous for the terrestrial environment

Classification of preparations using the risk phrases below will follow after the detailed criteria for use of the phrases have been incorporated in Annex VI to Directive 67/548/EEC.

R54 Toxic to flora

R55 Toxic to fauna

R56 Toxic to soil organisms

R57 Toxic to bees

R58 May cause long-term adverse effects in the environment.

PART B

Concentration limits to be used for the evaluation of environmental hazards

I. For the aquatic environment

The concentration limits fixed in the following tables, 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 1

Acute aquatic toxicity and long-term adverse effects

>TABLE>

Table 2

Acute aquatic toxicity

>TABLE>

Table 3

Aquatic toxicity

>TABLE>

Table 4

Long-term adverse effects

>TABLE>

II. For the non-aquatic environment

The concentration limits fixed in the following tables, expressed as weight/weight percentage or, for gaseous preparations as a volume/volume percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 5

Dangerous for the ozone layer

>TABLE>

>TABLE>

PART C

Test methods for the evaluation of the hazards for the aquatic environment

Normally, the classification of a preparation is made on the basis of the conventional method. However, for the determination of the acute aquatic toxicity, there may be cases for which it is appropriate to carry out tests on the preparation.

The result of these tests on the preparation may only modify the classification concerning acute aquatic toxicity which would have been obtained by the application of the conventional method.

If such tests are chosen by the person responsible for the placing on the market, it must be ensured that the quality criteria of the test methods in Part C of Annex V to Directive 67/548/EEC have been complied with.

Furthermore, the tests are to be carried out on all three species in conformity with the criteria of Annex VI to Directive 67/548/EEC (algae, daphnia and fish), unless the highest hazard classification relating to acute aquatic toxicity has been assigned to the preparation after testing on one of the species or a test result was already available before this Directive entered into force.


ANNEX IV


SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARATIONS OFFERED OR SOLD TO THE GENERAL PUBLIC

PART A

Containers to be fitted with child-resistant fastenings

1. Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic or corrosive in accordance with Article 10 and under the conditions laid down in Article 6 of this Directive, are to fitted with child-resistant fastenings.

2. Containers of whatever capacity containing preparations presenting an aspiration hazard (Xn, R65) and classified and labelled according to paragraph 3.2.3 of Annex VI to Directive 67/548/EEC with the exception of preparations placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment.

3.

>TABLE>

which are offered or sold to the general public are to be fitted with child-resistant fastenings.

PART B

Containers to be fitted with a tactile warning of danger

Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic, corrosive, harmful, extremely flammable or highly flammable in accordance with Article 10 and under the conditions laid down in Articles 5 and 6 of this Directive, are to carry a tactile warning of danger.

This provision does not apply to aerosols classified and labelled only as extremely flammable or highly flammable.


ANNEX V


SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS

A. For preparations classified as dangerous within the meaning of Articles 5, 6 and 7

1. Preparations sold to the general public

1.1. The labels on packages containing such preparations, in addition to the specific safety advice, must bear the relevant safety advice S1, S2, S45 or S46 in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.

1.2. When such preparations are classified as very toxic (T+), toxic (T) or corrosive (C) and where it is physically impossible to give such information on the package itself, packages containing such preparations must be accompanied by precise and easily understandable instructions for use including, where appropriate, instructions for the destruction of the empty package.

2. Preparations intended for use by spraying

The package label containing such preparations must compulsorily bear the safety advice S23 accompanied by safety advice S38 or S51 assigned to it in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.

3. Preparations containing a substance assigned phrase R33: Danger of cumulative effects

When a preparation contains at least one substance assigned the phrase R33, the label of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Annex I to Directive 67/548/EEC.

4. Preparations containing a substance assigned phrase R64: May cause harm to breastfed babies

When a preparation contains at least one substance assigned phrase R64, the label of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Annex I to Directive 67/548/EEC.

B. For preparations irrespective of their classification within the meaning of Articles 5, 6 and 7

1. Preparations containing lead

1.1. Paint and varnishes

Labels of packages of paints and varnishes containing lead in quantities exceeding 0,15 % (expressed as weight of metal) of the total weight of the preparation, as determined in accordance with ISO standard 6503/1984, must show the following particulars: "Contains lead. Should not be used on surfaces liable to be chewed or sucked by children".

In the case of packages the contents of which are less than 125 millilitres, the particulars may be as follows: "Warning! Contains lead".

2. Preparations containing cyanoacrylates

2.1. Adhesives

The immediate packaging of adhesives based on cyanoacrylate must bear the following inscriptions: "Cyanoacrylate

Danger

Bonds skin and eyes in seconds

Keep out of the reach of children".

Appropriate advice on safety must accompany the package.

3. Preparations containing isocyanates

The package labels of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) must bear the following inscriptions: "Contains isocyanates.

See information supplied by the manufacturer."

4. Preparations containing epoxy constituents with an average molecular weight <= 700

The package labels of preparations containing epoxy constituents with an average molecular weight <= 700 must bear the following inscriptions: "Contains epoxy constituents.

See information supplied by the manufacturer."

5. Preparations sold to the general public which contain active chlorine

The packaging of preparations containing more than 1 % of active chlorine must bear the following particular inscriptions: "Warning! Do not use together with other products. May release dangerous gases (chlorine)."

6. Preparations containing cadmium (alloys) and intended to be used for brazing or soldering

The packaging of the abovementioned preparations must bear the following inscription printed in clearly legible and indelible characters: "Warning! Contains cadmium.

Dangerous fumes are formed during use.

See information supplied by the manufacturer.

Comply with the safety instructions."

7. Preparations available as aerosols

Without prejudice to the provisions of this Directive, preparations available as aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 of the Annex to Directive 75/324/EEC as last amended by Directive 94/1/EC.

8. Preparations containing substances not yet tested completely

Where a preparation contains at least one substance which, in accordance with Article 13.3 of Directive 67/548/EEC, bears the inscription "Warning - substance not yet tested completely", the label of the preparation must bear the inscription "Warning - this preparation contains a substance not yet tested completely" if this substance is present in a concentration >= 1 %.

9. Preparations not classified as sensitising but containing at least one sensitising substance

The packaging of preparations containing at least one substance classified as sensitising and being present in a concentration equal to or greater than 0,1 % or in a concentration equal to or greater than that specified under a specific note for the substance in Annex I to Directive 67/548/EEC must bear the inscription: "Contains (name of sensitising substance). May produce an allergic reaction."

10. Liquid preparations containing halogenated hydrocarbons

For liquid preparations which show no flashpoint or a flashpoint higher than 55 °C and contain a halogenated hydrocarbon and more than 5 % flammable or highly flammable substances, the packaging must bear the following inscription as appropriate: "Can become highly flammable in use" or "Can become flammable in use".

C. For preparations not classified within the meaning of Articles 5, 6 and 7 but containing at least one dangerous substance

1. Preparations not intended for the general public

The label on the packaging of the preparations referred to in Article 14.2.1(b) must bear the following inscription: "Safety data sheet available for professional user on request".


ANNEX VI


CONFIDENTIALITY FOR THE CHEMICAL IDENTITY OF A SUBSTANCE

PART A

Information to be communicated in the request for confidentiality

Introductory notes

A. Article 15 indicates the conditions in which the person responsible for placing a preparation on the market may avail himself of the confidentiality.

B. To avoid multiple requests for confidentiality relating to the same substance used in different preparations, a single request for confidentiality may suffice if a certain number of preparations have:

- the same dangerous constituents present in the same concentration range,

- the same classification and labelling,

- the same expected uses.

A single alternative denomination must be used to mask the chemical identity of the same substance in the preparations concerned. Furthermore, the request for confidentiality must contain all information indicated in the following request, without forgetting the name or the trade name of each preparation.

C. The alternative designation used on the label must be the same as that given under heading 2 "Composition/information on ingredients" of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

This implies that the alternative designation used will contain enough information about the substance to ensure risk-free handling.

D. In making the request to use an alternative designation the person responsible for placing on the market must take into account the need to provide enough information for necessary health and safety precautions to be taken in the workplace and to ensure that risks from handling the preparation can be minimised.

Request for confidentiality

In accordance with Article 15 the request for confidentiality must obligatorily contain the following information:

1. Name and full address (including telephone number) of the person established in the Community who is responsible for placing the preparation on the market (manufacturer, importer or distributor).

2. Precise identification of the substance(s) for which confidentiality is proposed and the alternative designation.

>TABLE>

NB:

Where substances are classified provisionally, accompanying information (bibliographical references) should be provided as evidence that the provisional classification takes account of all existing pertinent information available on the properties of the substance.

3. Justification for confidentiality (probability - plausibility).

4. Designation(s) or commercial name(s) of the preparation(s).

5.

>TABLE>

If no, specify the designation(s) or commercial name(s) used in the different Member States:

Austria:

Belgium:

Denmark:

Germany:

Greece:

Finland:

France:

Spain:

Sweden:

Ireland:

Italy:

Luxembourg:

Netherlands:

Portugal:

United Kingdom:

6. Composition of the preparation(s) defined in point 2 of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

7. Classification of the preparation(s) according to Article 6 of this Directive.

8. Labelling of the preparation(s) according to Article 10 of this Directive.

9. Intended uses for the preparation(s).

10. Safety data sheet(s) conforming to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

PART B

Lexicon guide for establishing the alternative designations (generic names)

1. Introductory note

The lexicon guide is based on the procedure for the classification of dangerous substances (division of substances into families) which appears in Annex I to Directive 67/548/EEC.

Alternative designations to those based on this guide may be used. However, in all cases the names chosen must provide enough information to ensure the preparation can be handled without risk and that necessary health and safety precautions can be taken in the workplace.

The families are defined in the following manner:

- inorganic or organic substances whose properties are identified by having a common chemical element as their chief characteristic. The family name is derived from the name of the chemical element. These families are identified as in Annex I by the atomic number of the chemical element (001 to 103),

- organic substances whose properties are identified by having a common functional group as their chief characteristics.

The family name is derived from the functional group name.

These families are identified by the conventional number found in Annex I (601-650).

Sub-families bringing together substances with a common specific character have been added in certain cases.

2. Establishing the generic name

General principles

For the purposes of establishing the generic name, the following general approach, involving two successive stages, is adopted:

(i) identification of the functional groups and chemical elements present in the molecule;

(ii) determination of the extent to which account should be taken of the most important functional groups and chemical elements.

The identified functional groups and elements taken into account are the names of the families and sub-families set out in point 3 in the form of a non-restrictive list.

3. Division of substances into families and sub-families

>TABLE>

4. Practical application:

After having conducted a search to see if the substance belongs to one or more families or sub-families on the list, the generic name can be established in the following way:

4.1. If the name of a family or sub-family is sufficient to characterise the chemical elements or important functional groups, this name will be chosen as the generic name.

Examples:

- 1,4 dihydroxybenzen

family 604: phenols and derivatives

generic name: phenol derivatives

- butanol

family 603: alcohols and derivatives

sub-family: aliphatic alcohols

generic name: aliphatic alcohol

- 2-Isopropoxyethanol

family 603: alcohols and derivatives

sub-family: glycolethers

generic name: glycolether

- methacrylate

family 607: organic acids and derivatives

sub-family: acrylates

generic name: acrylate

4.2. If the name of a family or sub-family is not sufficient to characterise the chemical elements of important functional groups, the generic name will be a combination of the corresponding different family or sub-family names:

Examples:

- chlorobenzene

family 602: halogenated hydrocarbons

sub-family: halogenated aromatic hydrocarbons

family 017: chlorine compounds

generic name: chlorinated aromatic hydrocarbon

- 2,3,6-trichlorophenylacetic acid

family 607: organic acids

sub-family: halogenated aromatic acids

family 017: chlorine compounds

generic name: chlorinated aromatic acid

- 1-chloro-1-nitropropane

family 610: chloronitrated derivatives

family 601: hydrocarbons

sub-family: aliphatic hydrocarbons

generic name: chlorinated aliphatic hydrocarbon

- tetrapropyl dithiopyrophosphate

family 015: phosphorus compounds

sub-family: phosphoric esters

family 016: sulphur compounds

generic name: thiophosphoric ester

NB:

In the case of certain elements, notably metals, the name of the family or sub-family may be indicated by the words "organic" or "inorganic".

Examples:

- dimercury chloride

family 080: mercury compounds

generic name: inorganic mercury compound

- barium acetate

family 056: barium compounds

generic name: organic barium compound

- ethyl nitrite

family 007: nitrogen compounds

sub-family: nitrites

generic name: organic nitrite

- sodium hydrosulphite

family 016: sulphur compounds

generic name: inorganic sulphur compound

(The examples cited are substances taken from Annex I to Directive 67/548/EEC (19th adaptation) in respect of which requests for confidentiality may be submitted).


ANNEX VII


PREPARATIONS COVERED BY ARTICLE 12(2)

Preparations as specified by paragraph 9.3 of Annex VI to Directive 67/548/EEC.


ANNEX VIII


PART A

Directives repealed in accordance with Article 21

- Directive 78/631/EEC on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides)

- Directive 88/379/EEC on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations and its following adaptations to technical progress:

- Directive 89/178/EEC

- Directive 90/492/EEC

- Directive 93/18/EEC

- Directive 96/65/EC

- Directive 90/35/EEC defining in accordance with Article 6 of Directive 88/379/EEC the category of preparations the packaging of which must be fitted with child-resistant fastenings and/or carry a tactile warning of danger

- Directive 91/442/EEC on dangerous preparations the packaging of which must be fitted with child-resistant fastenings

PART B

Deadlines for transposition and for application in accordance with Article 22

>TABLE>

PART C

Special provisions for Austria, Finland and Sweden concerning the application of the following Directives in accordance with Article 21

1. Austria, Finland and Sweden do not transpose or apply Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides), as last amended by Council Directive 92/32/EEC of 30 April 1992.

2. Austria is to apply Council Directive 88/379/EEC of 7 June 1988 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations, as last amended by Directive 96/65/EC of 11 October 1996 under the following conditions:

The following provisions of Directive 88/379/EEC will not apply to Austria

(a) Article 13 in conjunction with Articles 3 and 7 with respect to preparations containing substances listed in Appendix 1;

(b) Article 13 in conjunction with Article 7 with respect to labelling respecting the Austrian provisions on:

- safety advice for waste disposal,

- pictogram for waste disposal until two years after the entry into force of this Directive,

- safety advice for countermeasures in case of accidents;

(c) Article 13 in conjunction with Article 7(1)(c) concerning the chemical names of dangerous substances present in dangerous preparations, until two years after the entry into force of this Directive.

3. Sweden is to apply Council Directive 88/379/EEC of 7 June 1988 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations, as last amended by Directive 96/65/EC of 11 October 1996 under the following conditions:

The following provisions of Directive 88/379/EEC will not apply to Sweden:

(a) Article 13 in conjunction with Articles 3 and 7 with respect to preparations

- containing substances listed in Appendix 2,

- containing substances presenting neurotoxic effects and defatting effects on the skin not covered by criteria for classification of Annex VI to Directive 67/548/EEC, and by risk phrases of Annex III to Directive 67/548/EEC,

- containing substances presenting acutely toxic effects not covered by criteria for classification of Annex VI to Directive 67/548/EEC, and by risk phrases of Annex III to Directive 67/548/EEC, until two years after the entry into force of this Directive,

- which are not classified as dangerous according to the "måttligt skadliga" (Swedish: "moderately harmful") criteria of Directive 88/379/EEC.

(b) Article 13 in conjunction with Articles 3 and 7 with respect to

- the criteria for classification and labelling of preparations containing carcinogenic substances classified on the basis of criteria in point 4.2.1 of Annex VI to Directive 67/548/EEC,

- labelling of preparations classified as carcinogenic, category 3, with a special R-phrase instead of R-phrase 40.


Appendix 1


Substances referred to in Annex VIII, Part C, paragraph 2 (Austria)

>TABLE>


Appendix 2


Substances referred to in Annex VIII, Part C, paragraph 3 (Sweden)

>TABLE>


ANNEX IX


CORRELATION TABLE

>TABLE>

CORRELATION TABLE

>TABLE>