Directive 1999/45/EC of the European Parliament and of the Council (repealed)Dangos y teitl llawn

ANNEX II U.K. METHODS FOR THE EVALUATION OF HEALTH HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 6

Introduction U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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.

Textual Amendments

F1 Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008], 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 U.K. Procedure for evaluation of health hazards

The evaluation proceeds stepwise as follows:

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

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; U.K.

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: U.K.

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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: U.K.

where:

P_T+

=

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

L_T+

=

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. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits.

2. The following preparations shall be classified as toxic: U.K.

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; U.K.

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: U.K.

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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: U.K.

Where:

P_T+

=

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

P_T

=

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

L_T

=

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. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits.

3. The following preparations shall be classified as harmful: U.K.

3.1. owing to their acute lethal effects and assigned the symbol ‘X_n’ and the indication of danger ‘harmful’ and the risk phrases R20, R21 or R22; U.K.

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: U.K.

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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: U.K.

Where:

P_T+

=

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

P_T

=

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

P_Xn

=

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

L_Xn

=

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 ‘X_n’, and the indication of danger ‘harmful’ and the risk phrase R65. U.K.

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 ‘X_n’, the indication of danger ‘harmful’ and the risk phrase [F2 R68]/route of exposure. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits;

Textual Amendments

F2 Substituted by Commission Directive 2001/60/EC of 7 August 2001 adapting to technical progress Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (Text with EEA relevance).

3.4. owing to their long-term effects and assigned the symbol ‘X_n’, the indication of danger ‘harmful’ and the risk phrase R48/route of exposure. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits.

4. The following preparations are to be classified as corrosive U.K.

4.1. and assigned the symbol ‘C’, the indication of danger ‘corrosive’ and the risk phrase R35; U.K.

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: U.K.

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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: U.K.

where:

P_{C, R35}

=

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

L_{C, 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; U.K.

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: U.K.

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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: U.K.

where:

P_{C, R35}

=

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

P_{C, R34}

=

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

L_{C, 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: U.K.

5.1. liable to cause serious eye damage and assigned the symbol ‘X_i’, the indication of danger ‘irritant’ and the risk phrase R41; U.K.

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: U.K.

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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: U.K.

where:

P_{C, R35}

=

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

P_{C, R34}

=

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

P_{Xi, R41}

=

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

L_{Xi, 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 ‘X_i’, the indication of danger ‘irritant’ and the risk phrase R36; U.K.

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: U.K.

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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: U.K.

where:

P_{C, R35}

=

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

P_{C, R34}

=

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

P_{Xi, R41}

=

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

P_{Xi, R36}

=

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

L_{Xi, 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 ‘X_i’, the indication of danger ‘irritant’ and the risk phrase R38; U.K.

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: U.K.

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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: U.K.

where:

P_{C, R35}

=

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

P_{C, R35}

=

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

P_{Xi, R38}

=

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

L_{Xi, 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 ‘X_i’, the indication of danger ‘irritant’ and the risk phrase R37; U.K.

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: U.K.

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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: U.K.

where:

P_{Xi, R37}

=

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

L_{Xi, 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: U.K.

where:

P_{C, R35}

=

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

P_{C, R34}

=

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

P_{Xi, R37}

=

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

L_{Xi, 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: U.K.

6.1. by skin contact and assigned the symbol ‘X_i’, the indication of danger ‘irritant’ and the risk phrase R43. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits;

6.2. by inhalation and assigned the symbol ‘X_n’, the indication of danger ‘harmful’ and the risk phrase R42. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits.

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

7.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R45 or R49. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits;

7.2. those of category 3 which are assigned the symbol ‘X_n’ and the phrase R40. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits.

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

8.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R46. U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits;

8.2. those of category 3 which are assigned the symbol ‘X_n’ and the phrase [F2 R68. U.K.

Preparations containing 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:

(a)

either the concentration specified in [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits.

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

9.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R60 (fertility). U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits;

9.2. those of category 3 which are assigned the symbol ‘X_n’ and the phrase R62 (fertility). U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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). U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits;

9.4. those of category 3 which are assigned the symbol ‘X_n’ and the phrase R63 (development). U.K.

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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008] or appear in it without concentration limits.

PART B U.K. 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 [F1 Part 3 of Annex VI to Regulation (EC) No 1272/2008].

1. Acute lethal effects U.K.

1.1. Non-gaseous preparations U.K.

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
	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 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 U.K.

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
Classification of the substance(gas)	Classification of the gaseous preparation
	T+	T	Xn
T+ with R26, R27, R28	concentration ≥ 1 %	0,2 % ≤ concentration < 1 %	0,02 % ≤ concentration < 0,2 %
T with R23, R24, R25		concentration ≥ 5 %	0,5 % ≤ concentration < 5 %
Xn with R20, R21, R22			concentration ≥ 5 %

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 U.K.

2.1. Non-gaseous preparations U.K.

For substances that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, [F2 R68/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
a In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.
Classification of the substance	Classification of the preparation
	T+	T	Xn
T+ with R39/route of exposure	concentration ≥ 10 % R39a obligatory	1 % ≤ concentration < 10 % R39a obligatory	0,1 % ≤ concentration < 1 % R68 a obligatory
T with R39/route of exposure		concentration ≥ 10 % R39a obligatory	1 % ≤ concentration < 10 % R68 a obligatory
Xn with R68/route of exposure			concentration ≥ 10 % R68] a obligatory

2.2. Gaseous preparations U.K.

For gases that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, [F2 R68/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
a In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.
Classification of the substance (gas)	Classification of the gaseous preparation
	T+	T	Xn
T+ with R39/route of exposure	concentration ≥ 1 % R39a obligatory	0,2 % ≤ concentration < 1 % R39a obligatory	0,02 % ≤ concentration < 0,2 % R68 a obligatory
T with R39/route of exposure		concentration ≥ 5 % R39a obligatory	0,5 % ≤ concentration < 5 % R68 a obligatory
Xn with R68/route of exposure			concentration ≥ 5 % R68] a obligatory

3. Severe effects after repeated or prolonged exposure U.K.

3.1. Non-gaseous preparations U.K.

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
a In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.
Classification of the substance	Classification of the preparation
	T	Xn
T with R48/route of exposure	concentration ≥ 10 % R48a obligatory	1 % ≤ concentration < 10 % R48a obligatory
Xn with R48/route of exposure		concentration ≥ 10 % R48a obligatory

3.2. Gaseous preparations U.K.

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
a In order to indicate the route of administration/exposure (route of exposure) the combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide (Annex VI to Directive 67/548/EEC) are to be used.
Classification of the substance(gas)	Classification of the gaseous preparation
	T	Xn
T with R48/route of exposure	concentration ≥ 5 % R48a obligatory	0,5 % ≤ concentration < 5 % R48a obligatory
Xn with R48/route of exposure		concentration ≥ 5 % R48a obligatory

4. Corrosive and irritant effects including serious damage to the eye U.K.

4.1. Non-gaseous preparations U.K.

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
a According to the labelling guide (Annex VI to Directive 67/548/EEC), 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.
[F3 NB: 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 to Directive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive.]
Classification of the substance	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 %a	1 % ≤ concentration < 5 % R36/38 obligatory
C with R34		concentration ≥ 10 % R34 obligatory	10 %a	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 consideration

4.2. Gaseous preparations U.K.

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
a According to the labelling guide (Annex VI to Directive 67/548/EEC), 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.
[F3 NB: 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 to Directive 67/548/EEC and in the second and third indents of Article 6(3), of this Directive.]
Classification of the substance(gas)	Classification of the gaseous preparation
	C with R35	C with R34	Xi with R41	Xi with R36, R37, R38
C with R35	concentration ≥ 1 % R35 obligatory	0,2 % ≤ concentration < 1 % R34 obligatory	0,2 %a	0,02 % ≤ concentration < 0,2 % R36/37/38 obligatory
C with R34		concentration ≥ 5 % R34 obligatory	5 %a	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

5. Sensitising effects U.K.

5.1. Non-gaseous preparations U.K.

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

• the symbol X_n and phrase R42 if this effect can be produced by inhalation,

• the symbol X_i 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
	Sensitising with R42	Sensitising with R43
Sensitising with R42	concentration ≥ 1 % R42 obligatory
Sensitising with R43		concentration ≥ 1 % R43 obligatory

5.2. Gaseous preparations U.K.

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

• the symbol X_n and phrase R42 if this effect can be produced by inhalation,

• the symbol X_i 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
Classification of the substance(gas)	Classification of the gaseous preparation
	Sensitising with R42	Sensitising with R43
Sensitising with R42	concentration ≥ 0,2 % R42 obligatory
Sensitising with R43		concentration ≥ 0,2 % R43 obligatory

6. Carcinogenic/mutagenic/toxic effects for reproduction U.K.

6.1. Non-gaseous preparations U.K.

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 symbol 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; [F2 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

[F4 Table VI

a In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.]
Classification of the substance	Classification of the preparation
	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 ( unless already assigned R45 a )
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 ( unless already assigned R46 )
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 ( unless already assigned R60 )
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 ( unless already assigned R61 )

Textual Amendments

F4 Substituted by Commission Directive 2006/8/EC of 23 January 2006 amending, for the purposes of their adaptation to technical progress, Annexes II, III and V to Directive 1999/45/EC of the European Parliament and of the Council concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (Text with EEA relevance).

6.2. Gaseous preparations U.K.

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:

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; [F2 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

[F4 Table VI A

a In cases where the preparation is assigned R49 and R40, both R phrases shall be kept, because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation route.]
Classification of the substance	Classification of the preparation
	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 ( unless already assigned R45 a )
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 ( unless already assigned R46 )
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 ( unless already assigned R60 )
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 ( unless already assigned R61 )