Legalize / Ireland / Statutory Instrument

S.I. No. 393/1992 - European Communities (Classification, Packaging and Labelling of Dangerous Preparations) Regulations, 1992

Type Statutory Instrument

Publication 1992-12-11

Last updated 1995-10-09

State Repealed superseded text

Text As published

Source Irish Statute Book

articles Not indexed

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

1 amending act · 1995-10-09, S.I. No. 272/1995 - European Communities (Classification, Packaging and Labelling of Dang…

Reform history JSON API

(2) In the case of its being classified very toxic in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R39 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.1 of Annex VI to Council Directive 67/548/EEC.

The provisions of paragraph 1 shall apply only in the case of a substance assigned a risk phrase mentioned in paragraph 1 when that risk phrase does not form part of a combined risk phrase with risk phrase R39.

PART III — TOXIC CLASSIFICATION

(1) Subject to Part II and to paragraph 4, a preparation shall be classified as being toxic if—

( a ) it contains at least one very toxic substance, assigned one or more of the risk phrases R26, R27 or R28, in a concentration—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in annex I to Council Directive 67/548/EEC or is therein but does not have the limit range specified, equal to or exceeding 1% but less than 7%; or

( b ) it contains at least one toxic substance, assigned one or more of the risk phrases R23, R24 or R25, in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 25%; or

( c ) It contains more than one substance classified as very toxic or toxic (as mentioned in subparagraphs (a) and ( b )), the concentration in the preparation of each of which does not satisfy the provisions of subparagraphs (a) or (b), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PT+ is the concentration in the preparation of each very toxic substance, and

(iii) PT is the concentration in the preparation of each toxic substance, and

(iv) LT is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a very toxic substance which is not contained in Annex 1 to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%, or

(C) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 25%.

( a ) In the case of its being classified toxic in accordance with the provisions of subparagraphs (a), (b) or (c) of subparagraph (1), the preparation shall, subject to subparagraph (3), be assigned the risk phrase which shall be appropriate to the substance or substances most responsible for the toxic classification of the preparation.

( b ) For the purposes of subparagraph (a), the reference to the risk phrase shall include a combination risk phrase.

(3) In the case of a risk phrase, in accordance with the provisions of subparagraph (2), being assigned to a preparation due to the presence in it of a very toxic substance, that risk phrase shall be appropriate to that substance, but as if that substance were classified as a toxic substance.

(1) A preparation shall be classified as being toxic if it contains at least one substance classified as very toxic or toxic and assigned the risk phrase R39 in a concentration—

( a ) in the case of a very toxic substance contained in Annex 1 to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

( b ) in the case of a toxic substance contained in Annex I to Council Directive 67/548/EEC, equal to or exceeding the appropriate limit specified therein for that substance, if it is so specified; or

( c ) in the case of a very toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit range specified, equal to or exceeding 1% but less than 10%; or

( d ) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 10%.

(2) In the case of its being classified toxic in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R39 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.2 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Part II and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a very toxic preparation which would be classified as toxic in accordance with the provisions of subparagraph (1).

(1) A preparation shall be classified as being toxic if it contains at least one toxic substance assigned the risk phrase R48 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 10%

(2) In the case of its being classified toxic in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R48 in a combined ask phrase to indicate route of administration or exposure in accordance with Chapter 3.2.2 of annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Part II and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a very toxic preparation which would be classified as toxic in accordance with the provisions of subparagraph (1).

The provisions of paragraph 1 shall apply only in the case of a substance assigned a risk phrase mentioned in paragraph 1 where that risk phrase does not form part of a combined risk phrase with risk phrases R39 and R48.

PART IV HARMFUL CLASSIFICATION

(1) Subject to Parts II and III and to paragraph 4, a preparation shall be classified as harmful if—

( a ) it contains at least one very toxic substance, assigned one or more of the risk phrases R26, R27, R28 or at least one toxic substance, assigned one or more of the risk phrases R23, R24 or R25 in a concentration—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified,—

(A) equal to or exceeding 0.1% but less than 1% in the case of a very toxic substance, or

(B) equal to or exceeding 3% but less than 25% in the case of a toxic substance; or

( b ) it contains at least one harmful substance assigned one or more of the risk phrases R20, R21 or R22 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 25%; or

( c ) it contains more than one substance classified as very toxic, toxic or harmful (as mentioned in subparagraphs (a) and (b)), the concentration in the preparation of each of which does not satisfy the provisions of subparagraphs (a) or (b), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PT+ is the concentration in the preparation of each very toxic substance,

(iii) PT is the concentration in the preparation of each toxic substance,

(iv) PXn is the concentration in the preparation of each substance, and

(v) LXn is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a very toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.1%, or

(C) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 3%, or

(D) in the case of a harmful substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 25%.

(2) ( a ) In the case of its being classified harmful in accordance with the provisions of subparagraphs (a), (b) or (c) of subparagraph (1), the preparation shall, subject to paragraph (3), be assigned the risk phrase which shall be appropriate to the substance or which shall be appropriate to the substance or substances most responsible for the harmful classification of the preparation.

( b ) For the purposes of subparagraph (a), the reference to the risk phrase shall include a combination risk phrase.

(3) In the case of a risk phrase being, in accordance with the provisions of subparagraph (2), assigned to a preparation due to the presence in it of a very toxic or toxic substance, the risk phrase shall be that appropriate to that substance but as if that substance were classified as a harmful substance.

(1) A preparation shall be classified as harmful if it contains at least one substance classified as very toxic or toxic and assigned the risk phrase R39 or harmful and assigned the risk phrase R40 (owing to non-lethal irreversible effects after a single dose, but not including carcinogenic, mutagenic or teratogenic effects) in a concentration—

( a ) in the case of a very toxic or toxic substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

( b ) in the case of a harmful substance contained in Annex I to Council Directive 67/548/EEC, equal to or exceeding the appropriate limit specified therein for that substance, if it is so specified; or

( c ) in the case of a very toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 0.1% but less than 1%;

( d ) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 1% but less than 10%; or

( e ) in the case of a harmful substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 10%.

(2) In the case of its being classified harmful in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R40 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.3 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Parts II and III and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a very toxic or toxic preparation which would be classified as harmful in accordance with the provisions of subparagraph (1).

(1) A preparation shall be classified as harmful if it contains at least one substance, classified as toxic or harmful and assigned the risk phrase R48, in a concentration—

( a ) in the case of a toxic substance contained in Annex I to Council directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

( c ) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit range specified, equal to or exceeding 1% but less than 10%; or

( d ) in the case of a harmful substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 10%

(2) In the case of its being classified harmful in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R48 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.3 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Parts II and III and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a preparation, classified as very toxic or toxic, which would be classified as harmful in accordance with the provisions of subparagraph (1).

Subject to the provisions of paragraph 6 a preparation shall be classified as harmful (unless otherwise classified as very toxic or toxic) if it contains at least one substance, assigned one of the risk phrases R42 or R42/43 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit specified therein for that substance, if it is so specified; or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.

( a ) In the case of a preparation being classified very toxic or toxic in accordance with the provisions of Part II or Part III and satisfying the provisions of paragraph 5, the preparation shall be classified very toxic or toxic as appropriate.

( b ) Notwithstanding the provisions of subparagraph (a) a preparation shall be assigned the risk phrase R42 or R42/43 (as appropriate) if it satisfies the provisions of paragraph 5.

PART V CORROSIVE CLASSIFICATION

A preparation shall be classified as corrosive and shall be assigned the risk phrase R35 if—

( a ) it contains at least one corrosive substance, assigned the risk phrase R35 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 10%; or

( b ) it contains more than one corrosive substance assigned the risk phrase R35, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PC, R35 is the concentration in the preparation of each corrosive substance assigned the risk phrase R35, and—

(iii) LC, R35 is

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 10%.

Subject to paragraph 1, a preparation shall be classified as corrosive and assigned the risk phrase R34 if—

( a ) it contains at least one corrosive substance assigned the risk phrase R35 or R34 in a concentration—

(i) in the case of a substance assigned the risk phrase R35 and contained in Annex I to Council Directive 67/548/EEC within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance assigned the risk phrase R34 and contained in Annex I to Council Directive 67/548/EEC, equal to or exceeding the appropriate limit specified therein for that substance, if it is so specified; or

(iii) in the case of a substance assigned the risk phrase R35 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified, equal to or exceeding 5% but less than 10%; or

(iv) in the case of a substance assigned the risk phrase R34 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, equal to or exceeding 10%; or

( b ) it contains more than one corrosive substance assigned the risk phrase R35 or R34, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (1), and the sum of their quotients satisfy the following equation—

where—

(i) Σ means the sum of,

(ii) PC, R35 is the concentration in the preparation of each corrosive substance assigned the risk phrase R35,

(iii) PC, R34 is the concentration in the preparation of each corrosive substance assigned the risk phrase R34,

(iv) LC, R34 is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance assigned the risk phrase R35 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%, or

(C) in the case of a substance assigned the risk phrase R34 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 10%.

PART VI IRRITANT CLASSIFICATION

Subject to Part V, a preparation shall be classified as irritant and assigned the risk phrase R38 if—

( a ) it contains at least one corrosive substance, assigned the risk phrase R34 or R35 in a concentration—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified,—

(A) equal to or exceeding 1% but less than 5% in the case of a substance assigned the risk phrase R35, or

(B) equal to or exceeding 5% but less than 10% in the case of a substance assigned the risk phrase R34; or

( b ) it contains at least one irritant substance assigned the risk phrase R38, in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 20%; or

( c ) it contains more than one substance classified as irritant (assigned the risk phrase R38) or corrosive, the concentration in the preparation of each of which does not satisfy the provisions of subparagraphs (a) or (b), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PC, R35 is the concentration in the preparation of each corrosive substance assigned the risk phrase R35,

(iii) PC, R34 is the concentration in the preparation of each corrosive substance assigned the risk phrase R34,

(iv) PXi, R38 is the concentration in the preparation of each irritant substance assigned the risk phrase R38, and

(v) LXi, R38 is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a corrosive substance assigned the risk phrase R35, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 1%, or

(C) in the case of a corrosive substance assigned the risk phrase R34, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%, or

(D) in the case of an irritant substance, assigned the risk phrase R38, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 20%.

Subject to Part V, a preparation shall be classified as irritant and shall be assigned the risk phrase R37 if—

( a ) it contains at least one irritant substance assigned the risk phrase R37 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit specified, 20%; or

( b ) it contains more than one irritant substance assigned the risk phrase R37, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PXi, R37 is the concentration in the preparation of each irritant substance assigned the risk phrase R37,

(iii) LXi, R37 is:

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 20%.

Subject to Part V, a preparation shall be classified as irritant and shall be assigned the risk phrase R36 if—

( a ) it contains at least one irritant substance assigned the risk phrase R36 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit specified, 20%; or

( b ) it contains at least one irritant substance assigned the risk phrase R41 in a concentration in the preparation—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) equal to or exceeding 5% but less than 10% in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit range specified; or

( c ) it contains more than one substance classified as irritant and assigned the risk phrases R36 or R41, the concentration in the preparation of each of which does not satisfy the provisions of subparagraphs (a) or (b), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PXi, R41 is the concentration in the preparation of each irritant substance assigned the risk phrase R36,

(iii) PXi, R36 is the concentration in the preparation of each irritant substance assigned the risk phrase R36, and

(iv) LXi, R36 is:

(A) in the case of an irritant substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of an irritant substance assigned the risk phrase R41, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%, or

(C) in the case of an irritant substance, assigned the risk phrase R36, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 20%.

Subject to the provisions of Part V, a preparation shall be classified as irritant and assigned the risk phrase R41 if—

( a ) it contains at least one irritant substance assigned the risk phrase R41 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained there in but does not have the limit specified, 10%; or

( b ) it contains more than one irritant substance assigned the risk phrase R41, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a), and the sum of their quotients satisfies the equation—

where—

(i) Σ means the sum of,

(ii) PXi, R41 is the concentration in the preparation of each irritant substance assigned the risk phrase R41, and—

(iii) LXi, R41 is

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of an irritant substance assigned the risk phrase R41, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 10%.

Subject to the provisions of paragraph 6, a preparation shall be classified as irritant and assigned the risk phrase R43 if it contains at least one substance, assigned the risk phrase R43, in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC, or is contained therein but does not have the limit specified, 1%.

( a ) In the case of a preparation being classified corrosive in accordance with the provision of Part V, the preparation shall be classified as corrosive.

( b ) Notwithstanding the provisions of subparagraph (a), a preparation shall be assigned the risk phrase R43 if it satisfies the provisions of paragraph 5.

PART VII CARCINOGENIC/MUTAGENIC/TERATOGENIC

A preparation shall be classified as carcinogenic and assigned the risk phrase R45 if it contains at least one substance assigned the risk phrase R45 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.1%

A preparation shall be classified as suspect for humans owing to its possible carcinogenic effects and shall be assigned the risk phrase R40 if it contains at least one substance assigned the risk phrase R40 (due to the suspicion for humans owing to the possible carcinogenic effects of the substance), in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.

(1) A preparation classified as carcinogenic in accordance with the provisions of paragraph 1 shall be assigned the 'toxic' symbol and 'toxic' indication of danger unless the preparation is otherwise classified as very toxic.

(2) A preparation classified as suspect for humans owing to its possible carcinogenic effects in accordance with provisions of paragraph 2 shall be assigned the 'harmful' symbol and 'harmful' indication of danger unless the preparation is otherwise classified as very toxic or toxic.

A preparation shall be classified as mutagenic and assigned the risk phrase R46 if it contains at least one substance, assigned the risk phrase R46 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.1%.

A preparation shall be classified as suspect for humans owing to its possible mutagenic effects and shall be assigned the risk phrase R40 if it contains at least one substance, classified as mutagenic category 3 and assigned the risk phrase R40 (due to the suspicion for humans owing to the possible mutagenic effects of the substance), in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.

(1) A preparation classified as mutagenic, in accordance with the provisions of paragraph 4, shall be—

( a ) assigned the 'toxic' symbol and 'toxic' indication of danger in the case of a preparation classified as mutagenic due to the presence in it of a substance classified as mutagenic category I, unless the preparation is otherwise classified as very toxic; or

( b ) assigned the 'harmful' symbol and 'harmful' indication of danger in the case of a preparation classified as mutagenic due to the presence in it of a substance classified as mutagenic category 2, unless the preparation is otherwise classified as very toxic or toxic.

(2) A preparation classified as suspect for humans owing to its possible mutagenic effects in accordance with the provisions of paragraph 5 shall be assigned the 'harmful' symbol and 'harmful' indication of danger unless the preparation is otherwise classified as very toxic or toxic.

(1) A preparation shall be classified as teratogenic and assigned the risk phrase R47 if it contains at least one substance classified as teratogenic category I and assigned the risk phrase R47 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.5%.

(2) A preparation classified as teratogenic in accordance with the provisions of subparagraph (1) shall be assigned the 'toxic' symbol and 'toxic' indication of danger unless the preparation is otherwise classified as very toxic.

(1) A preparation shall be classified as teratogenic and assigned the risk phrase R47 if it contains at least one substance classified as teratogenic category 2 and assigned the risk phrase R47 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 5%.

(2) A preparation classified as teratogenic, in accordance with the provisions of subparagraph (1) shall be assigned the 'harmful' symbol and 'harmful' indication of danger unless the preparation is otherwise classified as very toxic or toxic.

SCHEDULE 3

Conventional Method of Assessment of Classification of Gas Preparations, due to Health effects.

PART I — GENERAL

The methods by which a preparation is classified in accordance with the provisions of Regulations 5 (3) (b) (ii) and 7 (3) shall be in accordance with the provisions of this Schedule.

A preparation classified in accordance with this Schedule shall have the risk phrases assigned to it in accordance with the provisions of this Schedule.

For the purposes of this Schedule, a reference to a substance contained in a preparation shall include a reference to a preparation which is a constituent of the first-mentioned preparation.

In the case of a preparation being assigned the risk phrase R42/43 in accordance with the provisions of both paragraph 5 of Part IV and paragraph 6 of Part VI, it shall be classified as harmful unless otherwise classified as very toxic or toxic.

For the purposes of this Schedule—

( a ) carcinogenic categories 1, 2 and 3, mutagenic categories 1, 2 and 3, and teratogenic categories I and 2 shall have the same meanings as in Chapter 4 of Annex VI to Council Directive 67/548/EEC;

( b ) a reference to a substance assigned a risk phrase shall mean—

(i) in the case of a substance which is a substance within the meaning of Regulation 3, the risk phrase assigned to it in accordance with the provisions of Council Directive 67/548/EEC;

(ii) in the case of a preparation (forming a constituent of another preparation), the risk phrase assigned to it in accordance with these Regulations.

( c ) A reference to a preparation assigned a risk phrase, which preparation is being assessed in accordance with this Schedule, shall mean that risk phrase assigned to it in accordance with the provisions of this Schedule.

For the purpose of this Schedule—

( a ) "appropriate limit" means the lowest concentration specified for a substance in Annex I to Council Directive 67/548/EEC which, if present in a preparation in a concentration equal to or exceeding this limit, would itself have the effect of that preparation being classified as—

(i) very toxic in accordance with the provisions of paragraph 1 of Part II, or

(ii) very toxic in accordance with the provisions of paragraph 2 of Part II, or

(iii) toxic in accordance with the provisions of paragraph 1 of Part III, or

(iv) toxic in accordance with the provisions of paragraph 2 of Part III, or

(v) toxic in accordance with the provisions of paragraph 3 of Part III, or

(vi) harmful in accordance with the provisions of paragraph 1 of Part IV, or

(vii) harmful in accordance with the provisions of paragraph 2 of Part IV, or

(viii) harmful in accordance with the provisions of paragraph 3 of Part IV, or

(ix) harmful in accordance with the provisions of paragraph 5 of Part IV, or

(x) corrosive in accordance with the provisions of paragraph 1 of Part V, or

(xi) corrosive in accordance with the provisions of paragraph 2 of Part V, or

(xii) irritant in accordance with the provisions of paragraph 1 of Part VI due to—

(xiii) irritant in accordance with the provisions of paragraph 2 of Part VI, or

(xiv) irritant in accordance with the provisions of paragraph 3 of Part VI due to—

—the risk phrase R41 having been assigned to the substance or (as the case may be)

—one of the risk phrases R36, R36/37/38 having been assigned to the substance, or

(xv) irritant in accordance with the provisions of paragraph 4 of Part VI, or

(xvi) irritant in accordance with the provisions of paragraph 6 of Part VI, or

(xvii) carcinogenic in accordance with the provisions of paragraph 1 of Part VII, or

(xviii) suspect for humans owing to its possible carcinogenic effects in accordance with the provisions of paragraph 2 of Part VII, or

(xix) mutagenic in accordance with the provisions of paragraph 4 of Part VIII, or

(xx) suspect for humans owing to its possible mutagenic effects in accordance with the provisions of paragraph 5 of Part VII, or

(xxi) teratogenic in accordance with the provisions of paragraph 7 of Part VII, or

(xxii) having specific effects on health not further defined in accordance with the provisions of paragraph 9 of Part VII.

For the purposes of this Schedule, a reference to a Part is a reference to that Part of this Schedule, unless it is indicated that reference to some other provision is intended.

For the purposes of this Schedule, a reference to a substance or a preparation assigned one or more of the risk phrases R20, R21, R22, R23, R24, R25, R26, R27, R28, R36, R37 or R38 shall include a reference to a combination risk phrase which has two or more of the aforementioned risk phrases incorporated into it.

For the purposes of this Schedule, a reference to a substance or a preparation assigned any of the risk phrases R39, R40 (other than when assigned due to the substance's or preparation's possible carcinogenic or mutagenic effects) or R48 shall mean a reference to that risk phrase incorporated in a combined risk phrase.

10.

For the purposes of this Schedule, a reference to concentration is a reference to a concentration expressed on a volume/volume basis.

PART II — VERY TOXIC CLASSIFICATION

(1) Subject to paragraph 3, a preparation shall be classified as being very toxic if—

( a ) it contains at least one very toxic substance, assigned one or more of the risk phrases R26, R27 or R28, in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%: or

( b ) it contains more than one very toxic substance (as mentioned in subparagraph (a)), the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PT+ is the concentration in the preparation of each very toxic substance, and

(iii) LT+ is

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.

(2) ( a ) In the case of it being classified very toxic in accordance with the provisions of subparagraphs (a) or (b) of subparagraph (1), the preparation shall be assigned the risk phrase which shall be appropriate to the substance or substances most responsible for the very toxic classification of the preparation.

( b ) For the purposes of subparagraph (a), the reference to the risk phrase shall include a combination risk phrase.

(1) A preparation shall be classified as being very toxic if it contains at least one very toxic substance assigned the risk phrase R39 in a concentration equal to or exceeding—

( a ) in the case of a substance which is contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 1%.

(2) In the case of it being classified very toxic in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R39 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.1 of Annex VI to Council Directive 67/548/EEC.

PART III — TOXIC CLASSIFICATION

(1) Subject to Part II and to paragraph 4, a preparation shall be classified as being toxic if—

( a ) it contains at least one very toxic substance, assigned one or more of the risk phrases R26, R27 or R28, in a concentration—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit range specified, equal to or exceeding 0.2% but less than 1%: or

( b ) it contains at least one toxic substance, assigned one or more of the risk phrases R23, R24 or R25, in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 5%: or

( c ) it contains more than one substance classified as very toxic or toxic (as mentioned in subparagraphs (a) and (b)), the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a) or (b), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PT+ is the concentration in the preparation of each very toxic substance,

(iii) PT is the concentration in the preparation of each toxic substance, and

(iv) LT is

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a very toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.2%, or

(C) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 5%.

(2) ( a ) In the case of its being classified toxic in accordance with the provisions of subparagraph (a), (b) or (c) of subparagraph (1), the preparation shall, subject to subparagraph (3), be assigned the risk phrase which shall be appropriate to the substance or substances most responsible for the toxic classification of the preparation.

( b ) For the purposes of subparagraph (a), the reference to the risk phrase shall include a combination risk phrase.

(3) In the case of risk phrase being, in accordance with the provisions of subparagraph (2), assigned to a preparation due to the presence in it of a very toxic substance, that risk phrase shall be appropriate to that substance but as if that substance were classified as a toxic substance.

(1) A preparation shall be classified as being toxic if it contains at least one substance classified as very toxic or toxic and assigned the risk phrase R39 in a concentration—

( a ) in the case of a very toxic substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

( d ) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 5%.

(2) In the case of its being classified toxic in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R39 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.2 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Part II and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a very toxic preparation which would be classified as toxic in accordance with the provisions of subparagraph (1).

(1) A preparation shall be classified as being toxic if it contains at least one toxic substance assigned the risk phrase R48 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 5%.

(2) In the case of its being classified toxic in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R48 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.2 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Part II and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a very toxic preparation which would be classified as toxic in accordance with the provisions of subparagraph (1).

PART IV — HARMFUL CLASSIFICATION

(1) Subject to Parts II and III and to paragraph 4, a preparation shall be classified as harmful if—

( a ) it contains at least one very toxic substance, assigned one or more of the risk phrases R26, R27, R28, or at least one toxic substance, assigned one or more of the risk phrases R23, R24 or R25 in a concentration—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified,

(A) equal to or exceeding 0.02% but less than 0.2% in the case of a very toxic substance, or

(B) equal to or exceeding 0.5% but less than 5% in the case of a toxic substance: or—

( b ) it contains at least one harmful substance assigned one or more of the risk phrases R20, R21 or R22 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 5%: or

( c ) it contains more than one substance classified as very toxic, toxic or harmful (as mentioned in subparagraphs (a) and (b)), the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (a) or (b), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PT+ is the concentration in the preparation of each very toxic substance,

(iii) PT is the concentration in the preparation of each toxic substance,

(iv) PXn is the concentration in the preparation of each substance, and

(v) LXn is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a very toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.02%, or

(C) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 0.5%, or

(D) in the case of a harmful substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 5%.

(2) ( a ) In the case of its being classified harmful in accordance with the provisions of subparagraph (a), (b) or (c) of subparagraph (1), the preparation shall, subject to subparagraph (3), be assigned the risk phrase which shall be appropriate to the substance or substances most responsible for the harmful classification of the preparation;

( b ) for the purposes of subparagraph (a), the reference to the risk phrase shall include a combination risk phrase.

(3) In the case of a risk phrase in accordance with the provisions of subparagraph (2), being assigned to a preparation due to the presence in it of a very toxic or toxic substance, that risk phrase shall be that appropriate to that substance but as if that substance were classified as a harmful substance.

(1) A preparation shall be classified as harmful if it contains at least one substance, classified as very toxic or toxic and assigned the risk phrase R39 or harmful and assigned the risk phrase R40 (owing to non-lethal irreversible effects after a single dose but not including carcinogenic, mutagenic or teratogenic effects), in a concentration—

( d ) in the case of a toxic substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 0.5% but less than 5%; or

( e ) in the case of a harmful substance which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 5%.

(2) In the case of its being classified harmful in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R40 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.3 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Parts II and III and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a very toxic or toxic preparation which would be classified as harmful in accordance with the provision of subparagraph (1).

(1) A preparation shall be classified harmful if it contains at least one substance, classified as toxic or harmful and assigned the risk phrase R48, in a concentration—

( a ) in the case of a toxic substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

( d ) in the case of a harmful substance which is not contained in Annex I to Council directive 67/548/EEC or is therein but does not have the limit specified, equal to or exceeding 5%.

(2) In the case of its being classified harmful in accordance with subparagraph (1), the preparation shall be assigned the risk phrase R48 in a combined risk phrase to indicate route of administration or exposure in accordance with Chapter 3.2.3 of Annex VI to Council Directive 67/548/EEC.

(3) Notwithstanding the provisions of Parts II and III and irrespective of any other provisions of these Regulations, the provisions of subparagraph (2) shall apply in the case of a preparation classified as very toxic or toxic which would be classified as harmful in accordance with subparagraph (1).

Subject to the provisions of paragraph 6, a preparation shall be classified as harmful (unless otherwise classified as very toxic or toxic) if it contains at least one substance, assigned one of the risk phrases R42 or R42/43 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.2%.

( a ) In the case of a preparation being classified very toxic or toxic in accordance with the provisions of Part II or Part III and which satisfies the provisions of paragraph 5, the preparation shall be classified very toxic or toxic as appropriate.

( b ) Notwithstanding the provisions of subparagraph (a) a preparation shall be assigned the risk phrase R42 or R42/43 (as appropriate) if it satisfies the provisions of paragraph 5.

PART V — CORROSIVE CLASSIFICATION

A preparation shall be classified as corrosive and shall be assigned the risk phrase R35 if—

( a ) it contains at least one corrosive substance assigned the risk phrase R35 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 1%: or

( b ) it contains more than one corrosive substance assigned the risk phrase R35, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (1), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PC, R35 is the concentration in the preparation of each corrosive substance assigned the risk phrase R35, and—

(iii) LC, R35 is

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 1%.

Subject to paragraph 1 a preparation shall be classified as corrosive and assigned the risk phrase R34 if—

( a ) it contains at least one corrosive substance assigned the risk phrase R34 or R35 in a concentration—

(i) in the case of a substance assigned the risk phrase R35 and contained in Annex I to Council Directive 67/548/EEC within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance assigned the risk phrase R34 and contained in Annex I to Council Directive 67/548/EEC equal to or exceeding the appropriate limit specified therein for that substance, if it is so specified; or

(iii) in the case of a substance assigned the risk phrase R35 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified, equal to or exceeding 0.2% but less than 1%; or

(iv) in the case of a substance assigned the risk phrase R34 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, equal to or exceeding 5%: or

where—

(i) Σ means the sum of,

(ii) PC, R35 is the concentration in the preparation of each corrosive substance assigned the risk phrase R35,

(iii) PC, R34 is the concentration in the preparation of each corrosive substance assigned the risk phrase R34, and

(iv) LC, R34 is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance assigned the risk phrase R35 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.2%, or

(C) in the case of a substance assigned the risk phrase R34 and which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%.

PART VI — IRRITANT CLASSIFICATION

Subject to Part V, a preparation shall be classified as irritant and assigned the risk phrase R38 if—

( a ) it contains at least one corrosive substance assigned the risk phrase R34 or R35 in a concentration—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified, or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified—

(A) equal to or exceeding 0.02% but less than 0.2% in the case of a substance assigned the risk phrase R35, or

(B) equal to or exceeding 0.5% but less than 5% in the case of a substance assigned the risk phrase R34, or

( b ) it contains at least one irritant substance, assigned the risk phrase R38, in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%: or

( c ) it contains more than one substance classified as irritant (assigned the risk phrase R38) or corrosive, the concentration in the preparation of each of which does not satisfy the provisions of paragraphs (a) or (b), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PC, R35 is the concentration in the preparation of each corrosive substance assigned the risk phrase R35,

(iii) PC, R34 is the concentration in the preparation of each corrosive substance assigned the risk phrase R34,

(iv) PXi, R38 is the concentration in the preparation of each irritant substance assigned the risk phrase R38, and

(v) LXi, R38 is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a corrosive substance assigned the risk phrase R35 which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.02%, or

(C) in the case of a corrosive substance assigned the risk phrase R34 which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.5%, or

(D) in the case of an irritant substance, assigned the risk phrase R38, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%.

Subject to Part V a preparation shall be classified as irritant and shall be assigned the risk phrase R37 if—

( a ) it contains at least one irritant substance assigned the risk phrase R37 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%: or

where—

(i) Σ means the sum of,

(ii) PXi, R37 is the concentration in the preparation of each irritant substance assigned the risk phrase R37, and

(iii) LXi, R37 is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%.

Subject to Part V a preparation shall be classified as irritant and assigned the risk phrase R36 if—

( a ) it contains at least one irritant substance assigned the risk phrase R36, in a concentration in the preparation equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%; or

( b ) it contains at least one substance assigned the risk phrase R41 in a concentration in the preparation—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, within the appropriate limit range specified therein for that substance, if it is so specified; or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit range specified, equal to or exceeding 0.5% but less than 5%: or

( c ) it contains more than one substance classified as irritant and assigned one or more of the risk phrases R36 or R41, the concentration in the preparation of each of which does not satisfy the provisions of either subparagraph (a) or (b), and the sum of their quotients satisfies the following equation—

where—

(i) Σ means the sum of,

(ii) PXi, R1 is the concentration in the preparation of each irritant substance assigned the risk phrase R41,

(iii) PXi, R36 is the concentration in the preparation of each irritant substance assigned the risk phrase R36, and

(iv) LXi, R36 is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(B) in the case of an irritant substance, assigned the risk phrase R41, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.5%, or

(C) in the case of an irritant substance, assigned the risk phrase R36, which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%.

Subject to the provisions of Part V, a preparation shall be classified as irritant and assigned the risk phrase R41 if—

( a ) it contains at least one substance assigned the risk phrase R41 in a concentration equal to or exceeding—

(i) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

(ii) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 5%: or

( b ) it contains more than one substance assigned the risk phrase R41, the concentration in the preparation of each of which does not satisfy the provisions of subparagraph (1), and the sum of their quotients satisfies the equation—

where—

(i) Σ means the sum of,

(ii) PXi, R41 is the concentration in the preparation of each substance assigned the risk phrase R41, and

(iii) LXi, R41 is—

(A) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the limit specified therein for that substance, if so specified, or

(B) in the case of a substance, assigned the risk phrase R41, which is not contained in Annex I to Council Directive 67/548/EEC or is therein but does not have the limit specified, 5%.

PART VII CARCINOGENIC/MUTAGENIC/TERATOGENIC EFFECTS

A preparation shall be classified as carcinogenic and assigned the risk phrase R45 if it contains at least one substance assigned the risk phrase R45 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.1%.

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 1%.

(2) A preparation classified as suspect for humans owing to its possible carcinogenic effects in accordance with provisions of paragraph 2 shall be assigned the 'harmful' symbol and 'harmful' indication of danger unless the preparation is otherwise classified as very toxic or toxic.

A preparation shall be classified as mutagenic and assigned the risk phrase R46 if it contains at least one substance assigned the risk phrase R46 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 0.1%.

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified, or

( b ) in the case of a substance which is not contained in Annex I to Council Directive 67/548/EEC or is contained therein but does not have the limit specified, 1%.

(1) A preparation classified as mutagenic in accordance with the provisions of paragraph 4 shall—

( a ) be assigned the 'toxic' symbol and 'toxic' indication of danger in the case of a preparation classified as mutagenic due to the presence in it of a substance classified as mutagenic category I, unless the preparation is otherwise classified as very toxic; or

( b ) be assigned the 'harmful' symbol and 'harmful' indication of danger in the case of a preparation classified as mutagenic due to the presence in it of a substance classified as mutagenic category 2, unless the preparation is otherwise classified as very toxic or toxic.

(2) A preparation classified as suspect for humans owing to its possible mutagenic effects in accordance with the provisions of paragraph 5 shall be assigned the 'harmful' symbol and 'harmful' indication of danger unless the preparation is otherwise classified as very toxic or toxic.

(1) A preparation shall be classified as teratogenic and assigned the risk phrase R47 if it contains at least one substance, classified as teratogenic category 1 and assigned the risk phrase R47 in a concentration equal to or exceeding—

( a ) in the case of a substance contained in Annex I to Council Directive 67/548/EEC, the appropriate limit specified therein for that substance, if it is so specified; or

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