Paragraph 4 Classification of preparations by health effects

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

Sch. 3 Pt. 1 para. 18(1) words revoked by Chemicals (Hazard Information and Packaging for Supply) 1997 Sch. para. 8(a)
Sch. 3 Pt .02 Table 4A words deleted by Chemicals (Hazard Information and Packaging for Supply) 1996 Sch. 1 para. 4(a)
Sch. 3 Pt .02 Table 4A word substituted by Chemicals (Hazard Information and Packaging for Supply) 1996 Sch. 1 para. 4(c)(i)

(1)

The health effects of a preparation shall be assessed by one or more of the following methods—

(a)

by the conventional method described in the following paragraphs using concentration limits; or

(b)

by the criteria set out in the approved classification and labelling guide in relation to the preparation for an appropriate classification and label.

(2)

Any one or more of the health effects of the preparation which are not assessed by the method set out in sub-paragraph (1)(b) above shall be assessed in accordance with the conventional method.

(3)

Where the health effects have been established by both methods, the results of the method set out in sub-paragraph (1)(b) above shall be used for classifying the preparation except in the case of carcinogenic and mutagenic effects and toxic effects for reproduction, when the conventional method set out in sub-paragraph (1)(a) shall always be used.

(4)

Where it can be demonstrated that—

(a)

the health effects on man differ from those suggested by a toxicological determination or a conventional assessment, then the preparation shall be classified according to its effects on man;

(b)

owing to effects such as potentiation a conventional assessment would underestimate the health effects, these effects shall be taken into account in classifying the preparation; or

(c)

owing to effects such as antagonism a conventional assessment would overestimate the health effects, these effects shall be taken into account in classifying the preparation.

(5)

For preparations of a known composition classified in accordance with the method set out in sub-paragraph (1)(b) above, a new health effect assessment either by the method set out in sub-paragraph (1)(a) or (1)(b) above shall be performed whenever—

(a)

changes of composition of the initial concentration of a weight/weight percentage of one or more of the constituents are introduced by the manufacturer which exceed the permitted variations set out in the following table—

Initial concentration range of the constituent	Permitted variation in actual concentration of the constituent
< 2.5%	± 15%
> 2.5 < 10%	± 10%
> 10 < 25%	± 6%
> 25 < 50%	± 5%
> 50 <100%	± 2.5%

(b)

changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the definitions in Schedule 1, are introduced by the manufacturer.