# 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), Division 3.9.2.1: Substances are classified as specific target organ toxicants following repeated exposure by the use of expert judgement (see 1.1.1), on the basis of the weight of all evidence available, including the use of recommended guidance values which take into account the duration of exposure and the dose/concentration which produced the effect(s), (see 3.9.2.9), and are placed in one of two categories, depending upon the nature and severity of the effect(s) observed (Table 3.9.1).

Extent: E+W+S+N.I.

Table 3.9.1
Categories for specific target organ toxicity-repeated exposure
Categories
Criteria
Category 1
Substances that have produced significant toxicity in humans or that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to produce significant toxicity in humans following repeated exposure.
Substances are classified in Category 1 for target organ toxicity (repeat exposure) on the basis of:
reliable and good quality evidence from human cases or epidemiological studies; or
observations from appropriate studies in experimental animals in which significant and/or severe toxic effects, of relevance to human health, were produced at generally low exposure concentrations. Guidance dose/concentration values are provided below (see 3.9.2.9), to be used as part of a weight-of- evidence evaluation.
Category 2
Substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following repeated exposure.
Substances are classified in category 2 for target organ toxicity (repeat exposure) on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations. Guidance dose/concentration values are provided below (see 3.9.2.9) in order to help in classification.
In exceptional cases human evidence can also be used to place a substance in Category 2 (see 3.9.2.6).

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Source: https://www.legislation.gov.uk/eur/2008/1272/annex/I/division/3/division/3.9/division/3.9.2/division/3.9.2.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.9/division-3.9.2/division-3.9.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.