GHS Classification Guidance for the Japanese Government

classification and classifications of other organizations (Carcinogenicity)” and
insufficiency of other hazard information, it should be classified as such.
3) Data are not available →”Classification not possible”, Positive data are not available (only
negative data are available) for a substance → the substance shall be classified in “Not
classified” based on an expert's judgment
4) If EU classification together with its evidence information is not available, the substance
shall be classified in “Classification not possible”. If EU classification together with its
evidence information is not available but if the criteria for EU classification are different
from those for GHS classification, EU classification may be utilized in GHS classification
provided that the information on which the former is based is scientifically appropriate. If
EU classification together with its evidence information is not available and the criteria for
EU classification are the same as those for GHS classification, GHS classification may be
performed according to EU classification.
C) Descriptions requiring an expert's judgment
B) As for substances whose classification it is difficult to or impossible to determine in
accordance with B) 1) and B) 2) above and those for which human carcinogenicity is
strongly presumed to be impossible due to species difference and other factors as the result of
a proof or estimation of the mechanism of animal carcinogenicity, all the descriptions
regarding carcinogenicity cited in the assessment documents shall be collected and an
expert's judgment shall be sought for, as follows.
1) Descriptions relating to Carcinogenicity, or descriptions suggesting Carcinogenicity in
List 1 (except for assessment documents shown in B) 1))
2) Descriptions shown below in List 2 and List 3. This prescription shall not prohibit
persons responsible for classification from presenting the documents and descriptions
which they judged to be considered in the template.
・Descriptions given in a section clearly intended for “carcinogenicity”
・ Descriptions which confirmed the occurrence of tumor(s) after conducting
histopathological inspection in a long-term administration test with animals (or
descriptions clearly referring to the presence or absence of or suggestion of
carcinogenicity or tumor)
・Epidemiological studies in human groups
D) Substances especially requiring an expert's judment
1) The following substances are generally classified as carcinogens and need careful
examination. Since some substances induce cancer inherent to animals (with species
difference) through the mechanism different from that of humans, such as the different
157