ECHA’s experts: #talc should be classified as presumed #carcinogen

ECHA’s Risk Assessment Committee (RAC) has concluded that talc should be classified as a category 1B carcinogen under CLP rather than a category 2 carcinogen, as proposed by the Netherlands, thus putting it at risk of being listed as a substance of very high concern (SVHC).

Classifications are almost always based on "sufficient" evidence from animal studies, but in this case, for the first time, the committee used a provision in Annex I of the CLP Regulation that allows for the conclusion based on studies showing?limited?evidence in humans combined with?limited?evidence in experimental animals.

RAC unanimously agreed that talc is a presumed carcinogen based on human and animal data, with different routes of exposure and different types of cancer based on evidence of cancerogenic activity both in the lungs of female rats after inhalation and in human ovarian after perineal exposure; it also agreed on repeated exposure (STOT RE) for the lungs as a classification for specific target organ toxicity.

The industry has opposed it stating that talc has widespread use in consumer items, such as personal care products and body powders, but also as a filling agent in pharmaceuticals and in the coatings and printing inks industries.

The European association of talc producers (Eurotalc) disagrees with the RAC’s opinion because they state that "The available evidence shows that talc does not meet the classification criteria for carcinogenicity," confirming the desire to demonstrate that the proposed classification for carcinogenicity is wrong.

Under CLP, classification for carcinogenicity applies to all types of exposure, unless it can be conclusively proven that other exposure routes do not lead to the same hazard; since in the case of talc there is not enough information available to confirm or exclude the possibility that other exposure routes, including the oral route, may lead to the hazard observed, the classification does not designate any one route of exposure.

In July, the International Agency for Research on Cancer (IARC)?classified talc?as probably carcinogenic to humans based on limited evidence of ovarian cancer in humans, sufficient evidence of cancer in experimental animals and strong mechanistic evidence.

Although RAC worked independently with a slightly different data set, the conclusions are broadly aligned; the human evidence came from several case-control studies comparing talc users with non-users or non-regular users.

During the 2023 Harmonised Classification and Labelling (CLH) consultation, industry groups suggested that rats in a key inhalation study in the dossier may have suffered from?lung overload instead, but rats exposed to the study for life eventually gave rise to inflammation and lung tumours in females.

RAC’s working group on Harmonized Classification and Labelling discussed lung carcinogenicity and the possibility of lung overload during meetings in April and July and agreed that the statistically significant increase in incidence of lung tumours in female rats was considered as "limited evidence" of carcinogenic activity.

Some industry groups have compared the case of talc with that of titanium dioxide, classified as a category 2 carcinogen in 2020 by RAC and then overturned in 2022 by the EU’s General Court?for failing to consider all the relevant factors for the calculation of lung overload, but the case of talc is very different.

The classification proposal only applies to talc that?does not contain asbestos?or asbestiform fibres.

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