Classification of Talc: British and EU Authorities Evaluate Studies Differently

Is talc likely carcinogenic or not? The ECHA Committee for Risk Assessment (RAC) says yes; The British Health and Safety Executive (HSE) disagrees. British officials consider the study data to be insufficiently conclusive.

In September 2024, the ECHA Committee decided to classify asbestos-free talc as Category 1B under EU CLP, meaning it is presumed to be carcinogenic. It was also classified as specific target organ toxic (STOT RE 1), meaning the substance exhibits specific target organ toxicity upon repeated exposure to the lungs.

Although the British authority agrees with the classification as STOT RE 1 according to GB CLP, it considers the evidence provided by the study data to be insufficient for a further classification in category 1B.

Point of Contention: Study Data

The most important animal data comes from a 1993 study by the U.S. National Toxicology Program (NTP). According to this study, lung tumors developed only in female rats, not in males. In addition, the tumors appeared only after two years. According to the HSE, this finding is insufficient to justify classification according to the CLP criteria.

The European Association of Talc Manufacturers (EUROTALC) argues similarly. A panel of experts commissioned by the Association evaluated the study data. Their verdict? Neither animal nor human data provide sufficient evidence. Rather, they see lung overload as the cause of cancer. Such overload is typical for poorly soluble particles with low toxicity, such as titanium dioxide.

However, according to the RAC and HSE, the study data do not provide clear evidence of lung overload.

A Substance with High Demand

Many industries value the properties of talc. Its uses include:

A filler in pharmaceuticals
A carrier in dyes and coatings
A processing aid in ceramics
An additive in cosmetics and personal care products

The decision on classification is particularly controversial for the cosmetics industry, given that the EU Cosmetics Regulation prohibits the use of carcinogens of categories 1A, 1B, and 2 in cosmetics.

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