The PFAS and talc (now known to have carcinogenic properties) were the main highlights of the RAC and SEAC committee meeting.

Given the importance of PFAS and talc in the daily lives of European citizens, the committees focused all their attention on addressing these two issues. The Risk Assessment Committee (RAC) and the Socioeconomic Analysis Committee (SEAC) have reached provisional conclusions regarding the proposed restriction of PFAS in the oil and mining sectors. Additionally, the RAC has adopted its opinion on the harmonized classification and labeling of talc, recommending carcinogenicity as the strictest classification.

In their September meetings, the RAC and SEAC discussed the following sectors within the EU proposal to restrict per- and polyfluoroalkyl substances (PFAS):

• Oil and mining
• Textiles, upholstery, leather, clothing, and carpets
• Materials and packaging in contact with food

The committees provisionally concluded their assessment of the oil and mining sector. Discussions on the other two sectors—textiles, upholstery, leather, clothing, and carpets, and materials and packaging in contact with food—will continue in upcoming meetings.

The RAC agreed to review how PFAS emissions are calculated in different sectors, focusing on the waste stage, such as emissions from waste disposal and incineration. The revised approach emphasizes the need to distinguish between PFAS particle emissions (solid) and those leaching from materials. This distinction is important because concerns related to fluoropolymer particles differ from those associated with non-polymeric PFAS.

The committees also announced the sectors they will evaluate in future meetings. In November, they will discuss construction products for the first time. After November, the next sectors for discussion will be:

• Fluorinated gas applications
• Transport
• Energy

Harmonized classification and labeling

The RAC adopted 13 opinions on the harmonized classification and labeling of hazardous substances. One of these was on talc, where the committee recommends adding the following classification:

• Carcinogen 1B, H350 (may cause cancer)
• STOT RE 1, H372 (a substance that causes damage to the lungs through prolonged or repeated exposure via inhalation)

The RAC evaluated a vast database of information on talc and concluded that there is sufficient evidence that exposure to talc may cause cancer.

This conclusion was based on limited data from animal studies (lung tumors in female rats exposed via inhalation) and human studies (ovarian tumors in women after genital/perineal use).

The RAC also considered whether the classification for carcinogenicity should apply only to a specific route (or routes) of exposure. According to the Classification, Labelling and Packaging (CLP) Regulation, the classification for carcinogenicity applies by default to all routes of exposure unless it can be conclusively demonstrated that other routes do not lead to the same hazard. In this case, there was not enough information available to confirm or exclude the possibility that other routes of exposure, including the oral route, could lead to the observed hazard. Therefore, the classification opinion does not designate any route of exposure.

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Source: ECHA
Image: Mike Pennington