Dear members, please see below call for feedback regarding the classification of ‘Talc’ as Class 1B Carcinogen. The focus is on Medial devices. I’m not aware of any IVD devices that utilise ‘Talc’, but if your impacted please contact me via regulatory@bivda.org.uk
We are writing to inform you that recently, the European Chemical Agency’s (ECHA) Risk Assessment Committee (RAC) published the opinion it adopted on the classification of ‘Talc’ (EC Number: 238-877-9 / CAS Number: 14807-96-6 ) (link).
Background:
- This substance has been undergoing a CLH classification assessment since 2021, where the Netherlands (dossier submitter) originally proposed a Carcinogenic 2 classification.
- Last year, RAC adopted its opinion (link) in which it agreed on a Carcinogenic 1B classification, instead. Such a classification would therefore trigger MDR Section 10.4.1, should Talc be used in medical devices above 0.1% w/w.
- In December 2021, MedTech Europe members were informed of this development, however, there was no MedTech Europe activity on it, as no impact was flagged at that time.
Questions for members:
As the RAC opinion was recently made available (July 2025), the next step in the process is for the European Commission to draft a legislative proposal, using the RAC opinion, which would be subject to Member State discussion and approval in CARACAL in the coming months. We have understood that there may be some uses of Talc in certain medical device applications and would like to ask members for your feedback on the questions below by 29 August:
- Are there uses of Talc in medical devices?
- Would MDR Section 10.4.1 be triggered by your uses (and quantity) of a Carcinogenic 1B classification of Talc?
- What would be the impact of a potential MDR trigger? Are there other impacts we need to highlight (e.g. lack of alternatives, socio-economic impact, etc.?)
- What key arguments can we use to gain consideration for a potential change in classification?
Please note that:
- As with all files, we would need to reach a quorum of impacted members to engage on this file (minimum 5 members);
- To change such a classification, we would need strong data and arguments to be presented to the Commission and Member States;
- Due to the current stage in the decision-making process, we would need to do outreach to the Commission, but especially Member States à would there be national associations who are able to support our potential advocacy efforts and/or face a similar impact of a Talc Carcinogenic 1B classification?
