Ingredients in the spotlight: Talc

May 13, 2024. Recently there has been extensive media coverage of the use of Talc in cosmetic products mainly due to the talc-related lawsuits filed against Johnson & Johnson. Thus, we want to inform our community about how Talc is regulated in the European Union and United Kingdom.

Talc in the EU and UK Cosmetics Regulations

Talc (Hydrated magnesium silicate) is included in Annex III to the EU and UK Cosmetics Regulations. This is the list of restricted substances. According to it, powdery products for children under 3 years of age with Talc shall bear the warning “Keep powder away from children’s nose and mouth”.

In addition, Talc used in cosmetic products shall not contain asbestos. Asbestos is a fibrous silicate mineral classified as a carcinogenic substance. Therefore, it is prohibited for use in cosmetic products (Annex II to the EU and UK Cosmetics Regulations).

In the EU and UK, there are two channels to ensure the safety of cosmetic products on the market. On one side, the independent scientific committees Scientific Committee on Consumer Safety (SCCS) (in the EU) and SAG-CS (in the UK) evaluate the safety of cosmetic substances of concern. Based on these opinions, the European Commission and the UK Government regulate the status of these ingredients. On the other side, the safety assessor and the Responsible Person assess finished cosmetic products. Hence, the industry ensures their safety and compliance through the Product Information File (PIF) and the safety assessment report. This double system ensures a high level of consumer safety of cosmetic products on the EU and UK markets.

Proposal for harmonised classification and labelling in the European Union

In 2023, the Netherlands submitted to the European Chemicals Agency (ECHA) a proposal to classify Talc as Carcinogenic category 2 (suspected of causing cancer) under CLP Regulation. Currently, ECHA’s Risk Assessment Committee (RAC) is working on its opinion on the proposed new harmonized classification and labelling. The deadline for the RAC opinion is 4 December 2024.

The outcome of this process might affect the use of Talc in cosmetic products in the European Union. In fact, according to Article 15 of the EU and UK Cosmetics Regulations, CMR substances of category 2 can only be used in cosmetic products if they have been evaluated and found safe for the specific use by the SCCS in the EU and SAG-CS in the UK.

 

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