ZMUni Compliance Centre

Recently, the World Health Organization’s International Agency for Research on Cancer (IARC) classified talcum powder as a "Group 2A carcinogen," meaning it is “probably” causes cancer.

In response to IARC's assessment, ZMUni Compliance Centre has compiled information on compliance requirements for talc in China and Western countries, helping businesses and consumers better understand this ingredient.

| IARC Classified as the Second Highest Level of Certainty

After evaluating the evidence, the IARC has classified talc as Group 2A, indicating a probable carcinogen with the second-highest level of certainty. However, talc containing asbestos remains classified as Group 1, which represents the highest level of certainty regarding its carcinogenicity. Additionally, 1,4-Dioxane, frequently assessed in cosmetic safety evaluations, is classified as Group 2B, meaning it is possibly carcinogenic to humans, which is a lower classification than Group 2A.

| Compliance Analysis of Talc as a Cosmetic Ingredient

Given the safety concerns surrounding talc, regulatory authorities worldwide have been intensifying their oversight of products containing talc.

1. China

In 2009, the National Medical Products Administration (NMPA) of China mandated rigorous testing of talc products to ensure they are asbestos-free. On December 23, 2011, the NMPA explicitly required that no asbestos shall be detected in talc. On September 10, 2019, the NMPA reiterated that products containing talc must be tested for asbestos.

2. America

The U.S. Food and Drug Administration (FDA) is also continuously monitoring the safety of talc use in cosmetics.

In 2022, the Modernization of Cosmetics Regulation Act (MoCRA) was enacted, establishing standardized testing methods to identify asbestos contamination in talc-containing cosmetics, reflecting a strong emphasis on the safety of talc in cosmetics. In April 2024, US FDA tested 50 talc-containing cosmetic samples and found no asbestos.

3. European Union

The EU Cosmetic Ingredients Database (CosIng) has not yet updated the carcinogenic classification of talc. The requirements for talc as a cosmetic ingredient in the EU still follow the Cosmetic Regulation Annex III (substances can be used under the restrictions prescribed in the Annex).

In 2023, the Netherlands submitted a proposal to the European Chemicals Agency (ECHA) for a unified classification of talc, recommending that it be classified as a Category 2 carcinogen (Carc.2, H351) and a Category 1 substance for target organ toxicity (STOT RE1, H372).

| Conclusion

Given that IARC has classified talc powder as a Group 2A carcinogen, its use as a cosmetic ingredient may be impacted to some extent. Whether it will be listed as a prohibited substance in cosmetic regulations in the near future remains uncertain. However, the cosmetics industry is already taking proactive measures, exploring and adopting safe and reliable alternatives to meet increasingly stringent regulatory requirements and consumers' high expectations for health and safety.

ZMUni Compliance Centre is dedicated to providing compliance solutions for cosmetic ingredients, ensuring their compliant use in international markets. If you have any related business needs, feel free to reach out through info@zmuni.com!

Additionally, ZMUni will host a webinar on August 5th to explore the trends in China’s new cosmetics ingredients market. We’ll be discussing insights on the following topics:

• Is this currently a good time for international ingredient companies to expand into the Chinese market?

• From a policy perspective, how can companies safely navigate the application process for new cosmetic ingredients in China?

• What changes and trends can we observe in the newly approved cosmetic ingredients? For example, which ingredients are the "hottest"? What are the characteristics of the applicants?

If you're interested, click the image below to register for free!