Overview:
On January 13, 2022 , the U.S Food and Drug Administration (FDA) made available the white paper titled IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc (including Talc Intended for Use in Cosmetics).
The white paper outlines scientific opinions on the testing of talc-containing cosmetic products to ensure reliable detection and identification of Asbestos Particles if Present.
What are talc and asbestos?
- Talc is a natural mineral known as magnesium silicate, white to blue-gray in color. This mineral is widely used in industry, and is useful in the manufacture of ceramics, plaster, paint, and some cosmetic products. The use of talc alone is safe; the problem occurs when it is contaminated with asbestos fibers.
- Asbestos is a mineral composed of microscopic soft, elastic fibers. The properties of this substance make it an ideal raw material for many products, as diseases caused by this mineral can be fatal.
- Magnesium silicate is also the main component of talcum powder used on babies. These products are relatively safe for use at all ages. However, the mineral may contain other compounds that cause allergies.
How is talc used in make-up?
Talc is a common ingredient in many products and is widely used in personal care items because of its softness.
The use of talc in make-up and cosmetics is safe, provided that no asbestos fibers are found.
The list of make-up products that use talc in their composition is very wide. Face powders, blushes, eyeshadows, and foundations are some of the cosmetics that employ this compound.
The addition of the mineral in the products helps to give a soft texture and to absorb moisture.
Other uses of talc in makeup are as follows:
- Adds color to products.
- Improves appearance and texture.
- Helps correct makeup on the skin.
- Prevents makeup flaking.
Possible risks of asbestos in cosmetics
The problem of asbestos in cosmetics occurs due to the lack of regulation for the purification of talc.
The U.S. Food and Drug Administration (FDA) has been trying to impose unique measures for the purification of talc since 1977. However, companies have chosen to apply other remedies, proposed by different associations.
Companies that use talc in their products purify the mineral, but studies show that the method does not perform the task adequately.
The techniques used are not able to detect low levels of contamination, so that cosmetics have undetectable levels of asbestos, instead of being 100% free of the mineral.
The presence of asbestos in cosmetics can favor the appearance of diseases. All the pathologies caused by this substance have many years of latency and appear through inhalation. Among the main ones that can develop due to exposure to the fibers are the following:
- Asbestosis
- Lung cancer
- Pleural plaques
- Malignant mesothelioma
- Ovarian cancer
Finally, we can ask? What is IWGACP? What is the Purpose of IWGACP? What is the Asbestos Identification Proposal?
The IWGACP are a group of subject matter experts formed by the FDA and were asked to develop a consensus document that would support the development of standardized testing methods to improve the sensitivity and consistency of analyses and inter-laboratory concurrence when reporting asbestos and other similar particles in talc that could potentially affect cosmetic product safety.
IWGACP's Scientific research includes:
- Utilizing both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM) methods to identify and report the presence of asbestos and other similar particles.
- Providing analytical reports with adequate documentation of findings.
- Establishing policies and procedures covering rigorous training, quality assurance, and quality control, to accompany testing methods, to ensure testing laboratories are qualified and their qualifications are reviewed on a regular basis; and
- Encouraging future research on reference materials and sample preparation methods to support standardized test methods for the detection of asbestos in talc and talc-containing cosmetics.
Note: The FDA’s previous and current talc sampling assignments used PLM and TEM to detect asbestos.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.