White Paper on Testing for Asbestos in Cosmetic Products Containing Talc
Talc is used in a variety of consumer products, including cosmetics. Some talc deposits may contain Asbestos, a known human carcinogen. The FDA has published a white paper describing the IWGACP scientific opinions on testing methods for asbestos in cosmetic products containing talc.
Marta Pinto

Marta Pinto

Regulatory Affairs Associate

TALC AND ASBESTOS

Talc (CAS number: 14807-96-6) is a naturally occurring mineral, consisting of hydrous magnesium silicate and it can contain sometimes small quantities of aluminium silicate. It used in a wide variety of consumer products, including cosmetics. In cosmetics and personal care products, Talc is usually used as an abrasive, absorbent, anticaking, bulking, opacifying and skin protecting agent. The U.S. Food and Drug Administration (FDA) includes Talc (magnesium silicate) on its list of substances Generally Recognized As Safe (GRAS) for use in food as an anticaking agent and it also allows the use of talc as an indirect food additive (colorant in polymers) and as colorant in drugs. (see previous post)

Some Talc deposits may contain asbestos and other magnesium silicate minerals, notably members of the amphibole group. Asbestos is a term used to describe some silicate minerals that have an unusual fibrous (asbestiform) habit of crystal growth. Asbestos properties (flexibility, durability and heat resistance) make it useful for commercial purposes. Nevertheless, Asbestos is a human carcinogen and has well-documented health risks (e.g., inflammation, pleural disease, lung cancers, malignant mesothelioma).

Responding to test results indicating the presence of asbestos, the U.S. cosmetics industry implemented voluntarily a protocol to test cosmetic talc for asbestos using the Cosmetic, Toiletry, and Fragrance Association (CTFA) J4-1 method. A similar method is used by talc suppliers to the pharmaceutical industry. Both protocols have long-recognized shortcomings in specificity and sensitivity to detect the presence of asbestos and similar mineral particles that may pose a health concern.

WHITE PAPER ON TESTING FOR ASBESTOS IN COSMETIC PRODUCTS

Although the FDA regularly samples products containing talc for the presence of asbestos, laboratories that analyze the same product may reach to different conclusions. That happens because there are no uniform standard for identifying and counting asbestos fibers.

The FDA has published a white paper regarding scientific opinions on testing methods for asbestos in cosmetic products containing talc. The scientific opinions are from an Interagency Working Group on Asbestos in Consumer Products (IWGACP) and do not represent recommendations or policies of FDA or any other federal agency. IWGACP is composed of subject matter experts from eight different U.S. federal agencies.

The IWGACP’s aim was to develop a consensus document to support the development of standardized testing methods to improve the sensitivity and consistency of analyses, and inter-laboratory concurrence when reporting asbestos (or other amphibole mineral particles) in talc.

The Interagency Working Group recommends the use of both polarized light microscopy and transmission electron microscopy methods to identify/report the presence of these compounds. Moreover, it advises to report all asbestos and all amphibole and chrysotile particles that have a length greater than or equal to 0.5 µm and a ratio of length to width above or equal to 3:1. Other scientific opinions are described in the white paper.

The IWGACP proposes further research in some areas, like sampling methods for talc and talc-containing cosmetics, in order to promote reliability, sensitivity and interlaboratory agreement of analytical methods.

The FDA will conduct another talc sampling assignment in 2022. The Agency will test 50 additional talc-containing cosmetic products samples and communicate any results that indicate the presence of asbestos, if found.

If you wish to get more information regarding this or other subjects, feel free to contact us at info@criticalcatalyst.com.

References:

  1. Interagency Working Group On Asbestos In Consumer Products (IWGACP). White Paper: IWGACP Scientific Opinions on Testing Methods For Asbestos In Cosmetic Products Containing Talc. December 2021.

further
reading

drug_device_combination_1
medical devices

Regulatory Framework of Drug-Device Combination

The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.

Read More »
cosmetic products

SCCS Preliminary Opinion on Alpha-Arbutin and Beta-Arbutin

Alpha-arbutin and Beta-arbutin are used in cosmetic with antioxidant, bleaching and skin conditioning functions. Following concerns raised during discussion within the Working Group on Cosmetic Products and consequent call for data on these ingredients, the SCCS assessed the safety of Alpha-arbutin and Beta-arbutin in cosmetic products.

Read More »
cosmetic products

Request for SCCS Scientific Opinion on Citral

The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.

Read More »
cosmetic products

SCCS Scientific Advice on the Safety of Triclocarban and Triclosan

The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.

Read More »
cosmetic products

Cosmetic Regulation in the Andean Community

In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).

Read More »
cosmetic products

Cosmetic Product Labelling in the European Union

The Regulation (EC) No 1223/2009 lays down the mandatory information that needs to be included in the packaging and container of a cosmetic products. In addition to this information, most cosmetic products include certain claims, which must be supported and properly substantiated.

Read More »
cosmetic products

Environmental Claims in the UK

Green claims are a trend among consumer goods and services. We often see claims like ‘clean beauty’, ‘environmental friendly’ and so many others. But how can companies ensure that these claims are not misleading? The UK’s Competition and Markets Authority (CMA) has published its Green Claims Code, in order to help companies comply with legal obligations when making environmental claims.

Read More »
cosmetic products

Parabens in Cosmetic Products

Parabens are widely used as preservatives in cosmetic and personal care products. Over the years, there have been some concerns related to the safety of parabens. The SCCS has published several opinions regarding the use of these ingredients in cosmetics, indicating the concentration levels they considered safe for human health. In the EU, some parabens can be safely used as preservatives, while others are prohibited in cosmetic products.

Read More »
cosmetic products

The Product Information File (PIF)

A Product Information File (PIF) is mandatory for all cosmetic products placed in the European Union market. It is a document that compiles the technical information of the cosmetic product and it must be kept for a period of 10 years by the Responsible Person.

Read More »