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Testing cosmetic products for the global marketplace

Cosmetic products are used for their reported health and appearance benefits by billions of consumers around the world. But, because applied cosmetic products come in direct contact with the human body, they are subject to a range of testing to protect users from microbiological and chemical contamination and from other possible toxic effects. To ensure safety and stability of the cosmetic products, regulations and requirements have been established in various countries. For a detailed overview of cosmetic regulations and requirements in various countries, download our white paper here.

In this article, we’ll discuss the various safety considerations associated with cosmetic products, provide an overview of the various types of tests that are required, and address the challenges in meeting diverse regulations in the global marketplace. 

What are “cosmetics”?

The term “cosmetics” usually applies to a wide variety of personal care products intended to beautify or cleanse the body or parts of the body. Specific types of cosmetic products include facial makeup and perfumes, nail polishes, and skin moisturising products. Cosmetic products can also include hair shampoos and colouring agents, toothpastes and other dental care products, and body deodorants. Some cosmetics even offer certain health benefits, such as creams and lotions with sun-blocking properties that can help prevent skin cancers, or dental products with fluoride that can strengthen teeth and reduce tooth decay.

The variety and use of products classified as cosmetics are reflected in part in the definitions used by regulatory authorities around the world. For example, the European Union (EU) defines a cosmetic product as: 

”any substance or mixture intended to be placed in contact with the extended parts of the human body (epidermis, hair system, nails, lips, external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.”

However, the wide array of products to which the term cosmetics can be applied means that authorities in various jurisdictions may regulate certain cosmetic products but not others, or even classify certain types of cosmetics as a medicine or a drug, subjecting it to even more stringent requirements. Local regulations applicable to cosmetic products may also be affected by the intended use of the product and claims regarding its possible benefits, further complicating our efforts to understand the global regulatory landscape for cosmetic products.

Safety considerations with cosmetic products

There are literally thousands of natural and synthetic ingredients currently being used in the formulation of cosmetic products. While many of these ingredients have been found safe for use in cosmetics, there is no mandated testing for the safety of individual cosmetic ingredients themselves. Even the use of seemingly safe cosmetic ingredients, such as those labelled as “organic” or “natural,” is not by itself a guarantee of safety, since even organic substances can be toxic or can product an allergic reaction in humans.

As consumer use of cosmetic products increases, the risk of exposure to potentially harmful ingredients escalates. According to one estimate, consumers in the U.S. use about 10 cosmetic products every day, resulting in daily exposure to more than 125 different ingredients.  This frequency of exposure, combined with the number of cosmetic ingredients in use, dramatically increases the risk of an adverse reaction to a cosmetic product.

Most adverse effects from exposure to ingredients in cosmetic products are limited to skin or eye irritation or other types of allergic reactions. These effects usually disappear when use of the product containing the ingredient is discontinued. However, more severe and debilitating reactions can result from prolonged exposure. In addition, there are few studies on the impact of long-term exposure to cosmetic ingredients, meaning that more research is essential.

Primary cosmetic testing

While safety testing of individual cosmetic ingredients is generally not required, most finished cosmetic products are subject to five basic tests, as follows:

  • Microbiological testing — Microbiological testing assesses the presence of potentially harmful microbial contaminants, including bacteria and fungi.
  • Chemical contaminant testing — Chemical contaminant testing of cosmetic products helps to identify chemicals that a potentially toxic to humans, such as heavy metals and dioxane.
  • Preservative effectiveness testing — Preservatives are usually added to cosmetic preparations to prevent the growth of microbiological contaminants. Preservative effectiveness testing checks for levels of bacteria or fungi, and may signal when product reformulation is required.
  • Product stability testing — Product stability testing is used to assess any chemical or microbiological changes in key characteristics of a cosmetic product that can normally be expected to take place during the product’s shelf-life and that would adversely impact consumer use.
  • Product safety testing — Product safety testing measures dermal irritancy (the tendency of a product to irritate the skin), ocular irritancy (the tendency of a product to irritate the eyes), and dermal sensitisation (the tendency of a product to produce skin rashes, swelling or other types of adverse reaction).   

Manufacturers may elect to conduct further testing to ensure the safety and usefulness of their cosmetic products. They may also conduct tests to evaluate specific quality or performance requirements of buyers and consumers, including such characteristics as whitening, moisturising or wrinkle resistance.

Challenges in meeting diverse regulations

Individual countries and regions have diverse requirements and standards that apply to cosmetic products. Most often, these requirements include the banning or restricted use of certain ingredients. The U.S., Canada, the EU, China and Japan each maintain their own versions of such lists, while the EU, China and Japan also maintain lists of permitted colourants, preservatives and UV filters. Also, with the exception of the U.S. FDA, most national regulators currently require some form of pre-market notification before marketing cosmetic products. And most jurisdictions have specific regulations regarding the listing of ingredients on labelling applied to cosmetic products.

In general, the manufacturer has full responsibility for the safety of the cosmetic products they produce. But in China, current law also allows the government to hold inspection institutes liable in connection with product safety issues found in the cosmetic products they test and evaluate. (Chinese authorities are reportedly updating their regulations to more clearly place sole responsibility for quality and safety with the manufacturer to better align with requirements elsewhere in the world.)

There are some efforts underway to harmonise cosmetic product regulations. The International Cooperation on Cosmetics Regulation (ICCR), a partnership among regulators in the U.S. the EU, Canada and Japan, is working to align cosmetic product regulations in the four-member jurisdictions in an effort to reduce trade barriers while maintaining safety standards. But the complex, and frequently contradictory, landscape of regulatory requirements remains a major barrier for producers of cosmetic products seeking to take advantage of global distribution opportunities.

Summary and conclusion

The market for cosmetic products continues to grow, particularly in new emerging economies in Asia and the Pacific Region. Although most cosmetic products are safe when used as directed, rigorous material selection and testing is appropriate so that products perform as expected and consumers are protected. Global cosmetic product regulatory schemes are generally moving away from mandatory pre-market approval to post-market surveillance and enforcement efforts, but many challenges to international market access remain. For cosmetic manufacturers seeking international distribution of their products, advanced planning remains essential.

To get more details on specific regulations and requirements applicable to cosmetics and personal care products in the U.S., Canada, the EU, Japan, Brazil, China, India and ASEAN-member countries, download our white paper, “Cosmetic testing: Requirements for cosmetic products in the global marketplace".

 

[1] “Regulation (EC) No 1223/2009 of the European Parliament and of The Council of 30 November 2009 on cosmetic products (recast),” published in the Official Journal of the European Union, 22 December 2009. Available here. Accessed on 26 February 2019.
[2] Lisa Archer, national coordinator for The Campaign for Safe Cosmetics, quoted in “Saving Face: How Safe Are Cosmetics and Body Care Products,” Scientific American, May 5, 2009. Available here. Accessed on 26 February 2019.

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