Today, a number of techniques are used for testing the adverse impacts of cosmetic products. However, such techniques are impeded by several factors like short testing windows of lab assay models and poor data translation from animal models (pre-clinical trials).
The sale of cosmetic products as well as their ingredients tested on animal models was banned by the EU Cosmetics Directive in 2013.
Europe and the United States have over 33,001 cruelty-free companies that do not utilize animals for testing of hair care, skincare, wound care, and cosmetic products. Nevertheless, there still exist over 400 firms conducting experimental tests on animals. A majority of these companies, if not all, existed before restrictions on animal tests came into effect.
There are three factors inhibiting the present techniques for testing the performance, safety, and toxicology (the study of the detrimental effects of chemicals on living organisms) of cosmetic products. These factors have been described below.
1. Animal Models
Human physiology cannot be precisely simulated by animal models; hence, alternative techniques are required to generate more predictive results. In preclinical testing, the animal models used do not provide an economical option for a number of applications where personal care products are tested (Bojar, 2012a).
Table 1. Cost factors for testing methods in personal care products
|Table 1: Options for testing cosmetic and personal care products
|In vitro laboratory testing
|In vitro living skin equivalent
In certain countries (EU), the use of animals for cosmetic testing is also banned.
2. Viability of Assay Models
Existing assay models tend to have restricted testing windows because of cell death. Also, it is not always possible for repeat application testing, which means inconsistent data is produced.
By carrying out repeated exposures to the test material, models should establish whether a product causes undesirable irritation. Hence, models that have a longer testing window are needed.
3. Variation in Skin Types
Skin is a complex organ and relies on both the health status of individuals and the environment in which they live. For instance, a product may generate varied results based on the ethnicity of an individual. Problematic skin conditions such as acne may also influence the reaction between the skin and the cosmetic product.
Key Objectives to Look Out for in 3D Human Skin Testing
- A dry surface that provides a physical protective barrier similar to the human skin
- The potential to test personal care products like anti-dandruff products, sunscreens, and moisturizers for skin and inflammatory reactions
- Extended life of test components (for example, viability for 10 to 14 days)
- The potential to demonstrate the creation of pro-collagen production
- The potential to test harmful skin bacteria that activate an immune response, like viruses, bacteria, toxins, and other foreign substances
- The potential to enable aggressive testing conditions and numerous applications of a compound
- A huge testing surface area (for example, up to 4.5 cm)
- Shows the effect of formulation or ingredient on the microflora of the skin
Future Outlook and Trends
In vivo (in living humans/animals) pre-clinical and clinical studies are the point of reference for assessing the effectiveness of personal care products. However, these studies cannot be performed on animal models as they involve extensive cost and execution, which are beyond the means of several companies. As a result, the process is often outsourced to CROs.
In the next six years, the outsourcing of cell-based assay development and screening will turn out to be more prevalent, owing to advances in 3D cell culture assays. Such assays can simulate the in vivo setting (Visiongain, 2014) in a better way.
In 2013, Germany, Japan, and the United States were the top markets for cell-based assays. Considering the upcoming trend of outsourcing, more companies are likely to transfer research and development operations to rising cellular assay markets in India and China (Visiongain, 2014). As such, analysis of the social, political, and technological trends was carried out to examine the landscape of the cell-based assay market within the personal care sector.
- Within the personal care sector, companies have a social responsibility to act in an ethical way, and prevent any harm caused to animals via testing of cosmetic products.
- Companies also have a social responsibility to modify their practices and implement the latest regulations controlling cosmetic testing, as the legislations turn out to be more broadly accepted.
- The concept of the “green-consumer” is becoming widespread, with households currently showing a commitment to purchase socially and eco-friendly responsible products (Mintel, 2014)
- The need for technology that closely imitates the human skin’s functioning mechanisms has increased considerably, and this will go on to increase. This is because of the need for alternative testing models for pharmaceutical and cosmeceutical products.
- Improvements in 3D printing and stem cell research at a research-level are gradually being developed.
- The potential to upgrade and commercialize 3D printing and stem cell technologies will establish how rapidly 3D human skin equivalent products are moved in the industry.
The EU Cosmetics Directive banned the testing of cosmetic products and cosmetic ingredients on animal models in 2013. The marketing of any cosmetic product and/or its ingredients that had been tested on animal models was also banned within the EU (European Commission, 2014). Such a regulation led to the need for alternative testing techniques within the CRO and cosmetic sectors. The EU’s proactive movements have set the stage for other nations to reassess the way they test the performance and safety of cosmetic products.
Promoting awareness of the issues related to animal testing has paved the way for the market of alternative techniques, to test cosmetic ingredients and chemical compounds. As a result, 3D human skin equivalent solutions have become a huge demand. Ever since the EU ban, other countries like India, Israel, and Norway have implemented this legislative change.
The anticipated introduction of a cosmetic animal testing ban in New Zealand, Australia, and the United States will expand the need for alternative models, like 3D human skin counterparts in the cell-based assay market (Kantamneni, 2014).
In vitro (artificial environment outside the living human/ animal) testing models are expected to substitute all animal testing models due to their ease of use, safety and efficacy aspects, and reduced costs (Nagavarapu, 2014).
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