Background on the Cosmetics industry
In 2022, the value of the global cosmetics market was estimated to be worth USD 262.21 billion, with an annual growth of 4.2% projected by the year 2030. The justification for this growth projection lies in the increased popularity and demand for skincare and personal care products, joined by the aging of global population. Additional contributing factors include an increased awareness of fashion trends, innovations in the areas of hair coloring and skincare product formulations, and developments in the area of packaging. In spite of these beneficial market conditions, one factor that is expected to limit the expansion of the cosmetics market is the growing concern on the implications of the long-term use of cosmetics products on account of the inclusion of dangerous chemicals. Such concerns have led to strict regulations regarding the formulation of cosmetic products.
Regulations governing Cosmetics industry
Within the European Union (EU), the sale of cosmetic products is governed by Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. In addition to stipulating requirements regarding product labeling, the regulation makes it a liability to supply a cosmetic product that may be damaging to human health or contain potentially harmful substances. Furthermore, it is also an offense to fail to perform certain safety assessments and compile appropriate technical documentation.
Aside from the protection of human health, animal welfare is a factor that remains at the forefront of the minds of cosmetics consumers and regulators alike. In 2013, a ban on the testing of cosmetics products on animals came into effect within the EU, with similar regulations coming into effect in many other countries. Yet, in light of strict industry regulations, it is clear that reliable alternative test methods not using animals are required. In this context, Biobide has developed various in vivo toxicity and efficacy assays using zebrafish larvae considered New Alternative Methods (NAMs) respecting the 3Rs (reducement, replacement, and refinement of animals).
The use of Zebrafish for toxicity and efficacy assays in the Cosmetic industry
Ethical and regulatory opposition to the use of standard animal assays has resulted in an increased effort to identify NAMs, to analize whether certain chemicals and compounds used in cosmetic products are safe and effective. One of the most promising of these NAMs is the zebrafish larvae. Bearing in mind the use of animal testing in the production of cosmetic products is banned throughout Europe and in numerous other countries, it could be doubted how zebrafish can be included in the discussion surrounding NAMs. Zebrafish can be considered NAMs, because the larvae under 5-6 days post-fertilization are not yet classified as animals under the European legislation (EU Directive 2010/63/EU) due to the fact they are not feeding and swimming independently. Therefore, these individuals can be used for testing cosmetics´ toxicity and efficacy, representing a more ethical alternative for in vivo testing.
This small-scale fish has countless properties that make it ideal to be used use in preclinical assays of cosmetics:
- Zebrafish are genetically similar to humans, sharing 72% of their protein-coding genes. Furthermore, 84% of human disease genes have a zebrafish equivalent.
- During the larval phase, zebrafish are transparent, enabling direct observation of the effects of chemical to the internal organs.
- Zebrafish possess excellent regenerative capabilities, having demonstrated a capacity to regenerate their tail fins, hearts, central nervous system, and photoreceptors. Assays observing the effects of certain ingredients with regard to this capacity may prove useful within the context of preclinical assays for cosmetics; skin cell regeneration has been a point of focus within the field of cosmetic research for quite some time.
- Zebrafish embryos present fast organogenesis with a high organ development within 5 days post-fertilization (dpf). This allows the use of zebrafish larvae in numerous toxicity and efficacy assays.
- The small size of the zebrafish embryos (a few millimeters) and adults (a few centimeters) enables easy housing and even the implementation of High-Content Screening (HCS) assays with larvae.
Alluring to these advantages of this model Biobide has developed a pipeline of services during the last 18 years applicable to the cosmetic industry, taking into account the limitations that the cosmetic industry regulations impose. Thus, Biobide has developed a variety of HCS assays for toxicity including Acutetox Assay, Neurotox Assay, Teratotox Assay, Hepatotox Assays or Immunotox Assay, or Environmental toxicity Assays, among others. Also, specific efficacy assays are offered as the Regeneration Assay, the Melanin Quantification Assay, or the Antioxidant Assay. Besides, Biobide is able to offer tailor-made solutions to adapt the capacities of the company to clients’ specific needs.
The use of Zebrafish in Ecotoxicity assays
The potentially harmful effects of the chemical agents used in the cosmetic industry on humans are not the only concern, as their potential of their detrimental effects on the environment are of relevance. Chemicals used in cosmetic products can contribute to water pollution or air contamination by aerosols, which are a serious global issue,with profound implications, both for the survival of aquatic organisms and for human health. This has created an urgent need for toxin surveillance, the identification of consequences of exposure, and a greater understanding of the associated biological, chemical, and genetic mechanisms.
Thus, the zebrafish model is being used for assessing environmental toxicity of chemicals. In this sense the potential effects of the chemicals used in cosmetics on endocrine disruption are of special concern. Therefore, Biobide has developed a thyroid-disruption assay for evaluating the endocrine disruptive potential of chemicals in zebrafish larvae.
Conclusion
Due to increasingly strict regulation, combined with ethical and environmental concerns of the consumer, players within the cosmetics industry must continuously adapt, finding new and effective active ingredients. With a product that is intended for topical application or systemic absorption, human safety is one of the top priorities when it comes to acquiring approval for innovative active ingredients and supplements. Therefore, exhaustive, economically and logistically affordable toxicity and efficacy assays are needed. In this context, zebrafish larva has emerged as a reliable, time and cost-effective NAM for toxicity and efficacy assay of cosmetic products.
To overcome these difficulties Biobide has developed a wide pipeline of services for toxicity and efficacy assays that fit perfectly to the needs of the cosmetic industry. Biobide is your reliable partner on the development of them. The aim of the company is to accelerate the R&D processes, minimize the potential risks, and hazard, and add value to the preclinical process. Contact Biobide’s team of experts for tailored advice regarding toxicity, ecotoxicity or efficacy assays.
Sources
- Cosmetics Market Size, Share & Trends Analysis Report By Product (Skin Care, Hair Care, Makeup, Fragrance), By End-user (Men, Women), By Distribution Channel, By Region, And Segment Forecasts, 2023 – 2030, (https://www.grandviewresearch.com/industry-analysis/cosmetics-market)
- Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, (https://health.ec.europa.eu/system/files/2016-11/cosmetic_1223_2009_regulation_en_0.pdf).
- Cosmetic Products, business companion, (https://www.businesscompanion.info/en/quick-guides/product-safety/cosmetic-products#:~:text=Regulation%20(EC)%20No%201223%2F,an%20incorrectlyesra%20labelled%20cosmetic%20product.)
- Cosmetics animal testing FAQ, The Humane Society of the United States, (https://www.humanesociety.org/resources/cosmetics-animal-testing-faq#:~:text=Internationally%2C%2044%20countries%20have%20prohibited,Turkey%20and%20the%20United%20Kingdom.)
- Zebrafish Ecotoxicity Assays, Creative Biogene, (https://zebrafish.creative-biogene.com/zebrafish-ecotoxicity-assay.html)
