Alternatives to Animal Testing in Cosmetics Safety Assessment

From efficacy verification to cosmetic safety assessment, animal testing provides key data support for technological progress. However, ethical awareness and scientific limitations have increasingly challenged this traditional approach. Since the EU banned animal testing for cosmetics in 2013, more and more countries have followed suit. Governments, certification bodies, standardization organizations and regulatory agencies are actively developing and accelerating the identification of alternatives. Nowadays, alternatives to animal testing have evolved from “optional” to a “mandatory” requirement for sustainable industry development.

What are Alternative Methods to Animal Testing?

Alternative Methods to Animal Testing refer to experimental techniques that assess the safety, efficacy, and toxicity of chemicals, drugs, and cosmetics without using live animals. Such methods aim to reduce, refine, or replace animal experiments while ensuring data reliability. Alternative Methods to Animal Testing usually have the following 3R principles:

①  Replacement: Complete substitution of animal tests with non-animal methods.

②  Reduction: Minimizing animal use.

③  Refinement: Improving methods to reduce animal suffering.

What do alternatives to animal testing include?

China is also accelerating its transformation. Although regulations are still based on animal test data, research on alternative methods continues to deepen. More and more alternatives are included in the Cosmetic Safety Technical Specifications. Many institutions have established various alternatives in multiple fields.

❑ Test methods that completely replace animal testing

Based on the definition of animal testing alternatives,

Alternative Methods to Animal Testing ≠ Animal Replacement Tests.

Animal Replacement Tests refer to methods that entirely replace animal testing without using any living animals.

❑ Reduction and Refinement Methods

In addition to completely replacing test methods, we can also focus on the following improved methods to reduce and optimize animal testing.

In addition, the Cosmetic New Ingredients Registration and Filing Data Management Regulations issued in 2021 mentioned that when animal alternative methods are used for toxicological safety evaluation, the Integrated Approaches to Testing and Assessment (IATA) should be selected to evaluate the toxicity of new ingredients based on the structural characteristics of the ingredients and specific toxicological endpoints.

If the alternative test method is not included in China’s Cosmetic Safety Technical Specifications, the alternative test method should be a method that has been included by an international authoritative alternative method verification agency, and at the same time, proof that the method can accurately predict the toxicological endpoint should be submitted. The proof should include a brief description of the research process of the alternative test method and research data, result analysis and conclusions for more than 10 known toxic substances.

In other words, those replacement methods which are not listed in China but recognized by international bodies such as the Organization for Economic Co-operation and Development (OECD), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and International Cooperation on Cosmetics Regulation (ICCR) can be applied for safety assessment.

What are the costs of alternative animal testing?

It is worth noting that there is a significant difference in cost between animal testing and animal alternative testing. Due to the widespread demand and well-establi

shed animal testing systems, animal testing is generally more cost-effective than replacement methods. Typically, in vitro animal testing replacement methods cost more than cell-based animal tests. For example, skin sensitization testing requires only one single assay in animal testing, whereas replacement methods may require two tests with consistent negative results, increasing time and economic costs.

Furthermore, QSAR (Quantitative Structure-Activity Relationship) models and toxicological databases are increasingly applied in cosmetic safety assessments. These technologies leverage computational simulations and data analysis to rapidly and efficiently predict chemical toxicity, reducing reliance on animal testing. Developed countries and regions such as the EU and US have extensively integrated these approaches into ingredient safety evaluations and regulatory supervision. China is also gradually introducing these technologies to promote the cosmetics industry to develop in a more scientific and efficient direction.

In the wave of innovation in the cosmetics industry, animal testing alternatives have emerged as a key force of sustainable development. Only by embracing technological innovations can companies ensure product quality, avoid potential risks and seize the initiative in the fierce competition.