Evolution of Regulatory Framework for Toxicology Testing in the Cosmetic Industry

For many years toxicologists have been studying the safety and biological effects of drugs, chemicals agents, and other substances on living organisms and their alternatives. These toxicology methods are developed to determine harmful effects, the dosages that cause those effects, and safe exposure limits. These tests are important because they ensure the general public or consumers of these products, as well as the environment, are safe. Across countries and across industries toxicology testing for products has been mandated. However, the test requirements may differ based on the guidelines for a specific country. According to IQ4I analysis, Toxicology Services Global Market is poised to reach $14,343.0 million by 2025 growing at a high single-digit CAGR.

The regulations for ensuring the safety of cosmetics vary from region to region. The USFDA does not have any legal authority to approve cosmetic products and ingredients, other than colour additives, prior to entering the market. Also, it does not have a list of tests required for any cosmetic product or ingredient. In the U.S. a manufacturer or distributor of a cosmetic is legally responsible for ensuring that a marketed product is safe when consumers use it according to the directions in the labelling or in the customary or expected way. However, FDA can take action against the manufacturer if they have reliable information to show that a cosmetic does not meet the legal requirement for safety. Furthermore, FDA treats colour additives differently. Unlike other cosmetic ingredients, colour additives, other than colouring materials used in coal-tar hair dyes, have to be approved by FDA for the specific intended use before they are permitted in any cosmetic.

In the European Union toxicity studies needed to evaluate different toxicological endpoints as those reported in Commission Directive 87/302/EEC of 18 November 1987 and in Commission Directive 92/69/EEC of 31 July 1992. These directives represent the basic toxicity testing procedures internationally accepted as being the result of the long-term scientific agreement. These procedures include 27 studies based on in vivo animal models and 10 studies based on in vitro models including genotoxicity.

However, due to high opposition towards the use of animals for in vivo testing has affected the market substantially. This began with Germany banning the use of animal testing in 1986, that was extended to the entire European Union (EU) in 2004. This imposed import scrutiny. As Japan and the U.S. are major exporters to the EU, imports of cosmetic products tested on animals were banned in 2013. Since then, Israel, India, Norway, New Zealand, South Korea, Turkey, Taiwan and parts of Brazil have also banned testing of cosmetics on animals. Until recently China required all cosmetics to be tested on animals, although this requirement has now been relaxed for non-specialized cosmetics such as hair, skin and nail care products, perfumes and make-up. Similarly, until July 2018, animal testing will be required in Australia for some cosmetic ingredients, as it is considered by the Department of Health to be the best means of testing for potential toxicity. After this time industrial chemicals scheduled for use only in cosmetics may not be tested on animals.

Animal testing is increasingly opposed by the public but many governments including Australia’s require animal tests to be conducted for some potentially hazardous new cosmetic ingredients. Most prominent in this arena is the European Union. Animal testing for cosmetics was first banned in Germany in 1986. It was then extended to the entire Union in 2004. In 2009 the ban was expanded to include ingredients, not just the finished product. As a result, imports came under scrutiny, as Japan and the United States are major exporters to the EU, and imports of cosmetic products tested on animals were banned in 2013.

Since then Israel, India, Norway, New Zealand, South Korea, Turkey, Taiwan and parts of Brazil have all banned testing of cosmetics on animals. The US is considering a ban, which would drastically diminish the market for any manufacturers still using animal testing. Until recently China required all cosmetics to be tested on animals, although this requirement has now been relaxed for non-specialized cosmetics such as hair, skin and nail care products, perfumes and make-up. Other countries like Australia are in the process of imposing the ban on animal testing.This strong opposition is not only forcing changes in regulations but also hindering the in vivo toxicology market.