Cosmetics and personal care products companies are committed to eliminating animal testing whenever possible, while also ensuring the safety of the products that consumers use and trust every day.
While the FDA's Federal Food, Drug and Cosmetic Act (FD&C Act) does not specifically require the use of animals in testing cosmetics for safety, the Agency does require manufacturers to substantiate the safety of their products and ingredients. In some cases, after considering validated alternatives, companies may conclude animal testing is the only way to achieve this. Despite some limitations on these alternative test methods, the vast majority of the industry's safety assessments of cosmetics and personal care products are already performed without testing on animals.
Cosmetic and personal care products companies have been strong leaders in the search for and development of alternative testing methods for cosmetic safety assessments, and have worked with regulators in the U.S. and globally to accept these procedures as valid alternatives for all toxicity testing methods.
Alternative methods attempt to mimic the biological effects on an organism using bacteria, isolated cells, cell cultures or tissues (also known as in vitro tests). Once developed, alternative methods must be validated and accepted by government agencies, a process which can take as long as a decade to complete. Another approach involves the use of computational methods (mathematical and computer models) to predict adverse effects. This field continues to evolve rapidly as expertise is developed.
For nearly four decades, cosmetics and personal care products companies have been at the forefront in significantly reducing the use of animals in product safety testing. In 1981, the industry’s trade organization – The Personal Care Products Council (then, the Cosmetic, Toiletry, and Fragrance Association) – approved a $1 million grant to fund the Johns Hopkins University Center for Alternatives to Animal Testing (CAAT), dedicated to developing viable alternatives to animal testing.
As a direct result of industry’s leadership efforts, today the vast majority of safety assessments are conducted without animal testing, despite some limitations on alternative methods. Existing alternative approaches include the use of large databases leveraging historical data, computer modeling that estimates biological properties of ingredients (also known as in silico models), and the use of new safety assurance methods, such as Quantitative Risk Assessment for skin contact allergens.
The principles for incorporating these new approaches integrating in silico, in chemico, and in vitro approaches into risk assessments for cosmetic ingredients, so called ‘Next Generation Risk Assessment’ has been the subject of a task force consisting of scientists from both regulatory authorities and the cosmetics industry in the International Cooperation on Cosmetics Regulation (ICCR).
These advances enabled cosmetics manufacturers to discontinue the practice of testing finished products on animals in the 1980s, long before it was called for by the European Union in 2004.
In addition, the industry no longer tests product ingredients on animals, except in very rare cases when it is required to meet government regulations (e.g., China).
To date, the personal care products industry has spent hundreds of millions of dollars on the development of scientifically valid alternatives to animal testing. We remain committed to continuing this search and are working diligently to promote the acceptance of such alternatives by regulatory bodies around the world.
While there has been tremendous progress, alternatives are not yet available for all types of safety testing. There is enormous difficulty in trying to mimic the complex interactions of the body's many different organs, tissues, and cells and how an outside substance may trigger an effect in an organism - or have no effect at all.
This does not, however, change personal care product companies’ commitment to eliminating animal testing for all components of cosmetic and personal care products. The industry firmly believes in the feasibility of elimination, and that ending animal testing is of benefit for all parties – consumers, animal welfare, and industry.
Some cosmetics companies include promotional claims on their labeling or advertising materials that their products are “Cruelty-Free” or “Not Tested on Animals.” While there are no legal definitions for these terms in the U.S., companies are required to substantiate that a marketing claim is truthful and not misleading to consumers. In the EU, guidelines were established in the 2006 the Cosmetics Directive for the claim “not tested on animals.”
In the United States, there is no nation-wide ban on the use of animal testing to substantiate safety. California passed a law in 2000 that prohibits animal testing when alternatives have been scientifically validated and adopted by appropriate regulatory agencies.
Since its inception in 1989, China’s Cosmetic Hygiene Management Regulation has required animal testing on all imported cosmetics products. These tests are conducted in Chinese Government-owned labs as part of a larger process meant to validate product safety by Chinese standards.
Very recently, China has begun to allow certain products (manufactured in China) to forgo these required tests in favor of the safety assessment approach employed by global companies. The global personal care products industry continues to work with the Chinese government to encourage acceptance of alternatives to animal testing for all products, whether imported or manufactured locally.
In India, a national cosmetics animal testing ban was implemented in June 2014, and an import ban became effective in November 2014.
The European Union's Cosmetics Directive provides a regulatory framework for phasing out animal testing for cosmetics. Beginning in September 2004, animal testing of finished cosmetic products was banned. Subsequently, a ban on the marketing of products whose ingredients have been tested on animals for the purpose of cosmetics regulation, with the exception of tests for certain toxicological endpoints for which no alternatives existed, went into effect in March 2009. Finally, in March 2013, a full ban went into effect on the marketing of cosmetics whose ingredients have been tested on animals, with no exceptions.
While much has been achieved to end the use of animals in research, not all global regulators and authorities currently accept (or make the broadest use of) the alternatives currently available. In addition, accepted alternatives do not yet exist for all safety endpoints. The cosmetics industry remains firmly committed to continuing research and working closely with the global scientific community until validated alternatives are available to answer all relevant safety questions and meet the needs of government regulators around the world.
For further information on Animal Testing and alternative methods (referenced above) please visit:
“Science, Medicine, and Animals", Institute for Laboratory Animal Research, Published by the National Research Council of the National Academies 2004.
European Commission Recommendation of 7 June 2006 - Establishing guidelines on the use of claims referring to the absence of tests on animals pursuant to Council Directive 76/768/EEC