Global Cosmetic Compliance
Intelligence & Solutions
Home / News / Details

Overview on Regulations on Animal testing for Cosmetics

In this article we will talk about animal testing for cosmetic products in general, its legal status in various countries and how can companies with a "cruelty free" profile export their products to China avoiding this practice.

Introduction

Animal testing, that is to say the utilization of live animals for scientific purposes, used to be a practice initially confined to medical science, whose achievements would never be possible without it. In the first half of the twentieth century, some accidents with mascara and other unsafe maquillage pushed authorities to create a new institutional framework (exemplified by USA Federal Food, Drug and Cosmetic Act in 1938) and testing cosmetics on live animals became a common practice, sparking harsh opposition by animal rights advocates deeming it cruel and questioning its usefulness due to the merely aesthetic nature of such products. Its utilization peaked in the 80s and started to decline thereafter following stricter regulations and public opposition so that many countries eventually banned the practice, others limited its scope, while others (like China) still consider it unavoidable in order to ensure product safety.

Is there any alternative?

Industries have managed to find alternative methods to animal testing since the early 80's and many of them have been already validated and accepted. The convenience of these methods goes far beyond the advantage of not using live animals: they are more reproducible, scientifically accurate and sometimes even cheaper to perform. Apart from human tests, who are taken into consideration only when the safety assessment is already done and shows minimal risks, alternative methods name also human skin models, cell based models, cell cultures and many others. For a review of alternative methods and their advantages, take a look at our article.

Animal Testing Regulations worldwide

At the moment, despite many attempts to achieve so, there is no global, intergovernmental recognition of the importance of animal welfare legislation, and subsequently there is no such thing as international laws on animal testing in cosmetic products. This is why we will directly jump to how this matter is regulated in various countries and territories.   

EU

In 1976, European Union published "Council Directive 76/768/EEC of 1976-07-27 on the approximation of the laws of the Member States relating to cosmetic products". On February 2003, the 7th amendment to this law introduced some provisions concerning animal testing, setting a ban on cosmetic products in 2004 and a ban on cosmetic ingredients in 2009 (Reg. No 1223/2009 of the European Parliament and of the Council on cosmetic products). It also set the prohibition to market cosmetics containing ingredients tested on animals (companies can use animal testing to fulfill regulatory requirements in other countries). By 2013, all 28 EU countries achieved the complete ban on the production and marketing of animal-tested cosmetics and ingredients. In this regards, Europe is the leader and its provisions on the ban of animal testing in cosmetics are a model for other countries and territories in the world.

USA

Although FDA doesn't require explicitly animal testing for cosmetics and the USA have many laws protecting animals (namely "Animal Welfare Act"), this practice is not forbidden and therefore many companies use it extensively. When it comes to regulating cosmetic products, the peculiar institutional architecture of the USA leads to a situation in which cosmetics products and ingredients don't need FDA pre-market approval, but this institution can remove products containing unsafe ingredients or misleading labels at any moment. This is why many cosmetic companies use animal testing to assess the safety of their own products and until now there was no significant ban on this practice.

India

On 16th of March 2016, India amended its 1945 Drugs and Cosmetics Rules banning animal testing for cosmetics and ingredients. India is currently also moving towards a sale ban for cosmetic products tested on animals.

Republic of Korea

On 2016, South Korea passed a bill with the aim of banning animal testing for cosmetics by 2018. The Ministry of Food and Drug Safety (MFDS) also stated that it would impose a 1 million-won fine on producers or sellers whose products or product ingredients were tested on animals.

Japan

The Japanese situation bears similarities with the USA as Japanese law does not require cosmetic companies to perform animal testing, but not banned either. This is why many companies find it convenient and reliable to test their products using live animals. Animal testing is mandatory when referring to "Quasi Drug" products.

ASEAN countries

ASEAN has an already long history of regulations matching with EU ones, and it is therefore predictable that this region won't resist to this worldwide expansion of animal testing bans.
However, the current situation is as follows: all companies are required to provide safety assessment for their cosmetics, but there is no mandatory requirement referring to the methods to be used.

China

Last but not least, China is often cited as an example of country impermeable to recent developments on animal testing laws, as Chinese legislation still requires animal testing on most cosmetic categories and on all imported cosmetics. This is why Body Shop and other cruelty free cosmetic company decided to leave Chinese airports after suspects that their products might be randomly tested on animals after their commercialization. However, recent regulatory developments seem to show openness towards a partial limitation of the practice.
In fact, 2014 marks a turning point for animal testing regulations in this country, because on the 30th of June the Regulation Requirements for Record Keeping Documents of Domestic Non-Special Use Cosmetics came into force replacing previous regulations, meaning that even though animal testing is still necessary for registration with CFDA, the domestically manufactured non-special use cosmetics have some alternatives to that (3T3 photo toxicity assay among others).

How to escape animal testing and keep selling your products in China?

China is the biggest consumer market in the world, and many multinational cosmetic companies prefer to lose their most animal rights concerned customers over losing this profitable business opportunity. But is it actually possible to sell to China and keep a cruelty-free profile?
Yes, there are 4 ways this can be done.

For Non-Special-Use Cosmetics, Setting up a manufacturing facility in China

Any company wishing to export to China without undergoing animal testing can consider setting up a manufacturing facility on Chinese territory, as domestically manufactured non-special use cosmetics can use alternative ways to assess their toxicity. Special use cosmetics won't be exempted from that and so for them it would be useless to set up a facility in China.

CBEC

Products purchased through Cross Border E-Commerce at the moment don't require animal testing, so any company wishing to sell to China and avoid the practice can choose this channel.

Export the raw materials to China to then repackage them

Already registered cosmetic raw materials don't require animal testing and that's why cosmetic companies can consider exporting only the raw materials to China and then process, package and sell final products. We remind our readers that we are still talking about non-special use cosmetics.

Wait for Chinese laws on cosmetics to be less restrictive!

This is probably the most time demanding of them all, but when Chinese laws and regulations on cosmetics won't require animal testing anymore, it will be simple and perfectly legal to sell cosmetic products without any animal testing.

External Links:

Cruelty Free International Looks to End Animal Testing Globally by 2021: What’s in Store for China?

India to Ban Animal Testing on Imported Cosmetics

Investigation Report on Regulatory Status of Domestic Non-special Use Cosmetics Related with Animal Testing

We provide full-scale global cosmetic market entry services (including cosmetic registering & filing, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by [email protected]
Copyright: unless otherwise stated all contents of this website are ©2026 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact [email protected]
User Guide