Nowadays, animal welfare is a growing concern within our society. The reconciliation between preventing harmful effects of a product on our health or the environment – a public health issue – and ending animal suffering is delicate. Traditionally, the evaluation of these effects is examined through animal testing. However, the European Union has banned animal testing for cosmetic products. Animal research is highly regulated both legislatively and regulatorily.
What Are the Regulations on Animal Testing for Cosmetics?
Table des matières
What Is a Cosmetic Product?
A cosmetic product is defined as any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors
(Article L. 5131-1 of the Public Health Code).
For example, this includes perfumes, hygiene products, makeup…
What Is Animal Testing?
Animal testing concerns non-human living vertebrates, including autonomous larval forms and fetal forms of mammals from the last third of their normal development, as well as living cephalopods. Therefore, animal testing occurs when these animals undergo procedures in which they experience pain, suffering, or distress, or sustain lasting harm.
An experiment refers to any use of these animals for trials for experimental or other scientific purposes. It begins from the handling or preparation of the animal for its use and ends when no further use is to be made of the animal (Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes – Decree No. 2001-464).
For example, this may involve rats, monkeys, rabbits, etc., on which various tests are performed such as skin applications, injections…
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In France, the first law on animal protection is the law of July 10, 1976, governing practices on animals, partly incorporated into our Rural Code.
Within the European Union, animal testing of cosmetic products has been banned since March 11, 2009 (Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products – Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products). Therefore, the marketing of finished cosmetic products and their ingredients that have been subject to animal testing is prohibited. France – as a member state of the European Union – requires French cosmetic industries to comply with this.
In addition, animal welfare is a value of the European Union enshrined in Article 13 of the Treaty on the Functioning of the European Union. More broadly, a cosmetic product that has been tested on animals cannot be imported into the European Union (CJEU, 1st ch., 21 September 2016, case C-592/14 European Federation for Cosmetics Ingredients v Secretary of State for Business, Innovation and Skills).
Since 2015, France has gone even further by officially recognizing animals as “living beings endowed with sentience” whereas previously their legal status was akin to “movable property” (Article 515-14 of the Civil Code).
Thus, the European cosmetics industry is the only one providing for a ban on animal testing on this scale. According to the European Parliament, 80% of countries still use animal testing on cosmetic products.
What Is the “3 Rs Rule”?
The “3Rs rule” was developed by Russell and Burch, and forms the foundation of the ethical approach to animal experimentation. It aims to:
- Reduce the number of animals in experiments;
- Refine the methodology used to minimize the suffering imposed on animals while preserving the acquisition of a significant level of information;
- Replace methods using animals.
This 3Rs rule is found in various French legal standards such as Decree No. 2013-118 and internationally with the Council of Europe’s Convention STE No. 123.
Exceptions to the Ban?
As an exception, there are certain derogations from the ban on testing cosmetics on animals.
These are primarily permitted thanks to the European Regulatory Body for securing the manufacture and use of chemical substances in the European industry called Registration, Evaluation and Authorisation of Chemicals (REACH). The marketing of cosmetic products requires compliance with various obligations such as the provision of a Product Information File (PIF). To do this, the toxicity of products must be evaluated. These tests are mainly carried out using alternative methods to animal experimentation. However, skin sensitization testing is still performed on animals as the OECD has not yet validated an alternative method in this regard.
What Are the Alternatives?
The term “alternative methods” was introduced in 1978 by David Smyth with a view to using alternatives to animal testing to test the toxicity or safety of cosmetic ingredients.
The Organisation for Economic Co-operation and Development (OECD) establishes guidelines on experimental protocols and alternative methods. The European Centre for the Validation of Alternative Methods (ECVAM) coordinates the development and validation of alternative methods within the European Union.
These undergo a regulatory validation process before the OECD or ECVAM, referred to as validated methods.
The Scientific Interest Group has set up a French platform for the development, validation, and dissemination of alternative methods in animal experimentation called “Francopa”.
After extensive research, several alternative methods exist:
- Optimized/refined in vivo: imaging and animal biomarkers taking maximum account of animal welfare;
- In vitro: study on human or animal cells;
- In silico: mathematical modeling with computer assistance.
Who Controls?
In France, compliance with these standards is jointly monitored by the National Agency for the Safety of Medicines and Health Products (ANSM) and the Directorate General for Competition, Consumer Affairs and Fraud Control (DGCCRF).
The latter has found that some brands continue to use claims or logos referring to this legal obligation such as “not tested on animals”, when it is simply compliance with current regulations. According to Article 121-2 of the Consumer Code, this behavior can be considered misleading commercial practices.
Indeed, claims about characteristics mandated by law are prohibited (EU Regulation No. 655/2013 of the Commission of July 10, 2013 establishing common criteria to which claims relating to cosmetic products must respond in order to be used). This practice is likely to mislead the consumer and therefore the brand concerned could be punished with two years’ imprisonment and a fine of 300,000 euros (Article 132-2 of the Consumer Code).
However, certain claims are tolerated when they refer to specifications that go beyond regulatory obligations, such as vegan, cruelty-free, or Leaping Bunny logos.
From Theory to Practice
In theory, these legal standards put an end to animal abuse in cosmetic laboratories. According to PETA, 1900 cosmetic brands have adopted a cruelty-free policy.
In Europe, no “finished” cosmetic product can be tested on animals. However, certain ingredients in these products may be tested on animals as they fall under the regulation of chemical ingredients (REACH), which extends beyond cosmetic products. Compliance with REACH is monitored by the European Chemicals Agency (ECHA). Importantly, some brands market their cosmetics outside the European Union, such as in China, where animal testing is required in this regard.
To date, only cosmetics regulations prohibit the use of animal testing, unlike other sectors such as pharmaceuticals. According to the official report of the European Commission, approximately 10 million animals die in European laboratories each year.
Towards a Global Ban?
Globally, the scope of our regulations regarding the ban on animal testing for cosmetics is diminished by the requirement to test cosmetics on animals in other countries such as China. However, since May 1, 2021, China now allows the marketing of “general” cosmetics not tested on animals!
On February 20, 2018, the European Commission adopted a new resolution to globally ban animal testing for cosmetics. Thus, on May 3, 2018, Members of the European Parliament voted in favor of a global ban on animal testing for cosmetics by 2023, calling for a United Nations convention.
