Author: Maria Demetriou
Date of Publication: 29/10/2022
Have you ever thought that your favorite cosmetic products might have involved animal testing? Wouldn't it be harsh to realize that your skincare routine, your hair and makeup items were dangerous, harmful or tortuous to animals? Thankfully, that is not the case for the European Union anymore.
What are the animal tested cosmetic products?
According to the EU, cosmetic products cover a wide range of products and not just makeup. They refer to any substance used for cleaning, perfuming, enhancing, beautifying or protecting parts of the human body. For instance, we refer to skin, hair, nails, lips and teeth. Most common examples are:
✔ Makeup products (including lips and eyes’ products)
✔ Shampoos and soaps
✔ Creams, bath gels, oils, masks for skin and face
✔ Perfumes
✔ Hair products (dyes, lotions, conditioners)
✔ Shaving products
✔ Teeth/mouth hygiene
✔ Nail products
Generally speaking, animal testing is a method used by manufactures to ensure that their products or ingredients are safe and not toxic for human use. Thus, animal tested cosmetic products are those cosmetics, which are, firstly, being tested on animals before entering the market. However, the methods used in cosmetic tests are harsh, unethical and unreliable. Manufacturers cruelly treat the tested animals - mostly rats, mice or rabbits. The typical methods are:
● Lifetime in a small cage of a laboratory with artificial light and given food
● Application of chemicals to their -bare- skin
● Application of chemicals to their eyes
● Inhalation of -toxic- substances
● Injections to their bodies
To make matters worse, beyond their intolerable and tortuous life, the result is often the sacrifice of those animals for the sake of the cosmetic industry.
What is the current legal framework of the EU ban on animal tested cosmetic products?
The applicable EU legal framework of the ban is well-developed. Commission has submitted many reports and reviews and researchers have worked intensively in finding alternative solutions to animal testing. So, the importance and dedication to the development of non-animal safety tests is obvious. That’s why the EU has spent €238 million funding for that purpose. Specifically, the EU legal framework comprises of the:
✔ EU Cosmetics Directive 76/768/EEC
✔ EU Cosmetic Products Regulation (EC) No 1223/2009
✔ REACH Regulation (EC) No 1907/2006
Therefore, all cosmetic suppliers -manufacturers, importers and exporters- have to conform to the requirements of the above EU provisions in order to enter the EU cosmetic market.
EU Cosmetics Directive 76/768/EEC
The Cosmetics Directive created the framework for the gradual elimination of animal tested cosmetic products. It imposed two types of bans:
Testing ban: Prohibition of performing animal testing on finished cosmetic products or on their ingredients -raw materials- in the EU.
Marketing ban: Prohibition of marketing - selling - animal tested finished cosmetic products or their animal tested ingredients -raw materials- in the EU market.
Beyond the two bans, it provides some entry to the EU market-requirements for the cosmetic products. In particular, the cosmetic manufacturer/importer/exporter (appointed as a “Responsible Person” in the EU) need to comply with:
The safety assessment of the finished cosmetic product before entering the EU market:
Specifically, they shall guarantee:
● The intended usage of the product
● An assessment method based on evidence and overall data review
● An up-to-date assessment
The product information file (PIF):
The Responsible Person shall provide easily accessible information to the relevant authorities for the purposes of inspection. In addition, they must keep this information in their specific EU address. This information, for example, involves:
● Composition of the product in quantity and quality
● Physico-chemical and microbiological specifications
● Manufacturing method according to the EU good manufacturing practice
● Safety assessment for human health and possible unwanted effects
The notice to the relevant authorities and to the Commission for the cosmetic product before entering the EU market (pre-market notification).
The conditions on labeling and languages of the destination country.
EU Cosmetic Products Regulation (EC) No 1223/2009
The Cosmetics Regulation replaced the Cosmetics Directive by taking full binding effect in 2013. It, actually, provides the same regulatory framework as the aforementioned directive. The vital addition is that, except the ban of animal testing on finished products and their ingredients, the prohibition, now, expanded to carcinogenic or toxic substances for reproduction, as well. Moreover, it adds some useful provisions, considering the technological evolution. For example, it specifies that the Responsible Person shall ensure higher level of consumer’s protection, if the cosmetic product contains nanomaterials.
Are there any exceptions to the EU ban on animal tested cosmetic products?
The answer is, yes. According to the Article 18.2 of the Cosmetics Regulation, cosmetic suppliers are able to derogate from the prohibition. This happens only when severe concerns about the safety of an ingredient arise. For that, they need to meet two conditions:
If the ingredient is used widely and cannot be replaced by another one.
If there is proof of a human health problem and the animal testing is justified, following a research protocol.
What’s more, in that exceptional context, the REACH Regulation applies, complementary with the Cosmetics Regulation.
REACH Regulation (EC) No 1907/2006
The REACH Regulation refers to the Registration, Evaluation, Authorisation and restriction of Chemicals. Specifically, it is applicable to chemicals used both in ingredients and finished cosmetic products. These could be manufactured or imported into the EU market, if their annual quantity exceeds 1 tone. For such ingredients or products, EU cosmetic suppliers shall proceed to the REACH registration. This means that they need to register it with the European Chemical Agency (ECHA) and obtain its permission in order to perform animal tests. On the other hand, non-EU cosmetic suppliers need to appoint a REACH only representative for this registration. Moreover, it is important to note that REACH regulation allows animal testing for chemical substances in cosmetics as a last resort and only for two purposes:
Evaluation/control of risks to human health of the industrial workers exposed primarily to that chemical substance.
Assessment of chemicals’ risks to the ecosystem and determination of environmental data.
In both cases, cosmetic companies have to share their findings. As a result, they won’t proceed to any unnecessary animal testing. It is, also, worth mentioning that the Commission works hard in finding alternative solutions even to that last resort. Hence, nowadays the EU provides a well-established and strong legal framework to ensure that the cosmetic industry is animal-cruelty free and safeguard animals’ welfare. Either you are an animal lover or not, the prohibition of animal testing in the cosmetic industry is a matter of morality. Apart from that, it shows respect to these living beings.
Reference List:
EU Cosmetics Directive 76/768/EEC
EU Cosmetic Products Regulation (EC) No 1223/2009
REACH Regulation (EC) No 1907/2006
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