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FAQs Animal Testing 2011
An updated version (2013) of the FAQs is available here.
The following Frequently Asked Questions refer to the recently published Report "Alternative (non-animal) methods for cosmetics testing: current status and future prospects - 2010"
(Copyright © Springer-Verlag 2011 - Archives of Toxicology, Volume 85, Number 5, 367-485 - doi: 10.1007/s00204-011-0693-2)
In 2010, the Commission appointed a panel of
experts to report on the current status and future prospects on alternative
(non-animal) methods for cosmetics testing, and to provide realistic estimates
of the time required for the development of alternative methods where not
already existing. The resulting expert panel report underwent a period of
public consultation. The European Centre for the Validation of Alternative
Methods (ECVAM), hosted by the Institute for Health and Consumer Protection of
the European Commission's Joint Research Centre, coordinated the whole review
activity on behalf of the Commission's Directorate General for Health and
The experts concluded that considerable scientific challenges have to be overcome before a full replacement of animal tests will be possible. Whereas substantial progress has been made over the past years, they predict that, for five specific areas, alternative methods to fully replace animal tests will not be available by 2013. However, the experts noted that significant contributions to reduce, refine and partially replace animal testing have been made and are feasible before full substitution is possible.
Download all the FAQs in pdf format.
Q2. What are the principles and the major positive outcomes of non-animal testing?
Q3. Why is it so difficult to find and validate alternative (non-animal) test methods?
Q4. What progress has been made towards phasing-out animal testing of cosmetics?
Q5. Which projects on alternative methods are currently funded by the European Commission?
Q6. Apart from funding, what does the Commission do to make progress in this area?
Q7. What is ECVAM?
Q8. What is ECVAM's mandate?
Q9. What is the current number of alternative methods validated by ECVAM and accepted by OECD?
Yes, there can be no testing for cosmetic purposes in the EU. Animal testing for finished cosmetic products is banned in the EU since 2004, and animal testing for cosmetic ingredients is banned since 11 March 2009.
As from March 2009, it is also prohibited to market in the EU cosmetic products containing ingredients which have been tested on animals regardless of their origin. This applies to a series of aspects to be tested in order to demonstrate the safety of cosmetic products, such as skin and eye corrosion/irritation, acute phototoxicity, skin penetration, genotoxicity and acute systemic toxicity.
For the three most complex aspects (repeated-dose toxicity, including skin sensitisation and carcinogenicity, reproductive toxicity and toxicokinetics) the marketing ban deadline is extended to March 2013. This means that for these endpoints companies can still rely on tests carried out in countries outside the EU.
The aim of non-animal testing is to create models that will replicate the activity of a chemical in the human body as well as its interaction with the different cells in the different organs of the human body. Successes so far have been mainly in the area of skin and eye irritation. For example methods have been developed and validated using a three dimensional human tissue model of the skin and three of these methods have been accepted within international test guidelines. Methods using cells or tissues maintained in the laboratory (so-called in vitro techniques) have also been validated for predicting eye irritants. However, for assessing the potential of a chemical to cause cancer or reduce fertility or cause effects on unborn infants, even more sophisticated approaches will be required. The current strategy is to draw on many different disciplines to achieve this, including the use of in vitro methods, predicting activity based on chemical structure and reactivity using computational modelling, and in particular exploiting scientific advancements in the field of genomics and metabonomics.
There continues to be substantial gaps in scientific knowledge. For example, the types of cells that could be used to model the effect of the potential toxins, both as regards their availability and their suitability, only became available recently and the use of these cells within a test method will require much more development to be useful for the prediction of human toxicity. On top of this, there is still the need to model cell to cell interactions and complex messaging systems of the body, such as the hormonal, immune and nervous systems. To find a system or systems capable of modelling the complex nature of the interactions a chemical may have within the human body, is extremely challenging and it is therefore very time-consuming to develop, optimise and validate new methods. It is not envisaged that one method will be able to replace one animal test, rather a suite of assays and many types of other information will be required to be used in combination in testing strategies for predictions of specific types of toxicity.
Considerable progress has been made and many alternative methods, as individual building blocks within an overall test strategy as mentioned above, are in development and reaching a stage to enter into validation. Already now, in some cases the information provided by alternative methods and the combination of such methods, can be used to reduce the need for further testing in animals, before a full replacement is feasible.
Progress has also been made in reducing the number of animals used for certain animal tests.
Activities under the EU's 6th and 7th Research Framework programmes related to the advancement of the '3Rs' concept of Replacement, Reduction and Refinement can be found within the Alternative Testing Strategies Progress reports 2009 and 2010.
The European Centre for the Validation of Alternative Methods (ECVAM) is/was contributing to a number of these projects, including for example:
- The integrated project Sens-it-iv, which is investigating the development of non-animal tests to evaluate the allergenic potential of chemical compounds (www.sens-it-iv.eu).
- The carcinoGENOMICS project developing in vitro methods for assessing the carcinogenic potential of compounds (www.carcinogenomics.eu).
- The ReproTect project addressed reproductive toxicology and yielded a number of test methods, two of which are already under validation by ECVAM (www.reprotect.eu).
In addition in 2009, in relation to the deadline of 2013 for banning the marketing of cosmetic products containing ingredients tested in animals for repeated dose toxicity, there was a call for research proposals to investigate alternative testing methods to "repeated dose systemic toxicity", whereby €25 million will come from the EU research framework programme with matching funds from the European cosmetics industry, represented by Colipa (European Cosmetics Association). In consequence, seven new research projects in this field started in January 2011, for a total amount of €50 million.
The Commission's Joint Research Centre's Institute for Health and Consumer Protection/ECVAM is contributing to four of the seven projects. The kick-off meeting of the projects took place from 1 to 3 March 2011 in Cascais (Portugal). The objective is to lay the scientific foundation for future safety testing methods with a higher predictive value that, in addition, are likely to be faster and cheaper than tests involving animals. The projects will combine the research efforts of over 70 European universities, public research institutes and companies.
The Commission's Joint Research Centre is putting a lot of efforts into the validation of alternative methods and their dissemination, through its European Centre for the Validation of Alternative Methods (ECVAM), hosted by the JRC's Institute for Health and Consumer Protection. Moreover, in order to promote synergies between different sectors concerning the development of alternative methods, the European Partnership for Alternative Approaches to Animal Testing (EPAA) was created in 2005. It is a joint initiative of the European Commission, industry and trade federations. The Partnership’s work focuses on mapping existing research, developing new alternative approaches and strategies, and promoting communication, education, validation and acceptance of alternative approaches.
At international level, the Commission promotes intensified cooperation to facilitate the development and the validation of alternative methods and their recognition by our main partners. A framework of cooperation has been established between the US, Japan, Canada and the Republic of Korea, in a regulatory dialogue called "International Cooperation on Cosmetic Regulation" (ICCR), which led to the International Cooperation on Alternative Test Methods (ICATM).
Last but not least, ensuring progress is not the Commission's responsibility only. Industry and other stakeholders have to play their part.
The European Centre for the Validation of Alternative Methods (ECVAM) was set up by the European Commission in 1991 to promote the validation of alternative methods. ECVAM is part of the Institute for Health and Consumer Protection of the European Commission's Directorate-General Joint Research Centre.
It is the EU’s principal organisation for the scientific validation of alternative methods to animal testing. Methods developed by research laboratories are submitted to ECVAM whose assessment of the robustness, reliability and predictive capacity of the methods is based on independent peer review of validation study reports. The role of ECVAM in a validation study may vary considerably from full management of a validation study, including the funding of the participating laboratories in a prospective validation study, to evaluation of a validation study conducted by external parties and submitted to ECVAM at the end of the study. In each case ECVAM's Scientific Advisory Committee peer reviews the outcome of the validation study and ECVAM publishes recommendations on the validated test method. In some cases ECVAM's own in house laboratory may be one of the participating laboratories in a validation study.
ECVAM supports the post-validation regulatory acceptance process both at European Union level and also with international organisations such as the Organisation for Economic Co-operation and Development (OECD) and ICH (International Conference on Harmonisation). It also supports validation of methods in the partner validation bodies in USA, Canada, Japan and the Republic of Korea, as well as with OECD.
Focusing on an improved understanding of the way chemicals impact biological systems, ECVAM contributes to the development of methods and/or testing strategies that will reduce reliance on studies on living animals (in vivo), even for complex biological effects such as carcinogenicity.
ECVAM is a partner in many Commission-funded research projects in this field and aims at guiding test methods from these projects towards validation.
User oriented documentation of as well as access to quality controlled information on alternative techniques is one of ECVAM’s principal objectives. To promote the dissemination and practical use of alternative methods, ECVAM provides a publicly available DataBase service on ALternative Methods (DB-ALM) with evaluated information on various aspects of alternative methods at all stages of development, validation and regulatory acceptance. There are over 2000 registered users from 75 countries with all principal targeted user profiles covered.
The role of ECVAM was formalised in 2010 by the new Directive 2010/63/EU on the protection of animals used for experimental and other scientific purposes.
The Directive describes the specific duties and tasks of an EU
Reference Laboratory mirroring those duties and tasks described in a
Commission Communication of 1991 which led to the initial establishment
of ECVAM, and adding a requirement to promote the development and use of
alternatives in the areas of basic and applied research. Moreover,
the new Directive will require Member States to support ECVAM, by
nominating suitably specialised laboratories to participate
in validation studies, as well as by ensuring the promotion of
alternative methods at national level.
Since its creation, ECVAM has been involved in the validation of 34 methods, out of which 18 have achieved regulatory acceptance at international level by acceptance at OECD, and a further 9 methods have been accepted by the European Pharmacopoeia.
The methods adopted at OECD are in vitro methods permitting the identification of corrosive substances, skin irritants and severe eye irritants, skin phototoxicity, skin penetration, skin sensitisation (in this case an animal method but using less animals) and genotoxicity, as well as a refinement and reduction of the acute oral toxicity test. Those accepted by the European Pharmacopoeia deal with the potency and safety testing of vaccines and assessment of pyrogenicity.
As of June 2011, ECVAM is involved in 10 studies that aim to validate 14 methods.
- Repeated dose systemic toxicity refers to the general toxicological effects that may occur as a result of repeated (daily) exposure to a toxic substance rather than one single exposure (e.g. the type of exposure that occurs from the repeated use, over a long period of time, of cosmetic products)
- Reproductive toxicity refers to a wide variety of adverse effects that may occur in different phases within the reproductive cycle, as a consequence of one or more exposures to a toxic substance, including effects on fertility, sexual behaviour, embryo implantation, embryonic/foetal development, parturition, postnatal adaptation, and subsequent growth and development into sexual maturity.
- Toxicokinetics informs about the penetration into and fate within the body of a toxic substance, including its absorption, distribution, metabolism (producing less toxic metabolites (detoxification) or in some cases more toxic metabolites) and excretion.