1. What are alternative test methods?
[collapsed]The term "alternative" is generally associated with the principles of the Three Rs - reduction, refinement and replacement - of animal testing. In this context an alternative method serves to fully replace an animal test, to reduce the number of animals needed in a test, or to refine an animal testing procedure to reduce pain and suffering. Read also question no. 2.
Alternative test methods that are developed to reduce or replace animal experiments are typically based on either in vitrosystems, on computer-based models (in silico) or a combination of these two approaches.
In vitro test methods
These methods use tissues, reconstructed tissues, whole cells or parts of cells. Recent advances in cell-based research include the two and three dimensional cell cultures which mimic very closely cells and tissues in the human body.
The so-called 'omics' technologies (e.g. transcriptomics, proteomics and metabolomics) are increasingly used with in vitro approaches to gain detailed insights into the global impact of chemicals at the molecular level. Potential toxicity pathways can be identified with these techniques, and this may lead to insights into adverse health effects.
In silicotest methods
Computer-based approaches (often called non-testing methods) are becoming increasingly more powerful in the domain of alternative methods. They can be used to efficiently and effectively predict the toxicology of chemicals directly from their basic properties such as their structure, for example.
Computer modelling is an important approach to integrate toxicity information into wider data derived from complimentary in vitroand in silico methods.
A computational approach frequently used in the safety assessment of industrial chemicals is the so-called 'read-across' technique. In this approach the toxicological profile of one chemical is inferred from another on the basis of a variety of fundamental characteristics such as structure and known activity.[/collapsed]
2. What are the Three Rs?
[collapsed]The Three Rs stand for "replace", "reduce" and "refine" and refer to a framework in which the use of animal experiments and testing is gradually being replaced by alternative methods. The Three Rs concept was first defined in 1959.
Replacerefers to the avoidance of methods that use animals in experiments. Reduce refers to cutting the overall numbers of animals used for scientific purposes. Refine in turn looks towards animal welfare and methods to reduce or eliminate suffering during experiments.
More details on the Three Rs can be found on the DG Enviroment website.[/collapsed]
3. What is the historical context of EU legislation to reduce testing on animals?
[collapsed]As far back as the 1980s, the EU made a commitment to pursue efforts to replace the use of animals used in experiments and to improve the welfare of those still being used.
1986 - The first directive on the protection of laboratory animals
This led in 1986 to the adoption of Directive 86/609/EEC that set in place the first set of regulations regarding the protection of animals used for experimental and scientific purposes.
Measures included minimum requirements for welfare and husbandry (including the minimisation of pain) as well the requirement for authorisation of individuals and establishments involved in using animals in research.
The directive also requested that alternative non-animal methods of research be used when available and practical to do so. On top of this, it also encouraged the development of new methods to replace animal testing.
When animals were still needed for research, the directive requested that a minimum number of animals were used and that minimum pain was inflicted in the process.
The text did not explicitly mention the 3Rs and their principles.
2010 - A significant update to legislation
By 2008, it was clear that the original legislation needed an upgrade and so, the European Commission adopted a proposal to revise Directive 86/609/EEC.
The result was Directive 2010/63/EU, a significantly more detailed and comprehensive piece of legislation that came into force in 2010. The directive removed a number of legal ambiguities, spelt out the requirements for the Three Rs principles, and for the first time required the Commission and Member States to contribute to the development and validation of alternative methods.
It also set out the legal basis of EURL ECVAM (Read also question no. 4) and introduced measures to facilitate acceptance and promotion of alternative methods.
The REACH regulation further sets out requirements for the protection of experimental animals, stating that animal testing should be a last resort and that duplication of tests should be minimised. It also further sets out the legal requirements to develop alternative methods to assess hazardous substances.
Other relevant legislation includes the Cosmetic Products Regulation 1223/2009, the Plant Protection Products Regulation 1107/2009, the Biocides Products Regulation 528/2012, and Directive 2004/10/EC on principles of good laboratory practice.[/collapse]
4. What is the mandate of EURL ECVAM?
[collapsed]The European Centre for the Validation of Alternative (ECVAM) of the European Commission's Joint Research Centre was originally founded in 1991.
In 2010, however, its role was broadened and explicitly captured within legislation, namely the Directive 2010/63/EU on the protection of animals used for scientific purposes.
In this context ECVAM has been nominated as the European Union Reference Laboratory for Alternatives to Animal Testing, with the new acronym EURL ECVAM.
According to the Directive, the main tasks of the EURL ECVAM are:
- to promote the development and use of alternatives in the area of regulatory testing but also in biomedical research;
- to coordinate at the European level the validation of alternative methods, also by involving the newly established EU Network of Validation laboratories (EU-NETVAL) located in different Member States, and to participate with its own laboratories in the evaluation and validation of test methods;
- to disseminate information on alternative test methods through databases (e.g. TSAR, DB-ALM) and other media;
- to act as a focal point for information exchange on development, use and acceptance of methods and to promote dialogue between all relevant players in the field.
To this end, EURL ECVAM is fostering dialogue with EU Member States' competent authorities and EU agencies (e.g. ECHA, EFSA and EMA) through its consultation body for the regulatory relevance of proposed methods (via PARERE).
EURL ECVAM is also maintaining close dialogue with its stakeholders through the ECVAM Stakeholder Forum (ESTAF) that brings together European industry associations, non-governmental organisations (e.g. animal welfare groups) and academic research associations.[/collapsed]
5. What alternative methods have been validated by EURL ECVAM?
[collapsed]We have provided extensive information on most of the test methods we have validated over the years on this website and on TSAR, the Tracking System for Alternative methods towards Regulatory acceptance.
To date we have validated full replacement methods in the following toxicological areas:
We have also validated methods for the partial replacement and reduction of animal use in the following areas:
Many of these methods are now widely used for scientific testing for regulatory purposes across Europe and globally. Many have been taken up into EU law (Test Methods Regulation 440/2008) and other forms of internationally accepted test methods, such as the Test Guidelines of the OECD and the European Pharmacopoeia.[/collapse]
6. What are the main steps in the validation of an alternative method?
[collapsed]Our validation process has four major steps, each of which involves extensive interactions with various stakeholders and international partners.
The process steps are:
1. Assessment of test method submissions taking stakeholder and ICATM input into account;
2. Planning and conduct of validation studies, possibly in collaboration with EU-NETVAL laboratories;
3. Coordination of independent scientific peer review by the EURL ECVAM Scientific Advisory Committee (ESAC):
4. Development of EURL ECVAM Recommendations on the validity status of test methods taking stakeholder and ICATM input into account.
The description of each step is provided in the section 'Validation and submission process' in this website.
7. How long does validation take?
[collapsed]Validation has to be rigorous and impartial in order to convince regulators and end-users that an alternative method can provide the same or an enhanced level of protection of human health and the environment when compared to traditional methods.
Methods undergoing validation are typically assessed with respect to their reliability and relevance.
In terms of reliability, a method must first be stable and reproducible within one laboratory and then shown to be transferable and reproducible in at least two other laboratories that have not performed the method before. The relevance of a test refers to the extent to which the test method correctly measures or predicts the (biological) effect of interest, as appropriate.
Such "ring trials" can be difficult and time consuming to set up and execute due to their technical and administrative complexity. The selection, sourcing and distribution of test chemicals and the training of lab personnel can often pose considerable challenges.
In addition, pilot "pre-validation" trials are often necessary to optimise and refine the test protocol.
On completion of the validation study the results are then subject to independent scientific peer review by ESAC.
As said, these steps take time. Nevertheless, we are continually looking for opportunities to streamline our validation process to maximise efficiency while retaining high levels of quality and rigour.[/collapse]
8. Besides validating alternative methods, what else has EURL ECVAM accomplished?
[collapsed]The tasks entrusted to the JRC and EURL ECVAM are varied and go much further than validation of test methods. Here is a flavour of our wider portfolio of activities:
- Contribution, on behalf of Directorate-General Environment, to the Test Guidelines Programme at the OECD
- research and development of both in vitro and computational methods
- operation of a GLP compliant in vitrotest facility
- operation of a high-throughput screening (HTS) facility
- dissemination and promotion of methods
- training in alternative methods
- provision of direct support to other Commission Services and EU agencies
- organisation of expert workshops
- contribution to projects of the European Partnership for Alternative Approaches to Animal Testing (EPAA)
- participation in the International Cooperation on Alternative Testing Methods (ICATM).
We have also been involved in the formulation of a variety of international standards, legislation, user guidance and we have or are participating in a number of EU research projects.
Our latest EURL ECVAM Status Report describes all the activities we have undertaken or have been involved.[/collapse]
9. What is the EU doing to promote research and validation of alternative methods?
[collapsed]The European Commission is highly committed to guide and support the development, validation and promotion of non-animal methods for use in regulatory safety assessment and as tools in biomedical research.
The 6th and 7th Framework Programmes (FP6 and FP7) and Horizon 2020, the current research funding programme have all provided funds for the purposes of research and validation of alternative methods. In the period 2007 to 2011, about € 330 million was made available by the Commission for this area.
Public-private partnerships such as SEURAT-1 and the EPAA have a very important role to join forces in the development of alternative methods and to combine efforts across industry, academia, governmental and non-governmental organisations so that everybody is pulling in the same direction.
The Joint Research Centre (JRC) and EURL ECVAM will continue to look for innovative ways to translate the results of scientific research into useful and valid tools that can significantly reduce society's reliance on animal testing while ensuring the highest level of protection for human health and the environment and maintaining industrial and economic competitiveness of the EU.[/collapse]
10. What is the European Partnership for Alternative Methods to Animal Testing (EPAA)?
[collapsed]The aim of the EPAA is to promote the development, validation and acceptance of '3R' methods - replacement, reduction, refinement - as alternative approaches to the use of animals in quality, efficacy and safety assessments in the regulatory environment.[/collapse]
11. Are there cultural barriers preventing a larger diffusion of alternative methods?
[collapsed]In the past the regulatory community has been typically cautious when considering the use of alternative methods for safety assessment. Today, however, there is an overwhelming consensus in the scientific community that alternative test methods are indeed powerful tools capable of delivering relevant information that is useful in many regulatory contexts - especially when validated and peer-reviewed by international and independent bodies, such as EURL ECVAM.[/collapse]
12. Which scientific challenges are still limiting a reduction in animal testing?
[collapsed]Considerable progress has been made in the validation and regulatory adoption of non-animal methods for chemical safety assessment. Regarding skin sensitisation, for example, these methods, when used in combination, can already act as full replacement in the majority of cases for identifying chemicals as likely skin sensitisers or non-sensitisers.
However, in some cases barriers to a complete replacement of traditional methods do exist.
The main challenge concerning the reduction of animal testing is to sufficiently advance many areas of toxicological and biomedical sciences to deliver complete and effective non-animal solutions that can detect all the possible adverse effects that a chemical could possibly cause to an organism.
An example: human reproduction involves multiple organs, tissues and cells together with hormonal systems that act at the level of the entire human body. Chemicals that are potentially toxic to reproduction could therefore act in a plethora of ways through many different mechanisms.
This level of complexity most likely cannot be modelled in one in vitro test. It is much more likely that a bank of different tests and computational modelling would be needed to get close to mimicking real life human reproduction.[/collapse]
13. What scientific advantages do alternative methods have when compared to animal tests?
[collapsed]While animal tests are widely used for the protection of human health (and the environment) and there is considerable experience in applying them, a number of concerns have surfaced over the years.
Firstly, while many animal tests are considered standard methods in many areas of toxicology, some were developed decades ago and are not necessarily based on modern toxicological sciences or the latest biomedical technologies. In some cases, this might mean that a test does not account for these advances and may therefore be sub-optimal.
Next, animal and human physiology can be very different in some aspects (a mouse is not a human), which means extrapolating results from animal studies to humans can be difficult in certain circumstances and can even give wrong results.
Many animal tests are based on simply looking for adverse effects, such as lesions or tumours, caused by a chemical and do not go into any sort of underlying mechanisms.
While animal studies can go into these aspects through the use of careful experimental design, conducting standard tests in the traditional manner does not contribute to our overall understanding of toxicity or any possibility to predict it.
Finally, many animal studies take a long time to conduct (years in some cases), that also means that they can be very expensive.
In short, while animal tests can be useful in certain circumstances, they are also associated with many disadvantages and this can lead to questions about their real value in many circumstances.[/collapse]
14. Why do we look for validation of replacements - the animal tests were themselves never validated?
[collapsed]In the past, testing on animals was the best available and most reliable way of carrying out risk assessments in many industrial sectors. In fact, testing on animals was the only way of carrying out some forms of risk assessment.
While the animal test methods have not undergone the same type of validation that would be expected today, long standing experience with the use of animal methods has been attained and they have been included in a number of legal provisions.
In many circumstances this means they are required by law.
There are of course limitations with animal testing, which means development and validation of alternative methods is important from a number of perspectives. There is the ethical standpoint but it is important to continue to provide a better safety assessment framework for the protection of human health and the environment.[/collapse]
15. Isn't animal testing for cosmetics already prohibited in the EU?
[collapsed]Yes, animal testing for cosmetic purposes is banned in the EU. For finished cosmetic products, animal testing has been banned in the EU since 2004. Equally, for cosmetic ingredients animal testing has been banned since 11th March 2009.
In addition, a ban was enforced (and is fully binding since 2013) that prohibited the marketing of cosmetic products containing ingredients that had been tested on animals regardless of their origin.
On a more technical level the ban applied to a whole series of animal based tests that were used to demonstrate the safety of cosmetic products. This included tests for skin and eye corrosion and irritation, acute photo toxicity, skin penetration, genotoxicity and acute systemic toxicity.
For the more complex aspects of safety testing, the marketing ban came into force in March 2013. This included tests for repeated-dose toxicity, including skin sensitisation and carcinogenicity, reproductive toxicity and toxicokinetics.[/collapse]
16. If testing on animals for cosmetics is forbidden, what kinds of tests are still being done on animals in the EU?
[collapsed]Animal testing can still be carried out for several other purposes. A series of Commission reports detail the numbers and types of animals used in Europe for scientific and other purposes, with the latest data available for 2011. According to the latest report around 11.5 million animals were used in 2011 for experimental and other scientific purposes. This represents a drop in comparison 2008 (12 million).
The vast majority (60%) of animals are used in biological and medical research (e.g. fundamental biological research, research and development in medicine and related areas). In comparison, toxicological testing and other safety evaluations accounted for 8.7% (about a million animals).
Other areas where animals are used in testing include production and quality control of human and veterinary pharmaceuticals/products, diagnosis of disease, and education and training.
In terms of risk assessments in cosmetics all animal testing was banned in 2009. Even before 2009 the numbers of animals used was already very low in comparison to other areas: 5500 animals were used in 2005, 1818 in 2007 and 1510 in 2008.[/collapse]
17. Is animal testing for cosmetics done in countries beyond Europe?
[collapsed]Europe upholds the strictest position worldwide with respect to animal testing for cosmetics. No other country or region specifically prohibits animal testing of cosmetics. A number of countries (for example, China) explicitly require animal testing data in order to bring cosmetic ingredients on the market.[/collapse]
18. Which animals are used in testing for cosmetics?
[collapsed]Animals used for cosmetics testing are (or were) rabbits, rats and guinea pigs.[/collapse]
19. How can I know that a cosmetic product I buy is not tested on animals, if it comes from outside the EU?
[collapsed]Consumers can be sure that no finished cosmetic products have been subject to animal testing in the EU since 2004. Consumers can also be sure that no cosmetic ingredients have been tested for cosmetic purposes on animals in the EU since 2009.
This so called 'testing ban' was reinforced by a 'marketing ban' on all cosmetic ingredients or products tested outside the EU after the same date.
The only exception related to animal testing was made for the more complex toxicological effects (endpoints), such as repeated dose toxicity, reproductive toxicity and toxicokinetics, for which the deadline was set to 11 March 2013.
It is however important to realize that many ingredients used in cosmetics are also used for other purposes as well – such as in pharmaceuticals, detergents, food, paints etc., and they may be subject to animal testing requirements under the legislation which covers these products.[/collapse]
20. What is the meaning of animal testing-free labels on cosmetics?
[collapsed]Animal testing-free labels usually mean that animal testing has not been conducted on any of the ingredients in the cosmetic product after a certain (cut-off) date.
However, this does not necessarily mean that all the ingredients were never tested on animals, since in some cases the producing company may still rely on old animal test data generated before the cut-off date.[/collapse]
21. Is it true that alternative methods are not yet available for some adverse health effects?
[collapsed]It is correct to say that alternative test methods are not yet sufficiently developed to fully replace some standard animal tests. These include tests for the following adverse health effects or so-called "toxicological endpoints":
- Repeated-dose toxicity. This relates to issues associated with long term repeated exposure to a chemical.
- Carcinogenicity - the ability of a chemical to cause cancer.
- Reproductive toxicity. This refers to a wide variety of adverse effects that may occur in different phases within the reproductive cycle as a consequence of exposure to one or more chemicals. This includes effects on fertility, sexual behaviour and embryo implantation.
- Toxicokinetics. This is the examination of the absorption, distribution, metabolism and excretion characteristics of toxic substances in humans and for that matter any other living organism.
However, there exist methods that can be used for screening to understand whether there is a concern for adverse effetcs also for these endpoints.[/collapse]
22. Which validated methods are available today?
[collapsed]Validated alternative methods are available for the identification of corrosive substances, skin irritants and severe eye irritants, for investigating skin phototoxicity and skin penetration as well as to assess genotoxicity. In addition, significant advances have been made in reducing the number of animals used in tests, for example in relation to acute toxicity.
However, certain toxicological effects based on more complex processes are not yet or not fully covered by alternative methods. These relate to very complex biological processes for which the scientific basis to fully replace animal testing is still not fully established.
They mainly relate to repeated-dose toxicity, skin sensitisation, carcinogenicity, reproductive toxicity and toxicokinetics.
Please refer to thisquestion for more information on specific areas where this is the case.
While full replacement is not yet accomplished for those endpoints there is a potential for partial replacement strategies, to reduce the number of animals used. For more in depth information please refer to this report which was compiled by a panel of leading experts in 2010: "Alternative (non-animal) methods for cosmetics testing: current status and future prospects—2010".[/collapse]
23. What scientific improvements are still needed to address the most complex cases where alternative tests are not (fully) established?
[collapsed]We still lack basic scientific understanding of how exactly some chemicals lead to toxicological effects. One common challenge for assessing a chemical against complex systemic health effects is to simply predict where the chemical ends up in the body and for how long it stays there.
Moreover, chemicals are typically transformed and broken down in the body and sometimes the transformation products (metabolites) are actually the source of toxicity.
Understanding the fate of a chemical in the body, i.e. how it is absorbed, distributed, metabolised (transformed) and excreted, and its so-called toxicological "mode of action" is essential. The identification of key events in toxicity pathways would enable the targeted development of specialised test methods to produce the information needed to decide if a chemical would trigger an adverse outcome, and also, hopefully, the intensity of this effect in the organism.
In this context, there will not be one alternative method to replace one animal test method. Combinations of tests and computer models need to be used in an integrated way to predict systemic toxicity effects.[/collapse]
24. Does the EU promote alternative methods at an international level?
[collapsed]At the international level, the European Commission promotes cooperation to facilitate the development and the validation of alternative methods and their recognition by our main trading 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).
OECD Guidelines Programme for the testing of chemicals where the Commission promotes the 3Rs concept by supporting the inclusion and improvement of non-animal approaches as well as working towards the deletion of animal methods.
The Commission is also active in international working groups in relation to pharmaceutical products for humans (ICH - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and animals (VICH - International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products).
The Commission also contributes to he work of updating the United Nations' Globally Harmonised System of Classification and Labelling of Chemicals (GHS) to include non-animal methods,[/collapse]
25. Can substances tested on animals under REACH be used as cosmetics ingredients?
[collapsed]The majority of cosmetics ingredients will fall also under the scope of REACH, which means that they might have to be the object of animal testing in order to fulfil the REACH requirements.
It is, however, important to note that testing requirements are not the same for all legislative domains. For example, REACH does not require carrying out a two-generation reproductive toxicity test or repeated dose toxicity tests for an industrial chemical produced in low quantities (1 to 10 tonnes).
Performing such tests on a substance and annexing them to a REACH registration for the sole purpose of then allowing the use of this substance as a cosmetics ingredient would probably be subjected to legal challenges.[/collapse]
26. Are alternative methods accepted under the EU regulations on chemicals, REACH?
[collapsed]In general, REACH supports using any existing information to establish the toxicological profile of a substance. This includes "non-standard" information produced using, for example, in vitro methods, structure-activity relationships, read-across and chemical categories (comparing a given chemical with other ones for which toxicological information is available).
Thus in reality in many cases information requirements of REACH can be satisfied by a "weight of evidence" approach which combines various pieces of evidence coming from alternative sources, thereby avoiding prospective animal testing.[/collapse]
27. Did EURL ECVAM ever validate a method based on human embryonic stem cells as an alternative method to animal testing?
[collapsed]To date EURL ECVAM has not received any submission of a test based on human embryonic stem cells (hESC), nor has it conducted any validation activities on in vitro methods based on hESC.
Moreover, it is the current policy of EURL ECVAM not to enter into the validation of methods that rely on hESC.
EURL ECVAM is focusing on the validation of alternative methods that are of relevance for regulatory safety testing. Validation is a prerequisite for the acceptance of toxicological test methods for chemical hazard assessment both within Europe and worldwide, and as such the validation process contributes to the global mutual acceptance of toxicological data.
With respect to test methods based on hESC that might be proposed for regulatory safety assessment, it is unlikely that such methods would be accepted by all EU Member States because of differences in views on the use of hESC. As a consequence, a mutual acceptance of hESC-derived toxicological data would not be attainable.
A way out of this dilemma was the discovery of induced pluripotent stem cells (iPSC) that share similar characteristics of hESCs.
These cells are generated by genetic manipulation of human cells, e.g. derived from the skin, and make the destruction of any human embryo superfluous. iPSC hold great potential for in vitro methods, both for identifying therapeutic targets and for early safety assessment.
In particular, iPSC can be a powerful tool for understanding and considering specific side-effects of drugs due to slight differences in the metabolising capacity (polymorphism) of the human population.
However, iPSC technology is still rather new and in a rapid phase of development, supported both by industry and by the European Commission through its research Framework Programmes.
To date, EURL ECVAM has not received any submission of an in vitro method based on iPSC, but we are aware of numerous research initiatives involved in their development.[/collapse]
28. How does EURL ECVAM's work relate to the new vision of toxicity testing in the 21st Century?
[collapsed]The paradigm shift in toxicological hazard assessment, which is for example at the heart of the so-called Tox21 initiative in the United States, is a move from the traditional data-driven approach based on observations of effects derived from animal studies towards a knowledge-based framework, where we use our understanding of toxicological modes-of-action to rationally design integrated assessment and testing systems that are fit for a particular regulatory purpose/endpoint.
The push towards the use of mode-of-action based knowledge and information within a regulatory context has been led in particular by the WHO International Programme on Chemical Safety, and is also spearheaded by the OECD, who started a new Programme in 2013 on "Adverse Outcome Pathways" (AOPs).
The JRC as a whole and EURL ECVAM in particular are engaged proactively in this important endeavour. This includes co-chairing the OECD Advisory Group on Molecular Screening and Toxicogenomics, which is responsible for the AOP Programme.
The first concrete indication of how we can use AOPs as the knowledge base for developing integrated approaches to testing and assessment (IATA) is in the area of skin sensitisation.
The OECD has already published a comprehensive AOP related to this endpoint and EURL ECVAM has proposed to use this to guide the optimal combination of in vitro test methods and in silico tools (e.g. QSAR – Quantitative structure activity relationship models) to both identify and characterise skin sensitisation hazard in support of various pieces of chemicals legislation.
A number of the relevant in vitro methods to be included in such IATA underwent validation by EURL ECVAM and subsequently were taken up by the OECD in order to establish internationally harmonised Test Guidelines (TG) on these methods (e.g. TG no. 442C and no. 442D). During the past few years a number of Defined Approaches (DAs) integrating information from multiple non-animal methods (e.g. in silico, in chemico, in vitro) and other relevant information (e.g. physico-chemical properties) have been developed for the purpose of skin sensitisation hazard assessment and/or potency categorisation. The DA designation emphasises that predictions generated by these approaches are ruled-based and are not influenced by expert judgment, i.e. even though combined of several methods a DA can be treated is as one in a regultory context.[/collapse]
29. Is it possible to contemplate a future where animal testing is not necessary?
[collapsed]A lot of progress has been made during the last 20 to 30 years with regard to the development of alternative methods, especially in the field of routine toxicity and safety testing of chemicals and biologicals.
A full replacement of animal studies will be possible. However, at the moment it is impossible to say when animal testing can be eliminated.
Reliable alternative methods are already available for the identification of corrosive substances, skin irritants and severe eye irritants, skin phototoxicity and skin penetration as well as to assess genotoxicity. It is conceivable that in the mid-term most safety testing can be done through the intelligent combination of non-animal testing methods, computer models and integrative approaches. This also applies to basic research - non-animal models can be used to advance our knowledge.
The EU is strongly committed to phasing out animal testing tests in Europe and these advancements are surely paving the way for this ultimate goal.