VIER PFOTEN
EPO
COSMETIC TESTING ON ANIMALS
FAQ
1) Why testing cosmetics on animals?
According to EU legislation, all new substances including those used in cosmetic products have
to be tested for harmful effects on human health and the environment. These tests often
involve the use of live animals, mostly rodents, to test whether a substance will cause cancer or
birth defects.
But: Thousands of previously tested cosmetics ingredients are already available to companies
and consumers and these existing safe ingredients can be used and reformulated without the
need for further testing.
2) How is animal testing regulated in the EU?
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Since 1976, the laws of European Member States relating to animal testing for cosmetics is
harmonized through the Council Directive 76/768/EES of 27 July 1976 on approximation of
the laws of the Member States relating to cosmetic products.
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The so-called “Cosmetic Directive” was amended many times; its latest version, the 7th
amendment is Directive 2003/15/EC which for the first time laid down a fixed timeframe for
the phasing out of animal testing for cosmetics.
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From 11 July 2013, the Cosmetic Directive will be replaced with Regulation (EC) no.
1223/2009 on cosmetic products due to the many changes and new amendments that were
required.
3) How many / which animals are used for cosmetic testing?
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Two Member States reported using animals in cosmetic testing: France and Spain
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In 2009, according to the latest report of the EU Commission1, 344 animals were used for
cosmetic testing:
a) France: 302 (rat, rabbit, guinea-pigs)
1
EU Commission (2011): Report on the Development, Validation and Legal Acceptance of Alternative Testing Methods to
Animal Tests in the field of Cosmetics (2009)
b) Spain: 42 (rabbits)
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In the previous years, when testing was allowed during the entire period, it was 1.818
(2007) and 1.510 (2008).
4) Is cosmetics testing on animals not banned?
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Animal testing on finished products was banned in the EU in September 2004.
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Animal testing of new cosmetic ingredients was banned in the EU on 11 March 2009.
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The sale of animal tested cosmetic ingredients was also banned on 11 March 2009, with the
exception of three toxicity endpoints which were given a later deadline of 11 March 2013 to
allow alternative testing methods to be developed.
 Animal tested cosmetics are therefore not banned from the EU and animal testing for cosmetics
still continues worldwide.
5) Why might the ban be postponed?
The Commission states that a delay to the 2013 ban is likely due to alternatives not being ready.
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Reasons given for alternatives not being ready include ‘technical difficulties’ such as
replacement methods which show high numbers of false positive/negative results and so
animal testing is still performed to check these methods.
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Additionally, explanations include where tests for complex 2013 endpoints require several
validated replacement methods to cover all stages of ‘ADME’ (Absorption, distribution,
metabolism, excretion) to assess the full effect of a cosmetic ingredient.
6) What are the ‘2013 endpoints’ and what does it mean?
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The three types of animal test with a deadline of 11 March 2013 are:
1) Reproductive Toxicity
2) Repeat Dose Toxicity (including Carcinogenicity and Skin Sensitization)
3) Toxicokinetics
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“Three endpoints” does not sound like much but these are areas of testing which account
for many individual tests and countless thousands of animals used . Just one of theses tests
alone (e.g. for birth effects) may use several thousands animals for example.
7) What are alternative methods to animal testing?
Alternative methods – the term ‘alternatives’ is used to describe all methods categorized by the
3Rs (Reduction, Refinement, Replacement). Reduction and refinement methods seek to either
minimize the suffering or reduce numbers of animals used. While this is to be encouraged, these
are still animal tests. Therefore, only replacement tests can be considered as true alternatives.
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Replacement methods include a wide variety of testing types such as:
1) In-chemico tests (chemical based assessment of the properties of a substance)
2) In-vitro tests (test tube/cell based methods, e.g. human skin models)
3) Human based volunteer testing methods, e.g. skin patches
4) In-silico tests (Computer based methods of chemical screening, e.g. QSAR)
8) What are the 3Rs?
The principle of replacement, reduction and refinement (Directive 2010/63/EU, Art. 4) says that
a Member State shall ensure, that wherever possible,
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An alternative method to animal testing should be used
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The number of animals used is reduced to the minimum
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Refinement of breeding, accommodation and care of animals used in procedures, and to
reduce to a minimum any possible pain, suffering, distress or harm to the animals
9) Why are the alternatives not ready/available?
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Reasons given for this are that some alternatives require further research which will mean
the tests will not be validated for use by 2013. (note: Every alternative test must go through
a validation process before it can be approved for use).
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Another reasons given is that some alternatives are composed of several tests which
increase the time required for development and validation.
10) Are there other issues besides banning cosmetics testing in animals?
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Yes. The number of ingredients which are used only in cosmetics is relatively small and
approximately 80%-90% of cosmetics ingredients are tested for multiple uses.
Most ingredients are tested on animals within other industries (e.g. industrial, medical) and
are then also used in cosmetics.
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Additionally, other chemicals legislation such as REACH requires testing of all new
ingredients and re-testing already on the market. Some of this testing will be performed on
animals and again may be on ingredients which will be used in cosmetic products.