Report from the Commission to the Council and the European Parliament - Report on the Development, Validation and Legal Acceptance of Alternative Methods to Animal Tests in the Field of Cosmetics (2005)
Date: 2007-05-03
Institutions: European Commission
Subjects: animal experimentation, cosmetic product, drafting of EU law, report, research, research method, testing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 3.5.2007 
COM(2007) 232 final 

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

Report on the Development, Validation and Legal Acceptance of Alternative Methods to 
Animal Tests in the Field of Cosmetics (2005) 

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REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN 
PARLIAMENT 

Report on the Development, Validation and Legal Acceptance of Alternative Methods to 
Animal Tests in the Field of Cosmetics (2005) 

I. INTRODUCTION 

The  present  “Report  on  the  Development,  Validation  and  Legal  Acceptance  of  Alternative 
Methods to Animal Experiments in the Field of Cosmetics” is the sixth report presented by 
the  Commission.  It  reflects  the  state  of  play  on  the  number  and  type  of  experiments  on 
animals  relating  to  cosmetic  products  in  2004,  the  current  status  of  alternative  replacement 
methods as well as the acceptance and recognition of alternative methods at the international 
level.  The  report  is  produced  in  order  to  comply  with  Art.  9  of  the  Council  Directive 
76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating 
to  cosmetic  products  (Cosmetics  Directive),  as  amended  by  the  European  Parliament  and 
Council Directive 2003/15/EC of 27 February 2003. It is the second report on the basis of the 
7th  Amendment  to  the  Cosmetics  Directive  and  after  the  inclusion  of  the  Protocol  on  the 
Welfare of Animals in the Treaty of Amsterdam in 1999. 

II. NUMBER AND TYPE OF EXPERIMENTS RELATING TO COSMETIC PRODUCTS CARRIED OUT 
ON ANIMALS 

1. Legal Background 

According to Art. 9 (a) of the Cosmetics Directive, every year the Commission shall present a 
report  to  the  European  Parliament  and  the  Council  on  progress  made  in  the  development, 
validation and legal acceptance of alternative methods. The report shall contain precise data 
on  the  number  and  type  of  experiments  relating  to  cosmetic  products  carried  out  on 
animals.  The  Member  States  shall  be  obliged  to  collect  that  information  in  addition  to 
collecting statistics as laid down by Council Directive 86/609/EEC of 24 November 1986 on 
the  approximation  of  laws,  regulations  and  administrative  provisions  of  the  Member  States 
regarding  the  protection  of  animals  used  for  experimental  and  other  scientific  purposes 
(Laboratory  Animals  Directive).  The  Laboratory  Animals  Directive  includes  reporting 
requirements  at  regular  intervals  not  exceeding  three  years  on  the  number  and  kinds  of 
animals used in experiments. 

The information to be provided in accordance with the Cosmetics Directive should enable the 
European Commission and the Member States to get a complete idea of the situation in the 
field  of  animal  testing  in  relation  to  cosmetic  products.  This  information  will  be  useful  to 
apply the provisions of the Cosmetics Directive on this matter.  

The testing ban on finished cosmetic products applies since 11 September 2004, whereas the 
testing  ban  on  ingredients  or  combination  of  ingredients  will  apply  step  by  step  as  soon  as 
alternative  methods  are  validated  and  adopted,  but  with  a  maximum  cut-off  date  of  6  years 
after entry into force of the Directive, i.e., 11 March 2009, irrespective of the availability of 
alternative non-animal tests. The marketing ban will apply step by step as soon as alternative 
methods are validated and adopted in EU legislation with due regard to the OECD validation 
process. This marketing ban will be introduced at the latest 6 years after entry into force of the 

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Directive,  i.e.,  11  March  2009,  for  all  human  health  effects  with  the  exception  of  repeated-
dose  toxicity,  reproductive  toxicity  and  toxicokinetics.  For  these  specific  health  effects,  a 
deadline of 10 years after entry  into force of the Directive is foreseen, i.e., 11 March 2013, 
irrespective of the availability of alternative non-animal tests.  

2. Animal Testing Data1 

a) For the present report, 23 Member States2 conveyed information on animal tests carried out 
for the safety of cosmetic products in 2004. EL and UK did not transmit any information for 
this  report  pursuant  to  Art.  9  (a)  of  the  Cosmetics  Directive.  Both  Member  States  have 
repeatedly  informed  the  European  Commission  in  the  past  that  they  are  not  carrying  out 
animal tests for the development and safety assessment of cosmetic products. 

According to the information submitted, cosmetic ingredients have been tested on animals in 
the  territories  of  FR,  DK  and  ES  only.  However,  as  in  the  last  report,  these  Member  States 
have not indicated the number of animal tests performed  but instead the number of animals 
used. Also, these figures refer to “main uses” of substances in cosmetics or toiletry articles.  

In total, about 9000 animals were used in tests carried out for the safety of cosmetic products 
(Table 1). The other 20 Member States reported that they did not perform such animal tests in 
their territory in 2004. 

Number of animals used in Member States (2004) – Table 1 

France 

Denmark 

Spain 

NUMBER OF ANIMALS 
USED 

ANIMALS USED 

5496 

12 

3480 

Mice, rats, guinea pigs, 
rabbits 

Rats 

Mice, rats, guinea pigs, 
rabbits 

Compared  to  the  last  report,  the  total  number  of  animals  used  for  testing  the  safety  of 
cosmetics  increased  significantly  (2003:  1618).  At  the  same  time,  the  market  for  cosmetics 
has  continued  to  grow  by  1  %  compared  to  2004.  Sales  for  the  15  “old”  Member  States, 
Switzerland and Norway reached 60 billion Euro (retail sales prices) in 20053.  

There  are  several  reasons  for  this  increase  in  the  number  of  animals  used  in  the  area  of 
cosmetics. First, Spain did not transmit animal testing data in 2003, but did so for 2004. The 
increase of animals used in tests in France from about 1600 in 2003 to about 5500 in 2004 is 
caused, according to the French authorities, mainly by three additional test protocols carried 
out by two laboratories, two of which have been carried out for a French client and the other 
one for a client in another EU Member State.  

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2 

3 

See reservations on the accuracy of data in paragraph 3 “evaluation of submitted data”  
Bulgaria and Romania were not involved in the reporting system 
COLIPA, Annual Market 2005, June 2006, page 5 

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However,  the  reported  number  of  animals  mainly  used  for  cosmetics  or  toiletries  is  still 
relatively  small  compared  to  the  total  number  of  animals  used  for  experimental  and  other 
scientific purposes. The total number of animals used in the “old” fifteen EU Member States 
in 2002 was 10.7 Million according to the “Fourth Report on the Statistics on the Number of 
Animals  used  for  Experimental  and  other  Scientific  Purposes  in  the  Member  States  of  the 
European Union (2002)4”. 

b) For the first time, the Commission received information on the type of animal experiments 
performed  in  Member  States.  FR  and  ES  submitted  testing  data  in  relation  to  the  various 
toxicological endpoints (Table 2). For some types of animal tests, however, it remains unclear 
for what kind of human health effects they have been tested (“others”). 

Number of Animals Used in Relation to Toxicological Endpoints (2004) – Table 2 

TYPES OF TESTS / COUNTRIES 

FRANCE 

SPAIN 

DENMARK 

Tests of non lethal toxicity methods 

Skin irritation 

Skin sensitisation 

Eye irritation 

629 

283 

875 

115 

No data 

No data 

1282 

No data 

Subchronic and chronic toxicity 

1279 

1242 

418 

231 

206 

310 

998 

No data 

No data 

No data 

No data 

801 

Carcinogenicity 

Development Toxicity 

Mutagenicity 

Reproductive Toxicity 

Others 

3. Evaluation of submitted data 

4 

COM (2005) 7 of 20.01.2005 

No 
information 

No 
information 

No 
information 

No 
information 

No 
information 

No 
information 

No 
information 

No 
information 

No 
information 

No 
information 

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a) Reporting of animal testing data under the Cosmetics Directive has slightly been improved 
compared  to  the  last  report,  although  a  number of  questions  and  shortcomings  remain.  This 
again highlights the Commissions’ continued concerns about the accuracy of the figures being 
reported. 

After  publication  of  the  last  annual  report,  the  Commission  has  undertaken  a  number  of 
efforts  to  clarify  the  situation  and  to  assist  Member  States  in  collating  accurate  figures  in 
relation to animal testing data. The Commission contacted Member States and other relevant 
stakeholders to clarify the collation of animal testing data, in particular with a view to animal 
tests carried out for multiple uses. 

Several  discussions  with  industry,  animal  welfare  organisations  and  other  stakeholders 
showed that:  

•  chemicals  are  rarely  tested  on  animals  solely  for  their  use  as  ingredients  in 

cosmetics, 

•  the majority of animal tests are carried out for multiple uses by manufacturers of 
chemical  substances  (industry  assumes  that  approximately  80-90%  of  cosmetic 
ingredients are tested for multiple uses), 

The  Commission  also  provided  Member  States  with  guidance  on  the  interpretation  of  the 
reporting requirements laid down in Art. 9 (a) of the Cosmetics Directive and discussed ways 
and means of gathering complete and accurate animal testing data in the field of cosmetics.  

b)  The  information  the  Commission  received  from  Member  States  for  the  present  report 
demonstrates how difficult it is to generate accurate figures on animal testing in the field of 
cosmetics.  Data  on  animal  tests  relating  to  cosmetic  products  are  collated  and  generated 
differently  throughout  the  European  Union.  There  is  no  uniform  practice  to  collate  animal 
testing  data  in  an  accurate  manner.  In  particular,  the  collation  of  relevant  multiple  use  tests 
remains a significant problem.  

Member  States  are  confronted  with  two  different  reporting  systems  relating  to  the  use  of 
laboratory animals, namely the Laboratory Animals Directive 86/609/EEC and the Cosmetics 
Directive  76/768/EEC.  The  Cosmetics  Directive  has  established  much  more  ambitious 
reporting requirements than the Laboratory Animals Directive and Member States still have 
difficulties to adapt to this situation.  

It  can  be  assumed  that  the  current  situation  does  not  fully  provide  for  the  collection  of 
accurate data required under the Cosmetics Directive due to practices at national level. Some 
Member States 

•  collate  data  on  the  basis  of  an  authorisation-/notification-procedure  for  animal 
tests, but these procedures do not ensure concrete information on the number and 
type of animal tests carried out in relation to cosmetic products;  

•  collate animal testing data according to “main uses” on the basis of Art. 13 of the 

Laboratory Animals Directive 86/609/EEC; 

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•  request  animal  testing  data  from  cosmetic  companies  although  there  is  no 
downstream information on animal testing data from the chemicals manufacturer 
or other suppliers to the cosmetics manufacturer; 

•  claim  that,  according  to  their  national  legislation,  animal  tests  are  prohibited  for 
the development of cosmetic products; this information, however, does not clarify 
how Member States break down figures for multiple use tests, which can include 
cosmetics use. 

c)  It  is  up  to  each  Member  State  to  establish  an  internal  structure  enabling  it  to  collate  and 
transmit  to  the  European  Commission  precise  data  on  the  number  and  type  of  experiments 
relating  to  cosmetic  products  carried  out  on  animals.  Member  States  have  the  choice  to 
establish  their  own  mechanisms  to  collate  animal  testing  data.  However,  these  mechanisms 
shall  ensure  that  all  relevant  test  data  are  collated  and  transmitted  to  the  European 
Commission  for  publication  in  the  annual  report.  The  European  Commission  is  currently 
working on guidelines in order to facilitate accurate generation and collation of animal testing 
data relating to cosmetic products.  

III.  Progress  in  the  Development,  Validation  and  Legal  Acceptance  of  Alternative 
Methods 

1. Legally Accepted Replacement Methods 

There are currently four alternative in vitro methods in relation to two toxicological endpoints 
(skin  corrosion  and  acute  phototoxicity)  listed  in  Annex  V  of  Directive  67/548/EEC.  These 
alternative  test  methods  are  currently  the  only  legally  accepted  tests  at  Community  level 
aiming at fully replacing animal tests for toxicological endpoints in the area of chemicals and 
cosmetics. 

The  in  vitro  tests  for  skin  corrosivity  and  the  in  vitro  3  T  3  NRU  phototoxicity  test  were 
introduced  into  Part  B  (B.  40  and  41)  of  Annex  V  to  Directive  67/548/EEC  by  Directive 
2000/33/EC  of  25  April  2000  and  are  to  be  applied  in  the  framework  of  the  testing  and 
marketing bans under the Cosmetics Directive since 11 September 2004 (Art. 3 of Directive 
2003/15/EC). 

2. Progress in Development and Validation of Alternative Approaches 

a)  On  1  October  2004,  the  Commission  established  the  timetables  for  the  phasing-out  of 
animal  testing  according  to  Art.  4  a  §2  of  the  Cosmetics  Directive.  In  order  to  estimate  the 
time  necessary  to  achieve  full  replacement  of  animal  testing  in  the  field  of  cosmetics,  the 
Commission  set  up  an  Ad  Hoc  Group  with  representatives  from  industry,  academia,  animal 
welfare groups and governmental bodies that agreed on a “Report Prepared in the Context of 
the 7th Amendment of the Cosmetics Directive for Establishing the Timetable for Phasing Out 
Animal  Testing”5.  The  Ad  Hoc  Working  Group  was  re-launched  in  2005  to  monitor  the 
progress  on  development,  validation  and  legal  acceptance  of  alternative  methods  to  animal 
tests  for  cosmetic  products.  As  a  contribution  to  this  process,  the  European  Centre  for 
Validation  of  Alternative  Methods  (ECVAM)  of  the  EC’s  Joint  Research  Centre  (JRC) 

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prepared  a  “Cosmetics  Technical  Report”  which  was  submitted  to  Member  States  and  all 
relevant stakeholders for consultation6.  

The “Cosmetics Technical Report” assesses the possibility to fully replace animal tests before 
the cut-off dates provided by Art. 4 a of the Cosmetics Directive in a differentiated manner:  

•  The concerted activities seem promising for meeting the 2009 deadline. For skin 
corrosion, acute phototoxicity and skin penetration,  accepted replacement assays 
already exist, whereas for mutagenicity accepted partial replacement assays exist. 
Results from a validation study on acute skin irritation look promising for meeting 
the deadline. Significant progress is also being made in the areas of eye irritation 
although additional work is still needed in order to fully replace the animal test. 
For  acute  toxicity,  the  results  of  a  completed  validation  study  indicate  the 
possibility  to  identify  non-toxic  substances  without  the  use  of  animals. 
Furthermore, as a result of the FP6 integrated project A-Cute-Tox (2005-2010) the 
proportion  of  substances,  for  which  acute  toxicity  can  be  established,  might  be 
expanded in the near future. 

•  For the 2013 deadline, the situation is much more critical. It is highly unlikely that 
it will be possible to predict chronic toxicity with  any  test strategy or  battery of 
non-animal  tests.  For  reproductive  toxicity  some  opportunities  from  the 
ReProTect project (2004-2009) might emerge. Cancer bioassays are very unlikely 
to be requested for cosmetic ingredients, since chemicals identified as positive in 
mutagenicity/genotoxicity  assays  are  usually  abandonned.  However,  in  case  the 
carcinogenic potential needs to be evaluated, cell transformation assays, which are 
currently under validation, might be used. Promising alternative methods exist for 
skin and respiratory sensitisation (currently tests under validation might allow the 
identification of large parts of non-sensitizers), and the integrated project Sens-it-
iv seeks for new methods (2005-2010). 

b) During the reporting period, increased efforts and numerous activities have been launched 
at EU-level to promote alternative approaches to animal testing. Most of them are of a more 
general nature but cover also the cosmetics sector. 

•  Developing robust and effective novel, alternative methods is a priority under the 
Framework Research Programmes of the European Union since more than twenty 
years.  Between  1999  and  2002,  the  EU  supported  43  research  projects  with  65 
million  Euro,  several  of  which  are  still  ongoing.  In  the  current  6th  Framework 
Programme  on  Research  and  Development,  20  projects  were  awarded  with  80 
million  Euro  by  the  Health  Programme,  and  two  projects  on  Intelligent  Testing 
Strategies  for  chemicals  and  (Q)SARs, for  about  12  Million  Euro  were  awarded 
by  the  Global  Change  and  Ecosystems  Programme.  Research  activities  will 
continue  under  7th  Framework  Research  Programme  (2007-2013)  through  a 
coordinated  activity  on  alternative  methods  and  strategies  for  safety  testing  on 
pharmaceuticals  and  cosmetics  (in  the  Health  Programme)  as  well  as  industrial 
chemicals (in the Environment Programme). 

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The  “Cosmetics  Technical  Report”  as  well  as  stakeholder-  and  additional  ECVAM-comments  are 
available on http://ec.europa.eu/enterprise/cosmetics/html/cosm_animal_test.htm.  

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•  On  7  June  2006,  the  Commission  adopted  a  Recommendation  Establishing 
Guidelines  on  the  Use  of  Claims  referring  to  the  Absence  of  Tests  on  Animals 
pursuant  to  Council  Directive  76/768/EEC7.  Further  activities  in  relation  to 
alternative approaches to animal testing have been launched at EU level, such as 
the European Partnership for Alternative Approaches to Animal Testing (EPAA)8, 
the  Community  Action  Plan  on  the  Protection  and  Welfare  of  Animals9,  the 
revision  of  the  Laboratory  Animals  Directive  86/609/EEC10  and  the  revision  of 
SCCNFP’s  Notes  of  Guidance  for  the  Testing of Cosmetic Ingredients and their 
Safety Evaluation.  

•  Private  initiatives,  such  as  those  by  the  European  Consensus-Platform  for 
Alternatives  (ECOPA)11
  and  the  Steering  Committee  on  Alternatives  to  Animal 
Testing of the European Cosmetic Toiletry and Perfumery Association (SCAAT), 
also  play  a  crucial  role  in  promoting  alternative  test  methods.  Since  1992, 
SCAAT’s main mission is the coordination of the Cosmetics Industry’s efforts in 
the  development  and  acceptance  of  alternatives  to  animals  in  cosmetic  safety 
evaluation.  It's  work  is  based  on  collaboration  –  not  only  between  member 
companies  –  but  also  with  other  groups  who  have  a  legitimate  interest  in  the 
outcome of the research (academia, industrial trade associations, national research 
and  regulatory  bodies).  Research  comprises  the  understanding  of  biological 
mechanisms,  method/strategies  development,  method  optimisation,  as  well  as 
prevalidation and validation in collaboration with ECVAM. The Colipa / SCAAT 
research  programme  focuses  on  the  main  areas  of  needs  and  expertise:  skin  and 
eye  irritation,  skin  allergy,  genotoxicity  and  risk  assessment  methodology12.  

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OJ L 158 of 10.06.2006, page 18 
For further information see http://www.ec.europa.eu/enterprise/epaa/index_en.htm 
COM (2006) 13 final, 23.1.2006 
For further information see http://ec.europa.eu/environment/chemicals/lab_animals/revision_en.htm 
For further information see http://www.ecopa.eu/ 
For  further  information  in  this  context  see  the  “COLIPA  Contribution”  to  the  “Cosmetics  Technical 
Report” of ECVAM http://ec.europa.eu/enterprise/cosmetics/html/cosm_animal_test.htm 

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to 
Development,  Validation  and  Acceptance  of  Alternative  Methods 
Toxicological  Endpoints  applicable  in  the  area  of  Cosmetics  (State  of  Play)  –  Table  3  13 

in  relation 

Validated and legally accepted methods aiming at fully replacing animal tests 

for the relevant toxicological endpoints14 

Validated  methods  aiming  at  fully  replacing  animal  tests  for  the  relevant 

toxicological endpoints 

Alternative methods under development and/or under validation by ECVAM. 

IV.  ACCEPTANCE  AND  RECOGNITION  OF  ALTERNATIVE  METHODS  AT  INTERNATIONAL 
LEVEL 

1. Multilateral Level 

OECD might play the most prominent role in promoting and accepting alternative methods at 
international  level.  OECD  Test  Guidelines  (TG)  are  broadly  accepted  by  the  international 
scientific  community  and  by  appropriate  regulatory  authorities  of  OECD  Member  countries 

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14 

1st  figure  in  brackets  represents  the  cut-off  date  for  the  testing  ban  in  relation  to  the  respective 
toxicological end point (Art. 4 a para 1d of the Cosmetics Directive) ; 2nd figure represents the cut-off 
date for the marketing bans in relation to the respective toxicological end point (Art. 4 a para 1 a and b 
of the Cosmetics Directive) 
Validated and legally accepted alternative methods are also available in relation to other toxicological 
endpoints, such as genotoxicity and mutagenicity, but these methods are not designed to fully replace 
animal testing for the relevant endpoints. 

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and a number of Non-Member countries. The EC-DG JRC’s ECVAM is closely working with 
the OECD in the validation, acceptance and promotion of alternative methods. 

In 2004, OECD adopted for the first time alternative methods aiming at replacing animal tests 
(skin absorption, TG 428; skin corrosion, TG 430 and 431; phototoxicity, TG 432). 

2. Bilateral Level 

The EU takes also a leading role in the international regulatory dialogues with authorities in 
USA and Japan in order to facilitate the compatibility of cosmetics regulations and to avoid 
trade  conflicts.  A  key  element  of  the  EU-US  cooperation  is  the  implementation  of  the 
Guidelines  for  Regulatory  Cooperation  and  Transparency  agreed  in  June  2002  under  the 
Transatlantic  Economic  Partnership  (1998)  in  the  framework  of  the  New  Transatlantic 
Agenda (1995). 

In the 2005 roadmap for US-EU Regulatory Cooperation the EU and the US agreed that “the 
cooperation  on  the  development  of  alternative  methods  needs  further  strengthening  through 
bilateral  contacts  with  the  aim  of  mutual  acceptance  of  alternative  methods.”  A  recent 
example  for  this  cooperation  is  the  active  participation  of  US  regulators  at  the  EPAA 
Conference on Alternative Approaches to Animal Testing on 7 November 2005 in Brussels, 
organized  by  Vice  President  of  the  European  Commission  Günter  Verheugen  and 
Commissioner Janez Potočnik.  

In  2003,  the  Commission  and  the  US  Food  and  Drug  Administration  (FDA)  agreed  on 
cooperation  in  cosmetics  regulation  for  the  validation  of  alternative  test  methods.  In  this 
cooperation agreement it was agreed to aim at 

•  co-operation and early exchange of information on the validation of test methods 
so  as  to  facilitate  mutual  recognition,  acceptance,  and  implementation  of 
scientifically validated testing methods and 

•  joint efforts to facilitate the OECD process in providing harmonized protocols to 
the  scientific  community  and  promoting  international  adoption  of  validated 
alternative methods. 

In  the  scientific  field,  since  1995,  ECVAM  co-operates  with  the  US  Interagency  Co-
ordinating Committee on the Validation of Alternative Methods (ICCVAM) with a view to an 
early  exchange  of  information  on  the  validation  of  test  methods  so  as  to  facilitate  mutual 
recognition,  acceptance,  and  implementation  of  scientifically  validated  testing  methods;  and 
at  joint  efforts  to  facilitate  the  OECD  process  in  providing  harmonised  protocols  to  the 
scientific community and promoting international adoption of validated alternative methods. 

This  cooperation  was  extended  to  the  Japanese  Centre  for  the  Validation  of  Alternative 
Methods  (“JACVAM”)  which  was  founded  in  December  2005.  Already  now,  ICCVAM, 
JACVAM and ECVAM are discussing the creation of an International Council of Validation 
Bodies, in order to harmonize procedures and collaborate strategically with OECD. 

V. CONCLUSIONS 

According  to  the  information  from  Member  States  received  for  the  present  report,  it  can  be 
doubted whether all Member States have established mechanisms which provide for accurate 

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animal  testing  data  and  effective  monitoring  of  the  application  of  the  testing  and  marketing 
bans. 

The European Commission is currently working on guidelines in order to facilitate accurate 
generation  and  collation  of  animal  testing  data  relating  to  cosmetic  products  for  the  next 
annual report.  

There are currently four alternative in vitro methods in relation to two toxicological endpoints 
(skin  corrosion  and  acute  phototoxicity)  listed  in  Annex  V  of  Directive  67/548/EEC.  These 
alternative  test  methods  are  currently  the  only  legally  accepted  tests  at  Community  level 
aiming at fully replacing animal tests for toxicological endpoints in the area of chemicals and 
cosmetic  products.  However,  concerted  activities  on  the  development  and  validation  of 
alternative approaches seem promising for meeting the 2009 deadline provided by Art. 4 a of 
the  Cosmetics  Directive.  For  the  2013  deadline,  the  situation  is  much  more  critical.  The 
replacement  of  animal  test  methods  by  alternative  methods  in  relation  to  complex 
toxicological endpoints remains scientifically difficult, despite the additional efforts launched 
at different levels. 

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