REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Report on the Development, Validation and Legal Acceptance of Alternative Methods to Animal Tests in the Field of Cosmetics (2009)
Date: 2011-09-13
Institutions: European Commission
Subjects: animal experimentation, animal welfare, cosmetic product, international cooperation, market approval, product safety, research method, testing

EUROPEAN COMMISSION 

Brussels, 13.9.2011 
COM(2011) 558 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

Report on the Development, Validation and Legal Acceptance of Alternative Methods to 
Animal Tests in the Field of Cosmetics (2009) 

(Text with EEA relevance) 

 
 
 
 
  
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

Report on the Development, Validation and Legal Acceptance of Alternative Methods to 
Animal Tests in the Field of Cosmetics (2009) 

(Text with EEA relevance) 

1. 

INTRODUCTION 

The present report is the ninth Commission report on the development, validation and legal 
acceptance of alternative methods to animal tests in the field of cosmetics1. It has a twofold 
purpose: 

• 

• 

It is the yearly report in accordance with Article 9 of Council Directive 76/768/EEC 
of 27 July 1976 on the approximation of the laws of the Member States relating to 
cosmetic products (hereinafter “Cosmetics Directive”).2 In this regard it reflects the 
data on the number and type of experiments on animals relating to cosmetic products 
in 2009, as well as progress made in the development, validation and acceptance of 
alternative methods to animal testing in the Union and internationally.  

In  addition,  it  informs  the  European  Parliament  and  the  Council  that  for  technical 
reasons full replacement of the animal tests covered by the 2013 deadline will not be 
achieved  before  11  March  2013.3.  The  report  therefore  fulfils  the  first  part  of  the 
Commission  obligation  under  Article 4a  2.3  of  the  Cosmetics  Directive.  This 
provision  tasks  the  Commisssion  to  "inform  the  European  Parliament  and  the 
Council" and to "put forward a legislative proposal in accordance with Article 251 of 
the Treaty" if the Commission analysis concludes by 2011 "that for technical reasons 
one  or  more  tests  referred  to  in  paragraph  2.1  will  not  be  developed  and  validated 
before  the  expiry  of  the  period  referred  to  in  paragraph  2.1".  This  report  does  not 
prejudice how the Commission will respond to the second part, i.e. the decision how 
to address the lack of non-animal tests. 

2. 

COMPLIANCE WITH THE TESTING AND MARKETING BAN 

The  Cosmetics  Directive  foresees  a  phasing-out  of  animal  testing  for  cosmetics.  A  ban  of 
animal  testing  of  finished  cosmetic  products  has  been  in  force  since  September  2004  and  a 
testing ban on ingredients or combinations of ingredients since March 2009. As from March 
2009, it is also prohibited in the EU to market cosmetic products and their ingredients which 

1 
2 

3 

EN 

It is the fifth report following the 7th Amendment of the Cosmetics Directive 
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to 
cosmetic products, OJ L 262, 27.9.1976, p. 169. 
For  earlier  indications  see  already  the  'Report  for  establishing  the  timetable  for  phasing  out  animal 
testing 
Directive' 
http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-testing/index_en.htm 

Cosmetics 

purpose 

the 

the 

for 

of 

1 

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have been tested on animals, irrespective of the origin of these products. This marketing ban 
applies to all but the most complex human health effects to be tested to demonstrate the safety 
of cosmetic products (repeated-dose toxicity including skin sensitisation and carcinogenicity, 
reproductive  toxicity  and  toxicokinetics),  for  which  the  legislator  extended  the  deadline  to 
March 2013. 

2.1. 

Animal Testing Data 

For the present report, all Member States supplied information on animal tests carried out for 
the safety of cosmetic products in 2009. Given that the testing ban for ingredients applies as 
of 11 March 2009, testing in line with the Cosmetics Directive was only possible between 1 
January 2009 and 10 March 2009. In total, 344 animals were used in 2009 for tests carried out 
in relation to the safety of cosmetic ingredients (Table 1). In the previous years, when testing 
was allowed during the entire period, the figures were 1.818 for 2007 and 1.510 for 2008.  

According to the information received, cosmetic ingredients have only been tested on animals 
in  Spain  and  France.  These  Member  States  provided  detailed  information,  including  the 
testing  period,  the  toxicological  endpoint,  species  of  animals  used  for  experiments  and 
number of animals used for testing (Table 2). The other 25 Member States reported that no 
such animal tests were performed in their territory in 2009. 

Number of animals used in Member States (2009) – Table 1 

NUMBER OF 
ANIMALS USED 

ANIMALS USED 

SPAIN 

FRANCE 

Total 

42 

 302 

344 

Rabbits 

Rat, rabbit, guinea-pigs 

Number of Animals Used in Relation to Toxicological Endpoints (2009) – Table 2 

TYPES OF TESTS / COUNTRIES 

SPAIN 

FRANCE 

Skin irritation 

Eye irritation 

Skin sensitisation 

Non-lethal toxicity 

Other 

24 

18 

12 

3 

175 

72 

40 

2.2. 

Control and surveillance of the testing and marketing ban 

The performance of animal testing is closely controlled in Member States and this control will 
be  further  strengthened  as  of  1  January  2013  by  Directive  2010/63/EU  of  the  European 
Parliament  and  of  the  Council  of  22  September  2010  on  the  protection  of  animals  used  for 

EN 

2 

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scientific purposes4. One case of suspected testing after the deadline of 11 March 2009 was 
reported, which was given the respective follow-up by the responsible authorities. 

In relation to the marketing ban, Member States reported that they actively used the market 
surveillance instruments in place in order to enforce this ban. The main tool mentioned is the 
control of the product information file in accordance with Article 7a 1. (h) of the Cosmetics 
Directive. Controlling the provisions in relation to the testing and marketing ban is part of a 
check  list  agreed  by  Member  States  for  the  control  of  product  files.  Some  Member  States 
reported that they particularly drew the attention of the market surveillance authorities to the 
bans and provided training. Based on the experiences gathered so far Member States did not 
encounter infringements of the marketing ban.  

Member  States  however  also  pointed  out  that  ensuring  strict  market  surveillance  remains  a 
challenge,  considering  the  limited  resources  and  the  risk  that  manufacturers  would  include 
less  information  in  product  information  file  in  order  to  avoid  making  reference  to  animal 
testing data.  

3. 

PROGRESS  IN  THE  DEVELOPMENT,  VALIDATION  AND  LEGAL  ACCEPTANCE  OF 
ALTERNATIVE METHODS 

3.1. 

In the European Union  

3.1.1.  Availability of alternatives for the endpoints falling under the 2009 deadline 

Endpoints  falling  under  the  2009  deadline  of  the  marketing  ban  are  :  skin  corrosivity;  skin 
irritation; dermal absorption; mutagenicity/genotoxicity; phototoxicity; acute toxicity; and eye 
irritation5.  

Full  replacement  alternative  methods  are  currently  available  for  skin  corrosivity,  skin 
irritation,  dermal  absorption,  and  phototoxicity,  while  eye  irritation,  acute  toxicity  and 
mutagenicity/genotoxicity  are  only  covered  by  partial  replacement  methods.  For  these 
endpoints the marketing and the testing ban apply fully, thus unlike for the 2013 endpoints it 
is  not  possible  to  rely  on  data  generated  outside  the  Europan  Union,  so  that  industry  has  to 
rely on existing data.  

Commission Regulation (EC)  440/2008  brings  together all regulatory accepted test methods 
in  relation  to  the  2009  endpoints.  An  overview  of  regulatory  accepted  test  methods  is 
available  through  the  Tracking  System  for  Alternative  test  methods  Review,  Validation  and 
Approval  in  the  Context  of  EU  Regulations  on  Chemicals  (TSAR)6.  None  of  the  relevant 
animal tests is specific for cosmetics and none of the alternative methods validated so far was 
solely  applicable  to  cosmetic  ingredients  either.  Annex  IX  of  the  Cosmetics  Directive 
therefore has not been amended and does not list any specific alternative methods.  

The responsible scientific committee of the European Commission, the Scientific Committee 
on  Consumer  Safety  (SCCS),  has  recently  adopted  an  updated  version  of  its  "Notes  of 

4 

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Directive  2010/63/EU  of  the  European  Parliament  and  of  the  Council  of  22  September  2010  on  the 
protection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33 
See 
http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/antest/sec_2004_1210_en.pdf 
http://tsar.jrc.ec.europa.eu/ 

SEC(2004) 

established 

Timetable 

1210, 

2004, 

in 

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Guidance"7, in which it also describes the use of alternative methods in the safety assessment. 
In  June  2010,  it  issued  an  opinion  setting  out  "Basic  criteria  for  the  in  vitro  assessment  of 
ingredients"8. 
dermal 

absorption 

cosmetic 

of 

3.1.1.1 mutagenicity/genotoxicity 

In relation to mutagenicity/genotoxicity, the in vitro tests are not optimal yet as they are too 
sensitive  and  may  lead  to  an  undue  limitation  of  ingredients.  For  this  reason,  the  European 
Centre for the Validation of Alternative Methods of the Joint Research Centre (ECVAM) is 
working  on  improving  the  current  battery  of  in  vitro  tests.  The  European  Cosmetics 
Association  (Colipa)  is  focusing  on  the  development  of  genotoxicity  assays  based  on  3D 
human  skin  models  and  on  a  human  skin  metabolism  programme  focussed  on  safety 
assessment of topically applied substances. 

3.1.1.2 Eye irritation and acute toxicity 

For eye irritation and acute toxicity, several assays were validated by ECVAM, however none 
of  them  taken  individually  can  fully  replace  animal  testing  in  risk  assessment.  Testing 
strategies  which  combine  the  validated  assays  are  currently  under  development  and 
evaluation. Further results are expected in 2011. For acute toxicity, a previously validated test 
method was evaluated with regard to its capacity to identify substances with an LD50 > 2000 
mg/kg.  The  study  is  currently  under  peer  review  by  the  ECVAM  Scientific  Advisory 
Committee. 

3.1.2.  Availability of alternatives for the endpoints falling under the 2013 implementation 

date 

The  Commission  engaged  wide  expertise  and  public  input  for  its  assessment  of  the 
availability  of  alternatives  for  the  endpoints  falling  under  the  2013  implementation  date. 
Stakeholders  (industry,  non-governmental  organisations),  as  well  as  EU  Member  States  and 
the SCCS were invited to propose scientific experts. The selected experts analysed, under the 
co-ordination  of  ECVAM,  the  status  and  prospects  of  alternative  methods.  They  were  also 
asked to provide realistic estimates of the time required for the development of such methods 
(where they did not already exist) to a level approaching readiness for validation; i.e. meeting 
the criteria to enter pre-validation9. To allow broad input the Commission carried out a public 
consultation  between  23  July  and  15  October  201010  on  the  draft  report  drawn  up  by  the 
experts.  The  summary  of  the  outcome  of  the  public  consultation  is  accessible  on  the 
Commission's  website11.  While  the  majority  of  respondents  agreed  with  the  overall 
conclusions  of  the  report,  some  consider  that  the  available  methods  are  already  sufficiently 

7 

8 
9 

10 
11 

The SCCS'S Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 7th 
Revision, SCCS/1416/11, 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_004.pdf 
SCCS/1358/10 http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_002.pdf 
Pre-validation is a small-scale inter-laboratory study to assess the readiness of a test for inclusion in a 
formal large scale validation study 
http://ec.europa.eu/consumers/sectors/cosmetics/documents/public_consultation/index_en.htm 
See: http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-testing/index_en.htm 

EN 

4 

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advanced to allow for the safety assessment of cosmetics and that not enough emphasis was 
placed on the predictivity of the available alternative methods12.  

The  result  is  the  expert  report  "Alternative  (Non-Animal)  Methods  for  Cosmetics  Testing: 
Current  Status  and  Future  Prospects  –  2010"  (hereinafter  "the  technical  report"),  which  is 
available  on  the  Commission's  website13  and  is  also  published  in  a  peer  reviewed  journal14. 
This  report  contains  a  detailed  overview  of  the  alternative  methods  currently  under 
development.  

3.1.2.1.  Repeated Dose Toxicity 

Repeated  dose  toxicity  occurs  if  a  persistent  or  progressively  deteriorating  dysfunction  of 
cells,  organs  or  multiple  organ  systems,  results  from  long-term  repeated  exposure  to  a 
chemical. 

Alternative methods have so far been developed mainly with the aim of producing stand-alone 
methods predicting effects in specific target organs. In vitro models in relation to six of the 
most common targets for repeated dose toxicity (liver, kidney, central nervous system, lung, 
cardiovascular  and  haematopoietic  system)  exist.  However,  for  the  purpose  of  quantitative 
risk assessment, an integrated approach, e.g. based on the understanding of the mode of action 
and perturbation of biological pathways leading to toxicity, is needed.  

In  addition  to  in  vitro  techniques,  initial  attempts  of  computer-based  modelling  techniques 
have  suggested  the  feasibility  of  developing  models  providing  meaningful  predictions  of 
chronic or repeated dose toxicity. At present, a few such models are available. In addition, so-
called  "omics"-technologies  have  been  developed  in  recent  years  for  the  purpose  of 
understanding, and ultimately predicting toxicity. 

The  majority  of  these  tests  and  tools  are  however  at  the  research  and  development  level. 
While  these  methods  may  be  useful  for  hazard  identification  of  target  organ  toxicity  or  for 
obtaining  mechanistic  information,  none  of  them  is  currently  seen  as  appropriate  for 
quantitative  risk  assessment  for  repeated  dose  toxicity.  An  integrated  approach  needs  to  be 
developed. 

To  address  the  lack  of  methods  replacing  animal  tests  in  the  assessment  of  toxic  effects  of 
chronic  exposure,  the  Commission  launched  a  EUR  25  million  research  initiative  entitled 
“Towards  the  replacement  of  repeated  dose  systemic  toxicity  testing  in  human  safety 
assessment”15. As a result, 7 new research projects in this field have started in January 2011. 
These projects will closely cooperate to lay the scientific foundation for future safety testing 
methods  with  a  higher  predictive  value,  faster  and  cheaper  than  animal  tests.  They  will 
combine the research efforts of over 70 European universities, public research institutes and 
companies.  Colipa  has  committed  to  contribute  to  these  projects  by  an  additional  EUR  25 
million.  

12 

13 
14 

15 

See for example BUAV, Meeting the Deadline of the 2013 EU Marketing Ban. A Scientific Review of 
Non-Animal Tests for Cosmetics, 2011. 
See http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-testing/index_en.htm 
"Alternative (non-animal) methods for cosmetics testing: current status and future prospects—2010" in 
Archives of Toxicology: Volume 85, Issue 5 (2011), Page 367  
FP7-Health-2010-Alternative Testing 

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5 

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In  conclusion,  it  is  estimated  that  methods  for  full  animal  replacement  with  regulatory 
accepted tests/strategies will not be available by 2013. As full replacement for repeated dose 
toxicity is extremely challenging the experts could not provide a clear timeline by when they 
expect this to be possible. 

One  specific  endpoint  to  assess  repeated  dose  toxicity,  is  skin  sensitisation.  This  is  the 
toxicological endpoint associated with chemicals that have the intrinsic ability to cause skin 
allergy. 

Several  non-animal  methods  are  being  developed  for  hazard  identification;  but  data  from 
these test methods alone will not be sufficient for risk assessment decision-making as they do 
not  provide  potency  information.  Full  replacement  of  the  current  in  vivo  assays  will  not 
require  mimicking  all  mechanistic  steps  of  skin  sensitisation.  However,  at  present  it  is  not 
possible to predict which combinations of assays are needed to derive potency information for 
individual  chemicals  and  exposure  scenarios.  Consequently,  a  tool  box  covering  a  range  of 
mechanistic steps has been reviewed which could provide the required information. Previous 
efforts by Colipa have led to the successful development of three in vitro test methods for the 
detection  of  potential  sensitisers16.  At  present,  there  are  nine  ongoing  research  and  method 
development projects at Colipa in this area. 

In conclusion, the view of the experts is that in 2013 no full replacement of in vivo methods 
will  be  available.  By  2017-2019  the  experts  expect  the  scientific  ability  to  generate  the 
necessary information for making skin sensitisation risk assessment decisions using a toolbox 
of  non-animal  test  methods.  Hazard  identification  without  potency  information  might  be 
possible earlier, allowing for the identification of non-sensitisers. 

Another  specific  endpoint  on  repeated  dose  toxicity  is  carcinogenicity.  Carcinogenesis  is  a 
complex long-term multi-factorial process, and consists of a sequence of stages. Carcinogens 
have  conventionally  been  divided  into  two  categories  according  to  their  presumed  mode  of 
action: genotoxic carcinogens that affect the integrity of the genome by interacting with DNA 
and/or  the  cellular  apparatus,  and  non-genotoxic  carcinogens  that  exert  their  carcinogenic 
effects through other mechanisms. 

A combination of shorter-term in vitro and in vivo studies, including genotoxicity assays, is 
accepted to provide sufficient information for assessing the genotoxic potential of substances. 
Repeated  dose  (typically  90-day)  toxicity  studies  are  required  to  assess  the  risk  of  non-
genotoxic chemicals. 

Several  in  vitro  short-term  tests  at  different  stages  of  development  and  acceptance  are 
available.  However,  they  will  currently  not  be  sufficient  to  fully  replace  the  animal  tests 
needed to confirm the safety of cosmetic ingredients. The current alternatives are focused on 
hazard  evaluation  only  and  cannot  be  used  currently  to  support  a  risk  assessment  with  the 
necessary  quantitative  dose-response  information.  However,  for  some  chemical  classes  the 
available  non-animal  methods  might  be  sufficient  to  rule  out  carcinogenic  potential  in  a 
weight of evidence approach. 

16 

The  direct  peptide  reactivity  assay  (DPRA),  the  human  Cell  Line  Activation  Test  (h-CLAT)  and  the 
Myeloid U937 Skin Sensitisation Test (MUSST) 

EN 

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The  experts  conclude  that  alternatives  will  not  be  available  by  2013  and  they  are  unable  to 
suggest  a  timeline  for  full  replacement  of  animal  tests  currently  needed  to  fully  evaluate 
carcinogenic risks of chemicals.  

3.1.2.2.  Reproductive Toxicity 

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 
implantation, 
substance, 
embryonic/foetal  development,  parturition,  postnatal  adaptation,  and  subsequent  growth  and 
development into sexual maturity. 

fertility,  sexual  behaviour,  embryo 

including  effects  on 

Among the various stages in the reproductive cycle, embryo-foetal development is considered 
as  one  of  the  most  critical  steps.  Substantial  effort  has  been  spent  in  the  development  of 
promising in vitro assays, such as the Zebrafish embryo test and pluripotent embryonic stem 
cell  models,  to  allow  for  the  detection  of  the  teratogenic  potential  of  substances.  However, 
besides  their  current  role  as  mechanistic  support  and  screening  tools,  the  role  of  alternative 
methods  as  part  of  integrated  testing  strategies  for  regulatory  toxicity  evaluations  has  to  be 
defined further. 

The complexity of mammalian reproduction requires integrated testing strategies to be able to 
fulfil all needs for hazard identification and risk assessment. A promising way forward is the 
use  of  recently  established  comprehensive  databases  in  which  toxicological  information 
derived from standardised animal experimentations is collected. 

The experts estimate that the development of a testing strategy will need more than 10 years 
to complete. 

3.1.2.3.  Toxicokinetics 

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. 

Toxicokinetics is an essential and central body of information for non animal testing strategies 
for  systemic  toxicity.  A  whole  array  of  in  vitro/in  silico  methods  at  various  levels  of 
development  is  available  for  most  of  the  steps  and  mechanisms  which  govern  the 
toxicokinetics  of  cosmetic  substances.  Some  of  these  were  subject  of  EU  funded  projects, 
such as Predict-IV. By constrast, for excretion no in vitro/in silico methods are available. In 
addition, there is a lack of experience for absorption through the lung alveoli, which calls for 
strengthening relevant research and development given the fact that this route of exposure is 
important for cosmetics.  

The experts estimate that alternative methods to predict renal and biliary excretion, as well as 
absorption in the lungs need at least 5 to 7 years of development. However, the development 
of  an  integrated  approach,  linking  the  results  from  in  vitro/in  silico  methods  through 
toxicokinetics in silico modelling towards the full replacement of animals will take even more 
time. 

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3.2. 

At International Level 

The  Commission  has  put  the  issues  of  validation  and  regulatory  acceptance  of  alternative 
methods high on its agenda of sectoral regulatory dialogues at both multilateral and bilateral 
level. 

3.2.1.  Multilateral level 

The  Commission  continues  to  actively  work  with  its  counterparts  from  the  United  States, 
Japan  and  Canada  in  the  framework  of  the  "International  Cooperation  on  Cosmetic 
Regulation"  (“ICCR”).  In  this  context,  the  International  Cooperation  on  Alternative  Test 
Methods  (ICATM)  that  started  in  September  2008,  was  implemented  in  April  2009  by  a 
Memorandum  of  Cooperation  and  has  in  the  meantime  been  well  established.  ICATM 
members cooperate actively on the validation of alternatives and provide regular reporting to 
ICCR. Since March 2011 ICATM includes also the South Korean validation body. 

In  addition  to  these  efforts,  the  Commission  takes  a  leading  role  in  promoting  the 
development and validation of alternative test methods within the Organisation for Economic 
Co-operation and Development (OECD).  

In 2010 the OECD adopted alternative test method guidelines and guidance document based 
on validation studies and evaluations by the validation bodies of ICATM in the area of dermal 
irritation (a new TG 439 for three in vitro test methods), genetic toxicity (a new TG 487 for 
the  in  vitro  micronucleus  test  method),  as  well  as  reduction  and  refinement  methods  in  the 
area of skin sensitisation and in the area of oral acute toxicity. Several international validation 
studies are ongoing by ICATM organizations. 

3.2.2.  Bilateral level 

Questions of validation and regulatory acceptance of alternative methods are also at the core 
of  the  various  bilateral  regulatory  dialogues  with  the  main  trading  partners.  This  is  in 
particular  the  case  with  the  United  States  and  Japan,  who  are  also  ICCR  partners.  Much 
emphasis is placed on this subject in the bilateral contacts with China. 

4. 

CONCLUSION 

The overall conclusion and outlook is positive when looking at the developments since 2003, 
when  the  current  provisions  were  introduced.  Animal  testing  for  cosmetics  purposes  in  the 
European Union is once and for all a thing of the past. The testing ban is well implemented 
and controlled. The number of animals used has decreased over the years to the number 344 
registered for the first months of 2009, before the full testing ban entered into force. 

Regarding  the  2009  deadline,  of  the  seven  endpoints  relevant  for  cosmetic  products  safety, 
replacement 
For 
mutagenicity/genotoxicity  existing  methods  are  being  improved.  For  the  two  remaining 
endpoints, “eye irritation” and “acute toxicity”, progress is being made.  

alternative  methods 

available 

currently 

five. 

are 

for 

Regarding the 2013 deadline, validated alternative methods will not be available for either of 
the three toxicological endpoints before the marketing ban enters into force. Thanks to serious 
efforts,  a  number  of  partial  replacement  methods  are  available.  However,  full  replacement 
does not seem possible yet.  

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Progress has also been made in international cooperation, where the European Union is now 
building  trust  in  alternative  methods  and  joins  resources  with  international  partners  in  the 
validation  of  methods.  A  positive  development  is  also  the  strengthening  of  the  overall 
framework in relation to animal testing through the adoption of Directive 2010/63/EU on the 
protection  of  animals  used  for  scientific  purposes,  which  notably  reinforced  the  role  of 
validation and of ECVAM. The current report also shows that significant resources were and 
continue to be made available for research17 and that the cosmetics industry is taking an active 
and contributing role. 

The  Commission  is  currently  thoroughly  assessing  the  potential  impacts  of  the  situation  set 
out  in  this  report  on  the  animal  welfare,  on  the  safety  of  cosmetic  products  available  to 
consumers in the EU and on the social and economic context18. It is looking at all options and 
will make a decision based on the results of the said impact assessment as to whether or not to 
make a proposal to the European Parliament and the Council in relation to the implementation 
date 2013. 

17 

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For  an  overview  of  research  efforts  in  this  area  see:  Alternative  Testing  Strategies  –  Progress  Report 
2010, Replacing, Reducing and refining use of animals in research (http://axlr8.eu/axlr8-2010-progress-
report.pdf) 
See 
http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-
testing/stakeholders_consultation_en.htm 

consultation 

stakeholder 

received 

targeted 

under: 

input 

from 

a 

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