Report from the Commission to the Council and the European Parliament on the Development, Validation and Legal Acceptance of Alternative Methods to Animal Tests in the Field of Cosmetics (2004)
Date: 2005-04-29
Institutions: European Commission
Subjects: animal experimentation, cosmetic product, drafting of EU law, research, research method, testing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 29.4.2005 
COM(2005) 175 final 

Report from the Commission to the Council and the European Parliament 

on the Development, Validation and Legal Acceptance of Alternative Methods to Animal 
Tests in the Field of Cosmetics (2004) 

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I. INTRODUCTION 

The present 2004 report on the development, validation and acceptance of alternative methods 
to  animal  experiments  in  the  field  of  cosmetics  is  the  fifth  report  presented  by  the 
Commission. It reflects the state of play on the number and type of experiments on animals 
relating  to  cosmetic  products  between  1998  and  2003,  the  current  status  of  alternative 
methods, as well as the acceptance and recognition of alternative methods at the international 
level  as  of  December  2004.  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  first 
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.  

The  last  Commission  report  was  presented  in  1999  and  covered  the  situation  on  the 
development, validation and acceptance of alternative methods to animal experiments in the 
field  of  cosmetics  until  19971.  The  present  report  covers  the  situation  from  1998  to  2003, 
including data and information from the ten new Member States.  

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

ON ANIMALS 

The  European  Commission  has  adopted  on  20  January  2005  its  “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)2” according to Art. 26 of 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 purposes3. The report shows that the total number of animals 
used was in the same order of magnitude as in previous reports. The total number of animals 
used in the EU Member States in 2002 was 10.7 Million (France reporting for 2001).  

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COM (1999) 5 final of 6.1.1999 
COM (2005) 7 of 20.01.2005 
(http://europa.eu.int/comm/environment/chemicals/lab_animals/home_en.htm) 
OJ L 358, 18.12.1986, 1 

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Figure 1  

4 th  Statistical report : 
Purposes of experiments 
(in total : 10.7 million animals) 

Education and training   
 3,2%   

Other 5,57% 

Diagnosis of disease 
2.12% 
Toxicological and oth er     
safety evaluation 9,93%   

   Production and quality    
control veterinary   
medicine 2,47%   
Production and quality   
control human    
medicine and dentistry    
13,6%   

Fundamental biology
34.7%  

Research and develop  
human medicine  
+veterinary+dentistry 28,4% 

According to the 4th Statistical Report, more than 60% of the 10.7 million animals were used 
in  research  and  development  for  human  medicine,  dentistry  and  in  fundamental  biology 
studies,  about  16  %  in  production  and  quality  control  of  products  and  devices  in  human 
medicine,  veterinary  medicine  and  dentistry,  and  about  10  %  for  toxicological  and  other 
safety evaluation (Figure 1). From these 10 %, only 0.25 % (about 2600 animals) were used 
for  toxicological  or  other  safety  evaluations  of  products/substances  used  or  intended  to  be 
used mainly as cosmetics or toiletries (Figure 2). 

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Figure 2 

4th Statistical Report :
Animals used in toxicological or other safety 
evaluations of products 
(in total 1.07 million animals) 

Products/ 

 Products/  

substances used or  
intended to be used 
mainly as additives in 
food for human 
consumption 
1,2% 

substances used or 
intended to be used 
mainly as additives in 
food for animal 
consumption
0,3%

   Potential  or actual 
contaminants in the 
general environment 
which do not appear in 
other columns
12,4%

Products/ 

substances used or 
intended to be used  
mainly as cosmetics or 
toiletries 
0,25% 

Products/ 

substances used or 
intended to be used 
mainly in the household 
0,4% 

Products/ 

substances used or  
intended to be used  
mainly in industry 
12,75% 

Products/ 

substances used or 
intended to be used 
mainly in agriculture
11,5%

Other  

toxicological or safety 
evaluations 
10,3% 

 Products/ 

substances or devices 
for human medicine and  
dentistry and for 
veterinary medicine 
50,7%

For  the  present  report  on  the  number  of  animals  used  for  the  safety  testing  of  cosmetic 
products,  the  15  old  Member  States  conveyed  data  for  1998  –  2003,  the  10  new  Member 
States for 2003. According to the information submitted, cosmetic products/ingredients have 
been tested on animals from 1998 – 2003 only in the territories of FR, IT and DK (See the 
table  below).  The  other  12  old  Member  States  did  not  perform  such  animal  tests  in  their 
territory during this time period (ES did not convey complete data for 1998 -2003). The new 
Member  States  reported  that  they  did  not  perform  any  such  animal  test  in  their  territory  in 
2003. 

Number of Animals used in the Member States from 1998 to 2003 

France 

Italy 

1998 

4150 

1999 

3518 

2000 

2925 

2001 

2591 

2002 

2053 

2003 

1618 

Animals used : Mice, rabbits, fishes, hamsters, guinea pigs 

19 

98 

129 

Animals used : Rabbits, rats 

Denmark 

23 

14 

84 

1 

0 

60 

40 

0 

0 

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Animals used : Mice, Guinea pigs 

No data 
available 

No data 
available 

No data 
available 

No data 
available 

0 

0 

0 

0 

0 

0 

No data 
available 

0 

Spain 

Other 
Member 
States* 

*New Member States submitted data only for 2003 

In total, the number of animals used for testing cosmetics in the old Member States of the EU 
decreased significantly from about 4200 to 1600 (1998 – 2003), although the total number of 
animals  used  in  experiments  increased  in  all  sectors  outside  cosmetics  and  the  market  for 
cosmetics has continued to grow. Over the period 1999 – 2003, the Western European market 
(the EU-15 plus Norway and Switzerland) has grown by an average of around 4 % per year to 
increase to Euro 58,10 billion (retail sales prices) in 20034.  

The above mentioned figures on use of animals are unlikely to represent the full number of 
tests on substances used as cosmetic ingredients. There might be a number of reasons for this, 
e.g.  the  non-availability  of  comprehensive  records  on  animal  tests  on  substances  used  as 
cosmetic ingredients. Animal tests to assess the safety of ingredients are usually carried out on 
the  basis  of  chemicals  legislation,  because  they  are  normally  used  as  industrial  chemicals. 
Only in a few cases additional tests are necessary on the basis of the Cosmetics Directive. The 
cosmetic industry, as a downstream user of a number of such substances, mainly uses test data 
produced  by  the  supplier  under  chemicals  legislation  in  order  to  assess  the  safety  of 
ingredients in cosmetic products. Therefore, it is difficult to get hold of accurate figures.  

The  lack  of  accurate  figures  makes  a  comprehensive  assessment  of  the  use  of  animals  in 
cosmetic  tests  difficult.  The  Commission  will  contact  industry,  Member  States  and  other 
potential  sources  to  clarify  the  matter  and  to  establish  a  framework  which  would  provide  a 
more complete picture of animal tests carried out on ingredients used or intended to be used in 
cosmetic products. 

III.  PROGRESS  IN  THE  DEVELOPMENT,  VALIDATION  AND  LEGAL  ACCEPTANCE  OF 

ALTERNATIVE METHODS  

1. State of Play 

a)  In  comparison  with  the  last  report  from  1999,  significant  progress  in  the  development, 
validation and legal acceptance of alternative methods was achieved. On 1 October 2004, the 
Commission established the timetables for the phasing-out of animal testing according to Art. 
4 a §2 to Directive 76/768/EEC5. In order to establish these deadlines and 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  of  75  scientific  experts  representing  industries, 

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COLIPA, The European Cosmetic, Toiletry and Perfumery Market 2003, Brussels June 2004, page 5; 
COLIPA, The European Cosmetic, Toiletry and Perfumery Market 2001, Brussels June 2002, page 20 
Commission Staff Working Document of 1.10.2004, SEC (2004) 1210 

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academia,  animal  welfare  groups  and  governmental  bodies  that  agreed  on  a  “Report  for 
establishing  the  timetable  for  phasing-out  animal  testing  for  the  purpose  of  the  Cosmetics 
Directive (May 2004)”6.  

On  1  July  2004,  the  Scientific  Committee  on  Cosmetic  Products  and  Non-Food  Products 
intended  for  Consumers  (SCCNFP)  adopted  its  opinion  on  the  “Report  for  establishing  the 
timetable for phasing-out animal testing for the purpose of the Cosmetics Directive”7. 

b) The 6th Framework Programme on Research and Development8 supports the development 
of  alternative  methods  in  the  areas  of  development  of  new  in  vitro  tests  to  replace  animal 
experimentation (Thematic  Priority  1  -  Life  Sciences,  Genomics  and  Biotechnology  for 
Health)9  and  of  alternative 
testing  methods  and  strategies  for  chemical 
substances (Specific  activities  covering  a  wider  field  of  research  -  Policy  support  and 
anticipating  scientific  and  technological  needs)10.  The  Action  Plan  Science  and  society  also 
foresees activities in the area of ethics and animal welfare11. As an outcome of the first calls 
to proposals, specific projects have been selected for funding under areas of Thematic Priority 
1 and support to the chemical policy, amounting to 22.6 Mio Euros. 

in  vitro 

c) Private initiatives play a crucial role in promoting alternative test methods, as e.g. ECOPA 
and  SCAAT.  The  European  Consensus-Platform  for  Alternatives  (ECOPA)12  was  founded 
November 10, 2002, in Brussels by national platforms from ten European states (i.e. Austria, 
Belgium,  Czech  Rep.,  Finland,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  UK).  The 
purposes  of  ECOPA  are  to  facilitate  the  exchange  of  scientific  information,  expertise  and 
experience  between  national  consensus  platforms,  industry,  science,  animal  welfare  and  EU 
and government institutions. 

SCAAT is the Steering Committee on Alternatives to Animal Testing of COLIPA (European 
Cosmetic Toiletry and Perfumery Association). Since 1992, its main mission is to coordinate 
the Cosmetics Industry’s efforts in the development and acceptance of alternatives to animals 
in  cosmetic  safety  evaluation.  SCAAT  is  leading  a  Colipa-funded  research  program  which 
since 1992 focuses on mechanisms of eye irritation, skin irritation and skin allergy.  

d) The Commission  is  currently  preparing  a Recommendation on establishing guidelines  on 
the use of claims referring to the absence of tests on animals pursuant to Art. 6 §3 to Directive 
76/768/EEC. It aims at ensuring that common criteria are applied with regard to claims on a 
cosmetic product that no animal testing was carried out in relation to its development.  

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of 

on 

the 

website 

available 

Available on the website of the European Commission, http://pharmacos.eudra.org/F3/home.html 
SCCNFP/0834/04; 
the 
http://europa.eu.int/comm/health/ph_risk/committees/sccp/sccp_en.htm 
Decision n°1513/2002/EC of the European Parliament and of the Council of 27 June 2002 concerning 
the sixth Framework Programme of the European Community for research , technological development 
and  demonstration  activities,  contributing  to  the  creation  of  the  European  research  Area  and  to 
innovation, 2002-2006, OJ L232, 29.08.2002, page 1 
More information is available from the following web-site: http://www.cordis.lu/fp6/lifescihealth.htm 
More information is available from the following web-site: http://www.cordis.lu/fp6/support.htm 
More information available from the following: http://www.cordis.lu/science-society 
http://ecopa.vub.ac.be/ 

Commission, 

European 

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2. Future Activities 

a) The Ad Hoc Group which agreed on the “Report for establishing timetables for phasing-out 
animal testing” gave important recommendations and prospects for future activities13. It stated 
that  in  general,  the  longer  deadlines  for  phasing-out  the  animal  experimentation  were 
identified  in  those  areas  where  the  alternative  methods  are  still  under  research  and 
development (R&D), or where specific methods under R&D are required to complete the test 
strategies necessary to achieve full replacement of the animal tests. According to the report, 
the necessity to have funds and human resources at R&D level is one of the major bottlenecks 
for obtaining alternative methods.  

b) The Commission is currently working on a strategy for the monitoring of progress in the 
implementation  of  timetables  for  the  phasing-out  of  animal  testing  which  will  take  into 
account  the  recommendations  and  prospects  of  the  Ad  Hoc  Group  for  possible  future 
activities.  

IV.  ACCEPTANCE  AND  RECOGNITION  OF  ALTERNATIVE  METHODS  ON  INTERNATIONAL 

LEVEL  

The manufacture, distribution and sale of cosmetics are a global industry within which the EU 
is  a  major  player.  The  EU  cosmetics  and  perfumes  industry  market  volume,  based  on  retail 
prices at the point of sales, amounted to nearly 50 billion Euro in 2000, compared to the US 
(30,7  billion  Euro)  and  Japan  (14,3  billion  Euro)14.  Although  the  major  markets  in  the  EU, 
USA,  Japan  and  Canada  account  for  a  large  proportion  of  total  world  cosmetics  sale,  third 
countries represent significant and growing markets. In 2001, the export of cosmetics from the 
EU to third countries had a value of about Euro 7, 160 billion15.  

The international character of the cosmetic market was highlighted in a “Comparative Study 
on Cosmetic Legislation in the EU and other Principle Markets with special attention to so-
called Borderline Products (August 2004)”16 commissioned by DG Enterprise. 

1. Multilateral Level 

In  comparison  with  the  last  report,  a  number  of  additional  initiatives  to  promote  alternative 
methods to animal tests on the international level have been launched.  

a)  It  is  a  major  success  that  OECD  adopted,  for  the  first  time  in  2004,  alternative  methods 
aiming  at  replacing  animal  tests  (Skin  absorption:  In  vitro  method,  TG  428;  In  Vitro  Skin 
Corrosion:  Transcutaneous  Electrical  Resistance  Test,  TG  430;  In  Vitro  Skin  Corrosion: 
Human Skin Model Test, TG 431; In Vitro 3T3 NRU phototoxicity test, TG 432). OECD Test 
Guidelines  (TG)  are  broadly  accepted  by  the  international  scientific  community  and  by 
appropriate regulatory authorities of OECD Member countries and a number of Non-Member 
countries.  The  European  Centre  for  the  Validation  of  Alternative  Methods  (ECVAM)  is 
closely  working  with  the  OECD  in  the  validation,  acceptance  and  promotion  of  alternative 
methods.  

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See footnote 7 
http://europa.eu.int/comm/trade/issues/sectoral/industry/chem/cosmetics 
Eurostat (2003) 
Available on the website of the European Commission, http://pharmacos.eudra.org/F3/home.html 

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2,12% 
Diagnosis 
disease  

of 

b)  In  addition  to  these  initiatives,  DG  Enterprise  and  Industry  is  encouraging  the  technical 
harmonisation  process  in  the  field  of  cosmetics,  as  e.g.  between  EU  –  ASEAN  and  – 
MERCOSUR and intends to re-launch the discussions between the responsible authorities in 
USA, Canada and Japan under the Conference in International Harmonisation in the field of 
Cosmetics (CHIC). The next CHIC-conference is planned for March 2005 in Canada. 

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).  EU  and  U.S.  agreed  in  June  2004  on  a  road  map  for  further  cooperation 
between  the  U.S.  Food  and  Drug  Administration  (FDA)  and  DG  Enterprise  and  Industry 
regarding alternative non-animal testing methods. 

ECVAM  has  a  bilateral  co-operation  with  the  US  Interagency  Co-ordinating  Committee  on 
the Validation of Alternative Methods (ICCVAM) aiming at 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. 

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