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 (2007)
Date: 2008-07-02
Institutions: European Commission
Subjects: animal experimentation, cosmetic product, drafting of EU law, report, research, research method, testing

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 2.7.2008 
COM(2008) 416 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 (2007) 

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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 (2007) 

1. 

INTRODUCTION 

The  present  “Report  on  the  Development,  Validation  and  Legal  Acceptance  of  Alternative 
Methods to Animal Experiments in the Field of Cosmetics” is the seventh report presented by 
the Commission. It reflects the state of play in terms of the number and type of experiments 
on  animals  relating  to  cosmetic  products  in  2005  and  2006,  the  current  status  of  alternative 
replacement  methods,  and  the  acceptance  and  recognition  of  alternative  methods  at 
international  level.  The  report  is  produced  in  order  to  comply  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”),  as  amended  by  the 
European Parliament and Council Directive 2003/15/EC of 27 February 2003. It is the third 
report  on  the  basis  of  the  7th  Amendment  to  the  Cosmetics  Directive  and  following  the 
inclusion of the Protocol on the Welfare of Animals in the Treaty of Amsterdam in 1999. 

2. 

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

2.1. 

Legal Background 

According  to  Article  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 
includes 
(Experimental  Animals  Directive).  The  Experimental  Animals  Directive 
requirements  to  report  at  regular  intervals  not  exceeding  three  years  on  the  number  and 
kinds of animals used in experiments. 

The  information  to  be  provided  under  the  Cosmetics  Directive  should  enable  the  European 
Commission and the Member States to gain a complete picture of the situation in the field of 
animal  testing  in  relation  to  cosmetic  products.  This  information  will  be  useful  in  order  to 
apply the relevant provisions of the Cosmetics Directive. 

The  ban  on  the  testing  of  finished  cosmetic  products  has  been  in  force  since  11  September 
2004,  whereas  the  ban  on  testing  ingredients  or  combination  of  ingredients  will  be 
implemented gradually as alternative methods are validated and adopted; however there will 
be  a  maximum  cut-off  date  of  six  years  after  the  entry  into  force  of  the  Directive,  i.e.  11 
March 2009, irrespective of the availability of alternative non-animal tests. The marketing ban 

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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 six years after entry into force of the Directive, i.e. by 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  laid  down,  i.e.  11  March  2013,  regardless  of  the  availability  of 
alternative non-animal tests. 

2.2. 

Animal Testing Data1 

For the present report, 26 Member States supplied information on animal tests carried out for 
the safety of cosmetic products in 2005 and 2006. Despite several requests, Portugal did not 
transmit  any  information  for  this  report  under  Article  9  (a)  of  the  Cosmetics  Directive.  As 
mentioned  in  a  reminder  letter  addressed  to  Member  States,  the  Commission  will  consider 
opening infringement procedure. 

According  to  the  information  submitted,  cosmetic  ingredients  have  only  been  tested  on 
animals  in  the  territories  of  France2  and  Romania.  These  Member  States  provided  detailed 
information,  including  the  testing  period,  the  toxicological  test  endpoint,  species  of  animals 
used for experiments and number of animals used for testing (Table 2).  

In  total,  about  2 276  animals  in  2005  and  about  1329  animals  in  2006  were  used  in  tests 
carried out in relation to the safety of cosmetic ingredients (Table 1). The other 24 Member 
States reported that they did not perform such animal tests in their territory in 2005/2006 or 
that they cannot provide the information for the reasons explained below (see 3.b). 

Number of animals used in Member States (2005/2006) – Table 1 

NUMBER OF ANIMALS USED 

ANIMALS USED 

ROMANIA 

FRANCE 

Total 

2005 

40 

2236 

2276 

2006 

40 

1289 

1329 

Rats 

rats,  guinea 

Mice, 
pigs, rabbits 

1 
2 

See reservations on the accuracy of data in paragraph 3 “Evaluation of submitted data”  
There  are  four  laboratories  which  perform  animal  testing  in  France  for  cosmetic  ingredients  or 
combination of ingredients. Research protocols are done for French clients and client from one another 
Member State. 

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Number of Animals Used in Relation to Toxicological Endpoints (2005/2006) – Table 2 

TYPES OF TESTS / COUNTRIES 

ROMANIA 

FRANCE 

Skin irritation 

Eye irritation 

Skin sensitivity 

Photosensitivity 

Oral toxicity 

2005 

2006 

2005 

2006 

165 

205 

248 

250 

40 

40 

1473 

455 

132 

261 

113 

223 

The total number of animals used for testing the safety of cosmetics showed a significant fall 
compared to the last report (2003: 1618, 2004: 8998). Indeed, the figures for 2006 are below 
those of 2003, even though twelve3new Member States joined the EU in that period. 

As  mentioned  in  the  last  report,  the  reported  number  of  animals  used  for  the  testing  of 
cosmetics or  toiletries is still relatively small compared to the total number of animals used 
for  experimental  and  other  scientific  purposes.  The  Fifth  Report  on  the  Statistics  on  the 
Number  of  Animals  used  for  Experimental  and  other  Scientific  Purposes  in  the  Member 
States  of  the  European  Union4  mentioned  that  8%  of  the  total  number  of  animals  used  for 
experimental  purposes  are  used  for  toxicological  and  other  safety  evaluations,  of  which 
cosmetics represent 0.5%. 

2.3. 

Evaluation of submitted data 

In August 2007, the Commission asked Member States to send accurate data on the number 
and  type  of  experiments  relating  to  cosmetic  products  carried  out  on  animals  in  2005  and 
2006 in accordance with Article 9 (a) of the Cosmetics Directive. The Commission specified 
that this information should also explain precisely what the figures represent and the way in 
which they were collated. 

Furthermore, the Commission annexed to  this request the guidelines announced in the 2005 
Report in order to facilitate accurate generation and collation of animal testing data relating to 
cosmetic products. 

2.3.1.  Main explanations given by Member States: 

The majority of Member States replied that no animal testing in relation to cosmetic products 
was  performed  in  2005  and  2006  in  their  territory.  The  main  explanations  they  gave  to 
substantiate their replies were the following: 

– 

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National legislation prohibits the carrying out of animal experiments in order to test 
and develop cosmetic products and their ingredients. Interestingly, sometimes some 

Bulgaria and Romania provided data, even if they joined afterwards. 
5.11.2007, COM(2007) 675 final 

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Member  States  specify  that  testing  for  cosmetic  purposes  is  prohibited  within 
multiple use tests. 

– 

National  legislation  stipulates  that  animal  testing  must  be  authorised  in  order  to  be 
lawfully performed, and therefore:  

– 

– 

No  authorisation  was  given  to  laboratories  to  test  and  develop  cosmetic 
products and their ingredients; 

There  are  no  approved  establishments  for  animal  experiments  relating  to 
cosmetic products. 

– 

The following do not exist on national territory  

– 

– 

– 

– 

– 

testing facilities for animal testing related to human health; or 

laboratories  complying  with  the  requirements  of  good  laboratory  practice 
where non-clinical studies of the health and environmental safety of substances 
could be carried out. 

The authorities responsible for checking cosmetic products and carrying out market 
surveillance  do  not  conduct  or  commission  animal  experiments  for  the  purposes  of 
such checks. 

A  letter  and  a  questionnaire  were  sent  to  representatives  of  cosmetic  product 
manufacturers. 

Competent  authorities  checked  the  product  information  file  which,  according  to 
Article  7a,  paragraph  1(h)  of  the  Cosmetics  Directive,  must  contain  “data  on  any 
animal testing performed by the manufacturer, his agents or suppliers, relating to the 
development  or  safety  evaluation  of  the  product  or  its  ingredients,  including  any 
animal testing performed to meet the legislative or regulatory requirements of non-
member countries”. They found nothing to suggest that chemical substances used as 
ingredients in cosmetics had been tested on animals. 

2.3.2.  Details of difficulties encountered by Member States 

Some  Member  States  elaborate  on  their  replies  by  mentioning  the  difficulties  they  had  in 
collecting the information. 

As  mentioned  in  the  previous  report,  chemicals  are  rarely  tested  on  animals  solely  for  their 
use  as  ingredients  in  cosmetics,  and  the  majority  of  animal  tests  are  conducted  for  multiple 
uses by manufacturers of chemical substances (industry assumes that approximately 80-90% 
of  cosmetic  ingredients  are  tested  for  multiple  uses).  Therefore,  some  Member  States 
acknowledged  that  it  is  difficult  to  determine  which  results  of  which  research  may 
subsequently be referred to by the cosmetic industry. 

Sweden explained that it considers itself unable to provide the requested information, as in its 
view  it  does  not  have  the  legal  basis  to  make  such  a  request  to  companies.  Indeed,  the 
information  provided  according  to  Article  7a,  paragraph  1(h)  is  only  required  to  be  readily 
accessible to the competent authorities of the Member State. 

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2.3.3. 

Initiatives taken by Member States for the collection of data 

In view of the situation and the efforts requested of the Member States by the Commission to 
deliver  the  appropriate  information,  some  Member  States  did  provide  information  about  the 
initiatives considered: 

– 

– 

– 

In order to ensure greater transparency in the data received, the toxicology laboratory 
that  normally  carries  out  the  most  tests  for  third  parties  has  initiated  an  internal 
procedure  under  which  clients  are  required  to  declare  that  the  substances  sent  for 
testing will not be used as ingredients in cosmetic products. 

The  supplier  or  manufacturer  or  the  person  responsible  for  placing  the  cosmetic 
product  on  the  market  shall  inform  the  National  Chemicals  Bureau  about  the  types 
and number of tests they have conducted on animals in connection with the purpose 
of ensuring their suitability and compliance with the cosmetic legislation. 

In  order  to  simplify  data  collection,  the  possibility  of  making  it  obligatory  for 
manufacturers  to  submit  information  on  tests  carried  out  on  animals  once  a  year  is 
being examined. 

2.3.4.  Conclusion 

The Commission continues to be concerned about the accuracy of the figures being reported, 
and this concern is shared by Member States.  

The  main  issue  relates  to  multi-use  substances.  Interestingly,  some  Member  States,  when 
mentioning that no animal testing has been performed for cosmetic products, reported that no 
toxicological  tests  were  carried  out  for  multiple  or  uncertain  purposes  where  it  could  be 
considered that the substance might be used as an ingredient in cosmetic products. 

The Commission considers that the best available source for information at national level is 
the information held according to Article 7a (1) (h). It is also the most suitable way to enforce 
the marketing ban laid down in Article 4a of the Cosmetics Directive. The implementation of 
REACH5  would  allow  passing  this  information  to  the  downstream  user  of  the  ingredient. 
Within  this  context,  the  Commission  will  consider  how  further  improve  the  availability  of 
relevant information.  

5 

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC, OJ L 396 of 30.06.2006 p. 1. 

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3. 

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

3.1. 

Legally Accepted Replacement Methods 

3.1.1.  Under Annex IX of the Cosmetics Directive 

Annex IX of the Cosmetics Directive “lists the alternative methods validated by the European 
Centre  on  Validation  of  Alternative  Methods  (ECVAM)  of  the  Joint  Research  Centre 
available to meet the requirements of this Directive and which are not listed in Annex V to 
Council Directive 67/548/EEC on the approximation of laws, regulations and administrative 
provisions relating to the classification, packaging and labelling of dangerous substances”. 

The purpose of Annex IX of the Cosmetics Directive is to supplement Annex V of Council 
Directive 67/548/EEC. Annex IX was created in order to ensure, without delay, the regulatory 
acceptance of alternative methods that would not be applicable to the whole chemical sector, 
but  only  to  the  cosmetic  sector.  Indeed,  recital  5  of  Directive  2003/15/EC  of  the  European 
Parliament and of the Council provides the following background: “Currently [in 2003], only 
alternative  methods  which  are  scientifically  validated  by  the  European  Centre  for  the 
Validation of Alternative Methods (ECVAM) or the Organisation for Economic Cooperation 
and  Development  (OECD)  and  applicable  to  the  whole  chemical  sector  are  systematically 
adopted at Community level. However, the safety of cosmetic products and their ingredients 
may be ensured through the use of alternative methods which are not necessarily applicable to 
all uses  of chemical ingredients.  Therefore, the  use  of  such  methods  by  the  whole  cosmetic 
industry  should  be  promoted  and  their  adoption  at  Community  level  ensured,  when  such 
methods offer an equivalent level of protection to consumers”. 

Considering  that  ECVAM  did  not  validate  alternative  methods  to  animal  testing  that  would 
not  be  applicable  to  the  whole  chemical  sector,  Annex  IX  was  not  amended  in  2007  and  is 
still empty. 

3.1.2.  Under Annex V of Council Directive 67/548/EEC 

The adoption of the 30th adaptation to technical progress of Council Directive 67/548/EEC, 
amending in particular Annex V, has been delayed due to the procedure under the Technical 
Barriers to Trade agreement. 

This  draft  Directive  provides  for  an  update  of  the  following  methods  which  were  already 
listed:  

– 

– 

– 

B.  40.  In  vitro  skin  corrosion:  transcutaneous  electrical  resistance  test  (TER), 
equivalent to the OECD TG 430 (2004); 

B.  40  Bis. In vitro skin corrosion: human skin model test, equivalent to the OECD 
TG 431 (2004); 

B. 41. In Vitro 3T3 NRU phototoxicity test, equivalent to OECD TG 432 (2004); 

And for the introduction of the following method concerning skin absorption:  

– 

B. 45. skin absorption (skin penetration): in  vitro Method, equivalent to the OECD 
TG 428 (2004). 

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3.1.3.  Under  the  Commission  Regulation  on  the  adoption  of  testing  methods  under 

Regulation 1907/2006 (the “REACH” Regulation) 

Directive  2006/121/EC6  of  the  European  Parliament  and  of  the  Council  provides  for  the 
deletion of Annex V of Council Directive 67/548/EEC as from 1 June 2008. The Commission 
has therefore adopted an implementation Regulation under REACH, which brings together, in 
one Regulation, all the test methods contained in Annex V to Directive 67/548/EEC7.  

3.2. 

Progress in Development and Validation of Alternative Approaches 

3.2.1.  ECVAM Technical Report 

The European Centre for the Validation of Alternative Methods (ECVAM) of the EC’s Joint 
Research Centre (JRC) prepared a “Cosmetics Technical Report” which is published in annex 
to  this  report.  Although  the  figures  in  this  report  cover  the  period  2005-2006,  the  technical 
report  also  covers  the  year  2007.  It  assesses  the  possibility  of  fully  replacing  animal  tests 
before the cut-off dates set out in Article 4a of the Cosmetics Directive. 

3.2.1.1.  For the end points falling under the 2009 deadline 

For skin corrosion, acute phototoxicity and skin penetration, as mentioned in the 2005 report, 
accepted replacement assays already exist. 

For in vitro skin irritation testing, ECVAM declared as scientifically validated an assay based 
on  reonstituted  human  epidermis  (EPISKIN  TM)  in  April  2007.  This  method  is  currently 
undergoing regulatory acceptance in the EU. 

For mutagenicity, in vitro methods have already been incorporated in legislation8. However, 
under the current test strategy for genotoxicity, positive results obtained from these methods 
require confirmation by animal testing due to the fact that they produce a high number of false 
positives.  Although  the  primary  screening  of  substances  is  based  on  in  vitro  methods,  the 
deadline of 2009 might still pose a problem. Indeed, owing to the existence of false positives, 
which  cannot  be  reduced  in  the  absence  of  alternative  methods  to  animal  testing  for  the 
confirmation  of  results,  the  number  of  active  cosmetic  ingredients  would  be  reduced,  for 
reasons not linked to their safety. 

For  eye  irritation,  the  2009  deadlines  for  full  replacement  are  unlikely  to  be  met.  The 
validated  tests  and  tests  strategies  available  would  allow  only  for  the  partial  replacement  of 
the animal test. Therefore, research is ongoing in order to allow such a replacement in future. 

For acute toxicity, because the results of the DG RTD funded A-cute-Tox EU project will not 
be available until 2009 results will not become available until 2010 onwards. 

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Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending 
Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions 
relating  to  the  classification,  packaging  and  labelling  of  dangerous  substances  in  order  to  adapt  it  to 
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction 
of Chemicals (REACH) and establishing a European Chemicals Agency, OJ L 396 of 30.12.2006. 
OJ L 142 of 31.05.2008 
In Annex VIII of Regulation 1907/2006 REACH  

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3.2.1.2.  For the endpoints falling under the 2013 deadline 

As already mentioned in the 2005 report, there is unfortunately no indication that the deadline 
can  be  met  for  the  complex  endpoints,  such  as  chronic  toxicity,  reproductive  toxicity  and 
toxicokinetics,  although  several  activities  are  ongoing.  The  only  area  for  optimism  would 
appear to be skin sensitisation, depending on the results of the integrated project Sens-it-iv. 

3.2.2. 

SCCP statements 

In 2007, the Scientific Committee on Consumer Products (SCCP), who is responsible for the 
evaluation  of  the  substance  used  in  cosmetic  products,  delivered,  on  its  own  initiative,  two 
statements regarding the availability of alternative methods.  

In its memorandum of June 2007 on the Actual Status of Alternative Methods on the Use of 
Experimental  Animals  in  the  Safety  Assessment  of  Cosmetic  Ingredients  in  the  European 
Union9, the SCCP expressed its concerns regarding the availability of alternative methods to 
animal testing to conduct safety assessment, opposed to hazard identification. 

In  its  memorandum  of  December  200710on  the  in  vitro  test  EPISKIN™  for  skin  irritation 
testing,  the  SCCP  underlined  the  possible  limited  applicability  of  this  method  regarding 
colouring  agents  and  hair  dyes.  This  aspect  was  mentioned  by  ECVAM  when  transmitting 
this method for regulatory acceptance under Annex V of Council Directive 67/548/EEC. 

3.2.3.  RTD activities  

Developing  robust  and  effective,  novel,  alternative  methods  has  been  a  priority  under  the 
Framework  Research  Programmes  of  the  European  Union  for  more  than  20  years.  The  first 
calls for proposals under the 7th RTD Framework Programme resulted in the selection of five 
proposals on the Theme “Health” (two large–scale integrating projects, two focused research 
projects, and one specific support action, expected EU contribution: €30 million). The areas 
addressed  by  the  Theme  “Health”  include:  profiling  the  toxicity  of  new  drugs  and  of 
nanoparticles  in  medical  diagnostics  without  animal  tests,  QSAR  models  in  the  field  of 
predictive toxicology and bottlenecks in the 3R approach in pharmaceutical development. 

Two  proposals  have  been  selected  for  funding  in  the  Theme  “Environment”  (2  focused 
research  projects  in  the  field  of  in-silico  methods;  expected  EU  contributions:  €5  million). 
Even though the projects are tailor-made for specific areas, it is expected that their results will 
be widely transferable to other areas relevant for the implementation of the 3R concept. 

3.2.4.  COLIPA (The European Cosmetic Toiletry and Perfumery Association) 

It has a research programme on Alternative Approaches to Animal Testing (AAT) to support 
the  development,  validation  and  acceptance  of  alternative  approaches  in  order  to  replace 
animal use.  

For  eye  irritation,  COLIPA  submitted  to  ECVAM  in  beginning  of  2008  results  from  the 
optimization of the two most advanced Human Reconstructucted Tissue models11. 

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SCCP/1111/07; http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_s_06.pdf 
SCCP/1145/07; http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_s_07.pdf 
SkinEthic Human Corneal Epithelium (HCE) model and the MatTek Epiocular model 

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For genotoxicity and mutagenicity, COLIPA is working to develop approached to reduce the 
“false positive” rate of in vitro mammalian cell genotoxicity assays and to develop genotoxic 
assays in 3D human skin models. 

For  skin  allergy,  COLIPA  is  aiming  to  propose  three  methods  for  validation  to  ECVAM  in 
200812. 

3.2.5.  Others 

The  ongoing  activities  mentioned  in  the  2005  report,  such  as  the  European  Partnership  for 
Alternative  Approaches  to  Animal  Testing  (EPAA)13  the  Community  Action  Plan  on  the 
Protection  and  Welfare  of  Animals14  and  the  revision  of  Directive  86/609/EEC  on  the 
protection of animals used in experiments15, were continued. 

4. 

ACCEPTANCE AND RECOGNITION OF ALTERNATIVE METHODS AT INTERNATIONAL 
LEVEL 

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

4.1.  Multilateral level 

The Commission met with its counterparts from the United States, Japan and Canada at the 
"International  Cooperation  on  Cosmetic  Regulation"  (“ICCR”)  meeting  from  26  to  28 
September  2007.  One  focal  point  of  this  meeting  was  exploring  hurdles  in  the  international 
regulatory  acceptance  of  alternative  testing  methods.  It  was  concluded  that  it  is  therefore 
crucial to ensure that, at the validation stage, the assessments within different jurisdictions do 
not differ. 

An  agreement  at  the  “validation  stage”  would  be  a  great  help  in  ensuring  harmonised 
regulatory acceptance, thus facilitating trade and enhancing animal welfare. 

In  order  to  avoid  different  recommendations  after  validation  and  peer  review  of  alternative 
methods/approaches,  the  Commission  is  working  towards  establishing  an  international 
collaboration on validation/peer review processes in various regions. Discussions have started 
between the EU and US in the framework of the Transatlantic Economic Council (see below). 

In  addition  to  these  efforts,  the  Commission  is  cooperating  with  the  OECD  by,  regularly 
taking  part  in  meetings  and  working  groups,  such  as  the  OECD  Working  Group  of  the 
National  Coordinators  of  the  Test  Guidelines  Programme,  the  Endocrine  Disrupters  Testing 
and Assessment Task force and its subgroups, that deal with non-animal tests (e.g. Validation 
Management  Group  -  Non-Animal),  and  other  ad-hoc  expert  groups  dealing  with  various 
alternative methods. 

12 
13 
14 
15 

Human Cell Line Activation Test (h-CLAT), U937/CD86 and a pepttide-binding assay. 
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 

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4.2. 

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. In particular: 

4.2.1.  U.S. 

Making progress on issues of validation and regulatory acceptance of alternative methods is 
one  of  the  key  deliverables  agreed  under  the  Transatlantic  Economic  Framework,  and  this 
work is closely monitored by the Transatlantic Economic Council (TEC). 

The  issue  was  discussed  at  the  meeting  with  the  TEC  on  9  November  2007  in  Washington 
between  Vice-President  Günter  Verheugen  and  the  then  Director  of  National  Economic 
Advisors/Special Assistant to the US President, Al Hubbard. 

The EU and the United States agreed that the approach chosen at the multilateral level (see 
above)  is  crucial  and  are  working  towards  the  swift  establishment  of  a  joint  validation/peer 
review  process  taking  into  account  the  specific  demands  of  different  jurisdictions  as  far  as 
possible. 

ECVAM  and  IICVAM  are  collaborating  on  several  validation  studies  and  ICCVAM  has  an 
observer status on the EVCAM Scientific Advisory Committee (ESAC). 

ICCVAM also participated in the annual conferences of EPAA in 2006 and 2007. 

4.2.2. 

Japan 

In  Japan,  animal  testing  of  cosmetic  products  and  their  ingredients  is  not  obligatory  per  se. 
However,  animal  tests  are  conducted  in  the  framework  of  the  regulation  of  cosmetics 
ingredients  and  “quasi-drugs”,  some  of  which  are  considered  as  cosmetic  products  in  the 
EU.16 

Issues  of  animal  testing  have  been  repeatedly  raised,  particularly  in  the  framework  of  the 
regulatory  reform  dialogues  in  2006  and  2007.  In  2006,  Japan  stressed  its  commitment  to 
implement OECD testing guidelines. In 2007, Japan indicated a clear interest in participating 
in the setting-up of an international validation process as discussed at the ICCR (see above). 

Moreover,  activities  in  the  field  of  validation  are  also  ongoing  under  the  co-ordination  of 
JaCVAM (Japanese Centre for the Validation of Alternative Methods). ECVAM is an official 
member in the validation management teams whereas observers from JaCVM are regulatory 
invited to meetings of the ECVAM Scientific Advisory Board (ESAC). 

4.2.3.  China 

The regulatory system in China is particularly challenging, as animal testing on the finished 
cosmetic product is obligatory in order to have market access. These tests are often carried out 
by the competent authorities under a marketing authorisation. 

The issue has been discussed in numerous fora, and in particular at 

16 

For example, deodorants, hair dyes and certain oral care products. 

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the  EU-China  (AQSIQ)  working  group  on  cosmetic  products  which  met  on  15 
September 2006 in Brussels and on 24 October 2007 in Beijing. At the invitation of 
the Commission, AQSIQ also participated at the second annual conference of EPPA 
on 18 December 2006. 

– 

the meeting of the Commission with the Chinese SFDA on 4 July 2007 in Brussels; 

Moreover,  questions  about  animal  testing  were  raised  in  several  comments  by  the  EU  on 
notifications under the TBT agreement.17 

5. 

CONCLUSION 

It can be noted that Member States have improved their internal structure in order to provide 
for accurate animal testing data and effective monitoring of the application of the testing and 
marketing  bans,  as  it  was  encouraged  in  the  guidelines  annexed  to  the  request  to  Member 
States for accurate data18.  

There  are  currently  four  alternative  in  vitro  methods  in  relation  to  three  toxicological 
endpoints  (skin  corrosion,  acute  phototoxicity  and  skin  penetration)  listed  in  Annex  V  of 
Directive  67/548/EEC  and  one  method  for  the  mutagenicity  testing  listed  under  REACH19. 
These  alternative  test  methods  are  currently  the  only  legally  accepted  tests  at  Community 
level aimed at fully replacing animal tests for toxicological endpoints in the area of chemicals 
and cosmetic products. A method concerning skin irritation is likely to be soon accepted for 
regulatory  purposes.  For  eye  irritation  and  acute  toxicity,  the  situation  is  uncertain  and  the 
Commission will focus its efforts on these human health effects in view of the 2009 deadline. 

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 various levels. 

17 
18 
19 

Cf. in particular notification G/TBT/N/CHN/209 - Hygienic specifications for cosmetics. 
See paragraph 2.3. 
Listed under Annex VIII of Regulation 1907/2006. 

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