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 (2008)
Date: 2010-09-16
Institutions: European Commission
Subjects: animal experimentation, cosmetic product, drafting of EU law, report, research, research method, testing

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EUROPEAN COMMISSION 

Brussels, 16.9.2010 
COM(2010) 480 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 (2008) 

(Text with EEA relevance) 

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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 (2008) 

(Text with EEA relevance) 

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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 (2008) 

(Text with EEA relevance) 

1. 

INTRODUCTION 

The  present  “Report  on  the  Development,  Validation  and  Legal  Acceptance  of  Alternative 
Methods to Animal Tests in the Field of Cosmetics” is the eighth report concerning this issue 
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 2007 and 2008, 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/EEC1  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 fourth 
report on the basis of the 7th Amendment to the Cosmetics Directive. 

This present report is the last report covering the period before the coming into force of the 
full  testing  ban  for  ingredients  and  combinations  of  ingredients  for  cosmetics  and  the 
marketing  ban  for  all  human  health  effects  with  the  exception  of  repeated-dose  toxicity, 
reproductive toxicity and toxicokinetics on 11 March 2009.  

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

The  ban  on  the  testing  of  finished  cosmetic  products  has  been  in  force  since  11  September 
2004, whereas the ban on testing ingredients or combinations of ingredients, applies since 11 

1 

Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to 
cosmetic products (76/768/EEC); OJ L 262, 27.9.1976, p. 169 

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March 2009, irrespective of the availability of alternative non-animal tests. The marketing ban 
applies since 11 March 2009, for all human health effects with the exception of repeated-dose 
toxicity, reproductive toxicity and toxicokinetics. For the latter endpoints the marketing ban 
will apply as of 11 March 2013, regardless of the availability of alternative non-animal tests. 
The  Commission  must  study  the  progress  and  compliance  with  the  deadlines,  as  well  as 
possible technical difficulties in complying with the ban. By 2011 the Commission must, in 
particular, study whether for technical reasons one or more tests covered by the 2013 deadline 
will  not  be  developed  and  validated  before  March  2013.  It  shall  inform  the  European 
Parliament and the Council and will, if appropriate, put forward a legislative proposal. 

These provisions have not been changed within the new Cosmetics Regulation2. 

2.2. 

Animal Testing Data3 

For the present report, 27 Member States supplied information on animal tests carried out for 
the  safety  of  cosmetic  products  in  2007  and  2008.  According  to  the  information  submitted, 
cosmetic ingredients have only been tested on animals in the territories of France and Spain. 
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).  

In  total,  1818  animals  in  2007  and  1510  animals  in  2008  were  used  in  tests  carried  out  in 
relation to the safety of cosmetic ingredients (Table 1). The other 25 Member States reported 
that no such animal tests where performed in their territory in 2007/2008 or that they cannot 
provide the information for the reasons explained below (see 2.3.1). 

Number of animals used in Member States (2007/2008) – Table 1 

NUMBER OF ANIMALS USED 

ANIMALS USED 

2007 

12 

1806  

2008 

No data 

Rabbits 

1510 

rats,  guinea 

Mice, 
pigs, rabbits 

1818 

1510 

SPAIN 

FRANCE 

Total 

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3 

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 
on cosmetic products; OJ L 342, 22.12.2009, p. 59 
See reservations on the accuracy of data under 2.3 “Evaluation of submitted data”  

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Number of Animals Used in Relation to Toxicological Endpoints (2007/2008) – Table 2 

TYPES OF TESTS / COUNTRIES 

SPAIN 

FRANCE 

Skin irritation 

Eye irritation 

Skin sensitisation 

Mutagenicity 

Non-lethal toxicity 

2007 

2008 

20074 

2008 

12 

No 
data 

126 

82 

61 

25 

1154 

1283 

159 

266 

54 

66 

The total number of animals used for testing the safety of cosmetics showed a slight increase 
compared to the last report's figures for 2006 (2005: 2 276, 2006: 1 329).  

Nevertheless,  the  reported  number  of  animals  used  for  the  testing  of  cosmetics  or  toiletries 
remains  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  Union5 
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 2008, the Commission asked Member States to send accurate data on the number 
and type of experiments relating to cosmetic ingredients carried out on animals in 2007 and 
2008, 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. As for the last report, the Commission annexed to this request the 
guidelines drawn up in order to facilitate accurate generation and collation of animal testing 
data relating to cosmetic products. 

The  Commission  also  requested,  in  view  of  the  deadline  of  11  March  2009,  information 
regarding the way Member States intend to ensure the implementation of the marketing ban as 
provided by Article 4a of the Cosmetics Directive.  

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  2007  and  2008  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.  

Total figures includes 40 animals used for other tests not specified 
5.11.2007, COM(2007) 675 final 

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– 

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 and the answer indicated that no tests were carried out. 

Competent  authorities  checked  the  product  information  file  which,  according  to 
Article  7a,  paragraph  1(h)  of  the  Cosmetics  Directive,  must  also  contain  data  on 
animal  testing.  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  elaborated  on  their  replies  by  mentioning  the  difficulties  they  had  in 
collecting the information. 

As pointed out in the previous reports, 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 testing has been carried out with a view 
to cosmetic purposes. 

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2.3.3. 

Initiatives taken by Member States for the collection of data 

In  view  of  the  efforts  requested  of  the  Member  States  by  the  Commission  to  deliver  the 
appropriate information, some Member States described the measures taken to improve data, 
such as: 

– 

– 

– 

A notice was sent to all license holders authorised  to carry out  animal  experiments 
specifying  that  they  must,  when  submitting  information  on  experiments  in 
connection  with  cosmetics,  supply  information  on  the  number  and  type  of 
experiments  conducted,  including  the  purpose  of  the  experiments  and  the  type  of 
cosmetic  product  or  toiletry  the  substances  tested  were  expected  to  be  included  in 
(skin cream, toothpaste etc.). 

The notice also stated that those who had conducted experiments on animals in tests 
on multipurpose substances under chemicals legislation must supply information on 
the extent to which one of the secondary purposes of the substances could be used in 
cosmetics or toiletries. 

A  survey  based  on  a  questionnaire  involving  the  key  laboratories  most  likely 
involved in animal testing was carried out. 

On-the-spot inspections at bodies carrying  out toxicological tests on behalf of  third 
parties were carried out and more information was requested by directly contacting 
laboratory managers.  

2.3.4.  Measures foreseen in the light of upcoming marketing ban  

In  view  of  the  upcoming  marketing  ban  Member  States  have  essentially  informed  the 
Commission that they will use the market surveillance instruments in place in order to enforce 
the marketing ban. The main tool mentioned is the control of the information provided in the 
product  information  file  in  accordance  with  Article  7a  of  the  Cosmetics  Directive,  and  in 
particular  under  Article  7a  (1)  (h).  It  was  also  mentioned  that  the  provisions  of  the  new 
Cosmetics Regulation6 could facilitate this tasks as it spells out, in more detail, the content of 
the product information file. Some Member States gave more detailed information about the 
responsible  market  surveillance  authorities,  as  well  as  plans  on  project-based  checks.  A 
number  of  Member  States  also  planned  to  particularly  draw  the  attention  of  market 
surveillance authorities to the ban through guidance notes and similar tools.  

2.3.5.  Conclusion 

The  Commission  acknowledges  that  Member  States  have  made  efforts  to  improve  the 
availability of data and that the overall availability has improved. However, 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  multiple  use  substances.  Some  Member  States,  when  mentioning 
that  no  animal  testing  has  been  performed  for  cosmetic  ingredients,  reported  that  no 
toxicological  tests  were  carried  out  for  multiple  or  uncertain  purposes  where  it  could  be 

6 

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 
on cosmetic products; OJ L 342, 22.12.2009, p. 59 

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considered that the substance might be used as an ingredient in cosmetic products. Legislation 
stipulating that animal testing must be authorised in order to be lawfully performed appears a 
useful tool to determine the purpose of testing. 

The Commission considers that the information held according to Article 7a (1) (h) is also a 
valuable source of information.  

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.  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 2008 and 2009 and is still empty. 

3.1.2.  Council  Regulation  (EC)  No  440/2008  of  30  May  2008  laying  down  test  methods 
pursuant  to  Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH)  

Directive  2006/121/EC7  of  the  European  Parliament  and  of  the  Council  provided  for  the 
deletion of Annex V of Council Directive 67/548/EEC as from 1 June 2008. The Commission 
has  adopted  an  implementation  Regulation  under  Regulation  1907/2006  on  REACH,  which 
brings  together,  in  one  Regulation  all  the  test  methods  contained  previously  in  Annex  V  to 
Directive 67/548/EEC. This is Regulation 440/2008/EC8, which now also includes: 

–  B.10. Mutagenicity: In vitro mammalian chromosome aberration  

–  B.13/14. Mutagenicity: Reverse mutation test using bacteria  

–  B.17. Mutagenicity: In vitro mammalian cell gene mutation test 

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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. 
Council  Regulation  (EC)  No  440/2008  of  30  May  2008  laying  down  test  methods  pursuant  to 
Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the  Council  on  the  Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH) , OJ L 142 of 31.05.2008 

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–  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); 

–  B.42. Skin sensitisation: Local lymph node assay, equivalent to the OECD TG 429 (2002) 

(Note: this is not a replacement test); 

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

(2004); 

–  B.469. In vitro skin irritation. Reconstructed human epidermis model test  

3.2. 

Progress in Development and Validation of Alternative Approaches 

3.2.1.  ECVAM Technical Report 

ECVAM  prepared  a  “ECVAM  Technical  Report”  covering  the  period  2008-200910.  It 
assesses  the  possibility  of  fully  replacing  animal  tests  before  the  cut-off  dates  set  out  in 
Article  4a  of  the  Cosmetics  Directive  and  provides  detailed  information,  including  an 
overview table, on the ECVAM activities and progress in relation to the respective endpoints. 

3.2.1.1.  For the end points 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 
irritation.  Alternative  methods  are  currently  available  for  all  of  these  (see  3.1.2),  with  the 
exception  of  the  last  two,  eye  irritation  and  acute  toxicity.  However  in  relation  to 
mutagenicity/genotoxicity,  these  tests  are  prone  to  an  unacceptable  rate  of  false  positive 
results. ECVAM is working on improving the in vitro testing battery to address this. 

For eye irritation and acute toxicity several assays were validated by ECVAM, however none 
of them can fully replace animal testing in risk assessment. Testing strategies which combine 
the  validated  assays  are  currently  under  development  and  evaluation,  with  the  aim  to 
completely replace the animal test for eye irritation. Further results are expected by 2011. 

3.2.1.2.  For the endpoints falling under the 2013 deadline 

Endpoints  falling  under  the  2013  deadline  of  the  marketing  ban  are  repeated-dose  toxicity 
(including skin sensitisation and carcinogenicity), toxicokinetics and reproductive toxicology. 
For these no replacement alternatives are available yet and the situation is much more critical. 

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Included  by  COMMISSION  REGULATION  (EC)  No  761/2009  of  23 July  2009  amending,  for  the 
purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods 
pursuant  to  Regulation  (EC)  No 1907/2006  of  the  European  Parliament  and  of  the  Council  on  the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 
The technical report is available on the ECVAM website http://ecvam.jrc.ec.europa.eu/ 

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Toxicokinetics and metabolism in vitro and in silico test systems are of crucial importance to 
discard  artifactual  findings  secondary  to  the  in  vitro  environment.  A  collaborative  effort 
between  industry,  academia,  the  European  Commission  and  the  three  validation  bodies 
(ECVAM11,  ICCVAM12  and  JACVAM13)  was  therefore  set  up  to  validate  an  in  vitro 
metabolic competent test system as an important building block in integrated testing strategies 
for the complex endpoints. 

For  the  endpoint  on  carcinogenicity,  three  variants  of  the  cell  transformation  assay  in  vitro 
were validated according to modules 1 to 4 of the ECVAM modular approach and will shortly 
be submitted for ESAC peer review. In the field of skin sensitisation, three promising in vitro 
methods [the Direct Peptide Reactivity Assay (DPRA), the human Cell Line Activation Test 
(h-CLAT)  and  the  Myeloid  U939  Skin  Sensitisation  Test  (MUSST)]  were  sufficiently 
optimised by industry and were accepted in 2009 by ECVAM for entering prevalidation.  

In the area of reproductive toxicology, some promising methods, which were developed under 
Reprotect, an EU-funded collaborative research project in which ECVAM was also involved, 
may  be  submitted  to  ECVAM  for  (pre)validation  and  some  in  vitro  methods  for  the 
identification  of  endocrine  disruptors  are  currently  under  validation.  A  reduction  in  the 
number of animals used for reproductive toxicity testing is envisaged with the ongoing work 
that advocates a modular approach to the extended one-generation reproduction study (Moore 
et al., 2009).  

For the endpoints falling under the 2013 deadline, the lack relevant methods to fully replace 
the animal tests remains a challenge. 

3.2.2. 

Scientific Committee on Consumer Safety (SCCS) statements 

In December 2009 the SCCS issued a Memorandum on "Alternative Test Methods in Human 
Health  Safety  Assessment  of  Cosmetic  Ingredients  in  the  European  Union"14,  in  which  it 
gives advise  on  the  overall  status  of  available alternative methods and their potential use in 
the human health risk assessment process of cosmetic ingredients and finished products. 

In January 2009 the SCCP (Scientific Committee on Consumer products, now SCCS) issued a 
position  statement  on  genotoxicity/mutagenicity  testing  of  cosmetic  ingredients  without 
animal experiments15. In this statement the SCCP in particular underlines the high number of 
false positives (see 3.2.1.1.).  

The  concerns  expressed  in  December  2007  by  the  SCCP16  in  relation  to  the  in  vitro  test 
EPISKIN™  for  skin  irritation  testing  have  been  taken  up  and  the  test  has  been  included  in 
Part B of Commission Regulation No 440/2008 as test method B.46. The SCCS however still 
has concerns relating to the use of this method for coloured substances.  

11 
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14 

15 
16 

European Centre for the Validation of Alternative Methods 
Interagency Coordinating Committee on the Validation of Alternative Methods, United States  
Japanese Centre for the Validation of Alternative Methods 
SCCS/1294/10 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_001.pdf 
SCCP/1212/09 http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_s_08.pdf 
SCCP/1145/07 http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_s_07.pdf 

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3.2.3.  Support of research activities by the Commission  

Developing effective and novel alternative methods has been a priority under the Framework 
Research  Programmes  of  the  European  Union  for  more  than  20  years.  The  results  of  the 
ongoing research in relation to alternative testing strategies have recently been published17. To 
address  the  lack  of  methods  replacing  animal  tests  in  the  assessment  of  toxic  effects  of 
chronic exposure, the Commission has launched a call with a budget of €25 million entitled 
“Towards  the  replacement  of  repeated  dose  systemic  toxicity  testing  in  human  safety 
assessment”18.  The  cosmetics  industry  has  committed  to  match  the  funding  given  by  the 
European Commission, making a total of €50 million available for this research. 

The  Ethics  Review  of  all  research  project  proposals  involving  animal  experimentation  has 
contributed to the enforcement of EU animal welfare and experimentation standards and has 
strengthened the applicability of the "3 Rs" (replacement, reduction and refinement) principles 
when  testing  proposals  are  reviewed  in  the  context  of  the  evaluation  procedure  for  the 
purposes of the 7th Research Framework Programme. 

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

Colipa, with its research programme on Alternative Approaches to Animal Testing, plays an 
important  role  in  supporting  the  development,  validation  and  acceptance  of  alternative 
approaches in order to replace animal use. For eye irritation, Colipa submitted to ECVAM at 
the  beginning  of  2008  results  from  the  optimization  of  the  two  most  advanced  Human 
Reconstructucted  Tissue  models19.  For  genotoxicity  and  mutagenicity,  Colipa  is  working  to 
develop approaches 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 
aims  to  strengthen  the  understanding  of  how  chemicals  react  with  the  skin  and  immune 
system cells to cause skin allergies. Colipa has proposed three methods to ECVAM, which are 
currently under prevalidation20.  

A major contribution is Colipa´s €25 million fundi ng commitment in the context of the call 
for proposals in relation to repeated dose systemic toxicity testing (see 3.2.3.) 

3.2.5.  Others 

The  ongoing  activities  mentioned  in  the  2007  report,  such  as  the  European  Partnership  for 
Alternative  Approaches  to  Animal  Testing  (EPAA)21  the  Community  Action  Plan  on  the 
Protection  and  Welfare  of  Animals22  and  the  revision  of  Directive  86/609/EEC  on  the 
protection of animals used in experiments23, were continued. 

17 

18 
19 
20 

21 
22 
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EUR 23886 – Alternative Testing Strategies – Progress Report 2009, Replacing, Reducing and refining 
use of animals in research, Genomics & Biotechnology for Health  
FP7-Health-2010-Alternative Testing 
SkinEthic Human Corneal Epithelium (HCE) model and the MatTek Epiocular model 
Human  Cell  Line  Activation  Test  (h-CLAT),  Myeloid  U937  Skin  Sensitisation  Test  (MUSST)  and 
direct peptide reactivity assay (DPRA). 
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. 

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  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”).  One  focal  point  of  ICCR  is  exploring  hurdles  in  the  international 
regulatory acceptance of alternative testing methods.  

Important progress has been made in the international cooperation on alternative test methods 
with  the  agreement  on  a  Framework  for  International  Cooperation  on  Alternative  Test 
Methods  (ICATM)  in  September  2008.  In  April  2009  representatives  from  the  validation 
bodies signed a Memorandum of Cooperation promoting enhanced international cooperation 
and  coordination  on  the  scientific  validation  of  non-  and  reduced-animal  toxicity  testing 
methods. 

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. 

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).  Alternative 
Methods to Animal Testing are included in the TEC work programme 2009 until 2010 and the 
implementation  of  the  ICATM  and  continuous  dialogue  in  view  of  alternative  methods 
(possible priorities) will remain high on the agenda. 

4.2.2. 

Japan 

Alternatives  to  animal  testing  have  been  repeatedly  raised,  particularly  in  the  framework  of 
the regulatory reform dialogues in 2006, 2007 and 2008 and Japan stressed its support of the 
activities of the Japanese Center for the Validation of Alternative Methods (JACVAM).  

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4.2.3.  China 

Replacing  animal  testing  for  cosmetics  continues  to  be  discussed  in  numerous  fora,  and  in 
particular at an AQSIQ24-DG ENTR Working Group meeting on Cosmetics on 17 November 
2008 and in meetings with the SFDA25 and AQSIQ in January 2009. There is basic agreement 
that China must be more involved in the development of alternative methods. 

5. 

CONCLUSION 

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 
was encouraged in the guidelines annexed to the request to Member States for accurate data26. 
Nevertheless  enforcement  of  the  testing  and  marketing  ban  continues  to  pose  challenges  in 
relation to multiple use substances.  

Regarding the 2009 deadline, of the seven end points relevant for cosmetic products safety, 
replacement  alternative methods  are  currently  available  for  five.  For  the  two  remaining  end 
points, “eye irritation” and “acute toxicity”, progress is being made but the deadlines for full 
replacement could not be met. Progress has been good and the Commission expects that the 
last two human health effects might be covered in the course of 2010. In the interim, industry 
can rely on data of tests performed before the March 2009 deadline. 

Regarding 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  significant  additional  efforts  that  have  been  launched  at 
various levels. The situation will be thoroughly analysed during the preparation of the study 
required under the Cosmetics Directive for 2011.  

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25 
26 

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of 
China 
State Food and Drug Administration China 
See paragraph 2.3. 

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