COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics
Date: 2013-03-11
Institutions: European Commission
Subjects: animal experimentation, animal welfare, cosmetics industry, international cooperation, market approval, marketing standard, research method, testing

EUROPEAN 
COMMISSION 

Brussels, 11.3.2013  
COM(2013) 135 final 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 

on the animal testing and marketing ban and on the state of play in relation to 
alternative methods in the field of cosmetics 

(Text with EEA relevance) 

{SWD(2013) 66 final} 
{SWD(2013) 67 final} 

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TABLE OF CONTENTS 

1. 

2. 

2.1. 

2.2. 

2.3. 

2.4. 

3. 

3.1. 

3.2. 

3.3. 

Introduction .................................................................................................................. 3 

The 2013 marketing ban............................................................................................... 3 

The legal framework .................................................................................................... 3 

Availability of alternative methods.............................................................................. 4 

Assessing the impacts of the 2013 marketing ban ....................................................... 5 

Deciding on the way forward....................................................................................... 5 

The way forward .......................................................................................................... 7 

Implementing the 2013 marketing ban and monitoring its effects .............................. 7 

Commitment to support research, development and validation of alternative methods 
to assess human safety ................................................................................................. 9 

Alternative methods as a prominent part of the Union's trade and international 
agenda ........................................................................................................................ 11 

4. 

Conclusions ................................................................................................................ 13 

Annex ....................................................................................................................................... 14 

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COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT AND THE COUNCIL 

on the animal testing and marketing ban and on the state of play in relation to 
alternative methods in the field of cosmetics 

(Text with EEA relevance) 

1. 

INTRODUCTION  

This Communication has a twofold purpose: 

– 

– 

It  informs  the  European  Parliament  and  the  Council  of  the  Commission's 
decision not to propose any changes in the animal testing related provisions in 
Directive 76/768/EEC (Cosmetics Directive)1 and in Regulation 1223/2009/EC 
(Cosmetics Regulation)2, the reasons why and the way forward.  

It  presents  the  yearly  report  in  accordance  with  Article  9  of  the  Cosmetics 
Directive  and  as  such  the  tenth  Commission  report  on  the  development, 
validation  and  legal  acceptance  of  alternative  methods  to  animal  tests  in  the 
field of cosmetics.  

2. 

THE 2013 MARKETING BAN  

2.1. 

The legal framework 

The  Cosmetics  Directive  foresees  a  phasing-out  of  animal  testing  for  cosmetic 
products.  Animal  testing  of  finished  cosmetic  products  in  the  Union  has  been 
prohibited since 2004 and of cosmetic ingredients since March 2009 ("testing ban"). 
As  from  11  March  2009,  it  is  also  prohibited  to  market  in  the  Union  cosmetic 
products and their ingredients which have been tested on animals in order to meet the 
requirements of the Directive ("2009 marketing ban"). This marketing ban applies to 
all  but  the  most  complex  human  health  effects  ("endpoints")  to  be  tested  to 
demonstrate  the  safety  of  cosmetic  products  (repeated-dose  systemic  toxicity,  skin 
sensitisation, carcinogenicity, reproductive toxicity and toxicokinetics), for which the 
European  Parliament  and  the  Council  extended  the  deadline  to  11  March  2013 
("2013 marketing ban"). The Cosmetics Regulation, which repeals and replaces the 
Cosmetics  Directive  as  of  11  July  2013,  contains  the  same  provisions.  Data  from 
animal testing that has been carried out before the respective implementation dates of 
the marketing ban (11 March 2009/11 March 2013) can continue to be relied on in 
the safety assessment of cosmetic products.  

The testing and marketing bans in the Cosmetics Directive/Regulation apply even in 
case alternative methods to animal testing are not yet available. This reflects a sector-
specific  political  choice  by  the  European  Parliament  and  the  Council.  Other  Union 
legislation recognises that animal testing is still needed in the absence of alternative 
methods to ensure the protection of human health and the environment, but sets very 

1 

2 

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. 
Regulation  1223/2009/EC  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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high  animal  welfare  standards  for  such  testing  and  requires  that  whenever  possible 
testing is replaced, reduced and refined.  

According to Article 4a (2.3) of the Cosmetics Directive the Commission was called 
upon  to  inform  the  European  Parliament  and  the  Council  where,  for  technical 
reasons, one or more of the tests covered by the 2013 marketing ban would  not  be 
developed  and  validated  by  2013  and  to  put  forward  a  legislative  proposal.  The 
Commission has responded to this provision in two steps.  

2.2. 

Availability of alternative methods 

The  first  step  was  to  establish  to  which  extent  alternative  methods  for  testing 
cosmetic  products  and  their  ingredients  for  the  relevant  endpoints  are  available  by 
2013.  The  Commission  has  provided  a  report  to  the  European  Parliament  and  the 
Council  on  the  availability  of  alternative  methods  in  September  20113,  based  on  a 
comprehensive  technical  report  which  was  the  result  of  wide  scientific  input  and  a 
public consultation4. The basic findings of this technical report are still valid and the 
full replacement of the 2013 marketing ban endpoints by alternative methods remains 
not yet possible. 

Considerable  progress  has  been  made  in  recent  years.  Much  of  this  is  due  to  the 
sustained  efforts  of  the  European  Union  Reference  Laboratory  for  Alternatives  to 
Animal  Testing  (EURL  ECVAM),  run  by  the  Commission's  Joint  Research  Centre 
(JRC). For the endpoints falling under the 2009 marketing ban, replacement methods 
have been successfully validated and adopted as OECD test guidelines in the fields 
of  skin  irritation  and  corrosion,  phototoxicity  and  skin  penetration.  Partial 
replacement methods suitable for inclusion in testing strategies have been validated 
in the areas of acute systemic toxicity and eye irritation, and adopted as OECD test 
guidelines  in  the  field  of  eye  irritation.  Refinement  of  the  established  in  vitro 
genotoxicity  tests  and  testing  strategies  will  contribute  to  addressing  this  endpoint. 
For the 2013 marketing ban endpoints, ECVAM successfully validated test methods 
in the fields of skin sensitisation and carcinogenicity which are now being discussed 
at the OECD.  

A summary of recent validation activities at ECVAM and advancement concerning 
regulatory acceptance is provided in Tables 1 and 2 in the Annex. This update covers 
the period from 2010 to present day. Summaries covering periods prior to 2010 are 
covered in the ECVAM technical report 2008-20095. 

For  the  outstanding  complex  endpoints  replacement  will  not  be  achieved  by 
replacing  one  animal test  with one in vitro test.  Replacement can  only be achieved 
through  integrated  testing  strategies,  combining  several  in  vitro  and  in  silico 
approaches. For example, none of the methods under validation for skin sensitisation 
and  referenced  in  the  Annex  will  replace  skin  sensitisation  testing  as  a  stand-alone 
method, they constitute mosaic pieces needed for a comprehensive testing strategy. 

A  more  comprehensive  description  of  progress  being  made  in  the  development, 
validation  and  regulatory  acceptance  of  alternative  methods  in  the  different 

3 

4 

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Report on the Development, Validation and Legal Acceptance of Alternative Methods to 
Animal Tests in the Field of Cosmetics (2009), 13.9.2011, COM(2011) 558 final. 
"Alternative  (non-animal)  methods  for  cosmetics  testing:  current  status  and  future  prospects—2010", 
see:http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/final_report_at_en.pdf 
Zuang et al., 2010 ,see: 
http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/at_ecvam_2008-2009_en.pdf 

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toxicological areas will be provided in the ECVAM technical report 2013, which will 
become available in parallel with this Communication6.  

The  responsible  scientific  committee  of  the  Commission,  the  Scientific  Committee 
on Consumer Safety (SCCS), has recently adopted an updated version of its "Notes 
of  Guidance"7,  in  which  it  also  provides  an  overview  of  the  use  of  alternative 
methods in the safety assessment of cosmetics. Specific guidance was also adopted 
by  the  SCCS  in  relation  to  the  safety  assessment  of  nanomaterials  in  cosmetics8, 
including availability of alternative methods.  

2.3. 

Assessing the impacts of the 2013 marketing ban 

The second step was to carry out an impact assessment and an in-depth reflection on 
the  best  way  forward  in  relation  to  the  2013  marketing  ban  in  light  of  the 
unavailability of a full set of alternative methods. The resulting impact assessment is 
published  as  a  Commission  Staff  Working  document  accompanying 
this 
Communication9.  

The options assessed in the impact assessment were to maintain the 2013 marketing 
ban,  to  postpone  it  or  to  introduce  a  derogation  mechanism.  The  derogation 
mechanism  would  have  allowed  manufacturers  to  request  the  Commission  to  grant 
individual derogations from the 2013 marketing ban for innovative ingredients with a 
significant added value to consumer health, well-being and/or the environment.  

The impact  assessment shows that the 2013 marketing ban could lead to a reduced 
access  to  cosmetic  ingredients.  However,  stakeholder  views  on  the  effects  diverge. 
Despite  serious  efforts  to  establish  a  solid  body  of  data,  considerable  uncertainty 
remains  in  relation  to  the  quantification  of  these  impacts;  it  appears  possible  to  at 
least  mitigate  them  through  appropriate  action.  Even  for  the  2009  marketing  ban 
deadline, not all testing endpoints can be fully replaced by alternative methods which 
did not lead to major negative impacts so far. 

The  objective  to  provide  a  high  level  of  human  health,  key  to  the  Cosmetics 
Directive  and  reinforced  in  the  Cosmetics  Regulation,  is  not  impacted  by  the  2013 
marketing ban. If product safety cannot be demonstrated the product simply cannot 
be  placed  on  the  market.  New  tools  are  provided  in  the  Cosmetics  Regulation  to 
ensure this, such as enhanced market surveillance and new rules on communication 
of serious undesirable effects.  

2.4. 

Deciding on the way forward 

In light of this impact assessment, the Commission has come to the conclusion that it 
is most appropriate to let the 2013 marketing ban enter into force and not to present a 
legal proposal to either postpone the deadline or provide for individual derogations 
for the following reasons: 

First,  the  Commission  considers  that  further  postponements  of  the  2013  marketing 
ban  would  not  reflect  the  political  choices  of  the  European  Parliament  and  the 
Council when adopting the respective provision. Animal welfare considerations were 

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9 

See: http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-testing/index_en.htm  
The SCCS'S Notes of Guidance for the testing of cosmetic substances and their safety evaluation, 8th 
Revision, SCCS/1501/12,  
see: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_006.pdf 
Guidance on the Safety Assessment of Nanomaterials in Cosmetics, SCCS/1484/12,  
see: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_005.pdf 
See http://ec.europa.eu/consumers/sectors/cosmetics/animal-testing/index_en.htm  

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at  the  origin  when  the  first  provisions  on  a  marketing  ban  of  cosmetics  tested  on 
animals were introduced 20 years ago10. The marketing ban, first introduced in 1993 
with  a  deadline  for  1998,  was  introduced  with  the  clear  political  objective  to  end 
animal  testing  for  cosmetics  without  being  based  on  a  scientific  estimation  when  a 
full  set  of  alternative  methods  would  be  available.  Similarly,  the  European 
Parliament and the Council imposed the testing ban and the 2009 marketing ban in 
full knowledge that by that time a complete replacement of the relevant animal tests 
would not be possible. The European Parliament and the Council did not make the 
2013  marketing  ban  dependent  on  the  availability  of  a  full  set  of  replacement 
methods.  In  the  meantime  animal  welfare  has  been  enshrined  in  Article  13  of  the 
Treaty on the Functioning of the European Union (TFEU) as a European value to be 
taken into account in Union policies. 

to  swiftly  develop  alternative 

Secondly,  any  change  to  the  2013  marketing  ban  could  seriously  diminish 
determination 
test  methods.  Past  experience 
demonstrates clearly that animal testing provisions in the cosmetics legislation have 
been a key accelerator in relation to the development of alternative methods and have 
sent a strong signal far beyond the cosmetics sector and far beyond Europe. Methods 
developed in the cosmetics sector, such as reconstructed human skin models, are now 
used in other sectors as well and the interest in alternative methods for cosmetics has 
grown in many countries outside the Union. The animal testing provisions motivated 
the  creation  of  the  European  Partnership  on  Alternative  Approaches  to  Animal 
Testing (EPAA)11, an unprecedented voluntary collaboration between the European 
Commission,  European  trade  associations,  and  companies  from  various  industry 
sectors.  The  provisions  equally  contributed  to  a  great  increase  of  the  number  of 
validated methods since 2003 when the current deadlines were set12. 

Thirdly,  a  case-by-case  derogation  allowing  the  Commission  to  deviate  from  the 
2013  marketing  ban  for  individual  ingredients  offering  significant  benefits  for  the 
consumer or the environment would benefit mainly larger manufacturers capable of 
gathering the necessary evidence. In addition, it would raise controversial decisions 
by  the  Commission  on  what  is  a  significant  benefit,  a  decision  for  which  objective 
criteria are difficult to establish. 

Finally,  the  Commission  considers  that  the  possible  risks  from  the  2013  marketing 
ban can be turned into an opportunity for the Union to set an example of responsible 
innovation in cosmetics with positive impact beyond Europe. The need for a new risk 
assessment  paradigm  from  a  scientific  perspective  is  by  now  widely  recognized13. 
Impacts go beyond the cosmetics sector – the objective is to develop strategies that 
will lead to better and more predictive, faster and cheaper tools to assess consumer 
safety of chemical substances.  

Fully  reaping  the  potential  of  alternative  methods  is  a  challenging  endeavour  that 
will require a shift in thinking of all involved. The cosmetics sector can - once again 
- act as an accelerator and a pioneer in the development of these novel approaches. 
Considering  however  that  a  full  safety  assessment  for  cosmetics  only  relying  on 
alternative methods and approaches is not yet achieved and in some respects is not 
even close, it is necessary to set the appropriate framework by: 

10 
11 
12 
13 

Directive 93/35/EEC, OJ L 151, 23.06.1993, p. 0032. 
See: http://ec.europa.eu/enterprise/epaa/ 
Between 2003 and 2009 there were 13 new methods, compared to only 6 between 1998 and 2002.  
See  recent  Discussion  Paper  of  the  Scientific  Committees  "Addressing  the  New  Challenges  for  Risk 
Assessment"( http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_037.pdf 

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• 

• 

Implementing the 2013 marketing ban while carefully monitoring its effects; 

Continuing  to  support  research,  development  and  validation  of  alternative 
methods to assess human safety; and 

•  Making alternative methods part of the Union's trade and international agenda. 

3. 

THE WAY FORWARD 

3.1. 

Implementing the 2013 marketing ban and monitoring its effects  

Effective and coherent implementation and enforcement of the 2013 marketing ban 
are of key importance – not only to ensure that it actually achieves its objectives, but 
also  to  ensure  a  level  playing  field  for  economic  operators.  This  Communication 
focuses  on  the  2013  marketing  ban.  However,  the  described  implementation 
mechanisms and principles apply equally to the testing ban and the 2009 marketing 
ban.  

Going forward the  Cosmetics Regulation provides the adequate legal framework to 
ensure the implementation of the 2013 marketing ban and its provisions are directly 
applicable  in  all  Member  States  as  of  11  July  2013.  It  is  accordingly  the  task  and 
responsibility  of  the  Member  State  authorities  to  monitor  compliance  with  the 
Cosmetics Regulation via in-market controls of the cosmetic products made available 
on  the  market14.  The  Cosmetics  Regulation  lays  down  the  obligation  of  the 
responsible  person15  to  ensure  compliance  with  the  animal  testing  provisions16.  It 
requires  Competent  Authorities  to  take  all  appropriate  measures  to  ensure 
compliance with the animal testing provisions17 and requires Member States to have 
effective, proportionate and dissuasive penalties in place in case of infringements18. 
Until  11  July  2013  the  existing  implementation  mechanisms  under  the  Cosmetics 
Directive will continue to apply19.  

The  main  source  enabling  Member  State  authorities  to  verify  compliance  with  the 
2013 marketing ban is the product information file in accordance with Article 7a (1) 
h of the Cosmetics Directive/Article 11 of the Cosmetics Regulation. This file must 
contain  data  on  "any  animal  testing  performed  by  the  manufacturer,  his  agents  or 
suppliers, relating to the development or safety assessment of the cosmetic product 
or its ingredients, including any animal testing performed to meet the legislative or 
regulatory  requirements  of  third  countries".  In  addition  to  this  requirement,  the 
product  information  file  must  also  contain  the  cosmetic  product  safety  report  as 
specified  in  Annex  I  of  the  Cosmetics  Regulation,  which  must  include  information 
on the toxicological profile of the substance for all relevant toxicological endpoints 
and a clear identification of the source of the information. From this information it 
will become evident to Competent Authorities if animal testing data has been relied 
on in the safety assessment.  

Currently,  there  is  no  jurisprudence  of  the  Court  of  Justice  of  the  European  Union 
('the  Court')  on  the  interpretation  of  the  scope  of  the  2013  marketing  ban.  The 
Commission recalls that only the Court can provide a legally binding interpretation 

14 
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16 
17 
18 
19 

Article 22 of Regulation 1223/2009/EC. 
As defined in Article 4 of Regulation 1223/2009/EC. 
Article 5 (1) of Regulation 1223/2009/EC.  
Article 25 (1) (g) and Article 25 (5) of Regulation 1223/2009/EC.  
Article 37 of Regulation 1223/2009/EC. 
Article 3 of Directive 76/768/EEC. 

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of  Union  law.  The  Commission  will,  under  the  control  of  the  Court  oversee  the 
application  of  the  2013  marketing  ban.  The  Commission  will  do  so  in  accordance 
with its current understanding of the scope of the 2013 marketing ban, which is based 
on the Cosmetics Regulation/Directive and which does not create any new rights and 
obligations. The practical application of the 2013 marketing ban will remain a case-
by-case  decision  of  the  respective  Member  State  authority.  Under  the  Cosmetics 
Directive and its national transpositions Member States already oversee compliance 
with the testing ban and the 2009 marketing ban. The Commission has reported in its 
last  two  Annual  Reports  on  the  measures  taken  by  Member  States  to  ensure 
compliance with these bans.20  

The majority of ingredients used in cosmetic products are ingredients that are equally 
in use in many other consumer and industrial products, such as in pharmaceuticals, 
detergents and food, and animal testing may be necessary to ensure compliance with 
the legal frameworks applicable to these products. Ingredients used in cosmetics will 
generally also be subject to the horizontal REACH21 requirements and animal testing 
may  be  necessary  as  a  last  resort  to  complete  the  respective  data  packages.  It 
therefore  is  for  Member  States  to  assess  and  decide  whether  such  testing  for 
compliance  with  other  frameworks  is  considered  to  be  falling  in  the  scope  of  the 
2013 marketing ban. Critical to this is the wording 'in order to meet the requirements 
of  this  Directive/Regulation'  used  in  the  Cosmetics  Directive  and  the  Cosmetics 
Regulation22 in order to qualify the scope of the 2013 marketing ban.  

The  Commission  considers  that  animal  testing  that  has  clearly  been  motivated  by 
compliance  with  non-cosmetics  related  legislative  frameworks  should  not  be 
considered  to  have  been  carried  out  'in  order  to  meet  the  requirements  of  this 
Directive/Regulation'.  The  resulting  animal  testing  data  should  not  trigger  the 
marketing  ban  and  could  subsequently  be  relied  on  in  the  cosmetics  safety 
assessment. Reliance on such data is subject to its relevance for the cosmetics safety 
assessment and its compliance with data quality requirements23.  

Testing  carried  out  for  cosmetics  relevant  endpoints  on  ingredients  that  have  been 
specifically  developed  for  cosmetic  purposes  and  are  exclusively  used  in  cosmetic 
products  would  in  the  Commission's  view  always  be  assumed  to  be  carried  out  'in 
order to meet the requirements of this Directive/Regulation'.  

The Commission considers that the marketing ban is triggered by the reliance on the 
animal data for the safety assessment under the Cosmetics Directive/Regulation, not 
by  the  testing  as  such.  In  case  animal  testing  was  carried  out  for  compliance  with 
cosmetics requirements in third countries, this data cannot be relied on in the Union 
for the safety assessment of cosmetics.  

20 

21 

22 

23 

http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/annual_report2009.pdf 

See: 
and http://ec.europa.eu/consumers/sectors/cosmetics/files/pdf/animal_testing/at_report_2008.pdf 
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, Official Journal L 136, 29.5.2007, p. 3. 
See  Article  4a  (1(b))  of  the  Cosmetics  Directive  and  Article  18  paragraph  1  (b)  of  the  Cosmetics 
Regulation.  
Article 7a (2) Directive 76/768/EEC and Article 10 (3) of Regulation 1223/2009/EC 

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In  the  context  of  the  obligation  to  ensure  compliance  with  the  Cosmetics 
Directive/Regulation, Member States should ensure that the appropriate and effective 
mechanisms are put into place in order to counter the potential risks of abuse in the 
application of the testing and the marketing ban. Where needed, the Commission will 
work with Member States on guidance for the application of the 2013 marketing ban 
based on practical experiences and concrete case studies. The Platform of European 
Market  Surveillance  Authorities  for  Cosmetics  (PEMSAC)  provides  a  dedicated 
structure for cooperation on market surveillance. 

In  order  to  allow  effective  market  surveillance,  responsible  persons  should  ensure 
that for any animal testing data relied on in the product information file the date and 
place of the test is clearly documented. If testing took place after the 2013 marketing 
ban  deadline,  the  product  information  file  should  allow  verification  on  whether  the 
testing was carried out in order to meet the requirements of the Directive/Regulation 
or for other purposes. To this end the file should contain documentation on any use 
of the substance in products other than cosmetic products (product examples, market 
data etc.), as well as documentation on compliance with other regulatory frameworks 
(e.g.  REACH  or  other  legal  frameworks)  and  a  justification  of  the  need  for  the 
animal testing under that other framework (e.g. testing proposal under REACH).  

The  2013  marketing  ban  applies  to  all  cosmetic  products  placed  on  the  Union's 
market, thus to those produced in the Union and to imported cosmetic products alike. 
Competent  authorities  should  ensure  a  level  playing  field  between  the  different 
products on the market. 

the 

innovation 

in  cosmetic 

ingredients  and  products  and 

Considering  that  the  non-availability  of  alternative  test  methods  could  have  an 
impact  on 
the 
competitiveness of the sector, the Commission will closely monitor  the  situation in 
the  coming  years.  A  key  tool  for  the  monitoring  will  be  the  yearly  Commission 
reports required under Article 35 of the Cosmetics Regulation. These reports give a 
regular  review  of  the  state  of  play  of  the  development,  validation  and  regulatory 
acceptance  of  alternative  methods  in  the  field  of  cosmetics.  They  will,  as  has  been 
the case in the past, be based on technical reports prepared by the Commission's JRC 
(EURL ECVAM). Given that the testing bans are fully applicable, the reports will no 
longer contain statistical data on the number and type of animal experiments carried 
out  relating  to  cosmetic  products  in  the  Union.  The  reports  will  cover  any 
derogations  granted  in  accordance  with  Article  4a  (2.4)  of  the  Cosmetics  Directive 
and  Article  18  (2)  of  the  Cosmetics  Regulation.  These  provisions  allow  Member 
States to request a derogation in case a human health problem is substantiated for an 
ingredient that is in wide use and cannot be replaced by another ingredient capable of 
performing a similar function. So far only one such request has been received and the 
analysis is still on-going.  

In  addition,  the  Commission  will  monitor  instances  in  which  a  conclusive  safety 
assessment  is  not  feasible  as  a  result  of  the  2013  marketing  ban.  The  Commission 
will equally monitor the socio-economic impacts of the 2013 marketing ban, notably 
in  comparison  to  the  data  cited  in  the  Impact  Assessment  and  the  estimates  and 
predictions made in that context.  

3.2. 

Commitment  to  support  research,  development  and  validation  of  alternative 
methods to assess human safety  

The Union wishes to set an example of responsible innovation in cosmetics without 
new  dedicated  animal  tests.  It  is  therefore  crucial  to  continuously  support  the 

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research and development of methods to better assess human safety and capitalize on 
past efforts by ensuring that the latest scientific advances are translated into animal-
free solutions.  

The Commission has made about EUR 238 million available between the years 2007 
and  2011  for  research  into  alternative  methods  to  animal  testing  alone.  The  major 
part of this budget, around EUR 198 million, was spent on projects funded through 
the  6th  and  7th  Framework  Programmes  and  the  LIFE+  Programme.  The  second 
most  important  tranche,  about  EUR  38  million,  was  committed  through  the 
institutional budget of the JRC, in particular to support the activities of its Institute 
for Health and Consumer Protection in the alternatives area including the operation 
of  the  European  Reference  Laboratory  for  Alternative  Methods  to  Animal  Testing 
(EURL ECVAM).  
The  SEURAT-124  initiative  ('Safety  Evaluation  Ultimately  Replacing  Animal 
Testing')  is  unique  in  that  it  is  a  jointly  funded  initiative  by  the  European 
Commission  and  the  cosmetics  industry,  each  of  which  are  contributing  EUR  25 
million  between  2011  and  2015.  It  is  proof  of  the  active  role  assumed  by  the 
cosmetics  industry  in  the  development  of  alternative  testing  methods.  SEURAT-1 
brings  together  more  than  70  European  research  teams  working  together  within  a 
cluster  of  six  complementary  projects  and  facilitated  by  a  coordination  action.  The 
goal  of  the  5-year  SEURAT-1  programme  is  to  use  knowledge  of  toxicological 
processes  to  develop  and  rationally  assemble  novel  technology  building  blocks 
required for predicting repeated dose systemic toxicity in humans potentially caused 
by  exposure  to  chemicals.  Ultimately  SEURAT-1  aims  to  prove  key  concepts 
underpinning the credible use of combinations of computational and in vitro methods 
for supporting safety assessment decisions.  

The research into alternative methods is by no means near an end: in many areas the 
research  currently  underway  is  only  a  first  step.  Horizon  202025  is  the  financial 
instrument which implements the Innovation Union26 and will ensure the framework 
for  the  research  activities  between  2014  and  2020.  Horizon  2020  offers  the 
opportunity  to  continue  and  expand  the  Union's  commitment  to  research  in 
alternative,  better  methods  of  human  safety  assessment  and  capitalize  on  possible 
innovation in this field.  

The  Commission  recognizes  the  importance  of  research  in  this  field.  At  the  same 
time,  strong  commitment  is  required  from  the  sectors  that  would  benefit  from  the 
development of new alternative methods, including the cosmetics sector.  

The  Commission  will  engage  with  stakeholders  from  such  sectors  to  define  the 
research  priorities  going  ahead  and  the  best  implementation  instruments  which,  for 
example,  could  take  the  form  of  a  new  public-private  partnership.  A  recent 
Discussion Paper of the Scientific Committees on “Addressing the New Challenges 
for  Risk  Assessment”  points  to  research  needs  for  comprehensive  open  access 
databases,  in  silico  methods,  (toxicological)  mode-of-action  studies  and  exposure 
assessment  tools.  The  EPAA  can  also  play  a  role  in  defining  research  needs  and 

24 
25 

26 

See http://www.seurat-1.eu  
Proposal for a Regulation of the European Parliament and of the Council establishing Horizon 2020 - 
The Framework Programme for Research and Innovation (2014-2020), COM(2011) 809 final. 
Communication  from  the  Commission,  Europe  2020  Flagship  Initiative,  Innovation  Union,  COM 
(2010) 546 final. 

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priorities across industry sectors with special attention being paid to how to involve 
small and medium sized enterprises in these efforts.  

A crucial factor for success is to make sure that alternative methods, once developed, 
are  rapidly  made  available  for  end-users  to  generate  toxicological  information 
acceptable  to  regulators.  The  Commission  therefore  commits  to  work  with  the 
relevant European and international bodies to further improve the validation process 
for new test methods. 

Validation is an intrinsic part of the scientific process and of fundamental importance 
in  gaining  acceptance  of  alternative  methods  and  trust  in  the  information  they 
generate. In recent years JRC's EURL ECVAM has further refined and streamlined 
its validation processes and has increased the resources it commits to the alternatives 
area  including  dedicating  the  efforts  of  more  than  50  scientific  and  technical  staff. 
ECVAM  is  now  expressively  referenced  in  Directive  2010/63/EU27  and  its 
responsibilities are clearly spelled out. In addition to undertaking validation studies, 
ECVAM will also play a stronger role in guiding the development of alternatives and 
in  early  and  frequent  engagement  with  regulators  and  stakeholders  to  ensure  that 
priority is given to the most relevant methods that will have the greatest impact. To 
this  end,  ECVAM  has  also  established  its  regulatory  advisory  body28  and  its 
stakeholder forum29.  

The ECVAM Scientific Advisory Committee will continue to offer impartial expert 
advice,  particularly  during  its  peer  review  of  validation  studies,  while  ECVAM 
Recommendations  will  be  the  key  instrument  for  communicating  the  outcome  of 
validation  studies  and  additional  advice  on  how  an  alternative  method  should  be 
utilised  to  most  effect.  ECVAM  will  also  carry  on  its  active  dissemination  of 
comprehensive  information  on  available  methods  to  end-users  through  ECVAM's 
publicly  accessible  Data  Base  service  on  Alternative  Methods30  and  the  ECVAM 
Search Guide.  
Commission Regulation (EC) 440/200831 brings together all regulatory accepted test 
methods on Union level. An overview of how methods are progressing through the 
acceptance  process  is  available  through  the  Tracking  System  for  Alternative  test 
methods Review, Validation and Approval in the Context of Union Regulations on 
Chemicals32. It is important to note that although suitable for the safety assessment of 
cosmetics,  the  alternative  methods  validated  and  accepted  so  far  are  not  solely 
applicable  to  cosmetic  ingredients  but  can  successfully  be  used  for  other  purposes. 
Thus Annex IX of the Cosmetics Directive33 has not been amended and does not list 
any specific alternative methods.  

3.3. 

Alternative methods as part of the Union's trade and international agenda 

There  are  compelling  reasons  for  a  strong  international  cooperation  on  the 
development of alternative test methods for cosmetics. Cosmetic products and their 

27 

28 
29 
30 
31 

32 
33 

Directive 2010/63/EU on the protection of animals used for scientific purposes, OJ L 276, 20.10.2010, 
p.33. 
PARERE (Preliminary Assessment of Regulatory Relevance)  
ESTAF (ECVAM Stakeholder Forum) 
http://ecvam-dbalm.jrc.ec.europa.eu/  
See  Article  10  (3)  of  Regulation  (EC)  1223/2009  of  the  European  Parliament  and  the  Council  on 
cosmetics products, 22.12.2009, OJ L 342, p. 59 – 209. 
See http://tsar.jrc.ec.europa.eu/ 
Equivalent to Annex VIII in the Cosmetics Regulation, both list validated alternative methods which are 
not listed in Commission Regulation (EC) 440/2008. 

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ingredients  are  traded  worldwide  and  the  Union  is  home  to  some  of  the  world-
leading  brands  in  the  cosmetics  field.  A  common  understanding  of  the  safety 
assessment for cosmetics and acceptance of alternative methods will improve human 
safety,  help  animal  welfare  and  trade,  but  cooperation  is  also  a  must  because  the 
underlying scientific challenges are far too big to be shouldered by one region alone. 
Cooperation at the research level is therefore a first important step.  

A  key  instrument  in  agreeing  on  tools  for  safety  assessment  is  the  development  of 
OECD Test Guidelines in the framework of the Existing Chemicals Programme and 
the  Mutual  Acceptance  of  Data.  Alternative  methods  have  been  included  in  OECD 
Test  Guidelines  and  this  has  been  key  in  leading  to  their  international  acceptance. 
The  Commission  services  are  actively  involved  in  the  OECD  work.  One  particular 
challenge  to  be  addressed  if  significant  progress  is  to  be  made  is  how  to  reflect 
Integrated Testing Strategies in OECD Guidelines, since the information required to 
address  the  more  complex  health-effect  endpoints  will  require  the  optimum 
combination of both testing and non-test alternative methods.  

In  the  field  of  cosmetics,  the  International  Collaboration  on  Cosmetics  Regulation 
(ICCR)  provides  an  important  forum  for  cooperation  between  the  United  States  of 
America, Canada, Japan and Europe. Alternatives to animal testing have been a key 
focus  since  the  inception  of  ICCR.  ICCR  has  recently  started  work  on  in  silico 
(computational) prediction models, something that in addition to in vitro methods is 
of  central  importance  in  advancing  alternative  safety  assessment  approaches.  ICCR 
has also started reaching out beyond its membership, to countries such as Australia, 
Brazil and the People’s Republic of China.  

One  of  ICCR's  key  achievements  in  relation  to  alternative  methods  is  clearly  the 
setting up of the International Cooperation on Alternative Test Methods in 2009. It 
brings  together  validation  bodies  of  Europe,  the  United  States,  Japan  and  Canada. 
The  South  Korean validation  body  joined in 2010. The objective is to promote and 
harmonise  the  validation  of  alternative  methods  worldwide,  to  avoid  duplication  of 
effort  and  to  ensure  that  recommendations  on validated  methods  are  mutually 
acceptable  and  can  be directly  used  in  different  jurisdictions.  Importantly  too  it 
works  towards  establishing  common  positions  on validated  methods  between 
member  countries  and  organisations  of  the  OECD  to  accelerate  their  international 
acceptance.  

EPAA  concentrated  its  activities  in  2012  on  international  cooperation  and  will 
continue  to  do  so  in  2013,  offering  another  opportunity  to  promote  alternatives 
internationally. The cosmetics industry (Cosmetics Europe34 and several companies) 
is  one  of  the  driving  forces  and  has  in  2012  been  joined  by  the  Fragrances  and 
Flavours industry (IFRA).  

The Commission is convinced that the overall long-term objective to replace animal 
testing wherever possible and to move to new ways of improved safety assessment 
will  eventually  be  shared  by  many  of  the  Union´s  trading  partners,  even  though 
different  regions  may  be  at  different  steps  of  the  process  and  the  approaches  to 
achieve  the  objective  may  differ.  In  the  last  weeks,  there  have  been  encouraging 
signals  that  other  countries  such  as  Israel  or  India  are  considering  to  follow  the 
Union's example on animal tests for cosmetics.  

34 

Cosmetics Europe is the Trade Association representing the European cosmetics industry.  

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The Commission is therefore convinced that the issue of alternative test methods for 
cosmetics merits a prominent place on the EU's trade and international cooperation 
agenda. It will endeavour to put these issues on the agenda of all relevant multi and 
bilateral meetings in the cosmetics field in 2013, notably with the United States and 
China, but also in contacts with Brazil and India. The Commission will in this effort 
look  for  synergies  with  the  international  initiatives  of  industry  and  animal  welfare 
organisations.  

4. 

CONCLUSIONS 

The  deadline  for  the  2013  marketing  ban  in  the  Cosmetics  Directive/Regulation 
enters  into  force  on  11  March  2013.  This  completes  a  20  year  long  process  on 
phasing out animal testing for the purpose of cosmetic safety assessment. Promising 
progress has been made in advancing alternative methods to animal testing over the 
last years, but full replacement is not yet possible and will not be possible for some 
time. The Commission nevertheless believes that the most appropriate way forward 
is to let the marketing ban enter into force and to turn the challenges that the 2013 
marketing ban is posing into an opportunity, in particular by  

- ensuring a coherent implementation of the 2013 marketing ban and monitoring its 
impacts; 

- continuing the support for research, development and validation of new alternative 
methods for human safety testing; and 

-  making  alternative  methods  an  integral  part  of  the  Union's  trade  agenda  and 
international cooperation.  

The  marketing  ban  gives  an  important  signal,  not  only  in  relation  to  the  value 
attached to animal welfare in the European Union, but also in relation to the overall 
paradigm shift in relation to human safety assessment.  

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Annex 

Table 1. Status of validation of in vitro test methods at EURL ECVAM since 2010 

Nr.  Toxicity area 
1 

Carcinogenicity 

Test method description 
Cell Transformation Assay (CTA) SHE  

Validation status35 
EURL ECVAM 
recommendation published in 
2011 

2 

3 
4 
5 
6 

7 

Skin sensitisation 

Acute oral toxicity 

8 

Toxicokinetics 

9 

Eye irritation 

10 

11  Endocrine 
disruption 

12 

13 

Cell Transformation Assay (CTA) Balb/C  EURL ECVAM 

recommendation published in 
2011 

Cell Transformation Assay (CTA) BHAS  ESAC peer review finalised 
ESAC peer review finalised 
Keratinosens test method 
ESAC peer review finalised 
Direct Peptide Reactivity Assay (DPRA) 
ESAC peer review foreseen 
human Cell line Activation Test (h-
to start in 2013 
CLAT) 
EURL ECVAM draft 
3T3 Neutral Red Uptake (NRU) test 
recommendation underwent 
method 
public commenting in 2012 
ESAC peer review foreseen 
to start in 2013 

Cytochrome P450 (CYP) induction assay 
using the human cryopreserved HepaRG® 
cell line and cryopreserved human 
hepatocytes 
Reconstructed human tissue model 
(EpiOcular™ EIT) 
Reconstructed human tissue model 
(SkinEthic™ HCE) 
MELN® estrogen receptor transactivation 
assay (agonist and antagonist protocols) 
Androgen receptor transactivation assay 
(agonist and antagonist protocols) 
Androgen receptor transactivation assay 
(agonist and antagonist protocols) 

ESAC peer review foreseen 
to start in 2013 
ESAC peer review foreseen 
to start in 2013 
ESAC peer review foreseen 
to start in 2013 
EURL ECVAM validation 
foreseen to start in 2013 
EURL ECVAM validation 
foreseen to start in 2013 

Table 2. Status of regulatory acceptance of in vitro test methods since 2010 

Nr.  Toxicity area 
Skin corrosion 
1 

Test method description 
Recontructed human Epidermis test 
methods (RhE) as included in OECD 
TG36 431/EU TM37 B.40 bis 

2 

3 

Skin irritation 

Transcutaneous electrical resistance 
(TER) test as included in OECD TG 
430/EU TM B.40 

Recontructed human Epidermis test 
methods (RhE) as included in OECD TG 
439/EU B.46 

Acceptance status 
Accepted in 2004, updated 
version (sub-categorisation, 
performance standards, 
inclusion of SkinEthic™ 
RHE and epiCS®) will be 
discussed at WNT38 in 2013 
Accepted in 2004, updated 
version (performance 
standards) will be discussed 
at WNT in 2013 
Accepted in 2010, updated 
version (performance 
standards, inclusion of 

35 
36 
37 
38 

'Validation Status' refers to the different steps of the validation process. 
'OECD TG' refers to OECD Test Guidelines. 
'UNION TM' refers to methods included in Commission Regulation (EC) 440/2008. 
Working Group of National Coordinators of the OECD Test Guideline Programme. 

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4 

5 

6 

7 

8 

9 

Eye irritation  

Fluorescein Leakage (FL) test method as 
included in OECD TG 460 
Bovine Corneal Opacity and Permeability 
(BCOP) test method as included in OECD 
TG 437/EU TM B.47 

Isolated Chicken Eye (ICE) test method 
as included in OECD TG 438/EU TM 
B.48 

Carcinogenicity 

Cytosensor Microphysiometer (CM) test 
method 
Cell Transformation Assay (CTA) SHE  

Genotoxicity 

Existing OECD TGs under revision 

10  Endocrine 
disruption 

11 

Estrogen receptor transactivation assay 
(BG1Luc ER TA; agonist and antagonist 
protocols) as included in OECD TG 457 
Performance-Based Test Guideline for 
Stably Transfected Transactivation In 
Vitro Assays to Detect Estrogen Receptor 
Agonists (OECD TG 455) 

LabCyte EPI-model) will be 
discussed at WNT in 2013 
Accepted in 2012 

Accepted in 2009, updated 
version (positive control, use 
in a bottom-up approach to 
identify non-classified 
chemicals) will be discussed 
at WNT in 2013 
Accepted in 2009, updated 
version (use in a bottom-up 
approach to identify non-
classified chemicals) will be 
discussed at WNT in 2013 
New draft TG will be 
discussed at WNT in 2013 
New draft TG will be 
discussed at WNT in 2013 
Draft OECD TG 473 (in vitro 
chromosome aberration 
assay) and OECD TG 487 (in 
vitro micronucleus test) will 
be discussed at WNT in 2013 
Accepted in 2012 

Accepted in 2012 

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