REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2013-2015)
Date: 2016-09-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: animal experimentation, animal welfare, cosmetics industry, international cooperation, market approval, marketing standard, product safety, research method, testing

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 19.9.2016  COM(2016) 599 final   REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2013-2015)  
 
 
1.  INTRODUCTION 

This is the eleventh Commission report on the development, validation and legal acceptance 
of methods alternative to animal testing in the field of cosmetics.  

Under  Article  35  of  Regulation  (EC)  1223/2009  of  the  European  Parliament  and  of  the 
Council of 30 November 2009 on cosmetic products1 (the Cosmetics Regulation), each report 
must include information on: 

-  progress  made  in  the  development,  validation  and  acceptance  of  methods 

- 

alternative to animal testing; 
the Commission’s progress on obtaining the OECD’s acceptance of the alternative 
methods validated at EU level; 

-  progress on third-country recognition of the results of safety tests carried out in the 

EU using alternative methods; 
the specific needs of small and medium-sized enterprises (SMEs). 

- 

This  report  also  informs  the  European  Parliament  and  the  Council  of  compliance  with  the 
deadlines for the bans set out in Article 18(1) and of related technical difficulties, pursuant to 
Article 18(2) of the Cosmetics Regulation. 

Under Article 18(2) of the Cosmetics Regulation, the report should also cover any derogations 
to  Article  18(1)  granted  in  accordance  with  Article  18(2)  of  the  Cosmetics  Regulation. 
However, to date there have been no derogations granted under this provision. 

After the animal testing bans became fully applicable on 11 March 2013, the report does not 
anymore contain statistical data on the number and type of animal experiments carried out in 
relation to cosmetic products in the EU (as stated in the 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  cosmetics2  of  11  March 
2013). 

The part of the report on compliance with the testing and marketing bans and the impact of 
the bans is based on contributions from the Member States, covering the year 2013 or 2013-
2014,  depending  on  the  Member  State.  The  part  on  the  progress  made  in  the  development, 
validation  and  legal  acceptance  of  alternative  methods  is  largely  based  on  the  latest  EURL 
ECVAM3  Status  Report  on  the  Development,  Validation  and  Regulatory  Acceptance  of 
Alternative  Methods  and  Approaches  (2015)4  (2015  EURL  ECVAM  Status  Report)  which 
covers  the  period  from  May  2014  to  September  2015.  There  were  delays  in  receiving 
contributions from some Member States, which explains the timespan of the report. 

1 OJ L 342, 22.12.2009, p. 59. 
2 COM(2013) 135 final. 
3 European Union Reference Laboratory for Alternatives to Animal Testing, Directorate General Joint Research 
Centre  of  the  European  Commission,  previously  Institute  for  Health  and  Consumer  Protection,  currently 
Directorate F – Health, Consumers and Reference Materials. 
4 
acceptance-of-alternative-methods-and-approaches-2015--pbLBNA27474/. 

http://bookshop.europa.eu/en/eurl-ecvam-status-report-on-the-development-validation-and-regulatory-

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2.  BACKGROUND 

The animal testing of finished cosmetic products has been prohibited in  the EU since 2004, 
and the testing of cosmetic ingredients since March 2009 (testing ban). Since 11 March 2009, 
the marketing in the EU of cosmetic products and their ingredients which have been tested on 
animals in order to meet the requirements of Directive 76/768/EEC5 has also been prohibited 
(2009 marketing ban). This marketing ban applied to all but the most complex human health 
effects (endpoints) that needed to be tested to demonstrate the safety of cosmetic products in 
the absence of alternative non-animal tests (repeated-dose toxicity, reproductive toxicity and 
toxicokinetics);  the  European  Parliament  and  the  Council  decided  that  the  ban  would  take 
effect on 11 March 2013 (2013 marketing ban). On 11 March 2013, the Commission adopted 
a Communication on the animal testing and marketing ban and on the state of play in relation 
to  alternative  methods  in  the  field  of  cosmetics.  This  Communication  confirmed  the 
Commission’s  commitment  to  maintaining  the  2013  deadline.  Therefore,  the  marketing  ban 
became  fully  applicable  as  of  11  March  2013,  irrespective  of  the  availability  of  alternative 
non-animal tests.6 

3.  COMPLIANCE WITH THE TESTING AND MARKETING BANS AND THE IMPACT OF THE BANS 

In practice, the main way of verifying compliance with the testing and marketing bans is the 
cosmetic product’s product information file. Under Article 11(1) of the Cosmetics Regulation, 
the responsible person7 must keep a product information file for every cosmetic placed on the 
EU market.  

The product information file must include:  

the cosmetic product safety report referred to in Article 10(1); 

- 
-  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.8 

In the Communication of 11 March 2013, the Commission provided guidance on information 
which should be included in the product information file to make it possible to verify whether 
animal testing was carried out in order to meet the requirements of the Cosmetics Regulation 
or for other purposes. The file should contain documentation on any use of the substance in 
products  other  than  cosmetic  products  such  as  product  examples  or  market  data  and 
documentation  on  compliance  with  other  regulatory  frameworks  (e.g.  the  REACH 
Regulation9) and a justification of the need for the animal testing under that framework. 

5 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, repealed by the Cosmetics Regulation. 
6 A case on the interpretation of the marketing ban as laid down in Article 18(1)(b) of the Cosmetics Regulation 
is currently pending before the Court of Justice of the European Union (C-592/14). 
7 As defined in Article 4 of the Cosmetics Regulation. 
8 Article 11(2)(b) and (e) of the Cosmetics Regulation. 
9  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 

3 

 
 
                                                            
3.1. Inspections and compliance 

Monitoring  activities  and  checks  related  to  compliance  with  the  testing  and  marketing  bans 
were mostly carried out in the course of regular inspections on cosmetic products, or as part of 
general  inspections  or  inspection  programmes  targeted  at  specific  topics  or  risks.  No 
inspection  programmes  were  specifically  carried  out  to  monitor  compliance  with  the  testing 
and marketing bans.  Compliance was  usually verified through checks of cosmetic  products’ 
product information files made by competent national authorities. 

Four Member States reported not to have monitored compliance with the bans. This was due 
mostly  to  the  specificity  of  the  market,  where  cosmetic  products  originated  mainly  in  other 
EU Member States and where local production was very limited. 

During inspections carried out by market surveillance authorities, almost none of the Member 
States monitoring compliance detected any infringements of the testing and marketing bans. 

There  was  one  case  of  non-compliance  with  the  bans  reported,  for  a  cosmetic  product 
imported  from  a  third  country.  The  importer  had  to  withdraw  the  product  from  the  market, 
and was prosecuted and fined. 

3.2. Difficulties  encountered  with  monitoring  the  ban  and  suggestions  to  improve  the 

situation 

From the 23 Member States who had monitored the compliance of cosmetic products with the 
testing  and  marketing  bans,  a  dozen  did  not  encounter  any  difficulties  in  carrying  out  the 
checks. 

The main difficulty raised by most of the remaining Member States was the fact that product 
information files were incomplete with regard to data on animal testing, yet this information is 
necessary to verify compliance with the bans.  

In  particular,  the  toxicological  data  (including  animal  testing  data)  on  ingredients  was 
insufficient. Moreover, the product information files did not always contain complete data on 
compliance  with  legislative  frameworks  other  than  the  Cosmetics  Regulation  (e.g.  the 
REACH Regulation). The information relating to animal testing was in certain cases limited 
to  a  disclaimer  by  the  responsible  person  that  no  animal  testing  had  been  performed  on  the 
final  product.  In  addition,  it  was  found  that  some  small  companies  have  an  insufficient 
understanding of the bans or even misinterpret their requirements.  

In  certain  cases,  the  incomplete  animal  testing  data  could  be  explained  by  the  fact  that  the 
suppliers  of  cosmetic  ingredients  did  not  provide  sufficient  toxicological  and  animal  testing 
data to the cosmetic product manufacturer or responsible person. Responsible persons cannot 
always  access  this  information  if  it  is  not  provided,  as  it  is  the  ingredient  suppliers  who 
commission tests.  

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, 30.12.2006, p. 1. 

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In  future  reports, the issue  of incomplete animal  testing data in the product information  file 
should be followed closely by competent national authorities to see how it evolves. 

As  reported  by  four  Member  States,  there  were  difficulties  particularly  with  cosmetics 
imported  into  the  EU  from  third  countries  where  animal  tests  are  still  required.  In  some  of 
these  cases,  the  information  on  animal  testing  was  simply  missing  from  the  product 
information file. Two of these Member States questioned the reliability of the animal testing 
data received (in particular statements that no animal testing had been performed). 

Two  other  Member  States  raised  doubts  about  the  joint  application  of  the  Cosmetics 
Regulation  and  the  REACH  Regulation.  In  particular,  there  was  uncertainty  about  whether 
animal  testing  data  should  be  kept  for  ingredients  which  are  also  used  in  other  applications 
where animal testing is required under the REACH Regulation. 

One Member State reported that it was not always possible to conduct checks of the product 
information files onsite given their size and that in these cases the responsible persons were 
not always willing to submit product information files to the national authority. Two Member 
States raised the issue of market surveillance of cosmetic products for which the responsible 
person  is  established  in  another  Member  State,  in  which  case  the  authority  has  no  direct 
access to the product information file.10 

Several  Member  States  took  action  to  improve  operators’  understanding  of  the  bans’ 
requirements  by  communicating  on  the  requirements  to  industry  representatives.  They 
disseminated information on the bans to economic operators through various media.11 

3.3. Ban-related  issues  encountered  by  manufacturers,  in  particular  SMEs,  and  the 

bans’ impact on the innovativeness of the cosmetics sector 

Most Member States did not report12 any cases where a manufacturer, in particular an SME, 
was  not  able  to  place  a  cosmetic  product  on  the  market  due  to  an  inconclusive  safety 
assessment  of  the  product  or  ingredient  caused  by  a  lack  of  alternatives  to  animal  testing.13 
However,  one  Member  State  pointed  out  that  SMEs  do  not  have  the  financial  resources 
needed for cost-intensive toxicological tests on new products. 

10  However,  Article  30  of  the  Cosmetics  Regulation  makes  it  possible  for  the  competent  authority  of  any 
Member State where the cosmetic product is made available to request the competent authority of the Member 
State where the product information file is made readily accessible to verify whether the product information file 
satisfies  the  requirements  of  Article  11(2)  and  whether  the  information  set  out  in  it  provides  evidence  of  the 
safety of the cosmetic product. 
11  To  help  address  some  of  the  issues  described  above,  one  of  these  Member  States  suggested  developing  a 
common  platform  to  exchange  information  within  the  framework  of  the  PEMSAC,  the  Platform  of  European 
Market Surveillance Authorities for Cosmetics. However, no Member State proposed to include the topic in the 
PEMSAC Work Programme for 2016-2017. 
12 Among these Member States, some explicitly stated that no such cases had been encountered; the others did 
not specifically address this question. 
13  This  issue  was,  however,  raised  by  one  Member  State.  According  to  information  received  by  this  Member 
State  from  industry  associations,  it  has  become  impossible  to  place  certain  cosmetic  products  on  the  market 
because the safety assessment of the product or one of its ingredients was not conclusive. It was, however, not 
always possible to say with certainty whether this was a direct result of the testing and marketing bans. 

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On the question of how the testing and marketing bans have affected the innovativeness of the 
cosmetics sector, most Member States either did not provide any information or reported that 
such information was not available to them. Views varied among the remaining nine Member 
States. 

Four Member States were of the view that the bans had no negative impact on innovativeness. 
The  main  reason  put  forward  was  that  there  was  already  a  considerable  amount  of  animal 
testing data available, as well as animal testing data obtained in relation with other legislative 
frameworks  on  chemicals.  These  views  were  not  always  based  on  data  and  market 
information. 

The  remaining  five  Member  States  claimed  that  the  bans  may  have  a  negative  impact  on 
innovativeness  to  some  extent  because  the  current  level  of  methods  alternative  to  animal 
testing does not make it possible to fully replace in vivo tests for all toxicological endpoints 
and because the bans may restrict the data available for the safety assessment of products or 
make  it  difficult  to  place  new  cosmetic  ingredients  on  the  market.  These  views  were  not 
always based on data and market information. 

4.  PROGRESS  MADE  IN  THE  DEVELOPMENT,  VALIDATION  AND  LEGAL  ACCEPTANCE  OF 

ALTERNATIVE METHODS 

Significant progress was made in recent years in the development, validation and regulatory 
acceptance of alternative methods to test for skin irritation/corrosion, serious eye damage/eye 
irritation and skin sensitisation. 

For skin irritation/corrosion, the regulatory accepted alternative methods now make it possible 
to generate data that is adequate for the classification and risk assessment of most substances. 
For  serious  eye  damage/eye  irritation,  there  is  also  a  set  of  regulatory  accepted  alternative 
methods,  which  will  in  most  cases  be  sufficient  to  obtain  information  that  is  adequate  for 
classification  and  risk  assessment.  For  skin  sensitisation,  several  in  vitro/in  chemico  testing 
methods have been validated and some have already obtained regulatory acceptance.  

Despite  significant  progress  in  the  development  of  alternative  approaches,  considerable 
scientific  challenges  remain  for  the  more  complex  endpoints  for  which  more  research  is 
needed. 

Moreover, Directive  2010/63/EU  on  the  protection  of  animals  used  for  scientific  purposes14 
which took effect in 2013 requires the Commission and the Member States to contribute to the 
development  and  validation  of  alternative  approaches,  whereas  Directive  86/609/EEC  only 
provided for their promotion.15 

4.1. Progress in the EU 

14 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection 
of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33. 
15 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, OJ L 358, 18.12.1986, p. 1. 

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4.1.1.   Research and development activities 

Major research and development activities on alternatives to animal testing are ongoing in the 
EU. More than €250 million were dedicated during the Seventh Framework Programme (FP7: 
2007-2013),  including  from  the  Innovative  Medicines  Initiative  (IMI),  to  research  into 
alternatives. The five-year SEURAT-1 research initiative, which was completed in 2015, was 
a unique €50 million public-private partnership co-financed by the Commission’s FP7 (Health 
Programme)  and  Cosmetics  Europe,  the  European  personal  care  association.  It  consisted  of 
six  individual  research  projects  and  one  coordination  action,  and  combined  the  research 
efforts  of  over  70  European  universities,  public  research  institutes  and  companies.  The 
project’s  achievements  were  presented  at  the  final  SEURAT-1  symposium  on  4  December 
2015 in Brussels.16 

As a follow-up to SEURAT-1, the EU-ToxRisk project,17 An Integrated European ‘Flagship’ 
Programme  Driving  Mechanism-based  Toxicity  Testing  and  Risk  Assessment  for  the  21st 
Century, was launched in January 2016. It is a large €30 million collaborative project funded 
under  the  Horizon  2020  programme,  and  involves  academia,  SMEs,  large  industry  and 
regulatory bodies. It aims to achieve a paradigm shift in toxicology, towards a more efficient 
and  animal-free  chemical  safety  assessment,  in  particular  in  the  field  of  repeated  dose  and 
developmental/reproductive toxicity testing. 

There  have  also  been  other  projects  at  European  level,  including  the  CALEIDOS  project18 
that was funded under the Life+ programme from January 2013 to June 2015.19 

4.1.2.   Validation and regulatory acceptance of alternative methods 

An overview of the progress of alternative methods from proposal for validation to its final 
adoption  and  inclusion  into  the  regulatory  framework  will  be  available  through  a  revised 
version of the Tracking System for Alternative test methods towards Regulatory Acceptance 
(TSAR).20  

4.1.2.1. 

EURL ECVAM21 activities22 

EURL ECVAM has continued to fulfil its mandate laid down in Article 48 and Annex VII of 
Directive 2010/63/EU, including the validation of alternative test methods at EU level and the 
promotion of their regulatory acceptance. 

16 http://www.seurat-1.eu/. 
17 http://www.eu-toxrisk.eu/. 
18  Chemical  assessment  according  to  legislation  enhancing  the  In  silico  documentation  and  safe  use, 
http://www.caleidos-life.eu/. 
19  The  project  explored  the  regulatory  applicability  of  so-called  non-testing  methods  (quantitative  structure-
activity relationship (QSAR) and read-across) to substances registered under the REACH Regulation. 
20 The revised TSAR will also cover the needs of the individual partners of EURL ECVAM participating in the 
International Cooperation on Alternative Test Methods (ICATM); please see section 4.2.2. 
21 European Union Reference Laboratory for Alternatives to Animal Testing, Directorate General Joint Research 
Centre of the European Commission. 
22 https://eurl-ecvam.jrc.ec.europa.eu/. 

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During  the  period  covered  by  the  2015  EURL  ECVAM  Status  Report  (May  2014  to 
September 2015), EURL ECVAM evaluated thirty test submissions23 and successfully carried 
out several validation studies. In addition, the EURL ECVAM Scientific Advisory Committee 
peer  reviewed  validation  studies  and  issued  opinions  on  test  methods  in  the  fields  of  skin 
sensitisation, eye and skin irritation and toxicokinetics. 

EURL  ECVAM  published  a  recommendation  on  a  successfully  validated  skin  sensitisation 
test  and  produced  a  report  for  the  OECD  on  the  development  of  a  test  guideline  on  this 
method.24 Two additional recommendations are currently being prepared. 

More details on these activities can be found in the 2015 EURL ECVAM Status Report. 

Set-up of the EU-NETVAL 

In  2013,  EURL  ECVAM  set  up  the  EU-NETVAL,25  the  European  Union  Network  of 
Laboratories  for  the  Validation  of  Alternative  Methods,  based  on  Article  47(2)  of  Directive 
2010/63/EU.  EU-NETVAL’s  mission  is  to  provide  support  primarily  for  EURL  ECVAM 
validation studies. Following the 2015 call for membership, the network comprises more than 
thirty-five test facilities. 

4.1.2.2.  Regulatory uptake 

Commission  Regulation  (EC)  440/200826,  which  brings  together  all  regulatory  accepted 
testing  methods  at  EU  level,27  has  been  updated  three  times  since  2013.  Another  update  is 
underway.  

The  in  vivo  tests  for  skin  irritation/corrosion,  serious  eye  damage/eye  irritation  and  skin 
sensitisation  required  under  the  REACH  Regulation  did  not  adequately  reflect  the  state  of 
science any more. Therefore, in late 2014 the Commission proposed to amend Annex VIII to 
the  REACH  Regulation  to  fully  replace  in  vivo  with  in  vitro  testing  for  these  endpoints  for 
substances in the applicability domain of the available  in  vitro tests.  The  annex  amendment 
concerning skin irritation/corrosion and serious eye damage/eye irritation was adopted on 31 
May 201628. The Commission proposal on skin sensitisation received a favourable vote of the 
REACH Committee in April 2016. 

23 Not all test methods submitted would necessarily be relevant for carrying out safety assessments of cosmetic 
products. 
24 For activities at OECD level, please see section 4.2.1. of this report. 
25 https://eurl-ecvam.jrc.ec.europa.eu/eu-netval. 
26 Commission 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, 31.5.2008, p. 1. 
27  Annex  VIII  to  the  Cosmetics  Regulation  (‘List  of  validated  alternative  methods  to  animal  testing’)  must  be 
updated with alternative methods validated by ECVAM, which are not listed in Commission Regulation (EC) No 
440/2008. 
28 Commission Regulation (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) 
No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation and 
acute toxicity, OJ L 144, 1.6.2016, p. 27. 

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4.1.2.3. 

The  European  Partnership  for  Alternative  Approaches  to  Animal 

Testing 

The Commission and industry representatives together facilitate the regulatory acceptance of 
alternative  methods  and  approaches  under  the  European  Partnership  for  Alternative 
Approaches to Animal Testing (EPAA). They do so by running projects, and organising and 
financially supporting workshops and conferences.29 

4.1.3.  Alternative methods for assessing the safety of cosmetic ingredients 

The Scientific Committee on Consumer Safety (SCCS), in charge of evaluating the safety of 
cosmetic  ingredients,  recently  published  the  9th  revision  of  its  Notes  of  Guidance,  with  a 
special  focus  on  the  latest  developments  in  the  field  of  alternative  methods  and  their 
suitability for each endpoint of the safety assessment.30 

4.1.4.  Other activities in the area of alternatives to animal testing 

The topic of alternatives to animal testing, and more generally of animal welfare, has recently 
received  considerable  attention  in  the  EU.  1.17  million  citizens  signed  the  2015  Citizens’ 
Initiative ‘Stop Vivisection’31 which requested to end all animal experimentation. In reply to 
this initiative, in its Communication of 3 June 201532 the Commission committed to several 
actions  to  accelerate  the  development  and  uptake  of  non-animal  approaches  in  research  and 
testing. One of these is to organise, by the end of 2016, a conference33 engaging the scientific 
community and relevant stakeholders in a debate on how to exploit the advances in science 
for  the  development  of  scientifically  valid  non-animal  approaches  and  advance  towards  the 
goal of phasing out animal testing without compromising human safety. 

4.2. Progress at international level 

4.2.1.   Activities at OECD level 

The  methods  for  which  OECD  test  guidelines  are  adopted  are  legally  implemented  at  EU 
level through Commission Regulation (EC) 440/2008.34 In addition, OECD-accepted methods 
are  also  suitable  for  regulatory  use  in  the  EU  prior  to  their  official  inclusion  in  the 
Commission Regulation (EC) 440/2008. 

In 2015, the Working Group of National Coordinators of the OECD test guideline programme 
(TGP)  approved  six  new  test  guidelines,  of  which  four  were  based  on  in  vitro  methods  (on 
serious  eye  damage/eye  irritation  and  endocrine  disruption).  In  addition,  ten  existing  test 
guidelines were updated. 

29  EPAA  2015  Annual  Report,  see:  https://circabc.europa.eu/sd/a/54e9ad8e-0f49-4ed0-b581-36fe6e136ce4/ar-
2015.pdf. 
30 http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_190.pdf. 
31 http://ec.europa.eu/citizens-initiative/public/initiatives/successful/details/2012/000007. 
32 C(2015) 3773 final. 
33 Planned for December 2016. 
34 See section 4.1.2.2. of this report. 

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A  summary  of  the  status  of  the  adoption  in  the  OECD  TGP  (2012-2015)  of  test  guidelines 
based  on  alternative  methods  can  be  found  in  Annex  I  to  the  2015  EURL  ECVAM  Status 
Report.  

The  Commission,  through  EURL  ECVAM,  plays  an  active  role  at  OECD  level.  Within  the 
OECD TGP, EURL ECVAM leads or co-leads ten projects on the development of new test 
guidelines or guidance documents. 

Moreover,  within  the  OECD  Task  Force  on  Hazard  Assessment,  EURL  ECVAM  leads 
projects  related  to  the  integrated  approach  to  testing  and  assessment  (IATA)  which  has 
become  a  priority  over  recent  years  as  an  alternative  solution  to  animal  testing.  EURL 
ECVAM also co-chairs a group with the US Environmental Protection Agency.35  

4.2.2.  Other cooperation with third countries 

At  international  level,  the  Commission  is  involved  in  various  cooperation  projects,  notably 
through  EURL  ECVAM.  These  include  the  International  Conference  on  Harmonisation  of 
Technical  Requirements  for  Registration  of  Pharmaceuticals  for  Human  Use,  the  World 
Health  Organisation  International  Programme  on  Chemical  Safety  and  the  International 
Cooperation  on  Alternative  Test  Methods  (ICATM)36  set  up  in  2009  by  the  International 
Cooperation on Cosmetics Regulation (ICCR).37 

ICATM members agreed to strengthen their cooperation on conducting validation studies of 
test methods on a voluntary basis and to create guidance on how validation studies should be 
conducted.  An  overview  of  the  status  of  the  validation  of  alternative  test  methods  and 
regulatory  acceptance  by  ICATM  members  can  be  found  in  Annex  II  to  the  2015  EURL 
ECVAM Status Report. 

The ICCR includes various projects relating to alternatives to animal testing.38 At the ICCR 
ninth annual meeting held in Brussels (Belgium) from 4 to 6 November 2015, ICCR members 
decided to merge the different groups dealing with alternative testing methods into a working 
group  on  safety  assessment  methods.  The  group  is  to  have  a  broader  focus  on  integrated 
methods and approaches to the safety assessment of ingredients used in cosmetic products. 

5.  CONCLUSION 

It  has  been  possible  to  prepare  the  present  report  only  in  2016,  as  it  has  been  based  on  the 
contributions received from Member States between 2014 and end 2015. 

35 The OECD Extended Advisory Group on Molecular Screening and Toxicogenomics and its Adverse Outcome 
Pathways Development Programme. 
36 ICATM members are agencies from the EU, the United States, Japan, Canada and South Korea. 
37  ICCR  is  a  voluntary  international  group  of  cosmetics  regulatory  authorities  from  Brazil,  Canada,  the  EU, 
Japan and the United States. 
38 The ICCR working group on In silico/ QSAR Models produced a report on In Silico Approaches for Safety 
Assessment  of  Cosmetic  Ingredients  in  July  2014:  http://www.iccrnet.org/files/5314/1407/7607/2014-07_In-
silico_Approaches_for_Cosmetic_Product_Safety_Assessments.pdf. 

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Virtually no cases of non-compliance with the testing and marketing bans have been reported 
by  the  Member  States.  The  main  issue  encountered  in  their  market  surveillance  activities 
related  to  the  bans  is  the  presence  of  cases  of  incomplete  animal  testing  data  in  product 
information files. 

However,  this  report  covers  the  relatively  early  stages  of  the  implementation  of  the  2013 
marketing  ban.  It  will  be  interesting  to  follow  future  developments  in  this  field,  when 
economic  operators  and  market  surveillance  authorities  gain  more  experience  regarding  the 
implementation  of  the  full  marketing  ban.  In  particular,  the  issue  of  cases  of  incomplete 
animal  testing  data  in  the  product  information  file  should  be  monitored  by  the  competent 
national authorities, as the product information file is the main way to verify compliance with 
the testing and marketing bans. 

Considerable progress has been made in the development, validation and legal acceptance of 
methods  alternative  to  animal  testing.  Nevertheless,  some  challenges  remain  for  the  most 
complex endpoints where more research is needed. The current level of alternative methods 
does not make it possible to fully replace in vivo tests for all toxicological endpoints. 

Significant investments have been made in the development of alternative methods in the EU, 
notably  through  major  research  initiatives  bringing  together  public  and  private  players.  The 
European Commission has remained engaged in the validation of alternative methods through 
EURL  ECVAM,  and  in  the  promotion  of  their  regulatory  acceptance  at  OECD  level  and 
internationally. 

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