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 (2015-2017)
Date: 2018-07-10
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

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 10.7.2018 COM(2018) 531 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 (2015-2017)  
 
 
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 (2015-2017) 

1.  INTRODUCTION 

This  is  the  12th  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)  No 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  animal  testing  bans  set  out  in  Article 18(1)  and  of  related  technical 
difficulties, pursuant to Article 18(2) of the Cosmetics Regulation. Article 18(1) prohibits the 
testing on animals of finished cosmetic products and of cosmetic ingredients (testing ban), as 
well  as  the  marketing  of  finished  cosmetic  products  and  of  cosmetic  products  containing 
ingredients  tested  on  animals  (marketing  ban),  to  meet  the  requirements  of  the  Cosmetics 
Regulation. 

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

The  information  in  Section  3  on  compliance  with  the  testing  and  marketing  bans  and  the 
impact of the bans is based on contributions from Member States, mainly covering the years 
2015-20162.  The  information  in  Section  4  on  the  progress  made  in  the  development, 
validation and legal acceptance of alternative methods is largely based on the 2016 and 2017 
status  reports3  from  the  European  Union  Reference  Laboratory  for  Alternatives  to  Animal 

1   OJ L 342, 22.12.2009, p. 59. 
2   Some Member States reported to the Commission later than the requested deadline and also (partly) covered 

the year 2017. 

3   EURL  ECVAM  status  report  on  the  development,  validation  and  regulatory  acceptance  of  alternative 

methods and approaches (2016 and 2017). 

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Testing (EURL ECVAM) of the Commission’s Joint Research Centre4. Together, they cover 
the period from October 2015 to September 2017. 

2.  CLARIFICATION OF THE SCOPE OF THE MARKETING BAN BY THE COURT OF JUSTICE 

In  the  European  Federation  for  Cosmetic  Ingredients  case,  the  Court  of  Justice  made  an 
important  clarification  on  the  interpretation  of  the  marketing  ban  as  regards  animal  testing 
carried out in non-EU countries to comply with the cosmetics legislation of a third country5. 
The main question examined by the Court was whether Article 18(1)(b) may be interpreted as 
prohibiting  the  placing  on  the  EU  market  of  cosmetic  products  containing  ingredients  that 
have been tested on animals outside the EU to comply with the cosmetics legislation of a third 
country. 

The  Court  concluded  that:  ‘Article 18(1)(b)  of  Regulation  (EC)  No  1223/2009[…]  must  be 
interpreted  as  meaning  that  it  may  prohibit  the  placing  on  the  European  Union  market  of 
cosmetic products containing some ingredients that have been tested on animals outside the 
European Union, in order to market cosmetic products in third countries, if the resulting data 
is  used  to  prove  the  safety  of  those  products  for  the  purposes  of  placing  them  on  the  EU 
market’. 

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

In practice, the main way of verifying compliance with the testing and marketing bans is the 
cosmetic  product  information  file  (PIF).  The  ‘responsible  person’6,  who  has  to  ensure 
compliance  with  the  relevant  obligations  of  the  Cosmetics  Regulation  (usually  the 
manufacturer or the importer), must keep a PIF for every cosmetic placed on the EU market. 
The  PIF  must  include  the  cosmetic  product  safety  report  and  data  on  any  animal  testing 
performed  relating  to  the  development  or  safety  assessment  of  the  cosmetic  product  or  its 
ingredients7. The Commission Communication of 11 March 20138 provides further guidance 
as to what information should be included in the PIF. 

3.1. Inspections and compliance 

As  in  the  previous  reporting  period,  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  as  part  of  general  control  activities.  There  were  no 
inspection programmes specifically dedicated to monitoring compliance with the testing and 
marketing  bans.  Compliance  was  mainly  verified  through  checks  by  the  competent  national 
authorities on cosmetic products’ PIFs. 

4   https://eurl-ecvam.jrc.ec.europa.eu/ 
5   Judgment  of  21 September  2016  in  Case  C-592/14  European  Federation  for  Cosmetic  Ingredients 

(EU:C:2016:703). 

6   See Article 4 of the Cosmetics Regulation. 
7   Article 11(2)(b) and (e) of the Cosmetics Regulation. 
8   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 
(COM(2013) 135 final). 

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Only three Member States reported not monitoring compliance with the bans as part of these 
inspections. One of these Member States argued that it was not possible to verify the absence 
of animal tests in the context of general market surveillance, as it is a complex process. 

Based on inspections carried out by market surveillance authorities, a Member State reported 
two cases of infringement of the testing and marketing bans, following which the companies 
were asked to remedy the breach. Some other Member States reported cases where the breach 
was  actually  a  lack  of  (complete)  documentation  proving  compliance  with  the  bans,  rather 
than non-compliance with the ban itself (see Section 3.2.). 

3.2. Difficulties encountered with monitoring the ban and suggestions for improvement 

Of  the  Member  States  who  monitored  compliance  with  the  testing  and  marketing  bans,  the 
very large majority did not report any difficulties in carrying out compliance checks. 

In the previous reporting period, the main issue raised by several Member States was the fact 
that  PIFs  were  incomplete  with  regard  to  data  on  animal  testing  –  this  information  is 
necessary to verify compliance with the bans. The Commission therefore asked the Member 
States specific questions on this aspect, in particular regarding what type of data was missing 
and what measures had been taken. 

The issue of PIFs being incomplete as regards data on animal testing was confirmed by seven 
Member  States.  Most  of  these  Member  States  did  not  mention  or  note  any  changes  to  the 
situation  compared  to  the  previous  period.  They  did  not  specifically  monitor  the  issue  of 
incomplete  PIFs  or  monitored  it  through  continued  reviews  of  PIFs  as  part  of  market 
surveillance activities. 

The issues with PIFs were the following: the information on animal testing or alternatives in 
the PIF (or declaration thereof) was absent or insufficiently detailed (e.g. it did not reference 
the ingredients and the finished product, or it did not mention testing under other regulatory 
frameworks and a justification of the need for this); the toxicological data was insufficient for 
some  cosmetic  ingredients  (for  instance  the  ingredients’  suppliers  did  not  provide 
toxicological data on the ingredients but only a declaration). 

Three  Member  States  noted  a  correlation  between  the  size  of  the  operator  (SMEs)  and  the 
issue of incomplete information on animal testing in the PIF. Four Member States raised the 
issue  with  respect  to  cosmetics  imported  into  the  EU,  where  information  from  the  non-EU 
suppliers was missing. Two Member States noted that importers and/or SMEs lack knowledge 
regarding the application of the animal testing ban requirements. One of those Member States 
highlighted the difficulty for SMEs of finding an appropriate safety assessor9 for their product 
and noted that the safety assessment was sometimes incomplete. (However, this point is not 
specifically linked to the animal testing ban.) 

Nevertheless,  the  competent  authorities  appear  to  be  properly  addressing  the  few  above-
mentioned  shortcomings.  Operators  with  PIFs  that  did  not  provide  complete  animal  testing 

9   A person who carries out the safety assessment of a cosmetic product. 

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information  were  required  to  take  corrective  action.  They  had  to  provide  the  missing 
information,  for  instance  by  asking  their  suppliers  for  that  information  or  by  producing 
toxicological  data  based  on  alternatives.  If  the  information  was  not  provided,  the  ultimate 
consequence  was  the  withdrawal  of  the  product(s)  from  the  market.  However,  one  Member 
State  stressed  the  limits  of  this  approach  with  regard  to  missing  toxicological  data:  for  new 
ingredients, alternative methods would not always be available or affordable for SMEs. 

Four Member States suggested that guidelines/ information  should  be developed on the PIF 
and on the application of the animal testing ban. One of these Member States  also reported 
that  their  authorities  engage  with  operators,  in  particular  SMEs,  through  for  instance 
information events to explain the regulatory requirements. 

Other types of difficulty were reported in a few instances. One Member State mentioned the 
difficulty  of  verifying  the  accuracy  of  an  operator’s  declaration  that  no  animal  testing  had 
been  performed. This  is  due to the fact that supply  chains for  cosmetic ingredients are very 
long. Another Member State reported the issue of the reliability of information provided with 
respect to cosmetics imported from non-EU countries.  

Two Member States argued that checking compliance with the bans is a lengthy and complex 
process, as it requires in-depth verification of documents, specific training for inspectors and 
appropriate technical equipment (implying increased financial costs). In particular, according 
to one of these Member States, the PIF checks are hampered by the fact that the PIF is only 
accessible  onsite,  with  no  possibility  of  making  copies  and  carrying  out  checks  at  the 
competent authority’s offices. 

One Member State raised the issue of market surveillance of cosmetic products for which the 
‘responsible  person’  is  based  in  another  Member  State,  in  which  case  the  authority  has  no 
direct  access  to  the  PIF10,  or  where  the  Member  State  in  which  the  ‘responsible  person’  is 
based takes time to reply to an information request. This difficulty is not specific to the animal 
testing ban, but is linked to PIF checks in general. 

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 report11 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. 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 
this information was not available to them or had not been received from the industry. 

However, five Member States reported the issues below. 

10   Article 30 of the Cosmetics Regulation allows a competent authority of a Member State to ask the competent 

authority of the Member State where the PIF is accessible to verify whether the PIF is complete. 

11   Some  of  these  Member  States  explicitly  stated  that  they  were  unaware  of  such  cases  or  they  had  not 

encountered any; the others did not specifically address this question. 

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One Member State mentioned feedback received from some operators regarding difficulties in 
placing  cosmetic  products  on  the  market  due  to  insufficient  data  to  prove  product  safety 
without  animal  testing.  Another  Member  State  reported  the  concern  raised  by  its  cosmetics 
industry that it was not possible to perform a full safety assessment of a cosmetic ingredient in 
the  absence  of  animal  testing  and  that  it  was  not  possible  to  develop  new  ingredients  for 
cosmetic applications. 

Another Member State mentioned feedback from an operator, which stated that, although it is 
not impossible to develop innovative products, it takes more time and involves more costs, as 
alternative  (in  vitro  and  in  silico)  methods  require  new  knowledge  and  more  time  to  be 
analysed. 

Three Member States mentioned the need for alternatives to animal testing to be developed, in 
particular for repeated-dose toxicity, reproductive toxicity and toxicokinetics. These are areas 
in which it is not yet possible to completely replace animal testing with alternative methods. 
These shortcomings can potentially make it difficult to fully assess the safety of new cosmetic 
ingredients. 

The absence of full replacement alternative methods for the most complex toxicological areas 
is widely recognised. Therefore, research is ongoing to develop these methods. For the other 
toxicological areas, progress has been made towards the validation and regulatory acceptance 
of alternative methods. In particular, work is being done to develop ‘integrated approaches to 
testing and assessment’12 (IATAs). This is explained further in Section 4 below. 

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

ALTERNATIVE METHODS 

As  mentioned  in  the  last  Commission  report,  significant  progress  has  been  made  in  the 
development,  validation  and  regulatory  acceptance  of  alternative  methods,  for  skin 
irritation/corrosion, serious eye damage/eye irritation and skin sensitisation. 

Current research into and development of methods alternative to animal testing mainly focus 
on  integrating  a  variety  of  testing  and  non-testing  methods.  These  include  in  vitro 
technologies,  bioinformatics  and  computational  toxicology,  and  they  are  grouped  into  the 
IATAs mentioned above. IATAs have been developed and internationally harmonised in the 
areas of skin irritation/corrosion and serious eye damage/eye irritation, and are in the process 
of being approved for skin sensitisation13. 

The more complex human health effects (endpoints) still present challenges and require more 
research. This is the case, for example, for acute and chronic systemic toxicity, areas in which 
significant knowledge gaps currently limit the development of IATAs. 

12   An IATA is a framework used for hazard identification, hazard characterisation and/or safety assessment of a 
chemical  or  group  of  chemicals,  which  strategically  integrates  and  weights  all  relevant  existing  data  and 
guides  the  targeted  generation  of  new  data where  required  to  inform  regulatory  decision-making regarding 
potential hazard and/or risk. 

13   See Section 4.1.2.1. 

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4.1. Progress in the EU 

4.1.1.  Research and development activities 

Major  research  and  development  activities  on  methods  alternative  to  animal  testing  are 
ongoing in the EU. 

The  EUR  50  million  SEURAT-1  research  initiative,  co-funded  by  the  Commission  and 
Cosmetics Europe (the European personal care association) and completed in 2015, developed 
a  workflow  to  assess  safety  without  relying  on  animal  testing,  designed  for  cosmetic 
ingredients  but  also  applicable  to  other  types  of  chemicals.  The  outcome  was  published  in 
2017 and is freely accessible online14. 

EU-ToxRisk15,  the  integrated  European  ‘flagship’  programme  driving  mechanism-based 
toxicity  testing  and  risk  assessment  for  the  21st  century,  is  a  major  collaborative  project 
funded by the EU framework programme for research and innovation, Horizon 2020. With a 
budget of over EUR 30 million, it was launched in January 2016 and will last for six years. 
The  project,  which  builds  on  the  results  of  SEURAT-1,  aims  to  make  progress  towards 
animal-free  safety  assessments  and  tackles  complex  areas  of  toxicology,  such  as  repeated-
dose  and  reproductive  toxicity.  The  first  eight  case  studies  have  progressed  considerably, 
through 
establishing  collaborations  with 
EURL ECVAM. 

the  US  Tox2116  and 

the  Commission, 

Several other large Horizon 2020 research projects to assess chemical mixtures have begun in 
recent years, including EuroMix17 and EDC-MixRisk18. EuroMix aims to develop a strategy 
for the risk assessment of mixtures of chemicals from multiple sources, while EDC-MixRisk 
focuses  on  improving  the  risk  assessment  of  exposure  to  mixtures  of  endocrine-disrupting 
compounds. Both explore mixture assessments including  in vitro and in silico methods. The 
Commission  collaborates  on 
through  EURL  ECVAM.  The  human 
biomonitoring  project  HBM4EU19,  in  which  the  Commission  and  several  EU  agencies  are 
involved, includes one work package dedicated to mixtures. 

these  projects 

4.1.2.  Validation and regulatory acceptance of alternative methods 

EURL ECVAM is mandated under Article 48 of and Annex VII to Directive 2010/63/EU20 to 
validate alternative test methods at EU level and promote their regulatory acceptance. 

The  progress  of  a  test  method  from  submission  towards  acceptance  as  a  recognised  test 
method  for use  in  various sectors and its final adoption  into a regulatory  framework can  be 

14   http://www.seurat-1.eu/ 
15   http://www.eu-toxrisk.eu/ 
16   Toxicology in the 21st century. 
17   https://www.euromixproject.eu/ 
18   http://edcmixrisk.ki.se/ 
19   https://www.hbm4eu.eu/ 
20   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). 

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followed  through  a  new  version  of  the  tracking  system  for  alternative  test  methods  towards 
regulatory acceptance (TSAR)21. 

4.1.2.1. 

Evaluation and validation of test methods 

In the period covered by its 2016 and 2017 status reports, EURL ECVAM evaluated 11 test 
submissions.  It  carried  out  or  assessed  (in  the  context  of  submissions)  several  validation 
studies  in  the  areas  of  endocrine  disruption,  developmental  neurotoxicity,  skin  sensitisation 
and  genotoxicity.  In  addition,  the  EURL  ECVAM  Scientific  Advisory  Committee  peer-
reviewed validation studies carried out by the industry in the areas of (serious) eye damage / 
eye irritation, skin sensitisation and skin irritation. 

In 2017, EURL ECVAM published a recommendation on the use of non-animal approaches 
for skin sensitisation (allergy) testing. The performance of a number of ‘defined approaches’22 
based on different types of non-animal data is considered to be comparable with that of the 
standard  animal  test  for  identifying  potential  skin  allergens.  It  was  therefore  recommended 
that  these  approaches  be  used  where  applicable  and  appropriate,  instead  of  the  standard 
animal test. As a consequence, a project is currently running within the OECD test guidelines 
programme,  under  the  leadership  of  EURL  ECVAM,  the  US  Environmental  Protection 
Agency  and  Health  Canada,  to  develop  a  guideline  based  on  defined  approaches  for  skin 
sensitisation testing.  

The European Union Network of Laboratories for the Validation of Alternative Methods (EU-
NETVAL23) has supported the EURL ECVAM validation studies. It has also helped develop 
guidance  documents  and  training  materials  for  good  in  vitro  method  development  and 
provided input into drafting OECD technical guidance on that topic. 

It is worth noting that, in future, validation work may have to focus on standards for classes of 
methods rather than on validating individual methods. 

More  details  on  these  activities  can  be  found  in  the  2016  and  2017  EURL  ECVAM  status 
reports. 

4.1.2.2.  Regulatory uptake 

Since the last Commission report, Commission Regulation (EC) No 440/200824, which brings 
together all regulatory accepted testing methods at EU level, has been updated once25. 

21   https://tsar.jrc.ec.europa.eu/ 
22   A defined approach consists of a fixed data interpretation procedure applied to data generated with a defined 
set  of  information  sources  to  derive  a  result  that,  depending  on  the  regulatory  requirements,  can  be  used 
instead of standard animal testing to support an assessment. 

23   https://eurl-ecvam.jrc.ec.europa.eu/eu-netval 
24   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). 

25   Commission Regulation (EU) 2017/735 of 14 February 2017 amending, for the purpose of its adaptation to 
technical  progress,  the  Annex  to  Regulation  (EC)  No 440/2008  laying  down  test  methods  pursuant  to 

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the  REACH  Regulation26, 

tests  previously  required  for  skin 
Under 
irritation/corrosion, serious eye damage / eye irritation and skin sensitisation have been fully 
replaced  by  in  vitro  testing.  The  last  amendment  to  the  annex  on  skin  sensitisation  was 
adopted in April 2017. 

in  vivo 

the 

4.1.2.3. 

European Partnership for Alternative Approaches to Animal Testing 

The Commission and industry representatives continue to facilitate the regulatory acceptance 
of  alternative  methods  and  approaches  under  the  European  Partnership  for  Alternative 
Approaches  to  Animal  Testing  (EPAA)27.  According  to  its  updated  action  programme  for 
2016-2020, the EPAA plans to:  

  address  science  and  technology  gaps  and  optimise  translation  from  research  to 

 
 

regulatory practice;  
improve intra- and inter-sectoral collaboration and coordination;  
facilitate  regulatory  acceptance  of  additional  sources  of  evidence  in  the  current 
regulatory framework;  

  communicate scientific reality; and  
 

‘educate  the  educated’  (improve  access  to  information,  training  opportunities  and 
tools). 

In 2017 the EPAA launched the Partners Forum, which provides an opportunity for all EPAA 
members to share information about their existing research initiatives, learn from each other’s 
experience  and  build  synergies  across  business  sectors  to  potentially  speed  up  the 
development and acceptance of alternative methods for regulatory purposes. The 2017 forum 
was  dedicated  to  toxicokinetics  and  ‘read-across’,  and  similar  events  will  be  organised 
annually focusing on an area that is of current common interest to several sectors. 

EPAA has  been very active, for example in the area of skin sensitisation in recent years, in 
making  progress  on  and  facilitating  the  uptake  of  alternatives.  The  project  on  optimised 
strategies  for  assessing  skin  sensitisation  evaluated  the  reliability  and  predicting  capacity  of 
the three most advanced skin models. Other recent or ongoing EPAA projects have focused 
on  alternative  approaches  for  toxicokinetics  (exposure),  acute  toxicity  and  genotoxicity 
testing, and for vaccine potency and safety assessment. 

4.1.2.4.  Dissemination of information on alternatives 

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 112, 28.4.2017, p. 1). 

26   Regulation  (EC)  No 1907/2006  of  the  European  Parliament  and  of  the  Council  of  18 December  2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing 
a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 
793/93  and  Commission  Regulation  (EC)  No 1488/94  as  well  as  Council  Directive  76/769/EEC  and 
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 

27   EPAA annual report 2017; http://ec.europa.eu/docsroom/documents/26811 

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The  availability  of  information  on  alternatives  is  crucial.  Therefore,  information  has  been 
compiled in several databases at EURL ECVAM, including TSAR, the DB-ALM database on 
in vitro methods and the QSAR model database on in silico methods. 

EURL  ECVAM  has  also  carried  out  a  number  of  awareness-raising  activities  regarding 
alternatives to animal testing, such as knowledge-sharing and training. 

In  December  2016,  the  Commission  held  a  scientific  conference  in  Brussels  to  engage  the 
scientific  community  and  relevant  stakeholders  in  a  debate  on  how  to  exploit  cutting-edge 
advances  in  biomedical  and  other  research  in  the  development  of  scientifically  valid 
alternatives  to  animal  testing.  The  event  was  one  of  the  four  actions  announced  in  the 
Commission  Communication  responding 
initiative  ‘Stop 
to 
vivisection’28. 

the  European  citizens’ 

4.2. Progress at international level 

4.2.1.  Activities at OECD level 

The  Commission,  through  EURL  ECVAM,  plays  an  active  role  at  OECD  level  in  the 
regulatory acceptance of alternative methods and their international adoption. 

The  OECD  test  guideline  programme  is  the  main  instrument  for  promoting  a  globally 
harmonised  safety  assessment  of  chemicals29.  From  2016  to  2017,  a  total  of  24  new  and 
updated test guidelines were approved, of which four were based on in vitro methods (on skin 
sensitisation, skin corrosion and endocrine disruption). A summary of the adoption status of 
test guidelines in the OECD from 2011 to 2017 based on alternative methods can be found in 
Annex  1  to  the  2017  EURL  ECVAM  status  report.  In  addition,  16  guidance  documents  or 
supporting documents were approved during that period, in particular the guidance document 
on the IATA to testing and assessment for serious eye damage / eye irritation, which is a basic 
requirement for the safety assessment of chemicals in many regulations. 

Activities within the OECD working party on hazard assessment also play an important role 
in  improving  technical  convergence  on  alternative  methods  at  international  level.  OECD 
member  countries  work  together  to  improve  and  harmonise  assessment  methodologies  for 
chemicals and collectively gain experience in the development of IATAs which has become a 
priority over recent years as an alternative solution to animal testing. 

4.2.2.  Other international cooperation 

The Commission, through EURL ECVAM, has continued its cooperation with other members 
of the International Cooperation on Alternative Test Methods (ICATM)30. An overview of the 

28   http://ec.europa.eu/citizens-initiative/public/initiatives/successful/details/2012/000007 
29   The  methods  for  which  OECD  test  guidelines  are  adopted  are  legally  implemented  at  EU  level  through 

Commission Regulation (EC) No 440/2008. 

30   ICATM  is  an  international  cooperation  that  includes  governmental  organisations  from  the  EU,  the  United 
States, Japan, Canada, South Korea, Brazil and China. ICATM partners work together to promote enhanced 
international  cooperation  and  coordination  on  the  scientific  development,  validation  and  regulatory  use  of 
alternative approaches. 

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validation status of alternative test methods validated/peer-reviewed by ICATM partners and 
their  regulatory  acceptance  status  can  be  found  in  Annex  2  to  the  2016  and  2017 
EURL ECVAM  status 
ICATM, 
In  October  2016, 
EURL ECVAM  held  a  two-day  workshop  on  the  international  regulatory  applicability  and 
acceptance  of  alternative  non-animal  approaches  to  the  skin  sensitisation  assessment  of 
chemicals used in a variety of sectors. 

in  collaboration  with 

reports. 

Since  its  creation,  the  International  Cooperation  on  Cosmetics  Regulation  (ICCR)31  has 
focused on advancing work related to alternatives to animal testing worldwide. At the ICCR’s 
11th  annual  meeting  held  in  Brasilia,  Brazil  from  12  to  14 July  2017,  the  joint  regulators-
industry working group on integrated strategies for safety assessments of cosmetic ingredients 
gave a presentation on the major overarching principles for an integrated strategy for the risk 
assessment  of  cosmetics  ingredients  incorporating  ‘new  approach  methodologies’.  Its 
document  was  endorsed  by  the  ICCR  Steering  Committee  and  is  publicly  available  on  the 
ICCR  website.  Further  work  now  continues  with  the  objective  of  illustrating  how  these 
methodologies  may  be  used  in  the  cosmetic  safety  evaluation  process,  related  to  the 
principles, with examples of methods and their current strengths and limitations. 

The Commission is involved in other international projects, for instance in the context of the 
UN  subcommittee  on  globally  harmonised  system  of  classification  and  labelling  to  further 
explore the use of non-animal methods for classification. 

The  European  Parliament  has  recently  voted  in  favour  of  a  resolution  calling  for  a  global 
animal testing ban in cosmetics32. The Commission will continue to promote the EU animal 
testing  ban  in  cosmetics  at  international  level,  in  various  fora  and  through  bilateral 
cooperation, including with the OECD. It will also remain fully engaged in the development, 
validation and promotion of methods alternative to animal testing to support the promotion of 
a global ban. 

5.  CONCLUSION 

As in the previous reporting period, the Member States reported practically no cases of non-
compliance  with  the  testing  and  marketing  bans.  The  main  issue  encountered  by  a  small 
number  of  Member  States  in  their  market  surveillance  activities  related  to  the  bans  is  the 
presence  of  incomplete  animal  testing  information  in  PIFs.  However,  corrective  measures 
should be imposed on operators in such cases. 

Considerable  progress  continues  to  be  made  in  the  development,  validation  and  legal 
acceptance of methods alternative to animal testing and the Commission is fully engaged at 
all stages of the process. In particular, work has focused on developing defined and integrated 
approaches to testing and assessment which look at all existing safety data when assessing a 
chemical; these have become a priority in recent years. 

31   ICCR  is  a  voluntary  international  group  of  cosmetics  regulatory  authorities  from  Brazil,  Canada,  the  EU, 
Japan and the United States founded in 2007. It discusses common issues on cosmetics safety and regulation 
and is in dialogue with relevant cosmetics industry trade associations; http://www.iccr-cosmetics.org/ 

32   European  Parliament  resolution  of  3  May  2018  on  a  global  ban  to  end  animal  testing  for  cosmetics 

(2017/2922(RSP)). 

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Nevertheless,  the current  level  of  alternative  methods  does  not  yet  make  it  possible  to  fully 
replace  in  vivo  (animal)  tests  for  all  toxicological  endpoints  in  the  safety  assessment  of 
cosmetics.  Challenges  still  remain  for  the  most  complex  endpoints,  where  more  research  is 
needed. Significant projects, such as EU-ToxRisk, aim to address these challenges. 

The  validation  of  alternative  methods  at  EU  level  is  progressing  steadily,  through  the 
activities of the EURL ECVAM. The Commission also remains engaged in encouraging the 
regulatory  acceptance  of  alternative  methods  approved  at  OECD  level  and  maintains 
international  cooperation  in  this  field.  These  activities  aim  not  only  to  recognise  individual 
alternative  methods,  but  also  to  achieve  the  convergence  of  safety  assessment  methods  at 
international level. 

The  Commission  has  always  been  highly  committed  to  animal  welfare.  The  EU  legal 
framework in this regard provides  for  very  strict  requirements  and represents a model to  be 
promoted at international level. 

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