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 (2018)
Date: 2019-10-15
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, 15.10.2019  COM(2019) 479 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 (2018)    
 
 
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 (2018)  

1.  INTRODUCTION 

This is the thirteenth 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’s2  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.  

The  animal  testing  of  finished  cosmetic  products  has  been  prohibited  in  the  EU  since  11 
September 2004, and the testing of cosmetic ingredients since 11 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/EEC3 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 ban4 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 

1 OJ L 342, 22.12.2009, p. 59. 
2 Organisation for Economic Co-operation and Development 
3 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. 
4 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, 11 March 
2013. 

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2013  deadline.  Therefore,  the  marketing  ban  became  fully  applicable  as  of  11  March  2013, 
irrespective of the availability of alternative non-animal tests.5 

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)  of  the  Cosmetics  Regulation. 
However, to date there have been no derogations granted under this provision. 

The  information  on  compliance  with  the  testing  and  marketing  bans  and  the  impact  of  the 
bans in  Section 2 is  based on contributions  from  Member States, mainly  covering the  years 
2017-20186. The information on the progress made in the development, validation and legal 
acceptance of alternative methods in Section 3 is largely based on the 2018 status report7 from 
the  European  Union  Reference  Laboratory  for  Alternatives  to  Animal  Testing  (EURL 
ECVAM) of the Commission’s Joint Research Centre (JRC).  

2.  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’8,  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 
ingredients9.  The  Commission  Communication  of  11 March  2013  provides  further  guidance 
as to what information should be included in the PIF. 

2.1. Inspections and compliance 

National  market  surveillance  activities  and  controls  monitoring  compliance  with  the  testing 
and marketing bans were mostly carried out in the course of regular inspections on cosmetic 
products, or of regular inspections on cosmetic products as part of general control activities. 
No  inspection  programmes  were  specifically  carried  out  to  monitor  compliance  with  the 
testing  and  marketing  bans.  Compliance  was  usually  verified  through  checks  of  PIFs 
conducted by competent national authorities. 

Based  on  inspections  carried  out  by  market  surveillance  authorities,  one  Member  State 
reported  amongst  the  hundreds  cases  of  control  three  cases  of  non-compliance  with  the 
marketing ban, following which the companies were asked to remedy the infringement. Some 
other Member States reported very few cases where the infringement was actually a lack of 

5 Judgment on the interpretation of the marketing ban as laid down in Article 18(1)(b) of the Cosmetics 
Regulation was issued by the Court of Justice of the European Union on 21 September 2016 (C-592/14) 
6 Some Member States reported to the Commission later than the requested deadline and also (partly) covered 
the year 2018. 
7EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative 
Methods and Approaches (2018): 
http://publications.jrc.ec.europa.eu/repository/bitstream/JRC113594/eurl_ecvam_status_report_2018_online.pdf  
8 See Article 4 of the Cosmetics Regulation. 
9 Article 11(2)(b) and (e) of the Cosmetics Regulation. 

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complete documentation to prove compliance with the bans, rather than non-compliance with 
the ban itself (see Section 2.2.). 

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

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

As in the previous reporting periods, the main issue raised by a few Member States was the 
fact  that  the  checked  PIFs  were  incomplete  with  regard  to  data  on  animal  testing.  This 
information  is  necessary  to  verify  compliance  with  the  bans.  The  issue  of  a  very  limited 
number of incomplete PIFs regarding data on animal  testing was confirmed by six Member 
States.  

The  checked  PIFs  often  contained  limited  toxicological  data  of  ingredients  used  in  the 
finished  product.  This  is  because  suppliers  of  ingredients  do  not  provide  cosmetic  product 
manufacturers  with  adequate  toxicological  information,  or  they  only  attach  a  declaration 
stating  that  an  ingredient  has  not  been  tested  on  animals  for  the  purposes  of  the  Cosmetics 
Regulation.  It  sometimes  happens  that  manufacturers  cannot  gain  access  even  to  that 
information  since  their  ingredient  suppliers  refuse  to  provide  them  with  it.  When  cosmetic 
products  are  imported  from  non-EU  countries,  manufacturers  issue  a  declaration  to  the 
responsible  person  stating  that  neither  the  cosmetic  products  being  imported  nor  their 
ingredients  have  been  tested  on  animals  in  view  of  assessing  their  safety  pursuant  to  the 
Cosmetics  Regulation.  However,  they  do  not  provide  them  with  any  information  on  tests 
carried out in accordance with other legislation.  

One  Member  State  argued  that  checking  the  PIF  at  the  premises  of  a  responsible  person  is 
very  difficult  and  time  consuming  given  the  required  scope,  the  specific  training  for 
inspectors  and  the  need  for  appropriate  technical  equipment  in  place  (implying  increased 
financial costs). It is also quite challenging to ensure suitable training for responsible persons 
and safety assessors.  

The  competent  authorities  properly  addressed  all  the  few  above-mentioned  shortcomings. 
Manufacturers and responsible persons with PIFs that did not provide complete animal testing 
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  alternative  methods.  If  the  information  was  not  provided,  the 
consequence was the withdrawal of the product(s) from the market.  

2.3. 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 report10 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 

10  Among  these  Member  States,  some  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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assessment  of  the  product  or  ingredient  caused  by  a  lack  of  alternatives  to  animal  testing. 
However, two Member States reported that SMEs do not have sufficient knowledge about the 
testing  and  marketing  bans  and  sufficient  financial  resources  needed  for  cost-intensive 
toxicological tests on new ingredients. Furthermore, the cosmetic ingredients suppliers do not 
provide  them  with  the  required  safety  data  voluntarily.  Another  problem  concerns  safety 
assessors, who are insufficient  in  number. At the European level  there are no available lists 
from which responsible persons could select safety assessors to commission them to draw up 
a safety report. In particular SMEs therefore have problems finding a suitable safety assessor. 
Since they do not very often understand the specific requirements of Article 18 or of Article 
11 of the Cosmetics Regulation,  they  assume that the safety  report drawn up for them by  a 
safety assessor is in accordance with the requirements of Annex I to the Cosmetics Regulation 
and do not have any doubts about its correctness. 

On the question of how the testing and marketing bans have affected the innovativeness of the 
cosmetics sector, most Member States did not provide any information. 

Two  Member  States  reported  that  some  SMEs  face  difficulties,  due  to  the  absence  of 
alternative  methods,  to  fully  replace  animal  testing,  and  thus  to  compose  a  comprehensive 
safety  file  for  a  cosmetic  product  containing  a  new  cosmetic  ingredient,  particularly  with 
regard to skin sensitisation, repeated-dose toxicity and reproductive toxicity. 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 used exclusively in cosmetic products e.g. new 
UV filters or preservatives.  

One  Member  State  emphasized  the  need  for  developing  alternatives  to  animal  testing,  in 
particular for repeated-dose toxicity, reproductive toxicity and toxicokinetics. These are areas 
where  complete  replacement  of  animal  testing  with  alternative  methods  is  not  yet  possible. 
These shortcomings can potentially make it difficult to assess fully the safety of new cosmetic 
ingredients. 

The absence of full replacement alternative methods for the most complex toxicological areas 
is indeed 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.  

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

ALTERNATIVE METHODS 

Considerable  progress  was  made  on  several  fronts  in  the  development,  validation  and 
regulatory  acceptance  of  alternative  approaches  to  animal  testing  in  2018.  Research  and 
development  activities  continued  in  areas  for  which  replacement,  reduction  and  refinement 
(3Rs) solutions are more difficult to find. 

For  regulatory  toxicity  testing,  research  projects  focused  on  repeated  dose  and  reproductive 
toxicity  testing,  on  chemical  mixtures  and  endocrine  disruptors.  These  projects  are  either 

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based on read-across case studies or aim at developing new in vitro methods and integrating 
in vitro methods and in silico computational technologies in integrated assessment and testing 
strategies to translate mechanistic understanding of toxicity into risk assessment methodology.  

In  the  area  of  carcinogenicity,  EURL  ECVAM  is  currently  exploring  how  mechanistic  data 
across  toxicity  endpoints  (based  primarily  on  existing  in  vivo  and  in  vitro  OECD  test 
guidelines) could  be best  combined, instead of taking them  in  isolation,  to  waive redundant 
testing and, ultimately, improve carcinogenicity testing. 

The  well-advanced  areas  of  topical  toxicity,  skin  sensitisation  and  genotoxicity  were 
complemented  with  additional  in  vitro  methods  or  combined  (in  silico  and  in  vitro) 
approaches  which  have  either  already  been  adopted  or  are  currently  being  reviewed  and 
discussed in international fora. 

3.1. Progress in the EU 

3.1.1.   Research and development activities  

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

EU-ToxRisk  is  a  European  collaborative  project  funded  by  the  EU  Framework  Programme 
for  Research  and  Innovation,  Horizon  2020  (H2020),  to  advance  mechanism-based  toxicity 
testing  and  risk  assessment.  With  a  budget  of  over  EUR  30  million,  it  was  launched  in 
January 2016 and will last for 6 years. The project, which builds on the results of SEURAT-
111,  has  developed  several  case  studies  in  the  complex  fields  of  repeated  dose  and 
developmental/reproductive  toxicity  testing,  including  for  endocrine  disrupters.  Several 
industries, including some cosmetics companies, are currently establishing collaborations with 
the project, which also closely interacts with regulatory agencies and EURL ECVAM. 

The  Innovative  Medicine  Initiative  (IMI),  as  part  of  H2020,  also  supports  various  projects 
aiming at developing safety testing procedures without animal, namely for quality control of 
vaccines  and  safety  assessment  of  drugs.  These  projects  receive  €35M  from  the  European 
Commission plus an equal in-kind contribution from the pharmaceutical sector. 

Other  H2020  programmes  support  relevant  research  activities,  such  as  the  Euromix  project 
aimed  to  develop  an  animal-free  strategy  for  the  risk  assessment  of  mixtures  of  multiple 
chemicals,  several  projects  related  to  the  safety  of  nanomaterials,  and  finally  numerous 
projects  from  the  European  Research  Council  (ERC)  and  Marie  Sklodowska  Curie  that 
develop new in vitro and in silico tools that could be integrated into animal-free safety testing. 

11 The EUR 50 million SEURAT-1 research initiative, co-funded by the Commission and Cosmetics Europe (the 
European personal care association) was completed in 2015. 

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3.1.2.  Validation and legal acceptance of alternative methods  

EURL ECVAM is  mandated under Article 48 and Annex VII of Directive 2010/63/EU12 to 
validate alternative test methods at EU level and promote regulatory acceptance of these. 

The European Union Network of Laboratories for the Validation of Alternative Methods (EU-
NETVAL13) has continued to support the EURL ECVAM validation studies. The network has 
also  helped  develop  guidance  documents  and  training  materials  for  good  in  vitro  method 
practices. 

The validation of alternative methods intended for regulatory use has progressed on a number 
of fronts including novel methods for predicting the skin sensitisation potential of chemicals, 
assessing the leaching (bioelution) of chemicals from metal alloys, and for determining acute 
toxicity  in  fish.  Two  EURL  ECVAM  validation  studies  deal  with  methods  for  the 
identification  of  endocrine  disruptors  and  involve  the  EU-NETVAL.  Several  multi-
stakeholder discussions on validation took place in various fora which indicate that although 
well-established validation principles are still relevant today, the process of validation needs 
to be continually adapted to keep pace with scientific and technological progress. 

More details on these activities can be found in the 2018 EURL ECVAM status reports14. 

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 
followed  through  the  Tracking  System  for  Alternative  methods  towards  Regulatory 
acceptance (TSAR)15. 

3.1.3.  The European Partnership for Alternative Approaches to Animal Testing  

The European Partnership for Alternative Approaches to Animal Testing (EPAA) is a public-
private partnership between the European Commission, eight European trade associations and 
36 individual companies from the relevant business sectors16.  

The  partners  are  committed  to  pooling  knowledge  and  resources  to  accelerate  the 
development, validation and acceptance of alternative approaches to animal use in regulatory 
testing. The overall aim is the replacement, reduction and refinement (3Rs) of animal use  in 
regulatory testing. 

In  2018,  the  work  of  EPAA  included  seven  projects  to  facilitate  the  promotion,  validation, 
acceptance  and  implementation  of  3R  alternatives  in  European  regulatory  testing  and 
decision-making, and to promote international harmonisation of regulatory testing. In each of 
the  projects  the  over-arching  objective  is  to  apply  the  3Rs  without  compromising  safety; 

12 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. 
13 https://ec.europa.eu/jrc/en/eurl/ecvam/alternative-methods-toxicity-testing/eu-netval  
14 

http://publications.jrc.ec.europa.eu/repository/bitstream/JRC113594/eurl_ecvam_status_report_2018_online.pdf   
15 https://tsar.jrc.ec.europa.eu/   
16 Directorates General GROW, RTD, SANTE, ENV and JRC for the European Commission; Animal Health, 
CEFIC, Cosmetics Europe, ECPA, EFPIA, AISE and SMEunited for the industry sectors. 

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indeed,  several  of  these  projects  examine  how  human  (or  veterinary)  safety  and  product 
quality can be assured and sometimes even improved by the use of new integrated approaches 
based primarily on in vitro methods. 

In 2018, one new project started and six ongoing projects progressed well. A new project on 
‘Applying non-animal strategies for assessing skin sensitisation’ was launched, with the main 
objective to organise and run a knowledge-sharing workshop. This new project builds on the 
continuing  successful  progression  of  the  project  on  optimised  strategies  for  assessing  skin 
sensitisation.  EPAA  projects  are  good  examples  of  the  unique  synergies  that  EPAA  and  its 
partners  achieve  to  advance  alternative  methods,  by  bringing  together  the  relevant  industry 
sectors,  regulators,  academia  and  public  interest,  and  to  promote  the  3Rs  principle  in  the 
regulatory  environment  in  Europe.  EPAA  continues  to  seek  new  opportunities  for  3Rs 
alternatives  and,  following  the  highly  successful  first  Partners’  Forum  held  in  2017  on  the 
subject  of  toxicokinetics  and  read-across,  a  second  Forum  was  held  in  November  2018  on 
repeated-dose  toxicity.  The  output  of  these  fora,  as  well  as  information  on  the  projects  and 
EPAA's  other  activities  are  published  on  the  EPAA  website17.  These  activities  build  on 
existing  research  initiatives,  identify  synergies  amongst  sectors  and  seek  to  bridge  the  gap 
between science, innovation and regulation.  

3.1.4.  Dissemination of information on alternatives 

The dissemination of information about alternative approaches (e.g., in vitro techniques and in 
silico models) and of chemical datasets contributes to the advancement and strengthening of 
the  3Rs  knowledge.  In  this  context,  publicly  accessible  information  systems  not  only  can 
facilitate the engagement of the scientific community through the sharing and exploitation of 
existing data and information, but they can also inform regulators and assist educational and 
training activities.  

The information systems and services provided and coordinated by EURL ECVAM serve this 
purpose,  including  the  above-mentioned  Tracking  System  for  Alternative  methods  towards 
Regulatory acceptance (TSAR), the DB-ALM collection of in vitro methods, and the QSAR 
Model Database on in silico methods. In addition, EURL ECVAM has published, following 
the Commission Decision on the reuse of Commission documents (2011/833/EU), the results 
of  the  assessments  it  conducted  on  available  3Rs  knowledge  sources  and  related  education 
and training activities. 

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

Likewise,  the  EPAA  actively  contributed  to  knowledge-sharing  and  dissemination  on  3Rs 
through its Annual Conference, presentation of its projects in various events and fora and its 
publications.  

17 https://ec.europa.eu/growth/sectors/chemicals/epaa_en  

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3.2. Progress at international level 

3.2.1.   Activities at OECD and international level 

The  Commission,  through  EURL  ECVAM,  plays  an  active  role  at  OECD  level  in  the 
regulatory  acceptance  of  alternative  methods  and  their  international  adoption.  Several 
initiatives at  the OECD  are breaking  new  ground and delivering impact.  In  addition  to  new 
test guidelines and guidance documents to support non-animal approaches to assess chemical 
toxicity in fish, the OECD published guidance on Good In Vitro Method Practices (GIVIMP) 
to ensure the reliability and integrity of in vitro data intended for regulatory use. The OECD 
project  to  develop  a  Guideline  for  'Defined  Approaches'  for  skin  sensitisation  assessment 
which  combines  both  in  vitro  and  computational  methods  has  made  steady  progress  and  a 
draft  has  recently  undergone  commenting  by  OECD  member  country  experts.  The  Adverse 
Outcome Pathway (AOP) programme is growing and 2018 saw the publication of a second set 
of  AOPs  for  complex  endpoints  that  were  endorsed  by  OECD  expert  groups.  Further 
initiatives on Integrated Approaches to Testing and Assessment (IATA) included a new cycle 
of  IATA  case  studies  and  the  launch  of  a  project  to  map  relevant  guidance  documents. 
Incorporation  of  alternative  approaches  into  regulatory  frameworks  has  also  been  addressed 
by other international bodies such as the International Cooperation on Cosmetics Regulation 
(ICCR)18 and the United Nations sub-committee on the Globally Harmonised System (GHS) 
of classification and labelling of chemicals. 

3.2.2.  Other cooperation with third countries 

The Commission, through EURL ECVAM, has continued its cooperation with other members 
of the International Cooperation on Alternative Test Methods (ICATM)19. An overview of the 
validation status of alternative test methods validated/peer-reviewed by ICATM partners and 
their  status  of  regulatory  acceptance  can  be  found  in  Annex  2  to  the  2018  EURL  ECVAM 
status reports. Further to the successful workshop of October 2016, EURL ECVAM, together 
with  its  ICATM  partners,  hosted  another  ICATM  two-day  workshop  in  October  2018,  this 
time  on  the  topic  of  validation  of  alternative  methods  towards  internationally  recognised 
standards for regulatory application. 

Since its creation, the ICCR has focused on advancing work related to alternatives to animal 
testing  worldwide.  At  the  ICCR’s  twelfth  annual  meeting  held  in  Tokyo  from  10-12  July 
2018, the Joint Regulators-Industry Working Group (JWG) on integrated strategies for safety 
assessments of cosmetic ingredients presented the report on “Integrated Strategies for Safety 
Assessments of Cosmetic Ingredients – Part II”.  

18  The  International  Cooperation  on  Cosmetics  Regulation  (ICCR)  is  a  voluntary  international  group  of 
cosmetics regulatory authorities from Brazil, Canada, the European Union, 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: https://iccr-cosmetics.org/  
19  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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In brief, the Part I Report of the JWG, adopted at the ICCR eleventh annual meeting in July 
2017  in  Brazil  summarizes  major  overarching  principles  for  incorporating  new  approach 
methodologies (NAMs) into an integrated strategy for risk assessment of cosmetic ingredients 
(or ‘Next Generation’ risk assessment: NGRA), along with examples showing their usefulness 
to safety evaluation. 

The  Part  II  Report  of  the  ICCR  integrated  strategies  for  safety  assessments  of  cosmetic 
ingredients  JWG is  intended  to  provide some additional guidance to  safety assessors on the 
types  of  NAMs  that  may  be  used  in  a  NGRA.  The  report  was  published  on  the  ICCR  web 
site20. The ICCR Standing Committee agreed that the current JWG would continue to work on 
case studies as Part III of this activity. 

4.  CONCLUSION 

Based  on  the  contributions  from  Member  States,  three  cases  of  non-compliance  with  the 
testing  and  marketing  bans  were  reported  by  one  Member  State  for  2018.  The  main  issue 
encountered  by  a  small  number  of  Member  States  in  their  market  surveillance  activities 
related to the bans is the presence of a limited number of cases of incomplete animal testing 
information in PIFs. Immediate corrective measures were imposed on economic operators in 
all reported cases. 

Despite  considerable  progress  made  in  the  development,  validation  and  legal  acceptance  of 
methods alternative to animal testing, alternative test methods have not yet been accepted by 
the international regulatory  community  for the safety  assessment of ingredients for some of 
the  most  complex  endpoints,  such  as  repeated  dose  toxicity,  reproductive  toxicity  or 
carcinogenicity. Until all toxicological endpoints can be covered by alternatives, the European 
cosmetics industry remains limited in its ability to introduce new ingredients, apply for new 
uses  of  existing  ingredients,  or  respond  to  new  questions  regarding  the  safety  of  existing 
ingredients.  However,  important  projects,  such  as  EU-ToxRisk,  aim  to  address  these 
challenges. 

For more than 25 years the Commission has been fully engaged at all stages of the process to 
find  replacements  to  animal  testing  with  alternative  test  methods.  Work  is  increasingly 
focused  on  developing  defined  approaches  and  integrated  approaches  to  testing  and 
assessment which look at all existing safety data when assessing a chemical ingredient. 

The Commission has been and continues to be fully committed to encouraging the regulatory 
acceptance of alternative methods approved at OECD level and to promoting the EU animal 
testing  ban  in  cosmetics  at  international  level,  through  relevant  fora  and  bilateral  and 
multilateral  cooperation.  These  activities  aim  not  only  to  recognise  individual  alternative 
methods,  but  also  to  promote  animal  welfare  and  to  achieve  the  convergence  of  safety 
assessment methods at international level. 

20 https://www.iccr-
cosmetics.org/files/8315/4322/3079/ICCR_Integrated_Strategies_for_Safety_Assessment_of_Cosmetic_Ingredie
nts_Part_2.pdf  

9