COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT ON THE ANIMAL TESTING PROVISIONS IN REGULATION (EC) 1223/2009 ON COSMETICS Accompanying the document COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics
Date: 2013-03-11
Institutions: European Commission
Subjects: animal experimentation, animal welfare, cosmetics industry, international cooperation, market approval, marketing standard, research method, testing

EUROPEAN 
COMMISSION 

Brussels, 11.3.2013  
SWD(2013) 66 final 

COMMISSION STAFF WORKING DOCUMENT 

IMPACT ASSESSMENT ON THE ANIMAL TESTING PROVISIONS IN 
REGULATION (EC) 1223/2009 ON COSMETICS 

Accompanying the document 

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} 
{SWD(2013) 67 final}

EN 

   EN 

 
 
 
 
 
  
 
TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

1.6. 

1.7. 

2. 

Procedural issues.......................................................................................................... 6 

First Phase of Stakeholder Consultation on the Evaluation of the Availability of 
Alternative Methods..................................................................................................... 6 

Second Phase of Stakeholder Consultation on the Impacts of the 2013 Deadline....... 7 

Other contacts with stakeholders ................................................................................. 9 

Contacts with Third Countries ..................................................................................... 9 

External studies .......................................................................................................... 10 

Inter-Service steering group on the impact assessment ............................................. 10 

Follow-up to Impact Assessment Board recommendations....................................... 10 

Problem Definition..................................................................................................... 11 

2.1. 

General Policy Context .............................................................................................. 11 

2.1.1.  Cosmetics sector......................................................................................................... 11 

2.1.2.  Cosmetics Regulatory Framework............................................................................. 14 

2.1.3.  Previous Legislation in relation to the Marketing Ban .............................................. 15 

2.1.4. 

Implementation of the 2009 Testing and Marketing Ban and Impacts...................... 16 

2.1.5.  Legal clarity in relation to the scope of the testing and marketing ban ..................... 17 

2.1.6.  Provisions in relation to Animal Testing in other Union legislation ......................... 18 

2.1.7.  Animal Testing Requirements for Cosmetics in non-EU Countries.......................... 19 

2.2. 

Problem Description................................................................................................... 20 

2.2.1.  Animal Welfare.......................................................................................................... 20 

2.2.2.  Research into Alternatives to Animal Testing ........................................................... 23 

2.2.3.  Consumer Safety ........................................................................................................ 25 

2.2.4.  Consumer Choice and Product Innovation ................................................................ 25 

2.2.5.  The Competitiveness of the EU Cosmetics Industry ................................................. 29 

2.2.6.  Regional and Sectorial Impacts.................................................................................. 30 

2.2.7.  Trade Impacts............................................................................................................. 30 

2.2.8.  Employment ............................................................................................................... 31 

2.2.9.  Specific Impacts on SMEs and Micro-Enterprises .................................................... 32 

2.3. 

Subsidiarity ................................................................................................................ 33 

3. 

3.1. 

3.2. 

Objectives................................................................................................................... 34 

General objective ....................................................................................................... 34 

Specific objectives ..................................................................................................... 34 

3.2.1.  To maintain consumer safety and consumer choice (specific objective 1 – Consumer 
Safety and Choice) ..................................................................................................... 34 

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3.2.2.  To maintain innovation and competitiveness of the European cosmetics industry 

(specific objective 2 – Innovation and competitiveness) ........................................... 34 

3.2.3.  To provide animals with a high level of protection and welfare (specific objective 3 - 
Animal Welfare)......................................................................................................... 35 

3.2.4.  To maintain the incentive for continued research on alternative methods to animal 

testing (specific objective 4 – Research into alternatives) ......................................... 35 

4. 

4.1. 

4.2. 

Policy Options............................................................................................................ 35 

Option 1: Baseline/No Action.................................................................................... 35 

Option 2: Postpone the 2013 deadline ....................................................................... 35 

4.2.1.  Option 2 (a): Postpone the 2013 deadline with fixed deadline .................................. 36 

4.2.2.  Option 2 (b): Postpone the 2013 deadline in relation to certain endpoints only and 

maintain for others ..................................................................................................... 36 

4.2.3.  Option 2 (c): Postpone the 2013 deadline without fixed deadline ............................. 36 

4.3. 

Option 3: Maintain the deadline and introduce an additional derogation mechanism
.................................................................................................................................... 36 

5. 

Analysis of Impacts.................................................................................................... 38 

5.1. 

Methodology and possible impacts identified............................................................ 38 

5.1.1. 

Impacts Policy Option 1 - Baseline/No Action.......................................................... 38 

5.1.2. 

Impacts Policy Options 2 (a), (b) and (c) – Postpone the 2013 deadline................... 39 

5.1.3. 

Impacts Policy Option 3 - Maintain the deadline and introduce an additional 
derogation mechanism from the marketing ban......................................................... 40 

6. 

6.1. 

6.2. 

6.3. 

6.4. 

6.5. 

7. 

Comparing the options ............................................................................................... 44 

Comparing the options on Effectiveness.................................................................... 44 

Comparing the options on Efficiency ........................................................................ 45 

Comparing the options on Coherence ........................................................................ 45 

Preferred Option......................................................................................................... 47 

Financing.................................................................................................................... 47 

Monitoring and evaluation ......................................................................................... 47 

Annex 1: Summary Second Phase Stakeholder Consultation.................................................. 49 

Annex 2: Numbers of Animals used for Toxicological Testing .............................................. 52 

Annex 3: The Need for Toxicological Data for the Cosmetics Safety Assessment................. 55 

Annex 4: Testing Data Sources................................................................................................ 57 

Annex 5: Cosmetic Products and their Life Cycle................................................................... 59 

Annex 6: Overview of Cosmetic Ingredients Portfolio and Changes ...................................... 60 

Annex 7: Glossary.................................................................................................................... 65 

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COMMISSION STAFF WORKING DOCUMENT 

IMPACT ASSESSMENT ON THE ANIMAL TESTING PROVISIONS IN 
REGULATION (EC) 1223/2009 ON COSMETICS 

Accompanying the document 

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  

EN 

4 

   EN 

 
Disclaimer: 

This  Impact  Assessment  report  only  commits  the  Commission's  services  involved  in  its 
preparation  and  does  not  prejudge  the  final  form  of  any  decision  to  be  taken  by  the 
Commission. 

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PROCEDURAL ISSUES  

1. 
The  Cosmetics  Directive1  foresees  a  phasing-out  of  animal  testing  for  cosmetic  products.  A 
ban of animal testing of finished cosmetic products has been in force since September 2004 
and a  testing  ban  on  ingredients or combinations of ingredients since March 2009. As from 
March 2009, it is also prohibited in the EU to market cosmetic products and their ingredients 
which  have  been  tested  on  animals  in  order  to  meet  the  requirements  of  the  Directive, 
irrespective  of  the  origin  of  these  products.  This  marketing  ban  applies  to  all  but  the  most 
complex  human  health  effects  to  be  tested  to  demonstrate  the  safety  of  cosmetic  products 
(repeated-dose toxicity including skin sensitisation and carcinogenicity, reproductive toxicity 
and toxicokinetics), for which the legislator extended the deadline to March 20132. 

The  assessment  of  the  2013  marketing  ban  is  foreseen  in  the  Cosmetics  Directive  itself. 
Article 4a (2.3) of the Cosmetics Directive obliges the Commission to study the progress and 
compliance with the implementation deadlines in relation to animal testing and to report to the 
European Parliament and the Council. In particular, the Directive provides that if alternatives 
to  animal  testing  in  relation  to  the  endpoints  covered  by  the  2013  marketing  ban  are  not 
developed and validated by the 2013 implementation date, the Commission shall inform the 
European Parliament and the Council and put forward a legislative proposal.  

The  Commission  has  monitored  the  progress  of  the  development  of  alternative  methods  to 
animal testing on a yearly basis and presented its final report to the European Parliament and 
the Council3 on 13 September 2011. It concluded that alternatives to animal testing in relation 
to the endpoints in question will not yet be available by 2013.  

1.1. 

First Phase of Stakeholder Consultation on the Evaluation of the Availability of 
Alternative Methods  

The  Commission  services  evaluated  the  availability  of  alternative  methods  between  April 
2010 and May 2011. The evaluation exercise aimed at gaining a broad and objective picture 
of  the  scientific  and  technical  issues  related  to  establishing  alternative  test  methods  for  the 
human  health-related  effects  falling  under  the  2013  deadline.  To  this  end  the  Commission 
services  selected  scientific  experts  proposed  by  the  various  stakeholders.  The  work  was 
carried out under the co-ordination of the European Centre for the Validation of Alternative 
Methods  (ECVAM)4,  hosted  by  the  Institute  for  Health  and  Consumer  Protection  of  the 
European Commission's Joint Research Centre. 

In  total  39  experts  contributed,  nominated  from  amongst  proposals  received  by  Cosmetic 
Regulators  (Member  States  as  represented  in  the  Standing  Committee  operating  under  the 
Cosmetics Directive), the Scientific Committee on Consumers Safety (SCCS), the European 
Cosmetics Association (Colipa5), the European Federation for Cosmetic Ingredients (EFfCI) 
and the European Coalition to End Animal Experiments (ECEAE).  

The draft expert report was open to public consultation between 23 July and 15 October 2010. 
The  consultation  was  accessible  on  the  Commission's  "Your  Voice  in  Europe"  as  well  as 

1 

2 

3 

4 
5 

Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to 
cosmetic products, OJ L 262, 27.9.1976, p. 169. 
See  for  the  grouping  of  endpoints  under  the  2013  marketing  ban:  Commission  Staff  Working 
Document, Timetables for the phasing-out of animal testing in the framework of the 7th Amendment to 
the Cosmetics Directive (Council Directive 76/768/EEC), 1.10.2004, SEC(2004) 1210 
Report on the Development, Validation and Legal Acceptance of Alternative Methods to Animal Tests 
in the Field of Cosmetics (2009), 13.9.2011, COM(2011) 558 final 
Now the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM)  
Now named Cosmetics Europe 

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Directorate-General  SANCO's  cosmetics  website6.  Known  stakeholders  were  in  addition 
directly informed by e-mail and in stakeholder meetings. The consultation was carried out in 
accordance with the Directorate-General SANCO's "Code of Good Practice For Consultation 
of Stakeholders"7. The contributions of the stakeholders, a summary report of the consultation 
as  well  as  the  final  report,  are  published  on  the  Directorate-General  SANCO's  cosmetics 
website8.  

The large majority of stakeholders agreed with the draft reports findings. Some stakeholders 
from  the  animal  welfare  side  considered  the  report  as  too  conservative9.  While  they  based 
themselves  on  the  same  alternative  methods  as  those  described  in  the  expert  report,  they 
considered  that  these  methods  could  already  today  be  relied  on  for  the  safety  assessment. 
However,  the  overall  findings  of  the  expert  report  and  the  consultation  do  not  support  this 
view. The findings of the expert report are also consistent with the findings of the SCCS10 and 
with other evaluations in relation to the availability of alternative methods carried out within 
the Commission11. The expert report findings were overall also confirmed by an expert panel 
review12. 

This technical and scientific analysis was necessary in order for the Commission to be able to 
report to the European Parliament and the Council on the availability of alternative methods.  

1.2. 

Second Phase of Stakeholder Consultation on the Impacts of the 2013 Deadline  

In  order  to  obtain  information  on  the  potential  impacts  of  the  entry  into  force  of  the  2013 
deadline  the  Commission  services  consulted  targeted  stakeholders  and  cosmetic  regulators 
(Member  States  as  represented  in  the  Standing  Committee  operating  under  the  Cosmetics 
Directive)  between  December  2010  and  April  2011.  The  list  of  stakeholders  consulted 
included  besides  the  cosmetic  regulators  the  cosmetics  industry,  cosmetic  ingredient 
manufacturers,  animal  welfare  organisations,  a  consumer  organisation,  the  Scientific 
Committee for Consumer Safety (SCCS), and trading partners. The consultation document, as 
well  as  a  list  of  stakeholders  consulted,  is  available  on  the  Directorate-General  SANCO's 
cosmetics  website.  The  contributions  of  the  stakeholders  to  the  targeted  stakeholder 
consultation  are  published  on  the  same  website13.  The  consultation  was  carried  out  in 

6 

7 

8 
9 

10 

11 

12 

See:  http://ec.europa.eu/consumers/sectors/cosmetics/documents/public_consultation/index_en.htm  All 
Internet links provided in the footnotes of this report were last accessed on 24 August 2012 
Directorate-General  SANCO's  "Code  of  Good  Practice  For  Consultation  of  Stakeholders",  see 
http://ec.europa.eu/dgs/health_consumer/dgs_consultations/docs/code_good_practices_consultation_en.
pdf 
See: http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-testing/index_en.htm 
See  European  Coalition  to  End  Animal  Experiments  contribution  to  the  consultation  and  BUAV 
publication: Meeting the Deadline of the 2013 EU Marketing Ban. A Scientific Review of Non Animal 
Tests for Cosmetics, 2011 
Memorandum  on  "Alternative  Test  Methods  in  Human  Health  Safety  Assessment  of  Cosmetic 
Ingredients 
see: 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_001.pdf 
EFSA:  Existing  approaches  incorporating  replacement,  reduction  and  refinement  of  animal  testing: 
applicability  in  food  and  feed  risk  assessment,  Opinion  of  the  Scientific  Committee/Scientific  Panel, 
Question  No  EFSA-Q-2005-231,  See:  http://www.efsa.europa.eu/en/efsajournal/doc/1052.pdf  Echa: 
'The  Use  of  Alternatives 
the  Reach  Regulation',  2011 
http://echa.europa.eu/documents/10162/13639/alternatives_test_animals_2011_en.pdf 
An  Expert  Consortium  Review  of  the  EC-commissioned  Report  “Alternative  (Non-Animal)  Methods 
for Cosmetics Testing: Current Status and Future Prospects – 2010”, Altex 28, 3/11 
See: 

to  Testing  on  Animals 

SCCS/1294/10, 

European 

Union", 

the 

for 

in 

13 
http://ec.europa.eu/consumers/sectors/cosmetics/documents/animaltesting/stakeholders_consultation_en.htm 

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7 

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accordance with Directorate-General SANCO's "Code of Good Practice For Consultation of 
Stakeholders"14. A summary of the consultation is contained in Annex 1.  

A targeted stakeholder consultation was chosen as it was considered to be the consultation at 
the most appropriate level to obtain the information required to assess the impacts of the 2013 
deadline. This choice was confirmed by the large sample size on which the industry input was 
based.  The  Colipa  submission  was  based  on  input  from  24  large  and  100  small  companies, 
while in a public consultation carried out in 2007 in relation to the revision of the Cosmetics 
Directive15 a total of 47 industry stakeholders replied.  

The  consultation  document  outlined  the  option  to  postpone  the  deadline  (including  sub-
options,  such  as  postponing  for  certain  endpoints  only,  and  the  possibility  to  have  no  fixed 
cut-off date) and the option to maintain the deadline irrespective of availability of alternatives 
(thus not to make a proposal). It included a questionnaire that was aimed at obtaining data to 
allow the Commission services to assess the likely impacts of the 2013 marketing ban.  

As a result of the input received an additional option was added to the considerations by the 
Commission,  the  introduction  of  a  derogation  mechanism.  The  targeted  stakeholder 
consultation  was  therefore  followed  up  and  further  detailed  in  relation  to  the  derogation 
option  (Option  3,  below  4.3)  through  bilateral  consultation  with  stakeholders  and  through 
detailed presentations in the Cosmetics Committee and Working Group on 9 November 2011 
and 23 March 2012. In these meetings, as well as in several bilateral meetings, the details of 
the  derogation  option  were  described  to  stakeholders  and  discussed.  All  stakeholders  that 
were part of the targeted consultation were provided with an outline of the derogation and had 
the opportunity to comment.  

In the overall debate all stakeholders support the long term objective to replace animal testing 
for cosmetics. Animal testing is a tool to ensure consumer safety but has in itself no specific 
interest or value for the stakeholders involved. The question at stake is therefore how to deal 
with  the  situation  until  alternative  methods  become  available.  Here,  the  stakeholder 
consultation showed diverging views as to the expected impacts of the entry into force of the 
2013  marketing  ban  and  the  best  way  forward.  Industry,  several  Member  State  Competent 
Authorities (Czech Republic, Denmark, France, Germany, Greece, Italy and Poland) and the 

14 

15 

Directorate-General  SANCO's  "Code  of  Good  Practice  For  Consultation  of  Stakeholders",  see 
http://ec.europa.eu/dgs/health_consumer/dgs_consultations/docs/code_good_practices_consultation_en.
pdf 
See: http://ec.europa.eu/consumers/sectors/cosmetics/documents/revision/index_en.htm 

EN 

8 

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SCCS  expected  significant  negative  impacts  on  the  availability  of  cosmetic  ingredients  and 
products, the competitiveness of the cosmetics industry and on employment. They considered 
an extension of the deadline the most logical way forward. Animal welfare organisations and 
some Member State Competent Authorities (Austria and Sweden) by contrast considered that 
the  bans  were  based  on  an  ethical  decision,  that  possible  negative  economic  and  social 
impacts play no  role  in  the  decision-making and were clearly opposed to any  change in  the 
deadline. They considered that in any case such impacts were unlikely as manufacturers could 
rely on existing data and ingredients.  

Some  stakeholders,  in  particular  Colipa,  EFfCI  and  ECEAE,  collected  data  from  their 
members  for  a  consolidated  submission  of  their  respective  organisation  to  the  consultation. 
When  this  data  is  relied  on  in  the  following  impact  assessment,  reference  is  made  to  the 
respective data (Colipa data16, EfFCI data, ECEAE data based on companies taking part in the 
Leaping Bunny17). 

The  input  and  data  received  in  this  consultation  is  one  of  the  main  pillars  of  the  following 
assessment and reference is made to the received data throughout the assessment.  

Stakeholders were in addition informed and consulted in the framework of regular meetings 
of the Standing Committee and the Working Group18 on Cosmetics. Targeted meetings took 
place  at  senior  level  with  representatives  from  industry  associations  and  animal  welfare 
organisations on various occasions.  

1.3. 

Other contacts with stakeholders  

Since the beginning of its assessment, the Commission services have received a large amount 
of  e-mails,  faxes  and  letters  from  citizens  requesting  it  to  maintain  the  2013  deadline.  A 
petition  of  one  of  the  animal  welfare  organisations  alone  resulted  in  350  000  signatures  in 
favour  of  maintaining  the  ban19.  The  European  Parliament's  Intergroup  on  the  Welfare  & 
Conservation of Animals20 also called for no extension to the deadline.  

1.4. 

Contacts with Third Countries 

The  Commission  services  work  actively  with  its  counterparts  from  the  United  States,  Japan 
and  Canada  in  the  framework  of  the  "International  Cooperation  on  Cosmetic  Regulation" 
(“ICCR”). Animal testing has been a key issue for ICCR since its inception. In this context, 
the  International  Cooperation  on  Alternative  Test  Methods  (ICATM)  started  in  September 
2008,  was  implemented  in  April  2009  and  has  in  the  meantime  become  well  established. 
ICATM  members  cooperate  actively  on  the  validation  of  alternatives  and  provide  regular 
reporting  to  the  ICCR.  The  targeted  stakeholder  consultation  document  was  sent  to  ICCR 
partners,  however  no  input  was  received.  This  may  have  various  reasons,  from  not  having 
specific data to provide to political reasons. In the first phase of consultations a reaction from 
the United States Food and Drug Administration (FDA) was received.  

The issue has also been raised in the framework of bilateral contacts by the Commission, such 
as  with  Chinese  authorities,  who  submitted  their  support  for  a  postponement  of  the  2013 

16 

17 

18 

19 
20 

The Colipa submission is based on the input of 24 large companies (accounting for a major part of EU 
production) and 100 SMEs (from France, Italy, Spain, Germany and UK as main producing countries, 
as well as other countries such as Poland and Bulgaria) 
The Leaping Bunny trademark certifies compliance with the criteria of the Humane Standards, which 
are  in  the  EU  managed  by  ECEAE;  25  cosmetic  and  personal  care  companies  from  the  UK,  France, 
Germany, Sweden and Denmark were consulted – 2 of them were large, the rest SMEs. 
Cosmetics Committee: 08.02.2010, 08.11.2010, 08.02.2011, 14.06.2011, Working Group: 23.06.2010, 
08.02.2011, 14/15.06.2011 
Humane Society International, Cruelty Free 2013 
Letter from Intergroup to Commissioner Dalli of 16 February 

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deadline  in  the  framework  of  the  targeted  stakeholder  consultation.  China  has  over  the  last 
years overhauled its cosmetics legislation and requires in many instances animal testing data 
for the cosmetics safety assessment.  

1.5. 

External studies 

the  Cosmetics 

For  the  preparation  of  this  impact  assessment  no  specific  external  studies  have  been 
mandated,  as  it  was  considered  that  an  external  contractor  would  not  have  had  access  to 
additional  data  and  would  have  consulted  the  same  stakeholders.  In  addition,  the  recent 
the  adoption  of  Regulation 
revision  of 
1223/2009/EC21,  was  preceded  by  an  extensive  impact  assessment22.  The  Commission 
services  took  the  data  generated  in  that  context  and  in  particular  the  RPA  study  "Impact  of 
European Regulation on the EU Cosmetics Industry" of September 200723 and the work done 
by Global Insight "Study of the European Cosmetics Industry" of October 200724 into account 
for  this  assessment.  For  some  of  the  data  in  these  two  reports  the  targeted  stakeholder 
consultation provided updated or more accurate data.  

legislation,  which 

led 

to 

1.6. 

Inter-Service steering group on the impact assessment 

Commission  inter-service  steering  group  meetings  took  place  at  the  different  stages  of  the 
assessment  (20  July  2010,  21  September  2010,  23  June  2011  and  3  February  2012).  The 
following  Directorate-Generals  were  invited  and  regularly  informed  of  the  progress  of  the 
assessment: DG ENV, DG ENTR, DG RTD, DG TRADE, DG MARKT, SG, LS, BEPA and 
JRC.  

1.7. 

Follow-up to Impact Assessment Board recommendations  

The  Impact  Assessment  Board 
its  Opinion  on  25  May  2012  (Reference 
2011/SANCO/025). On the basis of this opinion the final report was adapted, in particular in 
line with the Board's recommendation to:  

issued 

• 

• 

• 

• 

• 

Improve the presentation of the problem; 

Better explain the options;  

Strengthen the assessment of impacts;  

Improve the comparison of options;  

In  relation  to  procedure  and  presentation,  to  better  present  the 
stakeholder's different views.  

A  number  of  more  technical  comments  made  by the Board  were equally  taken into account 
and the draft report was adapted accordingly.  

21 

22 

23 
24 

EN 

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 
on cosmetic products, OJ L 342, 22.12.2009, p. 59-2009 
Impact  assessment  -  Report  on  simplification  of  the  “Cosmetics  Directive”  –  Directive  76/768/EEC 
(COM(2008)49 
under 
accessible 
http://ec.europa.eu/consumers/sectors/cosmetics/documents/revision/index_en.htm#h2-impact-
assessment-report 
See: http://www.rpaltd.co.uk/documents/J574Cosmetics2.pdf 
See: http://ec.europa.eu/enterprise/newsroom/cf/_getdocument.cfm?doc_id=4562 

/SEC/2008/0117 

(SEC(2008)118) 

final) 

final, 

also 

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2. 

PROBLEM DEFINITION  

2.1. 

General Policy Context  

2.1.1.  Cosmetics sector  

Cosmetics  range  from  everyday  hygiene  products,  such  as  soap,  shampoo,  deodorant  and 
toothpaste to luxury beauty items including perfumes and decorative cosmetics.  

The  European  Cosmetics  and  Toiletries  industry  recorded  a  total  retail  sales  price  of  EUR 
71.8 billion in 201025. These figures are based on more recent Euromonitor data provided by 
the cosmetics industry than the one provided to the targeted stakeholder consultation. There 
the  market  was  estimated  at  EUR  66.6  billion  This  represents  almost  half  of  the  global 
market.  The  market  is  led  by  Germany  and  France,  followed  by  the  United  Kingdom,  Italy 
and  Spain.  These  five  Member  States  make  up  69%  of  the  total  retails  sales  price,  the 
remaining  31%  are  shared  between  two  groups  of  Members  States,  those  with  a  turnover 
ranging from EUR 800 to 999 and those between 1 000 to 3 000 billion. 

European Cosmetics & Toiletries Market
Total Retail Sales Price Europe 71.896 Billion EUR for 2010

Member States 
 EUR bn 800 - 
999; 
 6.202,60

Members States 
EUR bn 1.000 - 
3.000;
16.128,00

1. Germany
12.791,70 EUR bn

2. France
10.724,70 EUR bn

3. UK
9.653,40 EUR bn

4. Italy
9.261,00 EUR bn

 5. Spain
7.134,40 EUR bn

Source: Euromonitor International, 2010

The cosmetics industry is composed of five main sub-sectors and market segments that can be 
distinguished as follows: 

25 

Cosmetics Europe, Report of Euromonitor International, 2010 

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Market Segments of the Cosmetics & Toiletries Market
Five principal markets can be distinguished

Toiletries
25%

Skin Care
27%

Decorative 
Cosmetic
13%

Hair Care
19%

Fragrances
16%

Source: Euromonitor International, 2010

The two main segments, i.e. the skin care and toiletries segment, account for around 52% of 
the  total  market.  The  segments  hair  care,  fragrances  and  decorative  cosmetics  cover  the 
remaining  market  share  of  48%.  Almost  all  segments,  especially  decorative  cosmetics  and 
toiletries products, recorded a positive growth over the past years. 

The  structural  conditions  of  the  European  industry  are  on  the  one  hand  characterized  by 
multinational conglomerates. There are a significant number of major international cosmetic 
firms  in  Europe,  mainly  in  France  and  Germany.  The  leading  companies  are  L'Oreal, 
Beiersdorf, Henkel, Procter & Gamble, Unilever, Johnson & Johnson, Sara Lee and Colgate. 
European leader is the French company L'Oréal, which is also the world's leading cosmetics 
manufacturer.  Large  companies  are  estimated  to  have  a  market  share  of  about  70%.  On  the 
other  hand  the  clear  majority  of  companies  in number  in  the  cosmetics  field  are  small-  and 
medium-sized companies (SMEs), with several hundred of them in most Member States26.  

Overall, the EU cosmetics industry comprises approximately 4 576 companies, including over 
4  072  SMEs27.  It  is  estimated  to  directly  employ  more  than  184  000  people,  indirect 
employment of retail and beauty salons is estimated to about 1.7 million employees28. 

Many  of the SME's  in  the  Cosmetics and Toiletries industry have fewer than 10 employees 
and  thus  qualify  as  microenterprises.  For  example,  there  are  an  estimated  855  firms  with 
fewer than 10 employees in France and Italy.  

Extra  community  exports  of  cosmetic  products  from  the  EU  totalled  EUR  12.4  billion  in 
2010,  with  France  and  Germany  being  the  largest  exporters.  Exports  play  a  particularly 
important  role  for  larger  cosmetic  manufacturers,  as  well  as  for  cosmetic  ingredient 
manufacturers. Exports clearly outweigh imports within the Cosmetics market. 

26 
27 
28 

Global Insight, A Study of the European Cosmetics Industry 
COLIPA, Euromonitor International, 2010 
COLIPA, Euromonitor International, 2010 

EN 

12 

   EN 

 
 
                                                 
European Exports in the Cosmetics & Toiletries market
Europe's 10 leading Member States in 2010

n
m
R
U
E

,
t
r
o
p
x
E
y
t
i
n
u
m
m
o
C
a
r
t
x
E

Sweden

Ireland

Netherlands

Belgium

Poland

Spain

UK

Italy

Germany

France

0,0

500,0

1.000,0

1.500,0

2.000,0

2.500,0

3.000,0

3.500,0

4.000,0

4.500,0

5.000,0

Source: Euromonitor International, 2010

The European Cosmetics & Toiletries market faces new challenges in the highly competitive 
global  market.  There  is  increased  competition  and  simultaneously  potential  growth  in  the 
overall saturated global market from emerging markets. China's premium cosmetics market is 
for  example  expected  to  double  by  2015  to  reach  $7  billion  and  Latin  America’s  industry 
value in 2015 is expected to be the third largest globally.  

The innovation potential of Europe's Cosmetics and Toiletries market is highly important for 
trade and growth. Product innovation is a major driver for growth of the cosmetics industry in 
the EU; several thousand new or improved products are placed on the market each year with 
major  companies,  on  average,  reformulating  or  replacing  around  25%  of  their  cosmetics 
products annually29.  

Patent  activity  is  one  indicator  for  innovation.  The  cosmetics  industry  is  responsible  for  a 
large part of the overall patent activity in the EU, with a total of 6 082 patents filed in 2011, 
compared to a volume of 6 438 inventions in 2010. While there was a growing demand for 
patent protection in relation to ingredients for cosmetics and perfumes, with a steep increase 
since 200030, there is a decline of 6% between 2011 and 2010. 

29 

30 

Comparative  Study  on  Cosmetics  Legislation  in  the  EU  and  Other  Principal  Markets  with  Special 
Attention  to  so-called  Borderline  Products,  DG  ENTR,  2004  and  Colipa  submission  to  Targeted 
Stakeholder Consultation 
Union for Ethical Bio Trade, A review of patent activity in the cosmetics sector in the context of the 
ethical sourcing of biodiversity, 2010 

EN 

13 

   EN 

 
 
 
 
 
 
                                                 
European Cosmetics & Toiletries Market
Volume of Innovation in 2011

Antiperspirant 

Perfume

Skin 

Hair

Make-up 

Source: Thomson Reuters', State of Innovation, 2011

The sectors with the highest patent volume remain, despite a general decline in all subsectors 
with the exception of antiperspirants, hair, make-up, skin antiperspirant and perfumes.  

Ingredients  play  the  key  role  in  product  and  technology  innovation  in  cosmetics  and 
perfumes,  and  are  consequently  the  focus  of  significant  patent  activity.  Ingredients  and 
extracts  for  cosmetics  and  perfumes  may  be  drawn  from  a  variety  of  sources,  including 
synthetic  compounds,  botanicals  or  minerals,  such  as  mica  used  to  add  sheen  and  glitter. 
Among  the  main  European  players  for  patent  assignees  for  extracts  and  ingredients  is 
L’Oreal, followed by Unilever, Henkel and Beiersdorf. As regards the range of materials and 
technologies involved in patent applications for the cosmetics and perfumes sectors peptides 
play  an  important  role,  but  biochemistry  and  more  recently  emerging  areas  such  as 
nanotechnology  play  a  role  as  well.  Often  fields  referenced  in  cosmetics  patents  are  also 
referenced in the pharmaceutical field.  

2.1.2.  Cosmetics Regulatory Framework  

The  Cosmetics  Directive  76/768/EEC  is  the  regulatory  framework  for  the  placing  on  the 
market of cosmetic products. Its key objectives are to ensure consumer safety and to secure an 
internal market for cosmetic products. It is based on manufacturer responsibility for the safety 
of products. For certain ingredients - colorants, preservatives and UV-filters - only ingredients 
included in positive lists (Annexes IV, VI and VII to the Cosmetics Directive) can be used. 
Also, a large number of ingredients are either prohibited or restricted (Annexes II and III) and 
manufacturers  need  to  take  account  of  this  in  their  product  formulation.  Inclusion  in  the 
Annexes is preceded by a scientific risk assessment by the Scientific Committee.  

In  order  to  ensure  the  safety  of  products  manufacturers  must  carry  out  a  safety  assessment, 
which includes a study of the intrinsic properties of all ingredients contained in the product. A 
number  of  key  endpoints  need  to  be  addressed,  such  as  whether  the  ingredient  can  cause 
allergies or whether it otherwise causes damage to the human body as a result of repeated use, 
such as cancer. To assess these questions currently animal testing data is often relied on. The 
testing to obtain such data does not have to be carried out by the manufacturer - in many cases 
such safety data is available upstream from the ingredient manufacturer or through other data 
sources. Testing does not need to be carried out for each batch or each product, it is sufficient 
to have determined the profile of an ingredient once. Such testing would typically be carried 
out relatively early on in the product development, in most cases around 2 to 3 years before 

EN 

14 

   EN 

 
 
the  product  actually  reaches  the  market.  Testing  must  comply  with  the  principles  of  good 
laboratory practice31 and follows defined testing protocols set out in Council Regulation (EC) 
440/200832  and  in  most  cases  based  on  OECD  Testing  Guidelines.  Whether  animal  testing 
data is relied on or not becomes evident in the manufacturers safety assessment – which needs 
to be documented and kept available to the authorities.  

The  Cosmetics  Directive  aims  at  phasing  out  animal  testing  for  cosmetic  purposes.  Besides 
the  complete  testing  ban  for  cosmetic  products  and  their  ingredients,  a  marketing  ban  has 
applied  since  11  March  2009  for  all  human  health(-related)  effects  with  the  exception  of 
repeated-dose toxicity (including skin sensitisation and carcinogenicity), reproductive toxicity 
and  toxicokinetics,  for  which  the  deadline  is  11  March  2013.  As  a  result  no  testing  for 
cosmetic purposes can be carried out inside the EU, but for the endpoints covered by the 2013 
deadline  testing  can  be  carried  out  outside  the EU  and  the  results  of  tests  performed  before 
that date can be relied on in the safety assessment. There is a possibility for Member States to 
request a derogation from these provisions in case a human health problem is substantiated for 
an  ingredient  that  is  in  wide  use  and  cannot  be  replaced  by  another  ingredient  capable  of 
performing a similar function.  

The provisions in relation to animal testing were not changed by the recast of the Cosmetics 
Directive  by  Regulation  (EC)  1223/2009.  The  Cosmetics  Regulation  did  however  further 
strengthen the requirements for the safety assessment and will thus rather lead to an increased 
need for toxicological data. It also introduced specific provisions for nanomaterials, requiring 
manufacturers to inform the Commission about the toxicological profile and the safety data of 
the  material  before  placing  the  cosmetic  product  on  the  market.  The  Cosmetics  Regulation 
repealing  the  Cosmetics  Directive  as  of  11  July  2013,  any  proposal  would  amend  the 
Cosmetics Regulation only.  

2.1.3.  Previous Legislation in relation to the Marketing Ban  

The first provisions in relation to the marketing ban of cosmetic ingredients or combinations 
of  ingredients  tested  on  animals  in  order  to  meet  the  requirements  of  the  Directive  were 
introduced to the Cosmetics Directive by Directive 93/35/EEC33 with an application date of 1 
January 1998. The introduction of the marketing ban was based on the political objective to 
end  animal  testing  for  cosmetics.  The  '3R'  principle  –  aiming  to  replace,  reduce  and  refine 
animal testing wherever possible – had earlier on been integrated in Directive 86/609/EEC34. 
The  introduction  of  the  ban  at  the  time  was  not  based  on  a  science  based  assessment  that 
alternative  methods  would  be  available  by  1998.  Indeed,  the  European  Centre  for  the 
Validation  of  Alternative  Methods  (ECVAM)  had  only  been  founded  in  1992  and  no 
validated  alternative  methods  were  in  place  yet.  The  provisions  foresaw  that,  in  case 
alternative  methods  would  not  be  available  in  time,  the  Commission  would  propose  the 
postponement of the ban by 1 January 1997 for no less than 2 years.  
The ban was postponed for the first time by Commission Directive 97/18/EC35 to June 2000, 
essentially  stating  that  alternative  methods  were  not  yet  available  and  that  the  scientific 
developments were difficult to foresee, but that given the need of close follow-up of the issue 
the next scientific re-assessment should not be pushed out too far.  

31 

32 

33 
34 

35 

See  Article  10  (3)  of  Regulation  (EC)  1223/2009  of  the  European  Parliament  and  the  Council  on 
cosmetics products, 22.12.2009, OJ L 342, p. 59 - 209 
See  Article  10  (3)  of  Regulation  (EC)  1223/2009  of  the  European  Parliament  and  the  Council  on 
cosmetics products, 22.12.2009, OJ L 342, p. 59 - 209 
Directive 93/35/EEC, OJ L 151, 23.06.1993, p. 0032-0037 
Council  Directive  86/609/EEC  regarding  the  protection  of  animals  used  for  experimental  and  other 
scientific purposes OJ L 358, 18.12.1986, p. 1–28 
Directive 97/18/EC, OJ L 114, 01.05.1997, p. 0043-0044 

EN 

15 

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The second postponement was an interim Commission measure. In 2000 the Commission had 
already  made  the  co-decision  proposal  that  eventually  lead  to  Directive  2003/15/EC36,  the 
third postponement. But it was clear that this proposal would not be adopted before the lapse 
of the deadline in  2000. The Commission therefore proposed by  Commission Directive37 to 
postpone  the  deadline  until  30  June  2002.  Directive  2003/15/EC,  the  third  postponement 
which sets the current deadlines, was adopted in February 2003.  

With  the  proposal  for  Directive  2003/15/EC  the  Commission  intended  to  move  from  a 
marketing  to  a  testing  ban,  first  for  products  and  later  for  ingredients.  It  also  proposed  to 
postpone the entry into force of the testing ban for ingredients in the absence of alternatives. 
These  changes  were  proposed  in  order  to  address  enforcement  difficulties  and  the 
unavailability of alternative methods. However, in the co-decision procedure the testing and 
marketing ban were both imposed and the 2009 deadline for the full testing ban and the partial 
marketing ban was clearly made independent of alternatives being available.  

A  number  of  elements  are  therefore  different  in  the  situation  under  consideration  now 
compared to the earlier postponements. These are:  

• 

• 

• 

The European Parliament and the Council made it clear that it is willing to set fixed 
cut-off  dates,  even  in  the  absence  of  alternatives.  The  testing  and  part  of  the 
marketing  ban  accordingly  apply  since  2009  in  the  absence  of  alternatives  with 
respect to some endpoints;  

The  European  Parliament  and  the  Council  made  it  clear  that  a  constant  review 
process  with  postponements  by  the  Commission  is  not  the  acceptable  way  forward 
and  did  not  provide  this  right  to  the  Commission  in  Directive  2003/15/EEC  (any 
change now requires co-decision);  

Considerable progress has been made in the development of alternatives since 2003. 
The  extensive  expert  review  carried  out  in  the  above  described  first  phase  of 
stakeholder consultation made it however also clear that for most endpoints covered 
by  the  2013  deadline  it  will  take  at  least  10  years  and  most  likely  more  to  fully 
replace  animal  testing.  This  puts  the  overall  policy  approach  of  recurrent 
postponements in question.  

One of the options considered in this assessment is a postponement similar to the ones before 
(see  option  2  (a)  below).  However,  as  described  above,  the  current  situation  does  not 
necessarily require the same policy response as before.  

2.1.4. 

Implementation of the 2009 Testing and Marketing Ban and Impacts  

The implementation and enforcement of the testing and marketing ban is the responsibility of 
Member States. The Commission annual reports38 cover certain aspects of the implementation 
and  enforcement.  They  address  the  availability  of  alternative  methods  and  the  progress  in 
research,  the  number  of  animals  used  in  the  EU  for  testing  until  the  2009  ban  entered  into 
force and technical difficulties in complying with the bans. Endpoints falling under the 2009 
deadline  of  the  marketing  ban  are:  skin  corrosivity,  skin  irritation,  dermal  absorption, 
phototoxicity,  mutagenicity/genotoxicity,  acute  toxicity  and  eye  irritation.  Not  all  endpoints 
falling  under  2009  can  be  fully  replaced  by  alternative  methods  yet.  For  the  last  three 
endpoints  full  replacement  is  not  yet  possible,  respectively  limitations  exist.  The  2009 
marketing ban applies irrespective of this unavailability and appears not to have caused major 

36 
37 
38 

EN 

Directive 2003/15/EC, OJ L 66, 11.03.2003, p. 0026-0035 
Directive 2000/41/EC, OJ L 145, 20.06.2000, p. 0025-0026 
Available 
testing/index_en.htm 

under: 

http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-

16 

   EN 

 
                                                 
negative impacts so far. The Commission services are not aware of products being taken from 
the market by Member State authorities as a result of the marketing ban and the stakeholder 
consultation  did  not  result  in  concrete  information  on  negative  impacts,  even  though  this 
question was raised. Nevertheless the Commission services are faced with first cases in which 
the  SCCS  cannot  provide  a  conclusive  opinion  on  the  safety  of  a  substance  as  data  on  the 
2009 endpoints is missing or not sufficient for the assessment. These situations are expected 
to become more frequent.  

Impacts of the 2009 ban are therefore not excluded and the fact that not many were reported 
so far in no way prejudices the possible impacts of the 2013 deadline. A number of elements 
have to be taken into account here:  

• 

• 

• 

• 

• 

Since the animal testing data is needed at the early stage of the product development, 
any impacts would most likely become more evident later. The deadline was known 
and industry prepared;  

The endpoint acute toxicity plays in practice a limited role for the cosmetics industry. 
Ingredients used in this sector essentially do not raise the risk of acute toxicity and 
sufficient information is often available from repeated dose studies;  

As  regards  mutagenicity/genotoxicty  alternative  tests  are  available,  but  come  with 
some drawbacks in that they appear to be oversensitive. However in many cases they 
will be sufficient to exclude certain properties;  

As  regards  eye  irritation,  again  some  judgements  can  be  made  using  existing 
alternative  approaches,  eg.  existing  alternatives  provide  the  possibility  to  eliminate 
severe irritants;  

Another aspect why the 2009 deadline has apparently not had negative impacts is the 
uncertainty in relation to the interpretation (see below under 2.1.5.).  

These elements also explain why the derogation for Member States has only been requested 
one time so far.  

2.1.5.  Legal clarity in relation to the scope of the testing and marketing ban  

The  current  provisions  on  animal  testing  have  been  subject  to  diverging  interpretations  by 
different stakeholders. The main discussions on the scope centre on the wording used in the 
testing as well as the marketing ban "in order to meet the requirements of this Directive".  

Starting point for the discussion is the fact that the majority of ingredients used in cosmetic 
products  are  ingredients  that  are  equally  in  use  in  many  other  consumer  and  industrial 
products,  such  as  in  pharmaceuticals,  detergents  and  food,  and  animal  testing  may  be 
necessary  to  ensure  compliance  with  the  legal  frameworks  applicable  to  these  products. 
Ingredients  used  in  cosmetics  will  generally  also  be  subject  to  the  horizontal  REACH39 
requirements and animal testing may be necessary as a last resort to complete the respective 
data packages.  

Shortly after its adoption, the relevant provisions of Directive 2003/15/EC were challenged by 
the  French  Republic  before  the  European  Court  of  Justice  in  case  C-244/03.  However,  the 

39 

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC, Official Journal L 136, 29.5.2007, p. 3. 

EN 

17 

   EN 

 
                                                 
case was held inadmissible. Currently, there is no jurisprudence of the Court of Justice of the 
European  Union  ('the  Court')  on  the  interpretation  of  the  scope  of  the  2013  marketing  ban. 
Only  the  Court  can  provide  a  legally  binding  interpretation  of  Union  law.  The  Commission 
services role is to oversee, under the control of the Court, the application of the provisions by 
Member States.  

The  Commission  services  consider  that  data  from  animal  testing  generated  before  the 
respective  deadlines  can  be  used  and  relied  on  after  the  deadline  and  do  not  trigger  the 
marketing ban.  

The Commission services also consider that animal testing that has clearly been motivated by 
compliance  with  non-cosmetics  related  legislative  frameworks  should  not  be  considered  to 
have  been  carried  out  'in  order  to  meet  the  requirements  of  this  Directive/Regulation'.  The 
resulting animal testing data should not trigger the marketing ban and could subsequently be 
relied on in the cosmetics safety assessment.  

Independent of the option chosen, it is necessary to provide clarification on the interpretation 
in  order  to  ensure  a  coherent  application  of  the  legal  framework  by  Member  States  and  to 
provide a clear and predictable legal framework for the economic operators.  

2.1.6.  Provisions in relation to Animal Testing in other Union legislation  

The protection and welfare of animals is an area covered by a wide range of Union legislation. 
It  is  covered  by  Article  13  of  the  Treaty  on  the  Functioning  of  the  European  Union,  which 
requires  the  Union  and  Member  States  to  pay  full  regard  to  the  welfare  requirements  of 
animals when formulating policies. Prior to that, the issue was addressed in a Protocol to the 
Amsterdam Treaty.  

Already  in  1986  the  EU  introduced  specific  legislation  covering  the  use  of  animals  for 
scientific  purposes,  Directive  86/609/EEC.  In  September  2010  Directive  2010/63/EU40  was 
adopted, which updates and replaces the existing legislation. The aim of the new Directive is 
to  strengthen  the  legislation  and  to  improve  the  welfare  of  those  animals  still  needed  to  be 
used, as well as to firmly anchor the principle of the '3Rs', to replace, reduce and refine the 
use  of  animals,  in  Union  legislation.  Directive  2010/63/EU  has  taken  full  effect  since  1 
January 2013. Member States must accordingly ensure that, wherever possible, a scientifically 
satisfactory method or testing strategy, not entailing the use of live animals, is used instead of 
animal testing. If replacement is not possible reduction and refinement have to be ensured.  

Toxicological data requiring animal testing is needed under many pieces of Union legislation 
for  the  regulatory  safety  assessment.  This  is  for  example  the  case  under  REACH41  for 
chemical substances, which are a major ingredient source for cosmetics. REACH has several 
provisions  in  place  to  reduce  animal  testing  for  its  purposes.  It  requires  companies  to  share 
data in order to avoid unnecessary animal testing. If testing is needed and depending on the 
tonnage  a  testing  proposal  must  be  submitted  to  the  European  Chemicals  Agency.  Under 
REACH, animal testing is to be avoided in favour of alternative methods and registrants can 
only carry out tests involving the use of animals as a last resort. Similarly, the proposal for a 

40 

41 

Directive 2010/63/EU on the protection of animals used for scientific purposes, OJ L 276, 20.10.2010, 
p.33 
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning  the  Registration,  Evaluation,  Authorisation  and  Restriction  of  Chemicals  (REACH), 
establishing  a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council 
Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC, Official Journal L 136, 29.5.2007, P. 3 

EN 

18 

   EN 

 
                                                 
new  Regulation  on  Biocides42  will  require  toxicological  data  including  animal  data,  but 
animal testing is allowed as a last resort only and data sharing is required.  

In  summary,  Union  legislation  recognises  that  animal  testing  is  still  needed  to  ensure  the 
protection  of  human  health  and  the  environment  and  thus  acknowledges  that  animal  testing 
will  be  carried  out  to  fulfil  the  legislative  requirements.  Union  legislation  at  the  same  time 
sets very high animal welfare standards for such testing and requires that whenever possible 
this testing is replaced, reduce and refined. The Cosmetics legislation is the only legislation 
that prohibits animal testing irrespective of the availability of alternative methods.  

2.1.7.  Animal Testing Requirements for Cosmetics in non-EU Countries  

In  the  United  States  cosmetics  are  regulated  by  the  Federal  Food,  Drug  &  Cosmetics  Act, 
which  prohibits  the  use  of  any  unsafe  substance  in  a  cosmetic  product.  There  is  no  list  of 
toxicology  test  methods  for  use  in  determining  the  safety  of  cosmetic  ingredients  and 
cosmetic  products.  It  is  the  manufacturer  who  is  under  an  obligation  to  verify  whether  the 
cosmetics he places on the market present any risk to consumer health, but it is up to him to 
decide  on  the  data  (literature,  tests  on  animals  or  humans,  alternative  tests  etc.)  used  as  the 
basis for proving harmlessness. Otherwise the product must bear the statement ‘The safety of 
this  product  has  not  been  determined’.  New  active  ingredients  in  Over-The-Counter  (OTC) 
products  (anti-acne,  anti  caries/anti-plaque,  anti-hair  loss,  anti-dandruff,  anti-perspirant 
products, skin whiteners, sun protection products etc.) must prove their safety on the basis of 
tests on animals and also clinical tests.  

The United States, while not prohibiting animal testing, are also working towards the '3R's'. In 
1997, the United States created the Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) to reduce animal testing. Once ICCVAM recommends that 
an  alternative  method  has  been  adequately  validated  and  the  relevant  test  recommendations 
are accepted or endorsed by Federal regulatory and other agencies, it becomes available for all 
toxicology purposes in the United States.  

In Japan a number of products that are qualified as cosmetics in the EU are qualified as quasi-
drugs.  Quasi-drugs  include  hair  dyes  and  decolourants,  anti-hair  loss  products,  hair 
permanents/straighteners, depilatories, anti-perspirants, deodorants, anti-acne, skin whiteners, 
bath  treatment  products,  medicinal  cosmetics  such  as  anti-dandruff  shampoos  etc.  and  are 
subject to the regulations on pharmaceutical products. A toxicological dossier is required for 
approval of a new quasi-drug ingredient, including tests for which no alternatives are in place 
yet. The Act on Welfare and Management of Animals was revised in 2006 incorporating basic 
consideration  for  animal  testing,  handling  of  animals  and  introducing  the  '3Rs'  principle. 
Japan also set up the Japanese Centre for the Validation of Alternative Methods (JaCVAM) in 
2005.  

In China, the control of cosmetic products and new cosmetic ingredients is since 2008 under 
the responsibility of the Chinese State Food and Drug Administration (SFDA). For finished 
cosmetics, depending on the type of product, a hygiene license or record-keeping certificate 
from  the  Health  Administrative  Department  of  the  State  Council  is  required.  The  hygiene 
license  would  for  example  be  required  for  hair  dye  or  sun  protection  products  or  for 
deodorants.  Obtaining  the  hygiene  license  requires  a  testing  report  from  a  cosmetics  testing 
institution  approved  by  the  SFDA,  including  animal  data.  China  is  starting  to  consider  the 
acceptance of alternative methods.  

42 

Commission  Proposal  for  a  Regulation  of  the  European  Parliament  and  the  Council  concerning  the 
placing on the market and the use of biocidal products, COM (2009) 267 of 12.06.2009 

EN 

19 

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In  conclusion,  animal  testing  data  will  in  many  cases  be  needed  to  ensure  the  safety  of 
cosmetic  products  internationally.  If  alternative  methods  are  available  these  will  often  be 
acceptable, however levels of acceptance vary between countries. Notably methods included 
in OECD Test Guidelines will often be accepted.  

2.2. 

Problem Description 

According to the expert report on the availability of alternatives (see 1.1), alternative methods 
to  fully  replace  animal  testing  for  the  endpoints  covered  by  the  2013  deadline  will  not  be 
available  by  2013.  No  specific  timeline  could  be  estimated  in  the  areas  of  toxicokinetics, 
repeated-dose  toxicity,  carcinogenicity  and  reproductive  toxicity  due  to  the  underlying 
scientific challenges. The timelines estimated for full replacement of animal tests in the area 
of skin sensitisation pointed to a further 7-9 years (i.e. 2017-2019) for scientific development. 
Another 3 to 6 years are likely to be needed for validation and regulatory acceptance of the 
alternative methods. However, alternative methods able to simply discriminate between skin 
sensitisers and non-sensitisers are expected to become available earlier.  

The  problem  is  therefore  in  a  nutshell  that  the  marketing  ban  would  apply  as  of  11  March 
2013  in  the  absence  of  alternative  methods,  thus  effectively  limiting  the  tools  needed  for 
compliance with the Cosmetics Regulation. This would have several consequences:  

2.2.1.  Animal Welfare  

The  entry  into  force  of  the  marketing  ban  in  2013  would  be  positive  in  relation  to  animal 
welfare, in that it would end animal use for EU cosmetic purposes. This was the objective of 
the provisions when they were first introduced in 1993. This objective was based on overall 
ethical  considerations  and  not  on  animal  numbers.  Nevertheless  animal  numbers  are  an 
important indicator of the impacts of the 2013 bans on animal welfare.  

Since 11 March 2009, animal testing for cosmetic purposes is no longer allowed in the EU. In 
the reports under the Cosmetics Directive the number of animals used for cosmetic purposes 
in the EU were highest in 2004 with 8 988 animals and came down to 1 510 in 2008 and 344 
in 2009. Animals used for testing for cosmetic purposes include rats, mice, guinea-pigs and 
rabbits. Any animal testing currently done for EU cosmetic purposes is done outside the EU. 
Animals spared would therefore be animals of these species outside the EU. Annex 2 provides 
further data on animal use.  

Currently,  toxicological  animal  data  is  still  needed  for  the  cosmetics  safety  assessment. 
Whether or not ingredients can be used in cosmetic products depends on whether their safety 
can be demonstrated. Toxicological data needs arise in two scenarios, the manufacturers own 
safety  assessment  and  the  review  by  the  SCCS,  either  with  a  view  to  the  ingredient  being 
added to one of the positive lists or to being prohibited or restricted in use. The highest data 
need for cosmetic manufacturers exists for skin sensitisation tests, second for repeated dose, 
third for reproductive toxicity and then for toxicokinetics and carcinogenicity. Information on 
the need for toxicological data for the cosmetics safety assessment is included in Annex 3. 

Over the last ten years large cosmetics companies together carried out on average 213 animal 
tests  for  the  2013  endpoints  per  year,  out  of  which  151  addressed  skin  sensitisation  and  36 
repeated  dose,  thus  these  two  endpoints  represent  87%  of  all  testing43.  For  all  of  these 
endpoints the complete replacement of animal tests is not yet possible.  

These  figures  relate  to  testing  carried  out  for  cosmetic  purposes.  By  far  not  all  testing  data 
relied  on  for  the  cosmetics  safety  assessment  has  been  generated  for  this  purpose.  The  data 
used  so  far  for  the  cosmetics  safety  assessment  is  indeed  in  many  cases  not  generated 

43 

Colipa and EFfCI submissions to the Targeted Stakeholder Consultation 

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specifically  for  this  purpose.  About  90%  of  ingredients  are  used  in  other  areas  as  well.  In 
many cases testing data is provided by the ingredient supplier, who offers the ingredient also 
for other purposes. Testing data may also be available in publications, databanks, etc. Often 
the original reason for the testing will not be obvious from the testing data itself. Information 
on testing data sources is contained in Annex 4. 

Large cosmetics companies considered testing data from food, cosmetic products outside the 
EU and REACH as most important to them44. This does not necessarily indicate that this data 
is available in most cases, as the question was only how important it is considered to be, not 
in how many cases it was available. However, while there remains uncertainty, it is likely that 
the importance given also reflects the availability.  

As  regards  the  possible  total  number  of  animals  used  outside  the  EU  for  EU  cosmetic 
purposes  that  could  be  spared  as  a  result  of  the  implementation  of  the  2013  marketing  ban, 
there is no reliable statistical data. Simply taking EU numbers before the bans as a baseline 
does not work because 1) in a number of Member  States testing for cosmetic  purposes was 
banned  before  the  EU  ban  (eg.  in  the  United  Kingdom  in  1998),  2)  many  manufacturers 
already moved outside the EU for testing many years ago and 3) older animal numbers can 
not really give a reliable baseline as some of the tests that where still carried out 10 years ago 
were using more animals and might now not be needed as such. 

While there are no reliable statistics, the information supplied by stakeholders in the targeted 
stakeholder consultation allow a reasonably solid estimate.  

On the one hand, industry contributors confirm that tests were already done outside EU, also 
ahead of the 2009 testing ban deadline in the EU. About 90% of the testing for cosmetics took 
place  outside  the  EU  in  200845.  Given  that  testing  inside  the  EU  for  cosmetic  purposes  in 
2008  was  at  1  510  this  would  indicate  about  13  590  animals  were  used  outside  the  EU  in 
2008.  Since  after  2009  all  testing  for  cosmetics  purposes  has  to  take  place  outside  the  EU, 
around 15 000 animals are likely to be used. Large cosmetic companies carried out in 2010 
185 tests for 2013 endpoints using a total of 7 732 animals. They indicated that over the last 
ten years they carried out in average 213 tests per year. SMEs reported 8 tests in 2010 and a 
total  of  160  animals  and  a  yearly  average  of  7  tests  over  the  last  10  years46.  Taking  into 
account  that  in  addition  testing  is  also  done  or  commissioned  by  ingredient  manufacturers, 
this data suggests that the overall estimate of a minimum of 15 000 animals used outside the 
EU for EU cosmetic purposes per year is reasonable.  

On the other hand, animal welfare organisations provided an estimate for 2005, according to 
which  58  339  972  animals  are  used  in  actual  animal  testing  procedures  outside  the  EU 
annually47. Assuming that the percentage of cosmetics testing in relation to the overall testing 
would be the same as inside the EU, the respective animal welfare organisation estimates that 
about  26  836  animals  were  used  for  cosmetics  testing  in  2005  worldwide.  This  estimate 
relates to cosmetics specific testing. In contrast to the information supplied by industry above, 
this information does however not specifically relate to cosmetic specific testing done for EU 
cosmetic purposes, which could explain why the estimate is higher than the industry figures.  

Overall the data provided indicates that between 15 000 and 27 000 animals are used for EU 
cosmetics specific testing outside the EU yearly.  

44 
45 
46 
47 

Colipa submissions to the Targeted Stakeholder Consultation 
Colipa submissions to the Targeted Stakeholder Consultation 
Colipa submissions to the Targeted Stakeholder Consultation 
Taylor, K., Gordon, N., Higgins, W. and Langley, G. (2008) Estimates for worldwide laboratory animal 
use in 2005. Alternatives to Laboratory Animals (ATLA). 36 (3); 327-42 

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These figures remain comparatively limited in relation to the overall number of animals used 
in the EU for experimental purposes per year (about 12 million)48

 .  

However, not all of these 15 000 to 27 000 animals per year would be spared once the 2013 
marketing  ban  comes  into  force.  Cosmetic  specific  testing  outside  the  EU  may  be  for  two 
reasons at the same time. One is testing for non-EU cosmetics regulatory requirements. While 
the  EU  is  working  with  trading  partners  in  order  to  accelerate  acceptance  of  validated 
alternative  methods,  it  is  unlikely  that  other  countries  would  ban  testing  irrespective  of  the 
availability of alternatives or even accept alternative methods for regulatory purposes to the 
same extent as the EU in the short term. The other important reason for testing outside the EU 
is testing to meet the EU cosmetics requirements. 

There  is  no  reliable  data  that  would  allow  determining  exactly  which  part  of  the  testing 
outside  the  EU  is  carried  out  for  EU  cosmetics  purposes  only  and  would  not  take  place 
beyond 2013. Testing is often carried out at the supplier level to establish the safety dossier of 
an ingredient, without specifically targeting only a certain market. Equally, testing carried out 
by international cosmetic companies will be geared at establishing the safety of the ingredient, 
but  not  necessarily  only  with  a  view  to  a  specific  market.  Testing  carried  out  in  line  with 
OECD Test Guidelines can be relied on then in all OECD countries and beyond.  

To which extend testing outside the EU would diminish as a result of the ban depends largely 
on business decisions of companies. It concerns cases in which the data is needed to ensure 
the safety of the product and cannot be obtained through alternative methods. In the EU the 
ingredient  could  therefore  not  be  used.  Essentially  the  question  is  whether  a  cosmetics 
company would forego the testing for third countries in these cases. This depends on several 
criteria  and  strategic  decisions  of  companies  and  manufacturers,  e.g.  how  important  the 
ingredient  for  manufacturers  or  companies  is;  how  profitable  it  is  to  invest  in  a  certain  test 
(animal testing can be costly, from EUR 4 000 for a skin sensitisation test to about EUR 780 
000 for a carcinogenicity test49), whether or not the manufacturer considers that the non-EU 
market  alone  warrants  the  investment  or  if  the  company  considers  a  possible  shift  of 
investment into other non-EU markets.  

Due  to  these  underlying  uncertainties  making  further  assumptions  (such  as  all  animals 
currently used would be spared, versus none of them or a certain percentage of them) will not 
lead to a more reliable estimate. In addition, the exact number of animals spared is likely to 
play a limited role for the political decision-making. Animal welfare stakeholders recognise 
that  the  number  of  animals  used  for  cosmetics  is  comparatively  low,  but  consider  that  the 
question  is  one  of  principle.  For  the  purposes  of  this  impact  assessment  it  is  therefore 
considered that a sub-set of the 15 000 to 27 000 will be spared.  

The ban would have no immediate positive impacts in relation to the number of animals used 
in other sectors overall in the EU for the respective 2013 endpoints, which amounted in 2008 
to 257 350 animals50 and was estimated by animal welfare stakeholders to be 134 180 in 2005 
outside  the  EU.  In  the  absence  of  alternative  methods  animal  testing  will  still  need  to  be 
carried  out  to  comply  with  other  applicable  legislative  frameworks.  On  the  longer  run,  the 

48 

49 
50 

Union 

Sixth Report from the Commission to the Council and the European Parliament on the Statistics on the 
number  of  animals  used  for  experimental  and  other  scientific  purposes  in  the  member  states  of  the 
http://eur-
European 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0511:REV1:EN:PDF 
'Food for Thought … on the Economic of Animal Testing', Bottini and Hartung, Altex 
Sixth Report from the Commission to the Council and the European Parliament on the Statistics on the 
number  of  animals  used  for  experimental  and  other  scientific  purposes  in  the  member  states  of  the 
European 
see: 
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2010:0511:REV1:EN:PDF  

COM(2010) 

COM(2010) 

511/final 

511/final 

Union 

2, 

2, 

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marketing ban in the Cosmetics Directive is expected however to also have kick-off effects on 
the use of animals in other sectors. Alternative methods developed in the cosmetics context 
can and are used to replace animal testing in other sectors as well and vice-versa. All methods 
validated  and  accepted  at  regulatory  level  are  included  in  Commission  Regulation  (EC) 
440/2008,  and  not  specifically  in  Annex  IX  to  the  Cosmetics  Directive.  Also,  while  the 
Cosmetics  Directive  only  looks  at  replacement,  the  path  to  developing  a  full  replacement 
often leads first to refinement and reduction and thus already benefits animals.  

As  mentioned,  the  number  of  animals  used  is  not  the  sole  indicator  of  animal  welfare:  the 
existing  provisions  represent  a  clear  political  and  ethical  choice  to  value  animal  welfare 
higher  than  economic  and  “lifestyle”  driven  interests.  They  result  from  many  years  of  very 
engaged public and political discussions, going back more than 20 years.  

Most information on public opinion in relation to animal testing for cosmetics was presented 
by the animal welfare organisations in the framework of the targeted stakeholder consultation. 
The information provided indicates that, depending on the poll, between 60 and 88% of the 
citizens  favoured  a  complete  ban  on  animal  testing  for  cosmetics.  A  2009  "You  Gov"  poll 
showed  that  79%  of  respondents  were  against  testing  that  does  not  relate  to  serious  or  life-
threatening human conditions.  
A Eurobarometer51 study showed that the majority (66%) of respondents find  that scientists 
should be allowed to do research on animals, like mice, if it produces new information about 
human health problems, while only 18% of respondents disagree. However, the purpose of the 
testing is critical for the decision.  

The  overall  long-term  objective  to  end  animal  testing  for  cosmetics  is  shared  by  all 
stakeholders. Stakeholders have no interest in animal testing as such, other than as a tool to 
ensure  and  demonstrate  consumer  safety.  Indeed  alternative  methods  may  turn  out  to  be 
beneficial for industry. A recent example of an ECVAM validated method to address in vitro 
carcinogenicity testing – while it only presents a partial replacement - shows that the costs of 
the alternative (EUR 12 000 to 35 000 per substance) were low in comparison to the animal 
test (EUR 1 to 1.5 million per substance). With 2-7 weeks required per substance compared to 
3 years in the animal test the alternative would also be faster.52

Stakeholders  hold  however  diverging  views  on  the  impacts  of  the  ban  on  animal  welfare. 
Animal welfare groups consider the effects on animal welfare to be very high and point also 
to the kick-off effects for other sectors. They underline that actual numbers are in any case not 
decisive  for  their  view,  but  the  underlying  basic  ethical  decision  against  animal  testing. 
Industry stakeholders point out that the overall number of animals to be saved is very small in 
relation to overall animal use for scientific purposes. They also consider that the animal use 
would continue for outside EU use in any case.  

2.2.2.  Research into Alternatives to Animal Testing 

The  implementation  of  the  ban  is  expected  to  have  overall  positive  impacts  in  relation  to 
research into alternative methods.  

Considerable  amounts  of  funding  have  been  made  available  to  find  and  validate  new 
alternative  test  methods.  For  this  purpose  the  Commission  made  about  EUR  238  million 
available between the years 2007 to 2011 alone. The major part of this budget, around EUR 

51 
52 
Using  Syrian  Hamster  Embryo  Cells  (SHE)  and  the  BALB/c  3T3  mouse  fibroblast  cell  line,  see: 

Special Eurobarometer 340 / Wave 73.1 – TNS Opinion & Social, June 2010 
EURL ECVAM Recommendation of 14.03.12 on three Cell Transformation Assays (CTA) 

http://ihcp.jrc.ec.europa.eu/our_labs/eurl-ecvam/eurl-ecvam-recommendations/EURL-
ECVAM%20-Recommendation.pdf 

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198 million, was spent on projects through the 6th and 7th Framework Programmes and the 
LIFE + Programme. The second most important tranche, about EUR 38 million, was spent on 
the  European  Reference  Laboratory  (EURL)  for  Alternative  Methods  to  Animal  Testing 
(ECVAM).  

At Member State level the funding available varies strongly from Member State to Member 
State.  

Examples (Note that these figures are not always representative of the entire funding in the 
Member State concerned): 

Austria: Average for 1992 -2005 EUR 250 000 per year;  

Belgium: Between 2005 and 2013 EUR 1 395 847; 

Denmark: Between 2005 and 2008 EUR 47 million;  

France: In 2010 EUR 2.75 million; 

Germany: Between 2000 and 2009 EUR 42.5 million and in 2010 EUR 7.4 million;  

Netherlands: In 2010 EUR 2 million;  

Sweden: From 2004 onwards around EUR 1.6 million per year.  

On  the  industry  side  equally  there  have  been  significant  efforts.  In  the  recently  launched 
research  project  Seurat-153  on  methods  for  repeated  dose  systemic  toxicity,  the  EUR  25 
million which come from the EU research framework programme are matched with EUR 25 
million from the European cosmetics industry, represented by Colipa.  

This is in addition to various projects at association and company level. Individual companies 
often work in partnerships with academic institutions.  

Examples: One company invested EUR 30 million in the last 25 years, another has spent an 
overall of 285 million USD and another gave the figure of EUR 3 million a year for external 
research on alternatives in addition to own research. There are no overall figures available 
for the industry investments.  

The  percentage  of  cosmetics  and  cosmetic  ingredients  industry's  investment  in  research  and 
development (general,  not  alternative  method related) ranged from 0.5  to  3.5%  of  net  sales. 
The German industry association IKW estimates that about 2.5 to 5% of the turnover are used 
for  R&D.  EFfCI  assumes  that  up  to  1%  of  the  annual  turnover  achieved  in  the  cosmetic 
ingredients business by larger companies is used to develop alternative testing methods.  

The  majority  of  the  answers  received  in  the  stakeholder  consultation  highlight  the  positive 
impact  the  provisions  in  the  Cosmetics  Directive  and  in  particular  the  setting  of  the  2013 
deadline  had  on  research  into  alternative  methods  to  replace  animal  testing.  The  provisions 
are generally seen as a crucial accelerator of research and validation of alternative methods by 
all stakeholders. Indeed many projects in this area make explicit reference to the provisions in 
the Cosmetics Directive. Stakeholders also point out that the number of validated methods has 
greatly increased since 2003 when the current deadlines were set (13 methods between 2003 
and  2009  compared  to  6  in  the  period  between  1998  and  2002).  The  search  for  alternative 
methods is by now also more and more recognized as the search for better science and forms 
part of an overall shift of paradigm in safety assessment. Maintaining the deadline is expected 
by many to lead to a continuation or even acceleration of these developments. Certainly the 

53 

See: http://www.seurat-1.eu/ 

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deadline  leaves  industry  with  no  other  choice  than  research  into  alternatives  to  bring  new 
cosmetic ingredients on the European market.  

Industry stakeholders however point out that while the research investments were motivated 
by and linked to the deadlines, letting the marketing ban apply without alternatives would risk 
leading  to  less  funding  available  for  research  into  alternatives.  The  main  argument  brought 
forward is that the expected negative impacts from the marketing ban on competitiveness (see 
below  under  2.2.5)  will  also  weaken  the  industry's  ability  to  invest  in  alternatives.  Industry 
also cautions that research might move outside the EU.  

2.2.3.  Consumer Safety  

Specific  impacts  on  consumer  safety  are  not  expected  from  the  2013  deadline.  Consumer 
safety is the key objective of the Cosmetics Directive. Manufacturers can only place cosmetic 
products  on  the  market  if  they  are  safe.  Manufacturers  must  not  place  products  with 
ingredients for which insufficient safety data is available on the market. Market surveillance 
authorities  must  ensure  that  the  requirements  of  the  Directive  are  complied  with.  Most 
Competent Authorities in the replies to the targeted stakeholder consultation confirmed that in 
the course of market surveillance manufacturers that would rely on insufficient data would be 
identified.  

There is no pre-market authorisation for placing cosmetic products on the market. Compliance 
with the Directive, such  as  for  example not using ingredients that  are prohibited, is ensured 
through  market  surveillance,  thus  in  market  product  spot-checks.  Market  surveillance  is 
always  linked  to  resources  available,  only  a  sample  of  products  will  come  under  scrutiny. 
These limitations apply to all provisions of the Directive.  

Nearly all stakeholders agree that while it is clear that a full safety assessment solely based on 
alternative  methods  is  not  possible  yet,  this  will  result  in  not  being  able  to  place  certain 
products on the market, not in placing unsafe products on the market. Stakeholders agree that 
consumer safety is not put at risk through the 2013 deadline.  

2.2.4.  Consumer Choice and Product Innovation  

Overall negative effects are expected from the 2013 marketing ban for consumer choice and 
product innovation compared to the situation before the ban. The cosmetics industry is highly 
innovative. On average large cosmetic companies have a product portfolio of around 10 000 
different cosmetic  products, SMEs of around 160 products54. Companies working under the 
Leaping  Bunny  label  had  a  smaller  product  portfolio.  They  have,  for  large  companies,  592 
products on offer and, for SMEs, 40.  
Industry stakeholders indicate the product life of a cosmetic product at 3 years55. There is an 
estimated 25% - 30% renewal of cosmetic products on the market per year. Out of the 25% to 
30%  of  reformulations,  90%  rely  on  ingredients  already  used  in  the  cosmetics  sector,  10% 
depend on new to market (= ingredients not yet used in any other sector) or new to cosmetics 
market (= ingredients already in use in other sector, but new to cosmetics use) ingredients56. 
Information on cosmetic products and their lifecycle is contained in Annex 5. 

Cosmetic  products  consist  of  between  5  to  60  ingredients  each.  Large  cosmetics  companies 
have an ingredient portfolio of 2 000 ingredients and SMEs of 600 ingredients. This toolbox 
is constantly evolving.  

54 
55 
56 

Colipa submission to Targeted Stakeholder Consultation 
ECEAE submission to Targeted Stakeholder Consultation 
Colipa submission to Targeted Stakeholder Consultation 

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Large  companies  introduced  around  80  new  ingredients  per  year  between  2000  and  2009 
(SMEs  22),  representing  around  4%  of  their  ingredient  portfolio57.  Only  10%  of  these 
ingredients introduced into the portfolio are estimated to be new to the market. 90% are/have 
been  used 
the  EU,  food, 
pharmaceuticals,  detergents,  and  will  partially  be  covered  by  REACH.  Information  on 
cosmetic ingredients portfolios and changes to it are included in Annex 6. 

including  cosmetic  products  outside 

in  other  sectors, 

Negative impacts of the 2013 deadline are first expected in relation to ingredients that are new 
to  the  market  –  thus  ingredients  that  are  cosmetic  specific  and  have  not  been  used  in  other 
areas.  For  such  new  cosmetic  specific  ingredients  at  least  part  of  the  data  necessary  for  the 
safety assessment will not be available. Since these are new cosmetic specific ingredients it is 
not  possible  to  rely  on  existing  data  or  data  from  other  regulatory  frameworks.  4%  of  the 
ingredients portfolio are renewed each year and 10% of these 4% new ingredients introduced 
are new to the market. When calculating this down to total numbers per manufacturer a large 
manufacturer  with  an  ingredient  portfolio  of  2  000  ingredients  could  lose  8  of  the  80 
ingredients it would normally introduce per year.  

Second, negative impacts are expected, though to a lesser extent, for ingredients that are new 
to the cosmetics market, but have been used in other sectors. This is the case for 90% of the 
4%  newly  introduced  ingredients,  in  total  numbers  this  represents  about  72  ingredients  per 
large  manufacturer  per  year.  For  these  ingredients  in  the  majority  of  cases  data  from  other 
regulatory  frameworks  will  be  available,  however  not  in  all  cases  and  not  always  on  all 
relevant endpoints. In 50 to 70% of the cases submitted to the SCCS, data from other sources 
has  been  relied  on  in  the  past.  The  availability  of  such  data  from  other  sectors  depends 
however on many factors. Data may not have been necessary for other uses (for example low 
tonnage under REACH), it may not be accessible to the cosmetics manufacturer or the data 
may  not  be  sufficient  to  address the  use  (eg.  different  exposure  routes).  If  this is  calculated 
down to total numbers per manufacturer  this would mean that  a  large manufacturer with an 
ingredient portfolio of 2000 ingredients would in the worst case loose another 21 to 36 of the 
72  new  to  cosmetics  ingredients  it  would  normally  introduce  per  year.  However,  this  is  a 
worst case scenario. The SCCS review will often  require more  data than the manufacturer's 
safety  assessment.  The  majority  of  ingredients  are  not  reviewed  by  the  SCCS.  This  means 
that,  realistically,  the  loss  of  ingredients  from  other  sectors  would  likely  be  considerably 
lower but uncertainty remains.  

Example: Nanomaterials 

Nanomaterials are chemical substances or materials manufactured and used at a very small 
scale. Over the past years, the cosmetics industry has focused on nanomaterials and they play 
an  important  role  in  innovation.  The  number  of  patents  in  the  cosmetics  field  involving 
nanotechnology grew by 103% over the last seven years.  

Nanomaterials  display  improved  functionalities  in  UV  filters,  but  also  in  dental  care, 
appearance enhancement and skincare.  

Under  the  Cosmetics  Regulation,  nanomaterial's  come  under  special  scrutiny.  Products 
containing nanomaterial's need to be notified to the European Commission and information 
on  their  toxicological  profile  is  to  be  provided.  The  Commission  may  request  an  opinion  of 

57 

Colipa  submission  to  Targeted  Stakeholder  Consultation,  Note:  the  total  number  of  ingredients 
introduced per manufacturer provided there is 70, 4% of 2 000 is however 80 – the higher number of 
taken as a basis here 

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the  SCCS.  The  SCCS  has  issued  guidance  for  the  safety  assessment  of  nanomaterial's  in 
cosmetics58, which clearly underlines the specific challenges of this assessment in the light of 
the  marketing  ban,  which  will  make  the  introduction  of  new  nanomaterials  only  possible  in 
very limited cases in which data is already available.  

Third,  negative  impacts  are  also  expected  for  existing  ingredients.  This  can  be  the  case  if 
ingredients already in cosmetic use come under scrutiny and new safety concerns arise. Also, 
using existing ingredients in new types of products (e.g. spray) can raise new safety questions 
that  cannot  be  addressed  by  animal  testing  after  2013.  As  regards  existing  ingredients,  the 
SCCS delivered between 2000 and 2009 opinions on 220 substances, thus an average of 24 
per year. In at least 154 cases a full toxicological data set was provided. However, the activity 
in the last 10 years is not entirely representative, because the majority of cases concerned hair 
dyes.  Nevertheless  an  important  number  of  areas  of  future  concern  in  relation  to  existing 
substances were pointed out by stakeholders. Some of these cases could be addressed by the 
existing derogation for Member States, however this has only been requested one time so far. 
Uncertainty remains therefore in how many cases existing ingredients would be impacted.  

Examples:  

Parabens are widely used as preservatives in cosmetics. They have come under review as they 
were  considerd  to  have  endocrine  disrupting  effects.  The  SCCS  has  recently  reviewed  the 
safety  of  parabens59.  This  review  was  based  on  animal  data.  Without  the  relevant  data  to 
support the safety the SCCS can not provide a conclusive opinion. 

The negative impacts described above are expected certainly until the time when alternatives 
for  skin  sensitisation  tests  would  become  available,  but  also  well  beyond  as  for  the  other 
endpoints  no  clear  timeline  for  replacement  exists.  These  impacts  would  aggregate  over  the 
years, but would start diminishing once alternatives become available.  

This  loss  of  ingredients  will  also  have  negative  impacts  on  the  availability  of  cosmetic 
products. There is no linear link between ingredients and cosmetic products. 25% to 30% of 
the cosmetic products are on average reformulated per year. 90% of these reformulation rely 
on existing ingredients, 10% rely on new to market or new to cosmetics ingredients.  

Three  situations  can  be  differentiated.  The  first  one  concerns  cases  in  which  reformulations 
rely  on  new  to  market  ingredients  extensively  used  in  cosmetics.  These  are  unlikely  to  be 
possible  after  2013  as  the  safety  of  these  ingredients  cannot  be  demonstrated.  Second,  the 
cases  in  which  the  reformulation  depends  on  new  to  cosmetics  ingredients.  Also  here  in  a 
number of cases the reformulation will not be possible if existing data from other fields is not 
sufficient.  Third,  cases  in  which  reformulation  concerns  ingredients  used  already  in  other 
cosmetic products. This should in most cases remain possible, but different uses may lead to 
different types of exposure and therefore different data needs. Overall, while it is difficult to 
give a clear indication of the total number of products concerned, the data implies that in the 
worst  case  up  to  10%  of  the  total  25  to  30%  of  annual  reformulations  will  be  affected  (= 
2.5%), mainly those relying on new to market ingredients. Assuming a total number of 300 
000 products on the market this could mean that up to 7 500 products could be lost per year. 
Assuming the lower estimate of a total of 100 000 products on the market it could mean a loss 
of about 2 500 products.  

Example: 

58 

59 

Opinion 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_005.pdf 
Opinion SCCS/1348/10, see: 

SCCS/1484/12, 

see: 

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Company A (=ingredient manufacturer) develops after 2013 an ingredient with better anto-
ageing properties. Company B (=cosmetics manufacturer) would like to bring a new skin care 
product on the market using this ingredient. To do so it needs to comply with the Cosmetics 
Regulation  and  carry  out  the  required  safety  assessment.  This  requires  information  on  the 
toxicological profile of the new ingredient. While the Cosmetics Regulation contains no tick-
box  of  data  required,  at  a  minimum  information  on  skin  sensitisation  (=  can  the  ingredient 
cause allergies) and repeated dose toxicity (= are there other negative effects on the body as 
a  result  of  repeated  use)  will  be  needed.  Currently  no  alternative  methods  exist  for  these 
endpoints and since the ingredient is new and not used in other areas, no data is available. As 
a result Company B would not be able to place the new skin care product on the market.  

Impacts  would  likely  not  be  immediate  in  2013.  Due  to  the  product  development  cycle  and 
the fact that the deadline has been known for a long time it is expected that the impacts will 
mainly  kick-in  by  2014/2015  and  continue  over  the  following  years.  It  is  also  assumed  that 
the  cosmetics  industry  is  likely  to  be  able  to  counteract  some  of  these  developments  by 
innovating  using  existing  ingredients  or  new  ingredients  supported  by  sufficient  data.  As 
mentioned above impacts would start diminishing as alternatives become available.  

Stakeholders have different views on the likely impacts on ingredient and product availability. 
Industry stakeholder provided the figures discussed above and summarized in the table below 
and  consider  that  the  impacts  will  be  serious.  An  argument  made  by  some  animal  welfare 
stakeholders  on  the  other  hand  is  that  if  some  companies  can  innovate  and  reformulate 
without  animal  testing,  others  should  be  able  to  do  so  as  well.  The  argument  here  is 
essentially that the existing ingredient pool is sufficient.  

The  graph  below  summarises  the  figures  discussed  above  and  the  likely  impacts: 

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2.2.5.  The Competitiveness of the EU Cosmetics Industry  

The impacts of the 2013 deadline on the competitiveness of the EU cosmetics and cosmetics 
ingredients industry are expected to be overall negative compared to the situation before the 
ban.  This  assessment  concentrates  on  the  impacts  on  product  innovation  and  turnover 
resulting  from  a  limited  access  to  ingredients.  These  impacts  could  be  mitigated  by  other 
measures taken by the industry to maintain its role and turnover, such as marketing and new 
ways of innovation. While ingredients clearly are key to innovation, to some extent also other 
factors, such as product presentation, product application (brushes, form of delivery etc.) play 
a  role  in  innovation.  It  is  also  assumed  that  this  innovation  would  be  extended  if  the 
innovation capacity from ingredients is limited.  

The  innovation  capacity  of  the  cosmetics  industry  is  linked  to  the  availability  of  innovative 
ingredients and the possibility to reformulate products. The European cosmetics industry has a 
leading  role  in  product  innovation.  The  EU  is  home  to  some  of  the  most  advanced  and 
luxurious  cosmetic  products  brands.  Limits  on  the  ability  of  the  European  industry  to 
reformulate products and to introduce innovative ingredients could reduce its overall role as 
driver  of  future  developments.  Such  a  development  is  expected  by  industry  to  lead  to  more 
conventional,  mass  market  and  lower  priced  products,  which  is  in  turn  could  lead  to  a 
reduction in sales and profitability for the cosmetics companies.  

Along with a loss in innovation capacity, industry also expects potential impacts on turnover. 
The  cosmetics  industry  had  a  turnover  of  EUR  71  billion  in  2010.  New  ingredients  have  a 
significant impact on profitability as it is often these ingredients and the products formulated 
with them that lead to the greatest profit. There is however considerable uncertainty as to the 
exact impacts. The estimates provided by the Colipa respondents were that large companies 
expected an overall significant loss in turnover and profitability, with losses ranging from 3 to 
20%  in  the  short  term  (2013-2015),  7  to  20  %  in  the  medium  term  (2015  –  2018)  and  1  to 
25% in the long term (2018 and beyond).  

Turnover  and  profitability  may  also  be  affected  by  the  costs  of  loss  of  existing  ingredients. 
The examples below show the costs that could be occurred as a result.  

Examples of direct costs incurred in past in case of re-formulation: 

Product  Withdrawal:  Company  Y  decided  to  replace  a  UV-filter  (included  in  skin  care 
products) because its supplier had withdrawn it from the market rather than fund additional 
testing to support an SCCP dossier. 12 formulations were affected at a cost of between EUR 5 
000 and EUR 10 000 per formulation, equivalent to between EUR 60 000 and EUR 120 000. 

Product  Reformulation:  Company  Y  decided  to  replace  a  thickening  ingredient  in  70 
formulations, 30% of which were produced by a contract manufacturer, which increased the 
reformulation costs. The cost of this was between EUR 1500 and EUR 5000 per formulation, 
equivalent to between EUR 100 000 and 350 000. 

Impacts  are  expected  in  particular  for  ingredient  manufacturers.  In  particular  ingredient 
manufacturers specialised in cosmetics are expected to face difficulties. EFfCI data suggests 
that in the medium term (2015 to 2018) reductions in sales of up to 20% are expected.  

However,  stakeholder  views  on  the  effects  on  competitiveness  diverge  enormously.  While 
industry  and  some  Competent  Authorities  share  the  expectations  above,  animal  welfare 
stakeholders on the other hand point out that maintaining the ban provides the opportunity for 
the  EU  industry  to  be  the  leader  in  implementing  animal  free  safety  assessment  strategies. 
Companies following the 'Leaping Bunny' label and ECEAE considered to 57% that it would 
have  a  positive  impact  on  sales  and  to  43%  that  it  would  have  no  impact.  65%  of  the 

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participating companies considered that it would have a positive impact on the EU marketing 
position and its global positioning.  

Finally, the development of alternative methods in itself is innovation and leads to business 
opportunities. An example is the development of reconstructed skin by a cosmetic company 
now used in place of animal testing for skin irritation and which is being tried for other uses 
as well. It is by now also marketed outside the company and has become a business in itself.  

2.2.6.  Regional and Sectorial Impacts  

Member States with the largest cosmetics industry are Germany, France, the United Kingdom, 
Italy and Spain. These make up 69% of the total sales. It is these Member States that would 
likely  be  most  impacted  by  the  2013  marketing  ban.  These  countries  are  also  the  largest 
exporters of cosmetics.  

The largest market segments are skin care and toiletries (52% of the market share), overall all 
market segments had a positive growth over the last years. There is no clear indication which 
segments would be most impacted, but a number of assumptions can be made. Products which 
rely most on cosmetic specific ingredients, such as UV filters, hair dyes or specific skin care, 
are likely to be impacted most. It could also be assumed that sectors which currently have a 
high innovation activity based on the patents activity described under 2.1.1., such as make-up 
and skin care could be particularly impacted.  

Depending  on  the  ingredient  the  supply  chain  starts  with  either  raw  material  producers  or 
ingredient manufacturers. Some ingredients are also produced by the cosmetics manufacturers 
themselves. As regards the distribution channels for the cosmetic products they generally fall 
under  four  main  categories:  mass  distribution,  specialised  distribution,  pharmacy  sales  and 
direct  sales.  In  France  the  breakdown  in  2007  was  54%  mass  distribution,  28%  specialised 
distribution,  10%  pharmacy  sales  and  7%  direct  sales,  while  in  Italy  it  is  41%  mass 
distribution,  40%  specialised  distribution,  13%  pharmacy  sales  and  6%  sales60.  While  the 
impacts  on  the  ingredient  manufacturers  and  the  cosmetics  manufacturers  were  described 
above, there is no clear indication on how these impacts may affect the distribution chain.  

2.2.7.  Trade Impacts  

The  deadline  on  export  and  import  of  cosmetic  products  could  also  have  a  certain  negative 
impact. The EU cosmetics market represents almost half of the global market, with the United 
States and Japanese market estimated respectively at EUR 37.8 billion and EUR 29.4 billion.  

In relation to exports, industry stakeholders expect export losses. One reason brought forward 
in  the  targeted  stakeholder  consultation  is  that  less  innovative  EU  products  would  be  less 
attractive  for  export.  Also,  around  76%  of  the  larger  Colipa  companies  expect  the 
development  and  production  of  innovative  products  to  move  outside  the  EU  to  continue  to 
serve emerging markets, particularly in Asia.  

Similarly,  it  is  feared  that  ingredient  manufacturers  based  outside  of  the  EU  would  have  a 
competitive advantage. EU based manufacturers fear no longer being able to drive demand for 
new  ingredients  which  could  result  in  the  drivers  for  innovation  in  cosmetic  ingredients 
moving away from the EU.  

Another  problem  EU  products  are  expected  to  face  is  that  many  trading  partners  –  such  as 
China  –  still  require  animal  testing  data  for  certain  endpoints.  While  it  is  possible  to  have 
different product lines or safety assessments for inside and outside the EU and production in 
the EU could therefore still take place for export only, this is likely to be an option only for a 

60 

Global Insight, A Study of the European Cosmetics Industry 

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few larger companies. Larger companies may formulate more innovative products for export 
with ingredients for which they cannot show the safety purely based on alternative methods 
yet and which can therefore not be placed on the EU market. 

The 2013 deadline is also expected by industry stakeholders to lead to impacts on imports. At 
the  moment,  the  EU  is  the  only  region  with  such  stringent  bans  in  place.  New  products 
developed outside the EU will still mainly rely on animal data for the safety assessment and 
are  likely  in  many  cases  to  fall  under  the  marketing  ban.  Between  52%  and  64%  of 
responding large Colipa companies expect imports to be reduced. Similarly, between 60% and 
69%  of  EFfCI  companies  expect  such  impacts.  In  the  short  term  this  could  lead  to  a 
competitive advantage for EU companies on the EU market. While this may be a short-term 
advantage  for  industry  there  could  be  a  growing  risk  of  non-compliant  products  being 
imported to the EU to meet consumer demands.  

2.2.8.  Employment  

In relation to employment, while future developments are difficult to predict and to quantify, 
the cosmetics industry and the ingredients industry expect that the 2013 marketing ban could 
lead  to  negative  impacts  on  employment  though  again  it  needs  to  be  stressed  that  the  data 
basis is rather uncertain.  

The overall number of direct employees in the cosmetics industry in 2009 was approximately 
177 000, around 137 000 of whom were in manufacturing, including 17 000 in Research & 
Development,  and  around  40  000  in  distribution.  In  2010  direct  employment  had  grown  to 
184  000.  In  addition,  indirect  employment,  including  retail  and  salons,  is  estimated  to  be 
about 1.7 million. SMEs are estimated to employ around 35% of the total direct employees, 
thus around 62 000. However, figures supplied from Germany indicate that in Germany alone 
45  000  employees  work  in  the  cosmetics  industry  and  that  of  these  85%  to  90%  work  in 
SMEs. 

In  addition,  large  ingredient  manufacturers  (cosmetics  and  cosmetic  and  other  ingredients) 
employ about 110 000 people overall in the EU with approximately 5% of these employed in 
the  development,  manufacture,  import  or  supply  of  cosmetic  ingredients,  thus  about  5  500 
employees.  Taking  cosmetics  and  cosmetic  ingredients  manufacturer  together,  this  leads  to 
total of 182 500 employees based on 2009 data. The average number of employees in SME´s 
according  to  EFfCI  data  is  90,  with  71  of  them  employed  in  the  development  (including 
R&D), manufacture, import or supply of cosmetic ingredients.  

The main impacts on employment could occur as a result of possible relocation of activities in 
reaction  to  the  marketing  ban.  Industry  expects  that  a  limited  possibility  to  develop  new 
products  in  the  EU  will  favour  R&D  and  product  development  to  move  closer  to  emerging 
markets. Industry also points out that this could be a threat to the cosmetic industry's strong 
academic networks in the EU as well, with new networks being developed outside the EU.  

Example:  

One large company alone currently collaborates with around 60 academic groups and funded 
over EUR 3.5 million in external research in 2010.  

76%  of  responding  large  Colipa  cosmetic  companies  predict  that  R&D  would  be  relocated. 
The amount of R&D relocated could be up to 50%, depending on the company. 45% of SMEs 
considered that R&D facilities would relocate.  

The ingredient manufacturers have similar expectations; 53% predict that up to 50% of R&D 
could relocate. The development of innovative new raw materials and finished ingredients is 
expected  to  move  more  outside  the  EU.  Relocation  of  R&D  is  however  not  a  necessary 

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impact,  since  R&D  could  remain  in  the  EU,  even  for  products  that  can  as  a  result  of  the 
marketing ban not be placed on the EU market, but only exported. 

Besides the relocation of R&D, industry considers that production facilities could also move 
outside  the  EU  to  focus  on  growth  markets  and  because  of  the  reduced  turnover  and 
profitability  of  the  industry  in  Europe.  This  could  in  the  longer  run  also  impact  jobs  in 
supporting  functions  and  management.  89%  of  large  cosmetics  company  respondents  from 
Colipa considered that the ban would have such impacts on employment. It is estimated that a 
considerable part of the 17 000 scientists' posts would be endangered. In addition, the loss of 
jobs in the production and supporting functions is expected. More than 66% of EFfCI large 
company respondents considered that the ban would have impacts on employment. It was also 
pointed out that once the shift of excellence (and related jobs) outside the EU has occurred, it 
is unlikely to be reversed.  

It  needs  to  be  stressed  once  again  that  there  is  considerable  uncertainty  about  the  exact 
impacts  on  employment.  The  figures  above  are  forward  looking  industry  expectations. 
According to these expectations, the majority of industry stakeholders expects an impact that 
would affect several thousand R&D staff, up to 8 000, as well as other staff.  

However, many of the target markets for European  manufacturers  are already today outside 
the EU. The highest market growth is expected to take place by 2015 in South America and 
Africa.  The  market  for  premium  cosmetics  in  China  is  expected  to  double  by  2015. 
Relocation may therefore take place in any case.  

2.2.9.  Specific Impacts on SMEs and Micro-Enterprises 
Particular attention has been given to the situation of SMEs61 and micro-enterprises62 in the 
assessment.  Around  100  SME's  provided  input  to  the  Colipa  response  to  the  targeted 
stakeholder  consultation  and  the  Commission  services  met  with  a  number  of  national 
associations and small manufacturers to complement the information.  

The marketing ban applies to large and small companies alike and the cosmetics industry has 
a  high  percentage  of  SMEs.  SMEs  are  therefore  clearly  among  those  affected  by  the  ban. 
According  to  data  provided  by  Euromonitor  for  2010,  there  were  about  4  072  small  and 
medium sized cosmetic product manufacturers in the 27 EU Member States. In some Member 
States, SMEs represent more than 80% of the overall cosmetic manufacturers, as reported by 
Colipa  and  EFfCI.  In  Germany,  in  2008  SMEs  represented  76%  of  the  total  number  of 
cosmetic  manufactures  (but  the  statistics  do  not  cover  all  sectors,  so  the  percentage  for  the 
whole cosmetic sector is probably even higher). Figures from Germany also indicate that the 
overall  number  of  SMEs  in  the  cosmetics  field  is  much  higher  than  the  Euromonitor  data 
suggests.  The  European  Organization  of  Cosmetics  Ingredients  Industries  and  Services 
(UNITIS),  representing  companies  in  the  field  of  botanical  natural  complex  substances  is 
made up of 50 member companies, all of them SME's.  

Specific  data  on  the  number  of  micro-businesses is not available,  however data collected in 
the context of the earlier impact assessment63 indicated that there were 855 firms with fewer 

61 

62 

63 

Medium-sized: less than 250 employees, equal to or less than € 50 m turnover or equal to or less than € 
43 m balance sheet total 
Micro enterprise: less than 10 employees, equal to or less than € 2 m turnover or equal to or less than € 
2 m balance sheet total 
Impact  assessment  -  Report  on  simplification  of  the  “Cosmetics  Directive”  –  Directive  76/768/EEC 
under 
accessible 
(COM(2008)49 
http://ec.europa.eu/consumers/sectors/cosmetics/documents/revision/index_en.htm#h2-impact-
assessment-report 

/SEC/2008/0117 

(SEC(2008)118) 

final) 

final, 

also 

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than 10 employees in France in 2004 and that Italy had over 1000 firms with fewer than 10 
employees. These figures would indicate that the share of micro-businesses is very high.  

Colipa estimates that the SME market share is about 30% (about EUR 20 billion) of the total 
EU  cosmetics  industry.  This  is  confirmed  by  figures  received  from  Germany,  where  SMEs 
have 36% of the market share in this sector.  

SMEs  and  micro-enterprises  were  not  excluded  from  the  testing  and  marketing  ban  when  it 
was  introduced.  Exempting  SMEs  and  micro-enterprises  would  run  counter  the  animal 
welfare objective and is therefore also not considered in this assessment.  

SMEs and micro-enterprises face in principle the same impacts as those described above, ie. 
less access to ingredients and thus limited possibilities of product re-formulations. However, 
the impacts are not expected to be the same for all SMEs.  

SMEs and micro-enterprises specialised in cosmetics with a high rate of innovation could feel 
the impacts of the marketing ban. They often consider that the bans will have no impacts on 
them  since  they  do  not  themselves  test  or  commission  tests.  However  stakeholders  also 
underline (eg. the input received from UEAPME) that SMEs might be the least aware of these 
impacts. SMEs depend to a large extent on toxicological data being provided to them by their 
suppliers and may not be aware of the extent to which this data will not be available in the 
future. They will also often have less access to data from other sectors than larger companies 
with  a  varied  product  portfolio.  Also,  a  more  commoditised  market/mass  market  that 
competes  more  on  price  is  likely  to  disadvantage  SMEs  that  can  less  easily  compete  on 
economies  of  scale  rather  than  in  niche  markets.  SMEs  are  also  less  likely  to  relocate  or  to 
focus on exports.  

Another  group  of  SMEs  and  micro-enterprises  that  is  likely  to  be  affected  are  small  and 
specialised ingredient manufacturers. UNITIS in particular underlined in its submission to the 
targeted  stakeholder  consultation  impacts  on  its  around  50  SME  specialised  member 
companies.  Ingredient  manufacturers  and  especially  small  and  specialised  ones  depend  on 
constant ingredient innovation. 

There are however also a number of niche market SME's and micro-enterprises that might be 
less  negatively  affected  by  the  ban  or  even  benefit  from  it.  This  would  include  companies 
already working under  the 'animal testing' free label. Around 115 companies are part of the 
Leaping  Bunny  label  in  Europe  (400  worldwide)  alone,  many  of  whom  SME's.  This  would 
also apply to SMEs that work with well-established product lines, such as traditional soaps or 
other products less prawn to product innovation.  

2.3. 

Subsidiarity 

The  use  of  Union  competences  is  governed  by  the  principles  of  subsidiarity  and 
proportionality (Article 5 TEU). The current EU legislation on cosmetics is based on Article 
114 TFEU (ex-article  95  TEC)  and  its  aim  is to ensure a  high  level of protection of human 
health as well as the proper functioning of internal market. Article 13 of the TFEU contains 
the obligation to pay full regard to the welfare requirements of animals when implementing 
the internal market policies.  

The  Cosmetics  Directive/Regulation  exhaustively  harmonises  rules  on  consumer  safety  of 
cosmetic products placed on the EU market. Thus, changes to this legal framework can only 
be  achieved  by  EU  action.  The  marketing  ban  directly  addresses  the  free  movement  of 
cosmetic products in the Union. This is already subject to harmonized legislation and cannot 
be addressed at Member State level without leading to a serious fragmentation of the market. 
It can therefore only be achieved at Union level. Besides the testing and marketing ban, the 

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Cosmetics Regulation also harmonised the possibility to grant derogations from the bans and 
provided such a possibility under Article its 18 (2).  

All previous legislation in relation to the marketing ban was adopted at Union level. The first 
provisions  in  relation  to  the  marketing  ban  of  cosmetic  ingredients  or  combinations  of 
ingredients  tested  on  animals  in  order  to  meet  the  requirements  of  the  Directive  were 
introduced  to  the  Cosmetics  Directive  in  1993  with  an  application  date  of  1  January  1998, 
first postponed to June 2000, then to 30 June 2002 and finally for the endpoints in question 
here  to  March  2013.  These  extensions  of  the  deadline  were  essentially  due  to  the  non-
availability  of  alternative  methods  to  animal  testing,  however  the  last  extension  made  the 
testing ban and the 2009 marketing ban independent of the availability of alternatives (see for 
more details above 2.1.3.).  

3. 

OBJECTIVES 

3.1. 

General objective  

The general objective is to ensure a proper functioning of the internal market and maintaining 
a  high  level  of  protection  of  human  health,  while  paying  full  regard  to  the  welfare 
requirements of animals.  

3.2. 

Specific objectives 

The specific objectives followed are accordingly on the one hand linked to the functioning of 
the internal market (3.2.1. and 3.2.2., Article 114 TFEU) and on the other hand to the animal 
welfare objective (3.2.3. and 3.2.4., Article 13 TFEU).  

3.2.1.  To  maintain  consumer  safety  and  consumer  choice  (specific  objective  1  – 

Consumer Safety and Choice) 

For more than 30 years, the Cosmetics Directive has provided a legal framework that ensures 
consumer  safety.  The  Cosmetics  Regulation  strengthens  this  framework.  The  Cosmetics 
legislation  has  favoured  a  broad,  varied  and  innovative  offer  of  cosmetic  products  to 
European consumers. Consumer choice is likely to be impacted by a limited access to certain 
cosmetic  ingredients  and  thus  products.  The  objective  is  to  maintain  the  current  level  of 
consumer safety and consumer choice.  

3.2.2.  To maintain innovation and competitiveness of the European cosmetics industry 

(specific objective 2 – Innovation and competitiveness) 

The  Europe  2020  strategy  for  smart,  sustainable  and  inclusive  growth64  called  for  an 
‘Innovation  Union’  to  improve  the  framework  conditions  for  innovation65.  The  regulatory 
framework  for  cosmetics  should  therefore  be  supportive  of  innovation.  The  current 
framework has contributed to a thriving cosmetics industry that has also largely been able to 
resist  the  economic  crisis.  The  cosmetics  and  cosmetic  ingredients  industry  also  plays  an 
important role in creating jobs - direct and indirect. A reduced access to cosmetic ingredients 
and the resulting limited product innovation could impact the competitiveness of the industry. 
The objective is to maintain industry's capacity to innovate and its competitiveness. The EU is 
an  important  trading  partner  for  third  countries  when  it  comes  to  cosmetics,  with  the  EU 
representing almost half of the global market, followed by the United States and Japan. The 
objective is to maintain this trade.  

64 
65 

Communication from the Commission of 3 March 2010, COM(2010)2020 
Communication  of  the  Commission  on  Europe  2010  Flagship  Initiative  Innovation  Union,  6.10.2010, 
COM(2010)546final 

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3.2.3.  To  provide  animals  with  a  high  level  of  protection  and  welfare  (specific 

objective 3 - Animal Welfare) 

Animal welfare is enshrined in Article 13 of the Treaty on the Functioning of the European 
Union,  which  is  part  of  its  provisions  with  general  application.  The  objective  is  to  pay  full 
regard  to  animal  welfare  in  implementing  the  Union's  policies.  While  currently  animals  are 
still  used  outside  the  EU  for  the  purposes  of  the  EU  cosmetics  legislation,  once  the  2013 
deadline enters into force such testing data cannot be relied on, leading to a likely reduction in 
animal  use.  Animal  welfare  is  also  served  through  a  proper  enforcement  of  the  current 
provisions.  Legal  clarity  in  relation  to  the  scope  of  the  provisions  and  additional  tools  for 
Member State authorities to carry out the necessary checks in relation to the compliance with 
the  marketing  ban  will  help  ensure  the  effectiveness  of  the  provisions  in  place.  The 
Commission Communication on the European Union Strategy for the Protection and Welfare 
of  Animals  2012-201566  in  particular  underlined  the  need  for  better  implementation  and 
enforcement of existing provisions in relation to animal welfare.  

3.2.4.  To  maintain  the  incentive  for  continued  research  on  alternative  methods  to 

animal testing (specific objective 4 – Research into alternatives) 

A  safety  assessment  of  cosmetics  without  using  animals  can  only  be  achieved  if  alternative 
methods are in place. Considerable funding has been made available to develop and validate 
new  alternative  methods  to  animal  testing  by  the  Commission,  Member  States  and  the 
cosmetics industry. These efforts have contributed to validated alternative methods for several 
endpoints. Significant  advances  have  been made in reducing the number of  animals used in 
tests.  These  findings  have  not  only  benefited  the  cosmetics  industry,  but  help  to  reduce  the 
number of animals used across sectors. The objective is to keep up or step up the momentum 
for the remaining endpoints, not only out of animal welfare considerations, but also because 
this  work  allows  to  better  understand  the  toxic  pathways  and  to  make  better  safety 
assessments in the long run. Development of alternatives is itself innovation and creates new 
opportunities for industry. Continued efforts in research into alternatives is also in line with 
the  Commission's  international  co-operation  in  the  International  Cooperation  on  Alternative 
Test Methods (ICATM).  

4. 

4.1. 

POLICY OPTIONS  

Option 1: Baseline/No Action 

Option 1 is the scenario in which the Commission does not present a proposal in relation to 
the 2013 deadline of the marketing ban to the European Parliament and the Council. The legal 
framework  will  remain  unchanged,  resulting  in  an  entry  into  force  of  the  marketing  ban  in 
relation to the 2013 endpoints on 11 March 2013, irrespective of the availability of alternative 
methods to animal testing. The rationale behind option 1 is that it is the most effective way to 
obtain  the  overarching  political  objective  that  lead  to  the  current  provisions  -  to  abolish 
animal testing for cosmetic purposes.  

4.2. 

Option 2: Postpone the 2013 deadline  

In the absence of alternative methods by the 2013 deadline, the deadline could be postponed. 
This has already been done on several occasions (see above 2.1.3.). Option 2 foresees three 
sub-options  for  a  postponement  of  the  2013  deadline.  The  overall  rationale  behind  the 
different  sub-options  under  2  is  to  maintain  the  overall  objective  to  end  animal  testing  for 
cosmetic purposes, but to take account of the finding that alternatives are not yet available and 

66 

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COM(2012) 
http://ec.europa.eu/food/animal/welfare/actionplan/docs/aw_strategy_19012012_en.pdf 

15.2.2012, 

final/2, 

6 

35 

see: 

   EN 

 
                                                 
to  thus  make  reaching  the  objective  one  way  or  the  other  dependant  on  the  availability  of 
alternative methods.  

4.2.1.  Option 2 (a): Postpone the 2013 deadline with fixed deadline 

Option 2 (a) foresees the postponement of the deadline for a fixed time. Given that it is not 
clear  when  alternatives  will  be  available,  any  postponed  deadline  would  serve  mainly  as  a 
review  deadline,  by  which  progress  and  efforts  in  research  and  development  of  alternative 
methods would be evaluated. This option therefore would envisage a postponement of 7 years 
and  then  a  review  exercise  similar  to  the  one  recently  carried  out,  with  the  possibility  of  a 
further  postponement  should  alternatives  not  have  been  found  despite  the  demonstration  of 
serious  research  efforts.  The  rationale  behind  option  2(a)  is  that  it  follows  the  logic  of  the 
earlier interventions. It sets a deadline after which a review will take place, is thus not based 
on the assumption that at that point in time all alternatives will be available. The 7 years are 
chosen because the indication of the first phase of stakeholder consultation is that – in the best 
case – at least alternatives for skin sensitisation could be validated by then (experts expected 
the alternative methods to be available the earliest by 2017, in addition at a minimum 3 years 
are  needed  for  validation,  which  would  lead  to  2020),  so  that  a  possible  subsequent 
postponement could exclude this endpoint.  

4.2.2.  Option  2  (b):  Postpone  the  2013  deadline  in  relation  to  certain  endpoints  only 

and maintain for others 

Option  2  (b)  would  be  similar  to  Option  2  (a),  but  restrict  the  postponement  to  certain 
endpoints  only.  Essentially  this  would  foresee  no  extension  for  tests  used  less  frequently 
(carcinogenicity,  toxicokinetics  and  reproductive  toxicity),  a  one-off  extension  for  skin 
sensitisation and extension for repeated dose toxicity subject to review. The rationale behind 
option 2 (b) is to limit the postponement only to those endpoints most needed to demonstrate 
the safety of the cosmetic products, ie. skin sensitisation and repeated dose.  

4.2.3.  Option 2 (c): Postpone the 2013 deadline without fixed deadline  

Option  2  (c)  would  do  away  with  the  fixed  deadline,  but  maintain  the  current  mechanism 
according to which the ban applies as soon as an alternative method has been validated and 
adopted at EU level, with due regard to the developments of validation within the OECD. The 
ban would clearly apply once a method would be validated and included either in Regulation 
440/2008/EC  or  in  Annex  VIII  of  the  Cosmetics  Regulation.  It  would  also  be  possible  to 
already require replacement earlier, e.g. as soon as a satisfactory scientific method or testing 
strategy is available67. In the future, alternative methods will not be one-to-one replacements, 
but rather integrated testing strategies. The process for validation and regulatory acceptance of 
these  strategies  is  only  being  developed.  Option  2  (c)  would  be  most  coherent  with  the 
overarching  provisions  in  Directive  2010/63/EC  or  the  approach  in  REACH  to  use  animal 
testing as a last resort. The rationale behind option 2 (c) is essentially to let science deliver.  

4.3. 

Option  3:  Maintain  the  deadline  and  introduce  an  additional  derogation 
mechanism  

Option  3  aims  at  maintaining  the  deadline  while  allowing  access  to  market  for  innovative 
cosmetics with clear benefits when the safety assessment requires animal testing for cosmetics 
purposes.  To  this  end,  it  foresees  the  introduction  of  a  derogation,  complementing  the  one 
already existing for Member States68. Given that uncertainty remains about the actual impacts 
of the 2013 deadline, option 3 would be a kind of safety valve to allow key innovation. It will 

67 
68 

Such as in Article 4 of Directive 2010/63/EU on the protection of animals used for scientific purposes 
See Article 4a, 2.4. of Directive 76/768/EEC 

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36 

   EN 

 
                                                 
also make the problematic cases in which data is missing and the industry considers that the 
ingredient is of significant benefit transparent and will thus allow a better re-assessment of the 
policy in the future.  

The  derogation  could  apply  both  to  the  testing  and  the  marketing  ban.  Applying  it  to  the 
testing ban is not considered as the testing ban has applied in full since March 2009 and the 
review clause does not refer to the testing, but only to the marketing ban. In addition, there 
was no call to do so by stakeholders. It was further considered whether the derogation should 
apply to innovative ingredients only or to existing ingredients as well. This latter possibility 
was however discarded as in these cases, the derogation for Member States is in place. It is 
also considered that data from other legal frameworks may help.  

The provisions envisaged would allow a cosmetics/ingredients manufacturer (or associations 
of manufacturers) to request a derogation from the marketing ban for specific ingredients or 
combinations of ingredients under limited circumstances.  

(1)  A request would need to contain a demonstration that the ingredient in question 
would bring innovation and a significant benefit to consumer health, consumer 
well-being and/or the environment. Whether the conditions would be fulfilled 
would be a case-by-case assessment of the Commission. Innovation would be 
demonstrated  by  comparison  with  existing  ingredients  and  their  functions. 
Significant  benefits  could  be  shown  for  example  in  the  case  of  an  ingredient 
that is less likely to induce allergies than ingredients currently used, in the case 
of  a  new  preservative  (a  limited  number  of  preservatives  creates  the  risk  of 
microbial cross-resistance), in the case of a new sun protection ingredient with 
better environmental properties, in the case of an ingredient that would help to 
address needs of specific  parts  of  the population. These criteria would  not be 
fulfilled in the case of lower cost or greater accessibility of ingredients, in the 
case of ingredients that facilitate the production process, ingredients that only 
bring  incremental  product  improvements,  such  as  better  emulsifier,  product 
aesthetics  or  new  colour  shades.  Since  it  would  be  a  derogation,  the  cases  in 
which it applies should represent the exception, not the rule. 

The operational application would clearly be very challenging. Examples exist 
in other areas of similar evaluations and the criteria developed there could be 
partly  drawn  on.  This  is  notably  the  case  under  the  authorisation  procedure 
under REACH69, which requires the evaluation of socio-economic benefits of 
substances  for  which  an  authorisation  is  requested  and  the  exemptions  under 
Directive 2011/65/EU in relation to restrictions of hazardous substances, which 
allows an exemption taking into account 'the availability of substitutes and the 
socioeconomic impact of substitution', taking also account of adverse impacts 
on innovation70.  

However,  under  the  current  legislation  there  is  only  a  limited  requirement  to 
document the effect claimed for the cosmetic product under Article 11, 2, (d) 
of the Regulation. Article 20 of the Regulation requires that claims must relate 
to actual characteristics and functions of the product. Specific benefits of new 
ingredients as such do not need to be demonstrated. Nevertheless, the decision 

69 

70 

EN 

on 

guidance 

Extensive 
the 
http://echa.europa.eu/documents/10162/13637/sea_authorisation_en.pdf 
Article 5 of Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the 
restriction  of  the  use  of  certain  hazardous  substances  in  electrical  and  electronic  equipment,  L  174, 
1.7.2011, p. 8 ff. 

Socio-Economic  Analysis 

exists: 

cases 

these 

in 

37 

   EN 

 
                                                 
whether or not to change the formulation of a product and whether to introduce 
a new ingredient assumingly are based on company internal considerations on 
the expected benefit of the ingredient. These would need to be documented for 
the application.  

(2)  Manufacturers  would  need  to  demonstrate  that  toxicological  data  needed  for 
the safety assessment is not available and cannot be obtained using alternative 
methods to animal testing, in a reasonable timeframe. This verification would 
in any case be part of the safety assessment process, here it would need to be 
documented.  

(3)  Manufacturers  should  demonstrate  their  commitment  in  relation  to  their 
investments in research for alternative methods. Such a commitment could e.g. 
be  demonstrated  by  contributions  to  Framework  Programmes,  own  research 
activities or contribution to academic research work. It will be evaluated on a 
case-by-case  basis.  SMEs  and  micro-businesses  will  be  exempted  from  this 
requirement. The objective is to ensure that the derogation is not used as a way 
to  avoid  research  into  alternatives,  a  logic  similar  to  the  requirement  of  a 
substitution plan under REACH.  

In the application, the manufacturer would need to provide details on the proposed place of 
testing,  the  protocol  followed,  the  number  of  animal  involved  and  the  animal  welfare 
standards  applied.  This  will  include  information  on  the  test  protocol  followed,  such  as 
reference to OECD protocol. It would also include information on the purpose for which the 
testing was carried out and a description of the test that can be made public together with the 
description of the ingredient.  

Consideration  would  also  be  given  to  avoid  on  the  one  hand  that  the  derogation  excludes 
others than the applicant from the use of the ingredient (= not the create 'monopolies') and on 
the other hand to avoid that the derogation allows for duplicate animals testing.  

In  terms  of  procedure,  such  a  derogation  would  be  granted  in  the  form  of  a  Commission 
Decision. This would allow for the fastest decision-making. In terms of time between 6 month 
and 1 year are expected to be needed for the decision-making. Appropriate expertise , notably 
the SCCS, could be consulted on the questions whether the toxicological data is needed and 
whether the test in question is appropriate to provide it.  

5. 

ANALYSIS OF IMPACTS  

5.1.  Methodology and possible impacts identified  

The  following  assessment  of  the  impacts  is  focused  on  the  analysis  of  each  option  in  its 
entirety,  focusing  on  the  environmental,  economic  and  social  impacts.  The  environmental 
impacts  are  limited  to  the  impacts  on  animal  welfare  and  research  into  alternatives  and  are 
dealt  with  upfront.  The  environmental  concerns  that  substances  used  in  cosmetic  products 
may raise are considered through the application of REACH, which enables the assessment of 
environmental safety in a cross-sectoral manner. 

5.1.1. 

Impacts Policy Option 1 - Baseline/No Action 

The effects of the no action scenario have been described and analysed in detail above in the 
problem description and will only be summarized here. In the absence of an amendment to the 
Cosmetics Regulation, option 1 will apply as of 11 March 2013. 

As regards environmental impacts the application of the deadline is expected to spare a sub-
set of 15 000 to 27 000 animals per year. This concerns animals used for testing outside the 

EN 

38 

   EN 

 
EU  only,  as  the  testing  ban  applies  and  is  not  put  into  question.  Option  1  fully  meets  the 
overall  political  objective  to  end  animals  testing  for  cosmetics.  It  is  also  the  option  that  is 
expected to contribute most to the development of alternatives methods.  

As regards economic impacts, option 1 is expected to lead to a certain reduction of cosmetic 
ingredients. A large cosmetics manufacturer with an ingredient portfolio of 2 000 ingredients 
could lose 8 of the 80 new ingredients normally introduced per year as these would be new to 
the market. Also access to ingredients already used in other sectors would be limited. In the 
worst case a large cosmetic manufacturer could lose another 21 to 36 ingredients per year. In 
addition,  existing  ingredients  come  under  review  regularly  and  might  not  be  sufficiently 
defended. This could in total concern up to 24 existing ingredients per year. The data implies 
that  in  the  worst  case  up  to  10%  of  the  total  25  to  30%,  i.e.  2,5  to  3%,  of  annual 
reformulations will be affected, mainly those relying on new to market ingredients. This could 
impact between 2 500 and 7 500 products per year in total.  

This  loss  of  ingredients  could  lead  to  a  loss  of  competitiveness.  It  is  estimated  by  industry 
stakeholders that large companies could face losses in turnover ranging from 3 to 20% in the 
short term (2013-2015), 7 to 20 % in the medium term (2015 – 2018) and 1 to 25% in the long 
term  (2018  and  beyond).  Member  States  with  the  largest  cosmetics  industry  are  Germany, 
France,  the  United  Kingdom,  Italy  and  Spain.  Exports  and  imports  would  also  be  affected 
given that animal data is needed for the safety assessment in third countries.  

The  impacts  on  availability  of  ingredients  and  the  resulting  impacts  on  turnover  could  also 
lead to lower employment of R&D staff, up to 8 000 in the worst case, as well as other staff. It 
has  to  be  stressed  that  these  are  estimates  from  the  industry  stakeholders  and  that  no 
independent data is available to verify these  impacts and  that views  of stakeholders diverge 
enormously. 

5.1.2. 

Impacts Policy Options 2 (a), (b) and (c) – Postpone the 2013 deadline  

Environmental Impacts  

All sub-options discussed under option 2 maintain the overall objective to phase-out animal 
use  for  cosmetics.  They  do  however  allow  for  more  time  to  achieve  this  objective  as  they 
make it one way or the other dependant on the availability of alternative methods. Under all 
sub-options  of  option  2  animal  testing  outside  the  EU  for  EU  cosmetics  purposes  could 
therefore continue beyond 2013, meaning the continuous use of 15 000 to 27 000 animals per 
year.  In  relation  to  the  ethical  considerations  and  expectations  of  European  citizens  any 
extension of the deadline is likely to be seen negatively.  

There  are  some  differences  in  the  impacts  on  animal  numbers  between  the  sub-options. 
Option 2 (a) would lead to the continuation of the use of between 15 000 and 27 000 animals 
per year for the coming 7 years. Any further prolongation would require an amendment of the 
legislation.  

Option 2 (b) would limit the number of animal used compared to the situation now by at least 
12%,  this  represents  the  percentage  of  the  less  used  tests  excluded  under  this  option.  This 
would mean that at least 1 800 to 3 240 animals less would be used. However, this number is 
likely to be somewhat higher because in cases in which a reproductive toxicity study would be 
needed for the assessment and cannot be carried out it does also not make sense then to carry 
out the skin sensitisation test.  

Option 2 (c) would continue the use of animals as now and as under option 2 (a) per year. The 
difference  is  that  there  would  be  no  fixed  deadline,  but  that  the  ban  would  kick  in  once 
alternatives become available. It would still mean that the number would diminish. Assuming 
that  alternatives  for  skin  sensitisation  become  available  by  2020  this  should  mean  a  70% 

EN 

39 

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reduction of testing (this is the percentage of skin sensitisation testing now). This would mean 
that beyond 2020 the numbers would go down to about 4 500 to 8 100 animals per year, until 
further alternatives become available.  

All options under 2 are generally expected to have somewhat negative impacts in relation to 
research in that the postponement takes away the immediate need for research in alternatives. 
In  particular  option  2  (c)  would  make  the  ban  dependant  on  the  availability  of  alternative 
methods  and  but  would  not  set  a  fixed  deadline.  Many  stakeholders  considered  that  it  was 
exactly the deadline that led to intensified research funding.  

Economic Impacts  

Under  options  2  (a),  (b)  and  (c)  the  deadline  would  be  postponed,  with  the  result  that  also 
beyond 2013 new cosmetic-specific animal data could be relied on for the safety assessment 
of  cosmetics.  This  would  maintain  the  availability  of  ingredients  and  the  possibility  to 
reformulate  products  as  it  is  now  before  the  entry  into  force  of  the  marketing  ban.  There 
would  be  therefore  overall  no  economic  impacts  expected  under  option  2,  the  cosmetics 
market could continue to develop as described under 2.1.1.  

Slight  differences  exist  however  depending  on  the  sub-option.  Options  2  (a)  and  2  (c)  both 
foresee a postponement for all endpoints. Option 2 (b) foresees the postponement for certain 
endpoints only. Therefore option 2 (b) would have negative impacts in the few cases in which 
this data is needed, thus in about 12%.  

Also  in  relation  to  trade  the  situation  will  essentially  remain  as  it  is  now,  and  export  and 
import  activities  can  continue.  Under  option  2  (b)  slightly  negative  impacts  are  however 
expected in cases in which data on endpoints for which the deadline was not prolonged are in 
question.  

Social Impacts  

As  for  the  economic  impacts,  essentially  the  situation  will  remain  the  same  to  the  current 
situation. Of the sub-options, option 2 (c) would have possibly positive impacts compared to 
the situation now, as it takes away a fixed deadline and thus provides most confidence in the 
future  ability  of  the  cosmetics  industry  to  innovate  and  this  stability  could  lead  to  more 
employment. Under this option industry can be sure that innovation can be continued either 
based on animal data or based on alternatives.  

Stakeholders  have  split  views  on  option  2  and  its  sub-options.  Animal  welfare  stakeholders 
and some Competent  Authorities clearly  oppose any postponement, independent of the  sub-
option.  They  consider  that  enough  time  has  passed  since  the  bans  were  first  introduced  20 
years ago and that no further postponement is acceptable. As described above under 2.2.4 and 
2.2.5, they also do not consider that the marketing ban leads to considerable negative impacts, 
and therefore do not see the need of a postponement. The wish to maintain the 2013 deadline 
also seems to reflect the views of many citizens, as evidenced by the large number of letters 
and mails against any postponement directed to the Commission. Industry stakeholders on the 
other hand and several Competent Authorities generally support a postponement, with option 
2  (c)  being  the  preferred  option  that  is  considered  to  be  the  most  science  based  approach. 
They  consider  that  a  postponement  is  the  best  way  to  avoid  the  negative  impacts  expected 
from the marketing ban and consider that the impacts on animal welfare are limited.  

5.1.3. 

Impacts  Policy  Option  3  -  Maintain  the  deadline  and  introduce  an  additional 
derogation mechanism from the marketing ban 

Environmental Impacts  

EN 

40 

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Option 3 would essentially lead to similar positive impacts as option 1 in relation to animal 
welfare. It maintains the deadline and thus ends the use of a sub-set of the currently used 15 
000 to 27 000 animals per year.  

It would, however, lead to the possibility to request derogations and, thus, in a limited number 
of  cases  to  testing  outside  the  EU  for  EU  cosmetics  purposes  beyond  2013.  A  derogation 
would be sought in relation to the safety assessment of a specific ingredient. The number of 
animals impacted would depend on how often such a derogation would be granted.  

There is uncertainty about the overall number of ingredients introduced for the total industry. 
The data provided in the targeted stakeholder consultation indicates that in total there may be 
at a minimum around 150 new ingredients introduced for the cosmetics industry per year in 
Europe.  At  a  maximum  the  number  of  new  INCI  codes  indicates  that  up  to  500  new 
ingredients could be introduced to the cosmetics industry per year. Both figures include new 
to the market and new to the cosmetics market. Therefore it is likely that only about 10% of 
these  would  be  new  to  the  market  and  most  likely  to  require  a  derogation,  thus  somewhere 
between 15 and 50 ingredients per year. Other ingredients are more likely to have data sets 
from other uses. However, also for at a maximum for half of the new to cosmetics market at 
least some data may be needed (see above 2.2.4.). This would mean that between 82 and 275 
new ingredients would be likely to require animal data per year.  

Only assumptions can be made to the possible number of derogations requested and granted 
based on these figures. One assumption could be that the use would be similar to the use of 
the current Member State derogation, which has been applied for one time since 2009. This is 
however for various reasons not likely to be a valid assumption (see above 2.1.4.). Another 
assumption could be that a derogation would be requested for nearly all new ingredients, thus 
at the high end up to 275 times per year. The derogation is however designed to apply only in 
exceptional  circumstances  and  the  aim  is  not  to  turn  the  ban  into  an  authorisation  scheme. 
This assumption is therefore not likely to be valid either. The third assumption would be that 
the  derogation  would  only  apply  in  a  small  percentage  of  the  newly  introduced  ingredients 
and  would  probably  only  be  used  in  about  10  to  15  cases  per  year.  This  appears  the  most 
likely assumption.  

In the majority of cases testing on skin sensitisation and repeated dose would be needed. The 
data  in  Annex  2  implies  that,  per  derogation  granted,  a  minimum  of  100  animals  would  be 
used. This figure could in some cases be higher, depending on the testing needed. Based on 
these estimates the derogation could lead to a use of about 1 000 to 1 500 animals per year. It 
would in each case depend however which data is already available. It should be noted that 
the  derogation  could,  and  is  likely  to  be,  also  sought  in  order  to  rely  on  testing  data  which 
already  exists,  but  which  is  covered  by  the  marketing  ban,  e.g.  testing  done  to  meet  third 
countries cosmetics legislation. In these cases the testing would not be triggered by and not be 
a direct impact of the derogation.  

Option 3 will lead to a similar need for alternative methods as option 1 and thus equally have 
positive impacts on research. However, this effect may be somewhat limited by the possibility 
to request a derogation.  

Economic Impacts  

Under option 3 the situation is to some extent similar to the one under option 1, thus the ban 
enters into force and similar negative impacts can be expected than the ones described under 
2.2.4 and 2.2.5. However, option 3 would allow limiting the negative impacts of option 1 in 
that  it  provides  the  possibility  for  industry  to  request  a  derogation  on  a  case-by-case  basis. 
Most  of  the  new  ingredients  would  not  fulfil  the  criteria  for  a  derogation,  as  they  may  be 

EN 

41 

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added  for  example  for  reasons  of  better  availability,  price  or  other  rather  incremental 
innovation reasons. The derogation would therefore most likely cover only a small number of 
the cases. Nevertheless, Option 3 would provide the possibility to introduce the derogation for 
the most valuable ingredients and product innovations with particular benefit for consumers. 
It would therefore allow mitigating the most serious impacts. It is not possible to provide an 
estimate of to which extent the derogation would limit the impacts on turnover in quantitative 
terms.  While  the  derogation  may  only  apply  in  a  few  cases  in  terms  of  numbers,  they  are 
expected 
innovation  and 
competitiveness.  So  even  if  it  would  be  granted  as  assumed  above  in  only  about  10  to  15 
cases,  the  economic  impact  would  be  mitigated  to  a  higher  extent  as  the  ingredients  in 
question are likely to have a comparatively higher value. 

ingredients  with 

the  biggest 

to  concern 

impact  on 

the 

The derogation would apply to large and small companies essentially the same way. However 
the  derogation  mechanism  would  also  foresee  a  number  of  ways  to  take  account  of  the 
specific  needs  of  SMEs.  First,  the  derogation  could  also  be  applied  for  by  a  group  of 
applicants. Second, it could allow for ingredient manufacturers to apply. Third, the decision 
could  not  only  apply  to  the  direct  applicant,  but  to  anyone  which  whom  a  data  sharing 
agreement  is  in  place.  SMEs  and  micro-business  can  therefore  benefit  from  derogations 
requested by others, notably further up the supply chain. Indeed in most cases SME's do rely 
on  data  from  the  supply  chain  in  any  case.  Fourth,  SMEs  could  be  exempted  from  the 
requirement to demonstrate their commitment to research.  

In relation to trade option 3 would allow to mitigate some of the trade impacts. In relation to 
export, because the derogation would still allow for key innovations within the EU and for the 
EU  market,  which  could  then  be  exported.  In  relation  to  imports,  because  the  possibility  to 
request a derogation would also be open to third country manufacturers and would allow them 
access to the EU market with innovative products. 

Social Impacts  

As  regards  employment,  the  situation  is  essentially  similar  to  option  1  (see  above  under 
2.2.8). To which extent the derogation could mitigate the expected negative impacts cannot be 
quantified.  

Stakeholders  had  mixed  views  on  option  3.  Animal  welfare  stakeholders  reiterated  in  the 
consultation  on  the  derogation  that  they  wish  to  maintain  the  deadline  as  is,  thus  not  to 
introduce  a  derogation.  As  described  earlier,  their  concern  is  less  the  potential  number  of 
animals used under the derogation, but letting the marketing ban apply in full is a question of 
principle. Industry stakeholders recognised that – should no postponement be considered - the 
derogation could offer a solution at least for a few innovative ingredients. Given that industry 
considers that most of the testing would be done in any case for third countries, the impacts 
on animal welfare were considered to be very limited. Industry stakeholder underlined that the 
derogation  would  by  far  not  mitigate  all  negative  economic  impacts  of  the  2013  marketing 
ban. In comparison to a postponement it is clearly seen as less favourable by industry. It also 
comes with delays and administrative costs (see below 5.2). Administrative Costs  

Administrative  costs  are  defined  as  "the  costs  incurred  by  enterprises,  the  voluntary  sector, 
public  authorities  and  citizens  in  meeting  legal  obligations  to  provide  information  on  their 
action or production, either to public authorities or to private parties".71  

The options 1 and 2 do not raise any specific additional administrative costs for the industry, 
Member  States  or  the  Commission.  Option  3  however  does  raise  substantial  administrative 
costs at industry level.  

71 

Impact Assessment Guidelines (SEC(2009)92, Part III, page 45 

EN 

42 

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These  costs  would  arise  on  the  industry  side  for  the  preparation  and  the  follow-up  of  a 
derogation file. This would not involve a fee, but would consist of the time needed to compile 
and  substantiate  the  derogation  file.  To  some  extent,  the  information  needed  for  the 
derogation  file  would  be  information  industry  would  need  to  consider  in  any  case  when 
introducing  a  new  ingredient.  The  elements  to  be  covered  in  the  derogation  file  were 
described above under 4.3. and are:  

(a)  A detailed argumentation and substantiation of the innovation and the benefits 
of the ingredient in question. This is as such not required under the Cosmetics 
Regulation, with the exception of the cases in which due to the nature or effect 
of the cosmetic product proof of the effect needs to be included in the Product 
Information File (see Article 11, 2 (d)); 

(b)  Detailed  reasoning  in  relation  to  the  need  for  animal  data  in  the  safety 
assessment  versus  relying  on  alternative  methods  (description  of  possible 
existing  alternatives  routes,  such  as  Threshold  of  Toxicity  Concern  (TTC). 
While this does not require documentation currently, already now under the '3 
R's'  policy  manufacturers  must  reflect  on  whether  animal  testing  cannot  be 
avoided by other approaches. Information on any testing carried out or planned 
(numbers,  place,  protocol  etc.)  must  also  be  provided.  This  information  is 
readily  available  and  the  current  legislation  requires  that  the  source  of 
toxicological information must be clearly identified (Annex I, Part A, 8 of the 
Regulation);  

(c)  Demonstration  of  the  financial  commitment  to  research  into  alternatives 
(funding  provided  to  EU  Framework  Programmes,  own  research  activities, 
contribution to academic research work etc.). This is a new element.  

Apart from the financial commitment to research, the costs for such a derogation file can be 
estimated  to  some  extent  by  looking  at  the  costs  of  two  types  of  files  existing  under  the 
Cosmetics Directive, the costs for the safety assessment file on the one hand and the costs for 
submission  to  the  SCCS  on  the  other  hand.  For  both  cost  information  was  provided  in  the 
impact assessment preceding the adoption of the Cosmetics Regulation72.  
The costs were determined using the administrative costs the EU Standard Cost Model73: 

∑ P x Q 

where P (for price) = tariff x time 

Q (quantity) = number of business and frequency 

Accordingly,  the  costs  for  industry  to  establish  the  necessary  safety  evaluation  data  for  a 
SCCS submission range from EUR 100 000 to EUR 1 000 000 per substance. These costs are 
usually  borne  by  a  consortium  of  companies  to  share  these  costs.  The  costs  for  a  correct 
product safety assessment (for the product safety file) for a new formulation were estimated to 
in average be approximately EUR 15 000.  

72 

73 

Impact  assessment  -  Report  on  simplification  of  the  “Cosmetics  Directive”  –  Directive  76/768/EEC 
under 
accessible 
(COM(2008)49 
http://ec.europa.eu/consumers/sectors/cosmetics/documents/revision/index_en.htm#h2-impact-

/SEC/2008/0117 

(SEC(2008)118) 

final) 

final, 

also 

assessment-report 

The underlying cost elements are described in the Impact assessment - Report on simplification of the 
“Cosmetics Directive” – Directive 76/768/EEC (COM(2008)49 final) (SEC(2008)118) /SEC/2008/0117 
final  and  partly  based  on  the  RPA  study  "Impact  of  European  Regulation  on  the  EU  Cosmetics 
Industry" of September 2007 

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43 

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The costs to prepare the derogation dossier are likely to be closer to the second case, ie. the 
costs for the product safety assessment.  

Unlike the dossier for the SCCS, the derogation dossier would not have to address the safety 
of  the  substance.  It  would  also  not  address  all  endpoints,  but  only  the  ones  for  which  the 
additional data is needed. The costs for the derogation dossier would also not include the costs 
arising  for  producing  testing  data  to  demonstrate  safety.  These  were  included  in  the  cost 
estimates above and constitute a large part of the costs. Therefore the costs for the derogation 
file would not be comparable to the SCCS dossier.  

The derogation dossier would be rather comparable in overall complexity and likely cost to 
the product safety assessment file. It would not include certain elements of the product safety 
assessment, but on  the other  hand  include additional ones. Overall it is  therefore  in  balance 
considered  comparable.  It  would  only  address  one  ingredient  and  not  all  ingredients  of  the 
product, as does the product safety assessment. It would also not have to argue the safety of 
the ingredient. It would however have to include information and demonstration on the four 
elements above.  

6. 

6.1. 

COMPARING THE OPTIONS  

Comparing the options on Effectiveness  

When  looking  at  the  extent  to  which  the  options  achieve  the  objectives,  option  1  – 
maintaining the deadline – clearly makes the animal welfare objective paramount and is the 
most  effective  option  in  this  respect.  The  number  of  animals  spared  as  of  2013  would  be  a 
sub-set of the estimated 15 000-27 000 animals used for cosmetic specific testing outside the 
EU per year. Option 1 also clearly best reflects the ethical considerations of many EU citizens 
that animal welfare is not only about numbers, but about a basic ethical value decision. The 
expectation is that no animal should suffer because of a cosmetic product. In relation to the 
internal  market  objectives,  option  1  is  however  less  effective.  It  can  lead  to  a  more  limited 
consumer  choice  and  to  less  competitiveness  of  the  European  industry  compared  to  the 
current situation. 

Option 2 and its sub-options – the postponement options - are least effective in relation to the 
animal  welfare  objective  of  the  considered  options.  While  the  long-term  objective  to  end 
animal  use  is  kept,  under  all  sub-options  the  animal  use  outside  the  EU  for  EU  purposes 
would  continue,  even  though  with  some  differentiation  in  relation  to  number  of  animals  or 
time depending on the sub-option. Option 2 also meets the ethical consideration of citizens the 
least of the options. A further postponement of 7 years would mean a total postponement of 
22  years  after  the  first  foreseen  deadline.  In  addition,  given  that  for  several  endpoints 
alternatives are not expected to be available then either it would already foreshadow a further 
postponement. On the other hand option 2 is the most effective of the options in relation to the 
internal market objectives, as it essentially maintains the current situation, which has allowed 
the  industry  to  provide  a  wide  range  of  safe  and  innovative  cosmetics  to  the  market  and  to 
maintain a competitive position. Of the sub-option under option 2, sub-option 2 (c) is the most 
effective in this regard, it makes the ban dependant on the scientific criteria of availability of 
alternatives and thus would not leave industry in a situation in which the tools for the safety 
assessment of cosmetics would not be available. 

Option 3 – the derogation - is less effective than option 1, but more effective than option 2 in 
relation to the animal welfare objectives. The overall ban remains in place and only a limited 
number  of  animals  would  be  used  under  the  derogation.  The  derogation  would  be  granted 
under  exceptional  conditions  only.  In  relation  to  the  internal  market  objectives  option  3  is 
more effective than option 1, but less effective than option 2. Option 3 at least allows a certain 

EN 

44 

   EN 

 
amount of innovation and could mitigate possible negative impacts of option 1 to some extent. 
The likely challenging application, which would each time raise the same ethical debate and 
would have to involve considerable judgement on the Commission side, would however limit 
the effectiveness of the option. 

6.2. 

Comparing the options on Efficiency  

In relation to efficiency, option 1 scores lowest of the options considered in that achieving the 
animal welfare objective can have an impact on the internal market objectives. The sub-set of 
15 000 to 27 000 animals spared could come at the cost of a certain reduced availability of 
innovative  ingredients,  thus  leading  to  less  product  innovation.  It  could  equally  lead  to 
difficulties  in  relation  to  the  assessment  of  existing  ingredients,  even  though  the  existing 
derogation  for  Member  States  may  help.  Option  1  could  lead  to  a  somewhat  more 
commoditised  and  less  innovative  market  and  is  likely  to  impact  the  competitiveness  of  the 
EU cosmetics industry. Also, certain consumer demands could possibly not be met.  

Option  2,  and  specifically  option  2  (c),  comes  with  no  drawbacks  in  relation  to  the  internal 
market  objectives.  However,  while  it  maintains  the  long-term  objective  in  relation  to  the 
animal welfare, it comes at the price of continued animal use at the same level as now for the 
coming  years  and  the  drawback  of  the  'ethical  defeat'  and  of  being  considered  to  lose  the 
animal welfare objective out of sight.  

Option 3 maintains the deadline and thus adheres to the animal welfare objective, but at the 
same  time  provides  the  possibility  of  using  the  most  significant  innovative  ingredients  and 
thus mitigating some of the drawbacks of the deadline. The derogation would be subject to a 
Commission  decision,  and  thus  to  a  judgement  whether  in  the  case  at  hand  the  benefits 
offered by the ingredient can outweigh the drawback of the animal use. Option 3 is not likely 
to  reduce  the  negative  impacts  of  the  marketing  ban  on  the  internal  market  objectives 
completely, but could limit them in some specific cases. 

In quantitative terms the differences in efficiency between the options are limited. In relation 
to the animal welfare objective, because in comparison with other sectors the total number of 
animals involved is relatively low anyhow and because the differences in animal use between 
the options are difficult to quantify beyond the overall estimates. Also, under all options the 
animal numbers would decrease in time as alternative methods become available. In the best 
case  this  could  be  the  case  for  skin  sensitisation  by  2020,  leading  then  independent  of  the 
option chosen to a reduction of animal use of 70%. In relation to the internal market objective 
because while there will be undoubtedly a reduced access to existing and new ingredients and 
economic and social impacts are expected, they remain difficult to quantify and figures given 
were  to  a  large  extent  based  on  industry  estimates.  In  addition,  counterbalancing  measures 
such  as  EU  support  for  research  for  research  and  development  of  alternative  test  methods 
could not be taken into account due to a lack of solid data. 

6.3. 

Comparing the options on Coherence  

Option 1 scores high in coherence with the overall animal welfare objectives of the Union, but 
low in coherence with the way the same question is addressed in other Union legislation.  

All sub-options under option 2 score well in relation to coherence with overarching policies, 
in  particular  relating  to  innovation  and  competitiveness  orientated  objectives.  Option  2  (c) 
could be seen as the most coherent approach compared to the way the same issue is addressed 
in other areas of EU legislation. On the other hand option 2 is least coherent with the animal 
welfare objective.  

EN 

45 

   EN 

 
Option  3  comes  with  trade-offs  and  advantages  on  overarching  objectives.  It  aims  in 

Environmental Impacts  

Economic Impacts 

Social Impacts  

Option 1 

Sub-set of 15 000 to  

27 000 animals per year 
spared (for EU cosmetic 
purposes) 

Acceleration of development 
of alternative methods with 
impacts beyond the 
cosmetics sector  

Certain limitations in 
access to new 
ingredients, leading to a 
certain reduced product 
innovation. Possible loss 
of existing ingredients. 
Possible negative 
impacts on 
competiveness of the 
cosmetics and cosmetics 
ingredients industry and 
trade.  

Possible loss of R&D 
and other jobs as a result 
of the economic 
impacts.  

Option 2 (a) 

Sub-set of 15 000 to 27 000 
continues to be used per year 
for the next 7 years  

The current situation is 
maintained.  

The current situation is 
maintained.  

Option 2 (b) 

Option 2 (c) 

Option 3 

Sub-set of 15 000 to 27 000 
animals continues to be used 
per year, but minus 12% for 
tests excluded (- 1 800 to 3 
240) 

Sub-set of 15 000 to 27 000 
animals continues to be used 
per year, no fixed cut-off, 
but probably reduced as off 
2020 by 70%, so beyond 
that sub-set of 4 500 to 8 
100 animals per year 

Animal use stopped as under 
option 1, but possible to 
request derogation. Certain 
number of animals used 
under derogation about 100 
animals, total number 
depends on number of 
derogations granted, 
estimated to about 1 000 to 1 
500 per year.  

The current situation is 
maintained, but in a 
number of cases negative 
impacts (+/- 12%)  

The current situation is 
maintained, but in a 
number of cases 
negative impacts  

The current situation is 
maintained, but more 
planning safety is 
provided.  

The current situation is 
maintained, but more 
planning safety is 
provided. 

Negative impacts as 
under option 1, but 
certain mitigation 
through the derogation 
for the most beneficial 
ingredients.  

Negative impacts as 
under option 1, but 
certain mitigation 
through the derogation 
for the most beneficial 
ingredients. 

particular at ensuring the innovation related objectives under the EUROPE 2020 strategy, but 
it clearly is in some contradiction to the animal welfare objective. 

Looking  at the stakeholder  views,  all stakeholders share the overall  objective to end animal 
testing for cosmetics. Stakeholders have no interest in animal testing as such, other than as a 
tool to ensure and demonstrate consumer safety. Indeed alternative methods may turn out to 
be beneficial for industry.  

EN 

46 

   EN 

 
 
 
 
The question remains however what to do in the cases in which alternatives are not available. 
Here,  the  views  of  stakeholders  on  the  options  are  split.  Animal  welfare  stakeholders  took 
throughout the process a clear position against any proposal in relation to the 2013 deadline, 
thus clearly supporting option 1. Their position is one of principle and focussed on the animal 
welfare  objective,  irrespective  of  potential  negative  impacts  on  other  objectives.  Industry 
stakeholders have underlined that they expect significant negative impacts on them from the 
2013  deadline  and  limited  positive  impacts  for  animal  welfare.  They  have  therefore  overall 
supported  the  approach  to  let  science  deliver,  thus  supporting  option  2  (c).  Industry  has 
nevertheless  provided  input  on  the  derogation  in  option  3,  recognising  that  -  as  a  fallback 
position if a postponement is not proposed - the derogation is better than option 1. Member 
States  appear  to  have  split  views,  some  (Denmark,  Italy,  France,  Greece  and  the  Czech 
Republic) expressed their support for a postponement (for one of the sub-options under 2) and 
others  (Austria,  Sweden  and  the  Netherlands)  are  supporting  option  1.  However,  not  all 
Member States have expressed a view and, given that the issue has a clear political dimension, 
views taken at working level may not be representative for positions that would be taken in 
Council.  

6.4. 

Preferred Option 

The preferred policy option is in this case not a decision based on numbers only. It involves 
ethical  questions  of  principle.  There  is  a  long  history  of  political  decision-making  on  this 
issue, with the bans first introduced going back as far as 1993. The objective of the legislator 
has clearly been ending animal use for cosmetics. Any decision will therefore have to take the 
political background into account. 

6.5. 

Financing 

In case a proposal by the Commission was made scheduled, an adoption of the legislative act 
by the co-legislator could not be expected before the end of 2013, with the application of the 
derogation starting in 2014 so that credits for its implementation would need to be foreseen as 
of  2014  which  would  go  hand  in  hand  with  the  start  of  the  next  Multiannual  Financial 
Programme (MFF) 2014-2020.  

Costs for the Commission would arise under Option 3 as it would require additional resources 
to assess derogation requests, in the Cosmetics Unit as well as in the Unit administering the 
SCCS.  

While there is uncertainty as to the number of derogation request, it is estimated that about 10 
to 15 ingredients would be eligible per year. The staff required will depend on the number of 
derogations to deal with. 

Estimated budgetary needs 

The average staff costs for the Commission are taken as a basis of the calculation, i.e. EUR 
127 000/year for one AD/AST (2011 prices) 

Commission  (Operational  Unit  for  Cosmetics 
Regulation/Unit  responsible  for  the  Scientific 
Committee) 

 EUR 254 000 /year (for 2 FTE with overhead)  

7. 

MONITORING AND EVALUATION  

Monitoring and evaluation can be assured through existing mechanisms under the Cosmetics 
Regulation.  

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47 

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The Cosmetics Regulation foresees a mechanism of yearly reports to the European Parliament 
and the Council in its Article 35. These reports address the progress made in the development, 
validation  and  legal  acceptance  of  alternative  methods,  statistical  data  on  animals  used  and 
progress  in  international  acceptance  of  alternative  methods.  While  the  yearly  reporting  is 
considered as too frequent, these regular reports provide a valuable tool to determine to which 
extent the safety assessment for cosmetics can already be based on alternative methods.  

The  last  reports  have  equally  addressed  the  implementation  and  enforcement  of  the  testing 
and marketing ban. The enforcement of the rules is the task of the Competent Authorities and 
is part of their overall market surveillance activities. Market surveillance has been reinforced 
by the Cosmetics Regulation, in particular in its Article 22, which foresees that the Member 
States  should  at  least  every  4  years  periodically  review  and  assess  the  functioning  of  their 
market surveillance activities and inform the Commission and the Member States and make 
their  assessment  publicly  available.  This  would  present  an  additional  monitoring  tool. 
Cooperation on market surveillance is also supported through the Cosmetics Committee, the 
Working Group on Cosmetics and the Platform of European Market Surveillance Authorities 
(PEMSAC).  

In  case  option  3  is  chosen,  the  enforcement  of  the  marketing  ban  would  be  further 
strengthened and a reporting on the derogation scheme would be foreseen. The reporting on 
the derogation would look in particular at the following aspects:  

•  Number of derogations requested and granted;  

•  Number of animals used under the derogation;  

•  Test protocols requested under the derogation;  

•  Time required for the derogation process;  

•  Types  of  ingredients  covered  by  the  derogations  (granted  and  non-granted)  and 

benefits put forward.  

* 

* 

* 

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ANNEX 1: SUMMARY SECOND PHASE STAKEHOLDER CONSULTATION 

1. Introduction  

A first phase stakeholder consultation on the availability of alternative methods by 2013 was 
carried out between April 2010 and May 2011. Information on this exercise, the contributions 
of the stakeholders, a summary report of the consultation as well as the final report, have been 
published on the Directorate-General SANCO's cosmetics website74.  

The result of the first phase of the consultation showed that alternatives to animal testing for 
the 2013 endpoints will not be available by 2013. The Commission services therefore started a 
second  phase  of  stakeholder  consultation  in  order  to  obtain  information  on  the  potential 
impacts  of  the  entry  into  force  of  the  2013  deadline  in  the  absence  of  alternatives.  The 
Commission  services  consulted  targeted  stakeholders  and  Member  States.  The  list  of 
stakeholders  consulted  included  the  cosmetics  industry,  ingredient  manufacturers,  animal 
welfare organisations and the Scientific Committee for Consumer Safety (SCCS), as well as 
trading partners. 

The consultation questionnaire, as well as a list of stakeholders consulted, is available on the 
Directorate-General  SANCO's  cosmetics  website75.  The  consultation  took  place  between  7 
December  2010  and  11  April  2011.  The  contributions  of  the  stakeholders  to  the  targeted 
stakeholder  consultation  have  been  equally  published  on  the  same  Directorate-General 
SANCO's cosmetics website. None of the respondents claimed confidentiality.  

The main purpose of this second consultation was to obtain information and data allowing the 
analysis of the impacts of the 2013 deadline in the absence of alternatives.  

The  Commission  services  received  14  answers  from  Member  States  (Austria,  Belgium, 
Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Slovakia, 
Spain  and  Sweden)  plus  an  answer  from  Norway;  4  industry  association  replies  (Colipa, 
EDfCI,  UEAPME  and  UNITIS);  5  replies  from  animal  welfare  associations  (Eurogroup  for 
Animals, ECEAE, Four Paws, Animal Defenders and PETA); a reply on behalf of the SCCS 
and a reply from the Chinese SFDA. 

Some  stakeholders,  in  particular  Colipa,  EFfCI  and  ECEAE,  each  collected  data  from  their 
members for a consolidated submission of their respective organisation to the consultation.  

2. General Findings  

The consultation resulted in diverging views in relation to the possible impacts of the entry 
into  force  of  the  2013  marketing  ban  and  the  best  way  forward.  Industry,  several  Member 
States  (Denmark,  Italy,  France,  Greece  and  the  Czech  Republic)  and  the  SCCS  expected 
significant negative impacts on availability of cosmetic products, the competitiveness of the 
cosmetics  industry  and  on  employment,  and  considered  a  prolongation  of  the  deadline  the 
most  logical  way  forward.  Animal  welfare  organisations and some Member States (Austria, 
Sweden and the Netherlands) by contrast were clearly opposed to any proposal in relation to 
the deadline. Other stakeholders mainly described the expected impacts without taking a clear 
position. In particular industry stakeholders underlined to which extent the impacts depend on 
the interpretation of the existing provisions.  

3. Comments and information supplied on specific items of the Questionnaire  

74 

75 

See:  http://ec.europa.eu/consumers/sectors/cosmetics/documents/public_consultation/index_en.htm  All 
Internet links provided in the footnotes of this report were last accessed on 24 August 2012 
See:http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal 
testing/stakeholders_consultation_en.htm 

EN 

49 

   EN 

 
                                                 
The questionnaire was organised according to seven groups of questions.  

1) Existing Data on the Cosmetics market and the industry 

Industry  respondents  provided  additional  data  on  the  cosmetics  market  to  complement 
existing data from earlier impact assessments.  

2) Impacts on Animal Welfare/Environmental Impacts 

Respondents provided information on the number of animals affected (in and outside the EU), 
the needs in relation to testing data as well as the impacts on research and the incentive role 
the provisions play.  

Information  on  number  of  animals  affected  was  received  predominantly  from  industry  and 
animal  welfare  group  respondents.  The  answers  highlighted  that  the  testing  in  question  is 
testing  outside  the  EU  (testing  ban  already  in  place  in  EU  since  2009  and  much  earlier  in 
some Member States) and thus not covered by existing reporting requirements in the EU on 
animal  use.  Animal  welfare  groups  and  industry  provided  different  elements  to  allow  a 
quantification  of  the  possible  number  of  animals  concerned.  These  included  information  on 
the number of tests carried out by cosmetic companies, estimates based on extrapolations of 
the number of animals that were used in the EU for cosmetic testing in the past, testing and 
animal  numbers  normally  necessary  for  the  safety  assessment  of  an  ingredient  and  on  the 
number of animals used in tests submitted to the SCCS.  

In relation to research into alternatives, several respondents provided information on funding 
of  such  research,  either  through  Member  States,  industry  or  other.  There  was  overall 
agreement  between  all  respondents  that  the  provisions  in  the  Cosmetics  Directive  had  an 
important incentive function. Respondents had however split views on what will be the better 
incentive  for  research  going  ahead.  Industry  respondents  maintained  that  the  deadline  will 
negatively  impact  the  available  funding  for  research  and  may  even  lead  to  a  relocation  of 
research  into  alternatives,  while  several  Member  States  and  the  animal  welfare  respondents 
considered the deadline to be the best incentive for research into alternatives. 

3) Impacts on Consumers 

Respondents  provided  information  on  impacts  on  consumer  safety  and  product  availability. 
The  clear  majority  of  respondents  underlined  that  there  would  be  no  impacts  on  consumer 
safety since ingredients for which no sufficient data is available would not be allowed to be 
placed  on  the  market.  Some  Member  States  pointed  nevertheless  to  difficulties  in  market 
surveillance.  

The  clear  majority  of  respondents  considered  that  animal  data  on  the  endpoints  in  question 
will  be  necessary  for  the  safety  assessment  of  cosmetics.  The  highest  data  needs  identified 
were  skin  sensitisation,  second  repeated  dose,  reproductive  toxicity  and  toxicokinetics.  In 
particular industry respondents provided data on the testing carried out over the last 10 years 
to  substantiate  the  main  data  needs.  In  relation  to  data  used  from  other  sectors  many 
respondents – and particularly the industry – confirmed that data from the food sector, from 
cosmetics testing for outside EU regulatory requirements, from REACH/CLP, from biocidal 
products and from pharmaceuticals field were important.  

Respondents from Member States underlined that data will in the future not only be needed 
for new ingredients, but that also existing ingredients are likely to come under review. Often 
mentioned substances expected as future candidates for assessment were: colorants also used 
in  food  (this  is  expected  to  mainly  impact  decorative  cosmetics),  nanomaterials,  endocrine 
disrupters,  sun  protection  products  in  general,  and  skin  care  in  particular  in  relation  to 
preservatives.  

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While  in  particular  animal  welfare  stakeholders  considered  that  the  actual  impact  on 
availability of ingredients and thus cosmetics products would be negligible or should in any 
case  be  accepted  because  of  an  overriding  ethical  interest,  industry  and  other  stakeholders 
considered  that  there  are  likely  to  be  considerable  impacts.  Industry,  as  well  as  one  animal 
welfare  respondent,  provided  detailed  information  on  ingredient  and  product  portfolio  size 
and changes to allow quantification of the possible impacts.  

4) Impacts on Competitiveness of Cosmetic and Cosmetic Ingredients Manufacturers  

In particular industry respondents, but also some Member States, voiced clear concerns that 
the deadline will lead to a loss in competitiveness of the cosmetics and cosmetics ingredients 
industry. While industry provided data on the expected impacts, any quantification remained 
approximative and based on forward looking expectations.  

5) Impacts on Small and Medium sized Enterprises (SMEs) 

Overall respondents underlined the high percentage of SMEs in the cosmetics sector and their 
importance in terms of employment. Some Member State and industry responses highlighted 
that SMEs sometimes may not be sufficiently aware of the possible impacts, but are in reality 
likely to be hit harder than large companies. SMEs typically rely on less ingredients and less 
products,  and  may  have  more  difficulties  to  offset  loss  of  ingredients.  On  the  other  hand  it 
was also pointed out that SMEs often use the animal testing free label.  

6) Impacts on Employment 

Industry  and  some  Member  States  provided  information  on  the  current  employment  in  the 
cosmetics  industry.  Industry  respondents  expressed  the  fear  of  relocation  of  research  and 
development, which may also lead to a loss of employment in production and marketing. 

7) Impacts on Trade  

In particular industry respondents underlined the role of trade for the cosmetics industry and 
its  current  global  role.  They  considered  that  the  deadline  may  lead  to  reduced  imports  and 
exports.  

4. Follow-up contacts in relation to derogation  

The consultation on impacts was followed-up and further detailed in relation to a derogation 
option  through  bilateral  consultation  with  targeted  stakeholders  and  through  a  detailed 
presentation in relation to this option in the Cosmetics Committee and Working Group on 9 
November 2011 and on 23 March 2012. 

Animal welfare stakeholders reiterated in this context their position to maintain the deadline 
as is, without any derogation. Some industry and Member State stakeholders saw the benefits 
of a derogation approach as offering a possible balanced approach, but questioned the criteria 
to be applied, the practicalities of granting the derogation and the possible timeframes.  

* 

* 

* 

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ANNEX 2: NUMBERS OF ANIMALS USED FOR TOXICOLOGICAL TESTING  

1) Cosmetic Specific Animal Testing Data EU:  

Year 

2009 

2008 

2007 

2006 

2005 

2004 

2003 

2002 

2001 

2000 

1999 

Cosmetics 
Reports 

Commission 

344 

1510 

1818 

1329 

2276 

8988 

1618 

2153 

2592 

3138 

3630 

29396 

Estimated 
total 
1999-2008 

Reports 

Source: 
(http://ec.europa.eu/consumers/sectors/cosmetics/documents/animal-
testing/index_en.htm)  

published 

SANCO 

on 

as 

website 

2) EU Animal Numbers for the endpoints covered by 2013 deadline not cosmetic specific 
2008: 

2008 – overall per testing area 

Skin sensitisation 

Carcinogenicity 

38437 

20807 

Sub-chronic  and  chronic 
toxicity testing 

103005 

Developmental 
reproductive toxicity  

and 

31286 

63815 

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Total  

257350 

Source:  6th  Statistical  report,  compiled  by  Eurogroup  and  submitted  to 
the Targeted Stakeholder Consultation  

3) Estimated animal numbers per endpoint:  

Endpoints  

Animals per Test  

Assumes  that  underlined  protocols 
are followed  

Skin corrosion  

Skin irritation  

1  

2  

OECD 404  

OECD 404  

Skin absorption/penetration  

4  

OECD 427 (4 – 16)  

UV-induced  toxic  effects  – 
photogenotoxicity  

25  

UV-induced  toxic  effects  - 
acute phototoxicity  

10  

Eye irritation  

Acute toxicity  

3  

10  

OECD 474 : micronucleus –N=25  

Rarely done – nowadays in vitro 3T3 
NRU  

Acute test only  

See also Photosensitization  

OECD 405  

OECD 420: 5 to 20  

OECD 423: 6 to 12  

OECD  425:  5/doses  -  nb of doses:  1 
to 5  

Skin sensitisation  

20  

LLNA OECD 429: 20  

Sub-acute  and  sub-chronic 
toxicity  

80  

Genotoxicity 
Mutagenicity  

and 

25  

UV-induced 
photo-allergy  

toxic  effects, 

30  

Toxicokinetics 
metabolism  

and 

12  

Carcinogenicity  

240  

OECD 406: 32  

OECD 407: 40  

OECD 408: 80  

OECD  474  (Micronucleus):  5/group, 
3 dose levels, 2 controls = 25  

OECD 486 (UDS): 3/group, 2-3 dose 
levels, 2 controls = 12 to 15  

OECD  478  (lethal  dominant  test): 
test rarely performed but at least 240 
animals  

Photosensitization : see above  

OECD 417 (4 per dose/ 1 pilot plus 2 
doses = 12)  

OECD  452:  160  and 
sacrifice 80 additional  

if 

interim 

OECD 453: at least 400  

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Reproductive 
developmental toxicity  

and 

100  

Inhalation 
toxicity/allergy/sensitisation  

40  

OECD 414: 80 to 100  

OECD 416: 120  

OECD  412::Sub-acute 
Toxicity: 28-Day Study: 40  

Inhalation 

OECD  413:  Sub-chronic  Inhalation 
Toxicity: 90-day Study: 80  

Source: compiled by Colipa, based on OECD Guidelines and submitted 
to the Targeted Stakeholder Consultation  

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ANNEX 3: THE NEED FOR TOXICOLOGICAL DATA FOR THE COSMETICS SAFETY 
ASSESSMENT  

Whether or not ingredients can be used in cosmetic products depends on whether their safety 
can be demonstrated. Essentially toxicological data needs arise in two scenarios:  

The  first  is  the  manufacturer's  safety  assessment  of  cosmetic  products  he  places  on  the 
market. This assessment is based on the safety of the ingredients. In line with Annex I of the 
Cosmetics  Regulation  the  cosmetics  safety  report  must  contain  the  toxicological  profile  of 
each substance contained in the cosmetics product for all relevant toxicological endpoints. A 
particular focus is on local toxicity evaluation (skin and eye irritation), skin sensitisation, and 
in the case of UV absorption photo-induced toxicity. All significant routes of absorption must 
be  considered  as  well  as  the  systemic  effects  and  margins  of  safety  (MoS)  based  on  a  no 
observed adverse effects level (NOAEL) must be calculated.  

The highest data need for the cosmetic manufacturers exists for skin sensitisation tests, second 
for  repeated  dose,  third  for  reproductive  toxicity  and  then  for  toxicokinetics  and 
carcinogenicity. Skin sensitisation, i.e. allergic reactions to certain cosmetic ingredients plays 
an important role from a consumer safety point of view. An estimated 60% of all undesirable 
effects are cases of allergic reactions.76 Sensitisation is a significant pathology which affects 
the quality of life of consumers for the rest of their lives. Colipa data shows that over the last 
ten years large companies carried out on average 213 animal tests for the 2013 endpoints per 
year,  out  of  which  151  addressed  skin  sensitisation  and  36  repeated  dose,  thus  these  two 
endpoints  represent  87%  of  all  testing.  EFfCI  confirmed  the  order  of  importance  of  the 
different  tests.  SMEs  participating  in  the  Colipa  response  carried  out  on  average  7  tests  per 
year over the last 10 years and tested only on skin sensitisation.  

The second scenario is ingredients that are reviewed by  the SCCS,  either  with a view to be 
added to one of the positive lists or to be prohibited or restricted in use. It can not be assumed 
that all ingredients in use now will remain available to the cosmetics industry after 2013. A 
number of Member States pointed out that many ingredients in use now are not supported by 
sufficient  toxicological  data.  Often  mentioned  substances  expected  as  future  candidates  for 
assessment  were:  colorants  also  used  in  food  (this  is  expected  to  mainly  impact  decorative 
cosmetics), nanomaterials, endocrine disrupters, sun protection products in general, and skin 
care  in  particular  in  relation  to  preservatives.  Preservatives  in  particular  could  become  a 
sensitive area as a number of substances in this field are under review (such as parabens) and 
the list of available preservatives is likely to reduce.  

Example Hair Dyes:  

In Europe more than 60% of women and 5-10% of men colour their hair with a mean frequency of use 
by 6-8 times per year. The average age of majority of hair colour users is 30-60 years. 

The hair dye market in the EU was EUR 2.6 billion in 2004, i.e. some 8% of the value of output of the 
cosmetics industry in Europe. 

In  the  context  of  the  Commission  decision  to  review  the  safety  of  hair  dyes  used  in  the  EU,  45 
commonly  used  hair  dyes  which  represented  around  95%  of  what  is  used  in  the  EU  had  to  be 
reassessed with “2013 tests”. 

76 

On the basis of undesirable effects notified in France to the responsible market surveillance authority in 
2005 

EN 

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According  to  the  SCCS  Notes  of  Guidance77  if  a  substance  is  submitted  to  the  SCCS  the 
minimum data set that needs to be provided includes two endpoints that fall under the 2013 
deadline: skin sensitisation and repeated dose toxicity. 

When  considerable  oral  intake  is  expected  or  when  the  data  on  dermal/percutaneous 
absorption indicates a considerable penetration of the ingredients through the skin (taking into 
account  the  toxicological  profile  of  the  substance  and  its  chemical  structure),  data  on 
carcinogenicity, reproductive toxicity and toxicokinetics becomes necessary. A review of data 
submitted to the SCCS between 2000 and 2009 shows that of 220 substances reviewed 154 
had data intended to determine a full toxicological profile. All but 5 had repeated dose data 
and 137 had data on reproductive toxicity78. 

For  all  of  these  endpoints  a  full  replacement  of  animal  tests  is  not  yet  possible.  For  skin 
sensitisation  alternatives  are  however  expected  to  be  scientifically  available  by  2017-2019; 
validation and regulatory acceptance is expected to take another 3 to 6 years.  

Example: When the negative effects of UV-A became more known companies developed over 
the last 10 to 15 years several new UV-A filters. The approval of these filters to be added to 
the Annexes of the Cosmetics Directive was also based on animal testing data.  

However, this  does  not automatically mean that all new ingredients would be  blocked from 
the  market  or  that  no  existing  ingredients  could  be  defended.  Data  may  be  already  existing 
and it may be possible to rely on such old data. Data may also be available form other sectors. 
To some extent the existing derogation for Member States could be used in case data needs 
arise. Finally data may not always be needed and other tools may be able to be used for the 
assessment. Data on carcinogenicity, reproductive toxicity and toxicokinetics is as explained 
above  not  always  required.  The  Cosmetics  Regulation  also  supports  the  use  of  a  weight-of-
evidence approach and allows in duly substantiated and justified cases a read-across. Also, the 
scientific  committees  jointly  adopted  guidance  in  relation  to  the  use  in  certain  cases  the 
Threshold of Toxicological Concern (TTC)79. 

In a number of cases it will therefore be possible to carry out a safety assessment in line with 
the  legal  requirements  even  in  the  absence  of  toxicological  animal  data.  Since  the  safety 
assessment is a case-by-case evaluation it is difficult to assess in how many cases such other 
approaches will be sufficient. A recent review under REACH80 showed that read-across and 
weight  of  evidence  was  used  quite  extensively  in  the  absence  of  animal  data.  For  repeated 
dose toxicity 28.1% of the dossiers relied on read-across and 6.6% on weight of evidence. For 
skin  sensitisation  20.8%  relied  on  read-across  and  13.7%  on  weight-of-evidence.  These 
figures  are  however  considered  to  be  high  and  it  is  likely  that  in  a  number  of  these  cases 
additional data will need to be requested. Also, these figures all related to existing substances 
for which data allowing read-across was available. 

77 

78 

79 

80 

The SCCS's Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 7th 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_s_004.pdf 
Safety  Assessment  of  Cosmetics  in  Europe.  Rogiers  V  and  Pauwels  M  (Eds),  Current  Problems  in 
Dermatology Vol. 37 (2008). S. Karger, Basel, CH, ISBN 978-3-8055-8655-9 
The TTC concept aims to establish a human exposure threshold value below which there is a very low 
probability of an appreciable risk to human health, applicable to chemicals for which toxicological data 
are  not  available  and  based  on  chemical  structure  and  toxicity  data  of  structurally  related  chemicals. 
Opinion  SCCP/1171  on  the  Use  of  the  Threshold  of  Toxicological  Concern  (TTC)  Approach  for 
Human Safety Assessment of Chemical Substances with focus on Cosmetics and Consumer Products, 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_092.pdf 
'The use of alternatives to testing on animals for the REACH Regulation 2011', ECHA-11-R-004.2-EN 

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ANNEX 4: TESTING DATA SOURCES  

The  data  used  so  far  for  the  cosmetics  safety  assessment  is  in  most  cases  not  generated 
specifically for this purpose. In about 90% of the cases cosmetic ingredients are used in other 
areas as well. The testing data required for cosmetics testing is general testing data following 
OECD guidelines that is equally used for other purposes.  

However,  this  does  not  mean  that  in  all  these  cases  no  additional  data  would  be  needed 
specifically with a view to the cosmetics use. To which extent existing data from other sectors 
is sufficient and to which extent cosmetic specific data is needed is a case-by-case question 
that depends on a number of factors (which data is already available, is it an SCCS assessment 
or not, etc.). While there is no clear data allowing to say exactly in how many cases existing 
data is sufficient, estimates can be made based on the information supplied below.  

Colipa informed that in about 50% of the cases in which a substance was under SCCS review 
and supported by Colipa additional information including animal testing had to be provided to 
the SCCS. Colipa itself supported since 2004 7 dossiers for new UV filters and preservatives 
and  defended  58  ingredients  which  were  assessed  by  the  SCCS,  this  corresponds  to  20 
dossiers for which animal data had to be generated (skin allergy, reproductive toxicity, sub-
chronic studies, toxicokinetics and carcinogenicity).  

Example: In the case of the hair dye strategy, industry submitted 203 animal studies, out of 
which 101 had to be specifically generated.  

33% of Colipa companies responding informed that in 2010 they undertook animal testing to 
provide information to the SCCS, in earlier years on average 56% of the companies undertook 
such specific animal tests.  

This data does not allow a clear quantitative determination in how many cases additional data 
may be needed. From this it would nevertheless roughly appear that in relation to substances 
under  SCCS  assessment  in  50  to  70%  of  the  cases  sufficient  data  from  other  sources  is 
available.  The  SCCS  review  is  a  very  in  depth  and  general  evaluation  of  the  safety  of  the 
ingredients and it is likely that more in depth data is needed than for the manufacturer safety 
assessment. Only 10 % of the new substances fall under SCCS review.  

In  many  cases  testing  data  is  provided  by  the  ingredient  supplier.  Testing  data  may  also  be 
available in publications, in databanks, etc. Often the original reason for the testing will not be 
obvious from the testing data itself.  

According  to  the  Colipa  information,  large  companies  considered  testing  data  from  food, 
cosmetic  products  outside  the  EU  and  REACH  as  most  important  to  them.  This  does  not 
necessarily  reflect  that  this  data  is  available  in  most  cases,  as  the  question  was  only  how 
important it is considered to be, not in how many cases it was available. However, while there 
remains uncertainty, it is likely that the importance given also reflects the availability to some 
extent. The difference with the views expressed by SMEs is notably that they consider third 
country data less important and give more importance to REACH. SMEs are less likely to act 
internationally  and  will  therefore  in  fewer  cases  have  access  to  data  generated  for  third 
countries.  

Importance of Different Sources of Animal Test Data to Large Companies (Past 5 Years)  

Animal test data source   Number of companies  

Not important 

Moderately important   Very important  

EN 

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Pharmaceuticals 

Medicinal of veterinary 
products  

Biocidal products  

Food Products  

Cosmetic products 
outside the EU  

REACH or CLP  

Other  

6  

8  

5  

1  

2  

4  

3  

4  

2  

7  

5  

7  

5  

1  

7  

6  

4  

11  

8  

8  

4  

Source: Colipa submission to the Targeted Stakeholder Consultation 

A similar evaluation of important data sources was provided by EFfCI.  

Generally nearly all comments received on the question of the key data sources and on how 
they are likely to develop in the future indicate a higher availability of toxicological testing 
data as a result of REACH requirements. However, it was also pointed out that, although for 
substances above 100 tons/year data will be available in June 2013, for substances between 1 
to 100 tons/year data may only be available as of 1 June 2018 and may thus not be available 
for the first 5 years of the full ban.  

Example: Existing cosmetic ingredients may need to undergo animal testing under REACH. A 
recent  example  of  a  substance  widely  used  in  cosmetics  that  underwent  testing  is  calcium 
carbonate (used in toothpaste).  

So  far  a  total  of  1849  animal  tests  were  conducted  since  2009  for  REACH  registration 
purposes  and  711  testing  proposals  were  submitted  to  ECHA,  the  clear  majority  of  them 
relating to repeated dose and reproductive toxicity testing.  

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ANNEX 5: COSMETIC PRODUCTS AND THEIR LIFE CYCLE  

On  average  large  cosmetic  companies  have  a  product  portfolio  of  around  10  000  different 
cosmetic  products,  SMEs  of  around  160  products  according  to  data  supplied  by  Colipa. 
Companies that participated in the ECEAE survey had for large companies 592 products on 
offer  and  SMEs  40.  The  difference  between  these  figures  is  likely  to  be  due  to  a  higher 
percentage  of  small  and  specialised  companies  providing  data  to  ECEAE  (only  2  large 
companies participated). Overall it is estimated that there are between 100 000 and 300 000 
different cosmetic products on the market, but there is no reliable data on European level so 
far81.  Sweden  provided  the  information  that  there  were  35  000  products  in  total  notified  in 
Sweden in 2009 and 8700 new products were notified to be placed on the market in Sweden 
in 2009. In Portugal about 23 000 new notifications for new cosmetics products are received 
per year.  

Industry  stakeholders  indicate  the  product  life  of  a  cosmetic  product  at  3  years.  There  is  an 
estimated 25% - 30% renewal of cosmetic products on market per year.  

The development cycle of a new product is described by UEAPME to be between 9 months to 
1  year,  however  for  very  innovative  products  it  may  take  up  to  5  years.  While  this  pace  of 
innovation holds true for many, some manufacturers re-formulated a much higher percentage 
of  their  products  per  year,  up  to  90%.  Large  companies  participating  in  the  ECEAE  survey 
added  5  products  per  year,  representing  6%  of  the  market  value  of  their  overall  products, 
SMEs added 4 products, representing 22% of the market value of their overall products.  

Out  of  the  25%  to  30%  of  reformulations,  90%  rely  on  ingredients  already  used  in  the 
cosmetics sector, 10% depend on new to market or new to cosmetics market ingredients.  

Overview Cosmetic Products  

Product portfolio per 
manufacturer:  

Colipa 10 000 (SME 160) 

ECEAE 592 (SME 40) 

Total products: 

Estimated between 100 000 and 300 000 

Products reformulated: 

25-30% per year 

Reformulation depending on new 
to market and new to cosmetics 
market ingredients:  

10% (of the 25-30%) = 2.5% to 3% 

Source: Colipa, ECEAE and UEAPME submission to Targeted Stakeholder Consultation  

81 

This will change with the full implementation of the Cosmetic Products Notification Portal (CPNP) by 
July 2013 

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ANNEX 6: OVERVIEW OF COSMETIC INGREDIENTS PORTFOLIO AND CHANGES 

Cosmetic  products  consist  of  between  5  to  60  ingredients  each.  Overall  it  can  be  estimated 
that there are more then 19 000 cosmetic ingredients globally. CosIng lists 19 391 ingredients 
and 2099 substances82. Looking at the INCI  numbers  over the last years approximately 500 
new  International  Nomenclature  of  Cosmetic  Ingredients  (INCI)  names  are  introduced  per 
year.  As  regards  the  positive  lists  in  the  Cosmetics  Directive  they  currently  contain  29  UV 
filters,  58  preservatives  and  153  colorants.  However,  in  reality  the  number  of  ingredients 
actually used by manufacturers is far lower than these numbers would suggest. According to 
data submitted by Colipa in the stakeholder consultation, large cosmetics companies have an 
ingredient  portfolio  of  2000  ingredients  and  SMEs  of  600  ingredients.  This  makes  up  the 
toolbox companies use for product formulation.  

According  to  Colipa  data,  large  companies  introduced  around  80  new  ingredients  per  year 
between 2000 and 2009 (SMEs 22), representing around 4% of their ingredient portfolio. This 
represents the key innovation pool for industry. In 2010, 60 new ingredients were introduced 
by the participating large companies (SMEs 26). Less than 10% of these new ingredients are 
covered by the Annexes of the Cosmetics Directive.  

However, the number of new ingredients introduced varies considerably between companies. 
The  range  given  by  large  companies  was  between  0  and  734.  While  some  cosmetic 
manufacturers may have more 'conservative' product lines or may innovate and/or grow more 
based  on  marketing  strategies,  others  very  much  depend  on  innovative  ingredients  and 
products.  

According to data supplied by ECEAE in the stakeholder consultation, large companies have 
a portfolio of 11500 ingredients83, small companies have a portfolio of 151 ingredients. Large 
companies participating in the ECEAE survey added 15 ingredients per year, SMEs added 9 
to their portfolio.  

From this data it is not possible to deduce a total number of new ingredients introduced per 
year  for  the  entire  industry  (the  numbers  above  relate  to  manufacturers),  as  each  ingredient 
can  and  will  be  used  by  several  companies  and  in  a  variety  of  products.  Proprietary 
ingredients  developed  by  cosmetic  companies  themselves  would  typically  be  used  first 
exclusively and then be provided to the wider market under license. 

However,  data  from  EfFCI  gives  a  minimum  indication  of  total  numbers;  it  estimates  that 
from  the  ingredient  manufacturer  side  in  last  10  years  around  1100  new  substances  –  thus 
about  100  per  year  -  were  supplied  by  large  companies  to  the  cosmetics  market,  including 
substances used already in other sectors. A large supplier is estimated to introduce on average 
5 new ingredients per year. In addition SME´s introduce 2 to 3 new ingredients per year. In 
particular  for  botanical  natural  complex  substances  the  European  Organization  of  Cosmetic 
Ingredients Industries and Services (Unitis) informed that each company produced since 2000 
each  year  several  new  ingredients  from  known  or  new  plants.  Hundreds  of  new  botanical 
natural complex substances were made available to the cosmetics industry. These substances 
are in particular in demand as there is a strong consumer demand for more natural cosmetics. 
Ingredients are mostly sourced from ingredient suppliers. However 60% of large companies 
produce at least some ingredients themselves - according to Colipa data between 1 and 5 new 

82 

83 

See:  http://ec.europa.eu/consumers/cosmetics/cosing/  ,  Substances  are  those  that  are  regulated  under 
one of the Annexes of the Cosmetics Directive, ingredients are not. 
Note: this figure is not coherent with overall information available and may be based on a mistake 

EN 

60 

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ingredients  a  year  per  company.  Taken  together,  this  would  indicate  that  at  a  minimum 
approximately 150 new ingredients are introduced per year.  

On  the  other  hand,  up  to  500  new  INCI  codes  are  introduced  per  year.  This  represents  the 
maximum  of  new  ingredients  per  year.  It  is  however  likely  to  be  a  very  high  estimate  and 
most stakeholders considered that the actual number of new cosmetics ingredients in the EU 
is  lower  than  that.  The  reasons  were  that  INCI  is  not  exclusive  to  cosmetics,  covers 
ingredients worldwide and also mixtures.  

To  illustrate  the  link  between  ingredients  and  products,  below  the  example  of  a  frame 
formulation  for  a  sunscreen  cream  is  provided  and  an  example  of  a  formulation.  Frame 
Formulations  detail  the  type  of  ingredients  and  their  maximum  concentration  for  most 
cosmetic  products  on  the  European  market.  They  are  used  to  provide  information  to  poison 
centres and are included in the new Cosmetic Products Notification Portal (CPNP).  

EXAMPLE SUNSCREEN CREAM: 

Frame formulation Number: 

9.1 - 2011 
SUNSCREEN CREAM, LOTION 

Ingredients  Maximum 

levels (% w/w) 

Oils (e.g. vegetable and/or mineral), waxes and fats  

(e.g. long chain alcohols) 

UV filters 

Silicones including volatile silicones (e.g. cyclopentasiloxane, dimethicone) 

Humectants (e.g. glycerin, propylene glycol) 

Ethanol (alcohol, alcohol denat.) 

Emulsifying agents (e.g. glyceryl stearate, PEG-100 stearate) 

Bulking agents (e.g. talc, silica, nylon powder) 

Additional ingredients (e.g. bisabolol, vitamins) 

Film forming polymers (e.g. PVP) 

Thickeners (e.g. carbomer, xanthan gum) 

Parfum 

Preservatives, antimicrobials 

Colorants 

Aqua 

ACTUAL PRODUCT EXAMPLE: 

70 

40 

30 

30 

25 

10 

10 

6 

5 

5 

3 

2 

2 

to 100 

Ingredient (from example) 

Use (according to COSING) 

Aqua 

Solvent 

C12 C15 Alkyl benzoate 

Antimicrobial, Emollient, Skin conditioning 

Glycerin 

Denaturant,  Humectant,  Masking,  Perfuming,

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Skin protecting, Viscosity controlling 

Ethylhexyl salicylate 

UV absorber, UV filter 

Titanium dioxide 

Opacifying, UV absorber, UV filter 

Butyl methoxydibenzoylmethane 

UV absorber, UV filter 

Bis-ethylhexyloxyphénol 
triazine 

Alcohol Denat 

Pentylène glycol 

Octocrylene 

Methoxyphenyl 

Skin conditioning, UV absorber, UV filter 

Antiforming, 
Masking, Solvent, Viscosity controlling 

Antimicrobial, 

Astringent, 

Skin conditioning, Solvent 

UV absorber, UV filter 

Cyclopentasiloxane 

Emollient, Skin conditioning, Solvent 

Stearic acid 

Cleansing,  Emulsifying,  Emulsion  stabilising,
Masking, Refatting, Surfactant 

Potassium cetyl phosphate 

Surfactant 

Dimethicone 

Surfactant,  Antifoaming,  Emollient,  Skin 
conditioning, Skin protecting 

Methyl methacrylate crosspolymer 

Film forming 

Myristyl myristate 

Emollient, Opacifying, Skin conditioning 

Nylon-12 

Petrolatum 

Ethylhexyl triazone 

Aluminium hydroxide 

Bulking, Opacifying, Viscosity controlling 

Antistatic,Emollient 

UV absorber, UV filter 

Cosmetic  colorant,  Emollient,  Humectant, 
Opacifying, 
Protecting,  Viscosity 
controlling 

Skin 

Ammonium Polyacryloyldilmetyl taurate 

Emulsion stabilising,Viscosity controlling 

Caprylyl glycol 

Emollient,Humectant,Skin conditioning 

Cassia alata leaf extract 

Astringent 

CI 77491 (IUPAC Name: iron oxides) 

Cosmetic colorant 

CI 77492 

Cosmetic colorant 

CI 77891 (INN Name: Titanium Dioxide) 

Cosmetic colorant 

Disodium edta 

Chelating, Viscosity controlling 

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Drometrizole trisiloxane 

UV absorber, UV filter 

Glyceryl stearate 

Emollient, Emulsifying 

Hydroxylpropyl methylcellulose 

Maltodextrin 

PEG 100 Stearate 

Phenoxyethanol 

Stearyl alcohol 

Antistatic,  Binding,  Emulsion 
stabilising,
Film forming, Surfactant, Viscosity controlling 

Absorbent,  Binding,  Emulsion 
Film forming, Skin conditioning 

stabilising,

Surfactant 

Preservative 

Emollient,  Emulsifying,  Emulsion  stabilising,
Foam 
boosting,  Masking,  Opacifying,
Refatting, Surfactant, Viscosity controlling 

Terephthalylidene dicamphor sulfonic acid 

UV Absorber, UV Filter 

Tocopherol 

Triethanolamine 

Antioxidant, Masking, Skin conditioning 

Buffering, Emulsifying, Masking, Surfactant 

Only  10%  of  the  ingredients  introduced  into  the  portfolio  are  estimated  to  be  new  to  the 
market. 90% are/have been used in other sectors, including cosmetic products outside the EU, 
food, pharmaceuticals, detergents and are covered by REACH.  

Ingredients  do  not  all  have  the  same  importance  and  value.  While  no  data  was  provided  by 
stakeholders  on  actual  individual  ingredient  value,  it  is  clear  that  some  ingredients,  such  as 
preservatives, are used in a large portion of cosmetic products, have a key functionality and 
are  therefore  much  more  difficult  to  replace.  Equally,  new  ingredients  with  a  specific  and 
innovative  function,  eg.  in  anti-ageing  products,  may  produce  a  much  higher  industry  value 
than a new colorant.  

Ingredients are added to and taken out the portfolio for various reasons. In 2010 according to 
Colipa data more ingredients were taken out of the portfolio then added to it. On average large 
companies removed 120 ingredients from their portfolio in 2010 and SMEs removed 10. The 
main  reasons  for  removing  ingredients  were  regulatory  constraints,  followed  by  safety 
considerations, poor performance and/or quality. The reason to introduce new ingredients is in 
over  50%  of  the  cases  better  performance  and  quality,  including  better  tolerance  (e.g.  anti-
ageing properties, more natural, biological/organic, new categories (sprays), better tolerance). 
However, environmental  reasons were also considered important. In an effort towards more 
sustainability  the  cosmetics  industry  replaces  e.g.  more  and  more  silicon,  mineral  oils  and 
synthetic  alcohol.  Very  often  a  new  ingredient  will  lead  to  a  better  performance  eg.  better 
consistency, innovation is therefore often rather incremental. 

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Source: Colipa Submission to Targeted Stakeholder Consultation 

Examples of innovation:  

- A superior skin moisturisation ingredient has been introduced by company A. Four different 
formulations  were  launched  in  the  EU  using  technology  based  on  this  ingredient  and  this 
resulted in significant growth for the brand.  

- Development of ingredients to obtain odourless self-tanning.  

-  A  natural  ingredient  to  formulate  silicone-free  products  (highly  soluble,  absorbs  oil  at 
higher levels, enhancing its emulsifying effect). It contains an extremely low microbial count 
reducing the need for preservatives, is low cost and has enhanced anti-irritant properties. 

- A large part of the patent activity in the cosmetics industry appears to be in the field of 
peptides. Peptides stimulate skin regeneration, but in order to be effective, a high 
concentration of peptides is needed, without causing any irritation to the skin. Peptides are 
already in use, so here innovation would mainly mean enhancements.  

Overview Ingredients  

Ingredients portfolio per manufacturer:  

Colipa 2000 (SME 600), ECEAE 11 500 (SME 151) 

Ingredients added per year per manufacturer: 

Colipa 70 (SME 22) = 4%, ECEAE 15 (SME 9) 

New to market ingredients: 

Out of these 4% added ingredients only 10% new to market = 
90% used in other sectors, thus new only to cosmetics market 

Total ingredients added per year: 

Overall at least 100 (EfFCI) 

Ingredients removed:  

Removed: Between 2000 and 2009 Colipa 24 (SME 6), but in 
2010 120 (SME 10)  

Source:  Colipa,  EfFCI  and  ECEAE  submissions  to  the  Targeted 
Stakeholder Consultation 

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ANNEX 7: GLOSSARY 

Alternative methods: 

Methods that provide the same or higher levels of information as those obtained in procedures 
using  animals,  but  which  do  not  involve  the  use  of  animals  or  use  fewer  animals  or  which 
entail less painful procedures. In the context of the Cosmetics Directive only methods that do 
not involve the use of animals are relevant (not reduction and refinement).  

Carcinogenicity:  

A specific endpoint on repeated dose toxicity is carcinogenicity. Carcinogenesis is a complex 
long-term  multi-factorial  process,  and  consists  of  a  sequence  of  stages.  Carcinogens  have 
conventionally been divided into two categories according to their presumed mode of action: 
genotoxic carcinogens that affect the integrity of the genome by interacting with DNA and/or 
the  cellular  apparatus,  and  non-genotoxic  carcinogens  that  exert  their  carcinogenic  effects 
through other mechanisms. 

Cosmetic ingredients: 

‘ingredients’  means  any  chemical  substance  or  preparation  of  synthetic  or  natural  origin, 
including perfume and aromatic compositions used in composition of cosmetic products (see 
Commission  Recommendation  Establishing  guidelines  on  the  use  of  claims  referring  to  the 
absence of tests on animals pursuant to Council Directive 76/768/EEC, (2006/406/EC)). 

Cosmetic product: 

‘cosmetic product’ means any substance or mixture intended to be placed in contact with the 
external  parts  of  the  human  body  (epidermis,  hair  system,  nails,  lips  and  external  genital 
organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively 
or  mainly  to  cleaning  them,  perfuming  them,  changing  their  appearance,  protecting  them, 
keeping them in good condition or correcting body odours; (see Article 2, 1 (a) of Regulation 
1223/2009) 

Marketing ban: 

As  from  March  2009,  it  is  prohibited  in  the  EU  to  market  cosmetic  products  and  their 
ingredients  which  have  been  tested  on  animals,  irrespective  of  the  origin  of  these  products. 
This marketing ban applies to all but the most complex human health effects to be tested to 
demonstrate  the  safety  of  cosmetic  products  (repeated-dose  toxicity  including  skin 
sensitisation  and  carcinogenicity,  reproductive  toxicity  and  toxicokinetics),  for  which  the 
legislator  extended  the  deadline  to  March  2013  (see  Article  4a,1  (a)  and  (b)  of  Directive 
76/768/EEC and Article 18 1 (a) and (b) of Regulation 1223/2009).  

New to cosmetics market ingredient: 

A cosmetic ingredient that is new to use in the cosmetics sector, but has been used already in 
other sectors. 

New to market ingredient:  

A cosmetic ingredient that has not been used in other sectors before either, thus is completely 
new. 

Repeated-dose toxicity: 

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Repeated  dose  toxicity  occurs  if  a  persistent  or  progressively  deteriorating  dysfunction  of 
cells,  organs  or  multiple  organ  systems,  results  from  long-term  repeated  exposure  to  a 
chemical.  

Reproductive toxicity: 

Reproductive  toxicity  refers  to  a  wide  variety  of  adverse  effects  that  may  occur  in  different 
phases within the reproductive cycle, as a consequence of one or more exposures to a toxic 
substance, 
implantation, 
embryonic/foetal development, parturition, postnatal adaptation, and subsequent growth and 
development into sexual maturity. 

fertility,  sexual  behaviour,  embryo 

including  effects  on 

Skin sensitisation: 

One  specific  endpoint  to  assess  repeated  dose  toxicity  is  skin  sensitisation.  This  is  the 
toxicological endpoint associated with chemicals that have the intrinsic ability to cause skin 
allergy. 

Toxicokinetics:  

Toxicokinetics  informs  about  the  penetration  into  and  fate  within  the  body  of  a  toxic 
substance, including its absorption, distribution, metabolism (producing less toxic metabolites 
(detoxification) or in some cases more toxic metabolites) and excretion. 

Testing ban:  

A ban of animal testing of finished cosmetic products has been in force since September 2004 
and a testing ban on ingredients or combinations of ingredients since March 2009 (see Article 
4a,1  (c)  and  (d)  of  Directive  76/768/EEC  and  Article  18  1  (c)  and  (d)  of  Regulation 
1223/2009).  

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