COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT ON THE ANIMAL TESTING PROVISIONS IN REGULATIO (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) 67 final 

COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT ON THE ANIMAL 
TESTING PROVISIONS IN REGULATIO (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) 66 final} 

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COMMISSION STAFF WORKING DOCUMENT 

EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT ON THE ANIMAL 
TESTING PROVISIONS IN REGULATIO (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 

INTRODUCTION 
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  in  order  to  meet  the 
requirements of the Directive 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 2013.  

The  assessment  of  the  2013  marketing  ban  deadline  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. These 
provisions  were  not  changed  by  the  recast  of  the  Cosmetics  Directive  by  Regulation 
1223/2009/EC2.  The  Cosmetics  Regulation  repealing  the  Cosmetics  Directive  as  of  11  July 
2013, any proposal would amend the Cosmetics Regulation only.  

The  Commission  has  monitored  the  progress  in  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 concludes that alternatives to animal testing in relation 
to endpoints in question will not yet be available by 2013. It is against this background that 
the  potential  impacts  of  the  possible  policy  options  in  relation  to  the  2013  deadline  are 
assessed.  

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3 

Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to 
cosmetic products, OJ L 262, 27.9.1976, p. 169. 
Regulation (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 
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 

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1. 

PROBLEM DEFINITION  

Efforts  to  completely  end  animal  use  for  cosmetic  purposes  go  back  a  long  time.  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 a foreseen application by 1998, and then 
postponed  three  times  because  alternative  methods  were  not  yet  available.  The  current 
provisions were introduced in 2003.  

Virtually every European citizen uses a multitude of cosmetic products every day, from soap, 
shampoo,  conditioner,  deodorant,  toothpaste,  shaving  cream,  aftershave,  cleanser,  perfume, 
make-up to a whole range of other products. The objective of the Cosmetics legislation is on 
the one hand to ensure that consumer health is not put at risk by their use and on the other 
hand  to  ensure  that  these  products  can  circulate  freely  in  the  Union.  To  this  end  the 
responsible person 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  human  health 
endpoints need to be addressed in this assessment, such as whether the ingredient can cause 
allergies or damages health as a result of its repeated use.  

Some of the questions that must be addressed in the safety assessment can currently only be 
answered by relying on toxicological data obtained from animal testing. Alternative methods 
to replace these tests will according to the Commission findings not be available by 2013. The 
problem is therefore in a nutshell that the marketing ban would apply as of 11 March 2013 in 
the  absence  of  full  alternative  methods.  Under  the  Cosmetics  legislation  only  cosmetic 
products that are safe for human use can be placed on the market. As a result, ingredients with 
insufficient data packages and for which the safety is not established shall not be allowed to 
be  placed  on  the  market,  leading  to  a  reduced  access  to  new  ingredients  and  ultimately 
innovative products.  

1.1. 

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 
internal  market.  The  Cosmetics 
functioning  of 
Directive/Regulation exhaustively harmonises rules on consumer safety of cosmetic products 
placed  on  the  Community  market.  Thus,  changes  to  this  legal  framework  can  only  be 
achieved by Community action. The marketing ban directly addresses the free movement of 
cosmetic products in the Union. This is already subject to harmonized legislation and can not 
be addressed at Member State level. It can therefore only be achieved at Union level.  

the  proper 

2. 

OBJECTIVES 

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

The specific objectives followed are accordingly on the one hand linked to the functioning of 
the internal market (specific objectives 1 and 2, Article 114 TFEU) and on the other hand to 
the animal welfare objective (specific objectives 3 and 4, Article 13 TFEU): 

• 

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

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• 

• 

• 

To  maintain  innovation  and  competitiveness  of  the  European  cosmetics  industry 
(specific objective 2 – Innovation and competitiveness) 

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

To  maintain  the  incentive  for  continued  research  on  alternative  methods  to  animal 
testing (specific objective 4 – Research into alternatives) 

3. 

POLICY OPTIONS  

The policy options discussed in the assessment are:  

Option 1: Baseline/No Action 

Under  option  1  the  Commission  would  not  make  a  proposal  and  the  marketing  ban  would 
enter  into  force  on  11  March  2013.  The  rationale  is  that  this  is  the  most  effective  way  to 
obtain  the  overarching  political  objective  that  led  to  the  current  provisions  –  to  end  animal 
testing for cosmetic purposes.  

Option 2: Postpone the 2013 deadline 

Under  option  2  the  deadline  would  be  postponed.  Three  sub-options  are  considered,  to 
postpone  with  a  fixed  deadline,  to  postpone  in  relation  to  certain  endpoints  only  or  to 
postpone without fixed deadline. All sub-options follow the rationale to maintain the overall 
objective to end animal testing for cosmetic purposes. They take account of the finding that 
alternatives are not yet available and thus make reaching the objective one way or the other 
dependant  on  the  availability  of  alternative  methods.  Option  2  (a)  would  postpone  the 
application  of  the  marketing  ban  by  7  years,  the  time  by  when  alternatives  at  least  for  skin 
sensitisation are expected to be available. Option 2 (b) would equally postpone the deadline, 
but  would  limit  the  postponement  only  to  those  endpoints  most  needed  to  demonstrate  the 
safety of the cosmetic products, ie. skin sensitisation and repeated dose. Option 2 (c) would 
foresee a postponement without a fixed deadline. The ban would apply as soon as alternatives 
actually become available. The rationale behind this option is that it would let science deliver 
and that it follows a similar logic to those in other regulatory fields.  

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

Option  3  would  allow  cosmetics  and  cosmetics  ingredient  manufacturers  to  request  a 
derogation  from  the  marketing  ban  for  ingredients  or  combinations  of  ingredients  under 
limited circumstances. A derogation would be granted in case the ingredient brings innovation 
and  a  significant  benefit  to  consumer  health,  consumer  wellbeing  and/or  the  environment. 
Each  case  would  come  under  the  scrutiny  of  the  Commission  and  would  require  weighing 
benefits of any new ingredients against the stated objective of ending all testing of cosmetics 
on  animals.  Since  it  would  be  a  derogation,  the  cases  in  which  it  would  be  granted  should 
represent the exception, not the rule.  

Manufacturers  would  also  need  to  demonstrate  that  toxicological  data  needed  for  the  safety 
assessment  is  not  available  and  cannot  be  obtained  using  alternative  methods  to  animal 
testing. Details on the proposed place of testing, the protocol followed, the number of animal 
involved and the animal welfare standards applied must be provided. 

The  commitment  of  the  manufacturer  in  relation  to  investment  in  research  for  alternative 
methods would need to be substantited and provisions would be included to avoid duplication 
of testing. In terms of procedure, a derogation would be granted in the form of a Commission 
Decision, after consultation of the appropriate expertise.  

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4. 

COMPARISON OF POLICY OPTIONS AND THE ASSESSMENT OF THEIR IMPACT  

Option 1 would be the most effective of the options in relation to the animal welfare related 
objectives.  It  would  end  animal  use  for  EU  cosmetic  purposes  by  March  2013.  This  would 
mean  that  a  sub-set  of  the  15  000  –  27  000  animals  estimated  to  be  used  for  EU  cosmetic 
purposes outside the EU per year would be spared. Option 1 is expected to maintain or even 
increase the current research on alternative methods, simply because in most cases it will only 
be possible to bring new cosmetic ingredients on the market once alternatives are available. It 
would thus have effects beyond the Cosmetics legislation and beyond the EU in that it can act 
as  a  critical  accelerator  in  the  development  of  new  approaches  to  human  risk  assessment. 
Specific impacts on consumer safety are not expected from option 1. In case insufficient data 
is available for ingredients products containing them cannot be brought on the market.  

Option  1  could  however  come  with  certain  negative  economic  and  social  impacts.  It  could 
lead to a more reduced access to cosmetic ingredients, since ingredients for which insufficient 
data packages exist cannot be placed on the market or may not be able to be defended. This 
loss of ingredients and product innovation could lead to a certain loss of competitiveness of 
the cosmetics industry. It is estimated by industry stakeholders that large companies will have 
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).  Reduced  competitiveness  could  also  affect  employment. 
Industry  stakeholders  expect  a  reduction  of  several  thousand  R&D  staff,  up  to  8  000  in  the 
worst case, as well as other staff.  

It has to be stressed however that these figures are estimates from the industry stakeholders. 
Cosmetic manufacturers that work under the 'Leaping Bunny' label, thus already now are not 
relying on animal testing after certain cut-off dates, consider that the economic impacts could 
be positive. The cosmetics industry may also be able to counterbalance these effects by other 
approaches to innovation.  

Option  2  would  be  the  least  effective  in  relation  to  the  animal  welfare  objectives  in  that  it 
would  lead  to  a  continued  animal  use  for  cosmetic  purposes.  While  it  maintains  the  overall 
objective to end animal testing, it would postpone ending it beyond 2013. Under option 2 (a) 
this  would  mean  a  continued  use  of  the  15  000  to  27  000  animals  for  next  7  years.  Under 
option 2 (b), less animals would be used as the postponement would not cover certain tests, 
about 12% less animals are likely to be used. Under option 2 (c) there would be no fixed end 
date to the yearly use of 15 000 to 27 000 animals, but numbers would reduce in the future 
when alternatives become available.  

Option  2  would  however  have  no  or  very  limited  negative  economic  and  social  impacts. 
Under option 2 the current situation is basically maintained, a situation which has allowed the 
European  cosmetics  industry  to  be  home  to  some  of  the  most  advanced  and  luxurious 
cosmetic product brands and to largely resist the economic crisis.  

Option  3  would  lead  to  better  impacts  for  animal  welfare  than  option  2,  but  worse  impacts 
than optimal. It would lead to the possibility to request derogations and, thus, in a number of 
cases  to  testing  outside  the  EU  for  EU  cosmetics  purposes  beyond  2013.  The  number  of 
animals  impacted  would  depend  on  how  often  such  a  derogation  would  be  granted.  At  a 
minimum about 100 animals would be used per derogation. Assuming 10 to 15 derogations 
would be granted per year this would mean that between 1 000 and 1 500 animals would be 
used.  

As regards the economic and social impacts, option 3, while leading to a similar situation as 
option  1,  could  mitigate  the  possible  impacts  by  allowing  introducing  the  most  valuable 

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ingredients  and  product  innovations  with  particular  benefit  for  consumers.  The  operational 
application  of  Option  3  would  however  be  challenging,  as  every  single  derogation  would 
require  difficult  and  controversial  judgements  by  the  Commission,  in  particular  whether  the 
potential benefit of the cosmetic would be significant and hence justify animal tests.  

Overall, the quantitative assessment of the different options faces limitations in relation to the 
animal  welfare  objective,  because  the  total  number  of  animals  involved  is  relatively  low  in 
comparison with other sectors and because the differences in animal use between the options 
are  difficult  to  quantify  beyond  the  overall  estimates.  In  relation  to  the  internal  market 
objectives, while there will be a reduced access to existing and new ingredients and economic 
and social impacts are likely to result from this, they remain extremely difficult to quantify.  

All  stakeholders  concerned  share  the  overall  objective  to  end  animal  testing  for  cosmetics. 
None  of  the  stakeholders  has  an  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.  

However, the views of stakeholders voiced throughout the consultation process on what to do 
in cases in which alternatives are not available were split. Animal welfare stakeholders took a 
clear position against any proposal in relation to the 2013 deadline, be it a postponement or 
the  introduction  of  a  derogation  mechanism.  This  position  is  based  on  ethical  principles. 
Industry  stakeholders  have  underlined  that  they  expect  significant  negative  impacts  on 
availability  of  ingredients,  product  innovation  and  on  their  competitiveness  from  the  2013 
deadline  and  have  therefore  overall  supported  a  postponement  of  the  deadline.  Industry 
stakeholders  nevertheless  recognised  that  -  as  a  fall-back  position  in  case  the  Commission 
does  not  propose  a  postponement  -  a  derogation  will  at  least  allow  access  to  the  most 
innovative and beneficial ingredients.  

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  administrative  costs  at 
industry and Commission level.  

These  costs  would  arise  on  the  industry  side  for  the  preparation  and  the  follow-up  of  a 
derogation  file  and  are  estimated  to  be  approximately  EUR  15  000  per  file.  In  addition,  for 
each application the company would have to demonstrate financial commitment in research of 
alternative methods. 

Costs  arise  also  for  the  Commission,  as  it  would  require  additional  resources  to  assess 
derogation requests. Assuming that about 10 to 15 derogations per year would be dealt with it 
is estimated that 2 full time staff would be needed.  

5. 

CONCLUSIONS, MONITORING AND EVALUATION 

The report does not recommend a preferred option. It recognises that the choice is a political 
one.  

In order to ensure monitoring, the Cosmetics Directive/Regulation foresees a regular reporting 
mechanism to the European Parliament and the Council.  

Implementation  and  enforcement  issues  will  in  addition  be  reviewed  in  the  various  fora 
already in place, such as the Cosmetics Committee, the Working Group on Cosmetics and the 
Platform of European Market Surveillance Authorities (PEMSAC).  

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