Commission staff working paper - Impact assessment - Report on simplification of the “Cosmetics Directive” – Directive 76/768/EEC (COM(2008)49 final) (SEC(2008)118)
Date: 2008-02-05
Institutions: European Commission
Subjects: approximation of laws, chemical product, consumer information, consumer protection, cosmetic product, impact study, product safety, technological change

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.2.2008 
SEC(2008)117 

COMMISSION STAFF WORKING PAPER 

Impact assessment report on simplification of the “Cosmetics Directive” 
 – Directive 76/768/EEC  

(COM(2008)49 final) 
(SEC(2008)118) 

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TABLE OF CONTENTS 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

2. 

2.1. 

2.2. 

Procedural issues and consultation of interested parties .............................................. 5 

Consultation of other Commission Services ................................................................ 5 

External studies ............................................................................................................ 5 

Stakeholder consultation .............................................................................................. 5 

Contacts with Third Countries ..................................................................................... 7 

Scrutiny by the Commission impact assessment board ............................................... 7 

Problem Definition....................................................................................................... 8 

Background .................................................................................................................. 8 

Problem identification................................................................................................ 10 

2.2.1.  Legal unclarities/inconsistencies and burdensome management of the Cosmetics 

Directive..................................................................................................................... 10 

2.2.2. 

Incoherent and resource-intensive transposition without adding value ..................... 13 

2.2.3.  Ensuring the safety of cosmetic products in the light of innovation.......................... 13 

2.2.4.  Addressing substances classified as CMR 1 and 2 by considering, in exceptional 

cases, safe exposure limits ......................................................................................... 16 

2.3. 

Community competence and subsidiarity .................................................................. 17 

3. 

3.1. 

3.2. 

3.3. 

3.4. 

3.5. 

4. 

4.1. 

Objectives................................................................................................................... 17 

Preliminary remark: overall objectives ...................................................................... 17 

Objective 1: Clear and coherent single legal text including facilitated managing of 
the Cosmetics legislation ........................................................................................... 18 

Objective 2: Removing divergences between national law ....................................... 19 

Objective 3: Ensuring a high level of safety in cosmetic products in the light of 
innovation in the industry .......................................................................................... 19 

Objective 4: Introducing a possibility to regulate CMR 1, 2 substances on the basis of 
their actual risk........................................................................................................... 20 

Policy options............................................................................................................. 20 

Objective 1: Clear and coherent single legal text allowing easier management of the 
Cosmetics Directive ................................................................................................... 20 

4.1.1.  Policy option 1 (discarded): No EU action ................................................................ 20 

4.1.2.  Policy option 2: Adoption of informal guidelines by the Commission ..................... 21 

4.1.3.  Policy option 3: Amending the Cosmetics Directive................................................. 21 

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4.2. 

Objective 2: Removing divergences between national laws...................................... 21 

4.2.1.  Policy option 1: No EU action ................................................................................... 21 

4.2.2.  Policy option 2: Turning the entire Cosmetics Directive into a Regulation .............. 21 

4.2.3.  Policy option 3: Redrafting the enacting terms as a Directive and turning only the 

annexes into a Regulation .......................................................................................... 21 

4.3. 

Objective 3: Ensuring a high level of safety in cosmetic products in the light of 
innovation in the industry .......................................................................................... 22 

4.3.1.  Policy option 1: No EU action ................................................................................... 22 

4.3.2.  Policy option 2: Non-binding guidelines and self-regulation .................................... 22 

4.3.3.  Policy option 3: Restricting the scope of the Cosmetics Directive by reviewing the 

definition of “cosmetic product”................................................................................ 22 

4.3.4.  Policy option 4: Ex-ante authorisation for all cosmetic ingredients/products ........... 22 

4.3.5.  Policy option 5: Introducing additional “positive lists”............................................. 22 

4.3.6.  Policy option 6: Sharpening the focus on manufacturer responsibility ..................... 23 

4.4. 

Objective 4: Introducing a possibility to regulate CMR 1, 2 substances on the basis of 
their actual risk........................................................................................................... 25 

4.4.1.  Policy option 1 – no EU action .................................................................................. 25 

4.4.2.  Policy option 2 – taking risk into consideration at the classification stage ............... 25 

4.4.3.  Policy option 3 – giving the possibility to allow, in exceptional cases, the use of a 

CMR 1, 2 substance provided that the substance is safe............................................ 25 

5. 

5.1. 

Analysis of impact ..................................................................................................... 26 

Objective 1: Clear and coherent single legal text allowing easier management of the 
Cosmetics Directive ................................................................................................... 27 

5.1.1.  Policy option 2: Adoption of informal guidelines by the Commission ..................... 27 

5.1.2.  Policy option 3: Amending the Cosmetics Directive................................................. 28 

5.1.3.  Comparison of options ............................................................................................... 29 

5.2. 

Objective 2: Removing divergences between national laws...................................... 30 

5.2.1.  Policy option 1: No EU action ................................................................................... 30 

5.2.2.  Policy option 2: Turning the entire Cosmetics Directive into a Regulation .............. 30 

5.2.3.  Policy option 3: Redrafting the enacting terms as a Directive and turning only the 

annexes into a Regulation .......................................................................................... 31 

5.2.4.  Comparison of the options ......................................................................................... 32 

5.3. 

Objective 3: Ensuring a high level of safety in cosmetic products in the light of 
innovation in the industry .......................................................................................... 32 

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5.3.1.  Policy option 1: No EU action ................................................................................... 32 

5.3.2.  Policy option 2: Non-binding guidelines, self-regulation .......................................... 33 

5.3.3.  Policy option 3: Restricting the scope of the Cosmetics Directive by reviewing the 

definition of “cosmetic product”................................................................................ 34 

5.3.4.  Policy option 4: Ex-ante authorisation for all cosmetic ingredients/products ........... 35 

5.3.5.  Policy option 5: Introducing additional “positive lists”............................................. 35 

5.3.6.  Policy option 6: Sharpening the focus on manufacturer responsibility ..................... 37 

5.3.7.  Comparing the options ............................................................................................... 42 

5.4. 

Objective 4: Introducing a possibility to regulate CMR 1, 2 substances on the basis of 
their actual risk........................................................................................................... 44 

5.4.1.  Policy option 2 – taking risk into consideration at the classification stage ............... 44 

5.4.2.  Policy option 3 – giving the possibility to allow, in exceptional cases, the use of a 

CMR 1, 2 substance provided that the substance is safe............................................ 45 

5.4.3.  Comparing the options ............................................................................................... 45 

6. 

6.1. 

6.2. 

6.3. 

7. 

Synergies, Overview .................................................................................................. 46 

Synergies of the preferred options ............................................................................. 46 

Summary of impact on administrative costs of the policy options for objectives 1- 446 

Overview .................................................................................................................... 48 

Monitoring and evaluation ......................................................................................... 51 

ANNEX 1 - Synthesis of public consultation .......................................................................... 52 

ANNEX 2 - Description of European cosmetics industry and EU cosmetics market ............. 67 

ANNEX 3 – Assessment of the administrative costs of the Cosmetics Directive (before re-
cast) .......................................................................................................................................... 71 

ANNEX 4 – Assessment of the administrative costs of the Cosmetics Directive (after re-cast)72 

ANNEX 5 – Summary of the Cosmetics Directive.................................................................. 74 

ANNEX 6 – Impact assessment boar opinion of 31 August 2007........................................... 76 

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1. 

PROCEDURAL ISSUES AND CONSULTATION OF INTERESTED PARTIES 

Simplification  of  Council  Directive  76/768/EEC  of  27  July  1976  on 
the 
approximation of the laws of the Member States relating to cosmetic products1 (the 
“Cosmetics  Directive”)  was  announced  in  the  Commission  Communication 
“Implementing the Community Lisbon programme: A strategy for the simplification 
of the regulatory environment”2 and in the Commission’s Annual Policy Strategy for 
2007.3  It  is  scheduled  in  the  Commission’s  Agenda  Planning  (under  ref. 
2007/ENTR/002). 

1.1. 

Consultation of other Commission Services 

Work  on  the  impact  assessment  on  this  simplification  started  in  late  2006.  Three 
meetings  of  the  Inter-Service  Steering  Group  were  held  with  representatives  from 
Directorates-General  SANCO,  TRADE,  RTD,  JRC,  ENV  and  EMPL  and  from  the 
Legal Service and the Secretariat-General on 15 December 2006, 21 May 2007 and 
7 September 2007.  

1.2. 

External studies 

To  gain  additional  expertise,  the  Commission  ordered  three  studies  looking  at  the 
following aspects of this simplification exercise:4

•  A  description  of  the  EU  cosmetics  industry  in  order  to  gain  a  better 

understanding of its current performance and characteristics;  

•  An  assessment  of  the  impact  of  EU  regulation  on  consumer  safety  with  the 
aim  of  compiling,  assessing  and  presenting  information  on  the  impact  of  the 
Cosmetics Directive in terms of health protection, in order to define the potential 
for improvement; and 

•  An  assessment  of  the 

industry’s 
competitiveness  in  order  to  obtain  more  detailed  information  on  the  economic 
impact of the existing EU legislation for cosmetic products and possible changes 
to it. 

impact  of  EU  regulation  on  the 

1.3. 

Stakeholder consultation 

Moreover, a stakeholder consultation was held from 12 January 2007 to 16 March 
2007 on the basis of a public consultation document in English, French and German. 
A press release publicised the launch of this public consultation. 

In response to this public consultation the Commission received 72 contributions. Of 
these,  46  were  from  industry  (fine  chemicals,  cosmetics  and  others5),  18  from 

1 
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3 
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OJ L 262, 27.9.1976, p. 169, as amended. 
COM(2005) 535 of 25.10.2005. 
COM(2006) 122 of 14.3.2006. 
The studies are still under evaluation by the Commission Services. Once the evaluations are finalised 
and 
under 
to 
http://ec.europa.eu/enterprise/cosmetics/html/cosm_comparative_study.htm

are  made, 

published 

payments 

studies 

going 

are 

the 

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national  and  regional  authorities,  4  from  academics/health  professionals,  3  from 
consumers  and  consumer  organisations  and  1  from  an  animal  welfare  organisation. 

Responses 

to 

the  public  consultation  –  distribution  by  stakeholders  

3 from consumers and 
consumer organisations  

4 from 
academia/health 
professionals 

1 from Animal Welfare 
Organisation  

46 from Industry 

18  from  National  and 
regional authorities 

In  terms  of  regions,  7  contributions  were  received  from  EU-wide  associations,  15 
from  Germany,  9  from  France,  3  each  from  the  UK,  Austria  and  Sweden,  2  each 
from  Lithuania,  Belgium  (including  Luxembourg),  Denmark,  Norway,  the  Czech 
Republic,  Spain,  Poland  and  Ireland,  1  each  from  Finland,  Malta,  Hungary,  the 
Netherlands,  Slovenia,  Greece,  Slovakia,  Latvia  and  Switzerland  and  7  from  Third 
Countries. 

Responses to the public consultation – distribution by country 

MT + HU + NL + 
SL  +  GR  +  SK  + 
LV 

DE 

DK + LT + BE 
+  NO  +  CS  + 
ES +PL 

SE 

FR 

Non  EU  Third 
Countries 

AT 

UK 

EU 
Associations 

The  main  results  of  the  public  consultation  are  summed  up  in  sections  2-5  of  the 
impact  assessment  report.  An  overview  of  the  responses  to  the  consultation  is 
attached in Annex 1. 

5 

Including  retailers,  manufacturers  of  machinery/equipment,  chemists,  the  hairdressing  industry  and 
branding companies. 

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Seven  stakeholders  requested  that  their  submission  be  treated  confidentially.  The 
responses of the other stakeholders have been published on the “cosmetics website” 
of the European Commission.6  

All  the  standards  set  in  the  “General  principles  and  minimum  standards  for 
consultation of interested parties by the Commission”7 have been met. In particular, 
the public consultation was: 

•  open to all stakeholders for eight weeks and announced by a press release; 

•  accessible via the single access point on the internet8; and 

•  followed-up with an individual reception notice as well as with a summary of the 

responses.9 

1.4. 

Contacts with Third Countries 

In the run-up of the impact assessment, the Commission was in contact with several 
Third Country authorities and industry associations. For example: 

•  U.S. Food and Drug Administration (U.S. FDA): In the framework of its bilateral 
regulatory  dialogue  the  Commission  specifically  invited  U.S.  FDA  to  submit 
comments during the public consultation. The comments subsequently submitted 
were carefully studies by the Commission and duly taken into account. 

•  U.S., Japanese and Australian industry association: All three industry associations 

submitted comments during the public consultation. 

1.5. 

Scrutiny by the Commission impact assessment board 

The impact assessment board of the European Commission10 assessed a draft version 
of the impact assessment in August 2007. It issued its opinion on 31 August 2007.11 
Apart  from  some  technical  comments,  the  impact  assessment  board  made  several 
substantial suggestions for improvement. In the light of these suggestions, the final 
impact assessment report: 

–  Sets out in more detail the impacts of simplification in terms of product safety and 
costs  for  businesses  (in  particular  concerning  labelling;  cf.  sections  2.2.1.  and 
5.1.2.); 

–  Explains better the impact of a clarified cosmetic product safety report in terms of 

product safety and costs for businesses (cf. section 5.3.6.a.); 

–  Addresses the implications for the Community budget (cf. section 5.1.2.) 

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http://ec.europa.eu/enterprise/cosmetics/html/cosm_simpl_dir_en.htm. 
COM(2002) 704. 
http://ec.europa.eu/yourvoice/consultations/index_en.htm  
Cf. Annex 1. 
http://ec.europa.eu/governance/impact/iab_en.htm 
Cf. Annex 6. 

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–  Addresses  the  possibilities  of  non-legislative  measures  (cf.  sections  4.3.2.  and 

5.3.2.); and 

–  Puts a stronger emphasis on procedural matters (public consultation and contacts 

with Third States; cf. this section 1.) 

2. 

PROBLEM DEFINITION 

2.1. 

Background 

The Cosmetics Directive was adopted in 1976. Its aim is to harmonise the restrictions 
on  ingredients  and  rules  on  labelling  in  order  to  allow  free  circulation  of  cosmetic 
products on the internal market and to maintain a high level of consumer protection. 

The Cosmetics Directive12 is based on the principle of “manufacturer responsibility”, 
i.e. the “manufacturer”13 is responsible for the safety of the cosmetic product placed 
on the EU market. To this end, the person responsible for placing the product on the 
market has to prove that the product is safe by means of a “product information file” 
which  is  checked  on  an  ad  hoc  basis  by  the  competent  authorities  in  “in-market 
controls”. 

The principle of manufacturer responsibility is supplemented by detailed regulation 
of  selected  individual  cosmetic  ingredients.  In  fact,  in  1976  the  objective  of  the 
legislator  was  to  establish  a  “positive  list”  of  all  chemical  ingredients  permitted  in 
cosmetic  products  along  with  the  relevant  concentration  limits  and  any  other 
restrictions.  As 
industry  uses 
this  was  a  heavy  workload  (the  cosmetics 
approximately  10 000  chemical  ingredients),  the  legislator  decided  to  start  with  a 
“negative list” of substances which are restricted or banned and then to move on to 
address all relevant substances, thereby shifting step by step to a “positive list”.14  

Finally,  the  Cosmetics  Directive  is  a  highly  detailed  and  prescriptive  piece  of 
legislation which leaves very little room for varying transposition by Member States. 
Since 1976 the Cosmetics Directive has been amended 53 times. 

Cosmetic products are essentially mixtures of chemicals. The Cosmetics Directive is, 
in practice, a special chemicals law for products used by every consumer every day. 

Industry is constantly re-formulating products and on the quest for substances which 
could  be  applied  in  the  cosmetics  sector.  Studies  contracted  by  the  Commission 
suggest  that  in  average  between  20%  (SME’s)  and  30%  (non-SME’s)  of  product 
formulations  are  newly  developed  or  reformulated  by  the  cosmetics  industry  every 
year.  On  its  quest  for  “new”  ingredients,  industry  also  uses  substances  stemming 
from  the  pharmaceutical  sector  –  albeit  in  quantities  which  do  not  qualify  these 
products as “medicinal products”. 

12 
13 

14 

A more detailed description of the Cosmetics Directive can be found in Annex 6. 
In  this  context,  instead  of  “manufacturer”  it  would  be  more  correct  to  say  “person  responsible  for 
placing the product on the Community market”. 
See the minutes of the first meeting of the Working Group on Economic Matters on the proposal for the 
Cosmetics Directive, 17 and 18 July 1973, “General observations.” 

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The  EU  cosmetics  sector  is  characterised  by  SMEs:  97%  of  all  EU  cosmetic 
companies  are  SMEs  and  80%  have  fewer  than  19  employees.  SMEs  account  for 
approximately two thirds of all people directly employed in the cosmetics sector in 
the EU.15

In terms of employment, there are approx. 150 000 people employed in the cosmetics 
industry in Europe. Since 1999, the European sector has been steadily creating new 
jobs  (increase  of  1.2%  per  year).  Employment  growth  has  been  remarkably 
pronounced  in  EU10,  with  approximately  30%  growth  in  employment  over  the 
period 1999-2004, albeit starting from a low base.16

Apart from direct employment, the cosmetics sector has a strong indirect impact on 
employment such as retail, distribution and transport. It can be estimated that approx. 
350 000 jobs are created indirectly by the cosmetics industry. 

The volume and value of intra-community exports of cosmetics has increased year-
on-year since 1999 by an average of 5 per cent a year in terms of volume, and by 6.5 
per cent a year in terms of value.17  

Cosmetics industry is an international business in which Europe is a very important 
player.  

The global nature of this sector is particularly relevant to the EU as a net exporter. In 
2005  exports  outside 
imports  at 
EUR 4.4 billion. For example, 7% of all cosmetic products in the USA are imported 
from the EU, which adds up to trade of almost EUR 3 billion per year.18  

the  EU  stood  at  EUR 16 billion  with 

Moreover,  over  the  period  2000-2005  EU  exports  grew  by  8.7%.  This  trend  is 
expected to continue, mainly due to the growing markets abroad at a time when the 
market in the big economies is stagnating. For example, the Chinese market alone is 
expected  to  grow  by  12.8%  per  year  over  the  period  2006-2011  and  by  11.5%  per 
year over the period 2011-2016. On the other hand, the EU-15 market, including the 
big  economies  which  generate  almost  70%  of  sales,  has  been  practically  stagnant 
with growth rates in the range of 1-3% (2002-03: 3.5%; 2003-04: 2%; 2004-05: 1%). 
Consequently, today large EU companies record approximately 30% of their sales in 
non-EU countries. European SMEs average approximately 10% to 20% of their sales 
in non-EU countries.19

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17 
18 

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Cf. “Study of the European Cosmetics Industry”, Global Insight (2007), Chapter II. 
Cf. “Study of the European Cosmetics Industry”, Global Insight (2007), Chapter II. 
Cf. overview in Annex 2. 
The  value  of  cosmetic  products  imported  into  the  EU  from  the  USA  totals  approximately 
EUR 1.5 billion; Cf. “Study of the European Cosmetics Industry”, Global Insight (2007), Chapter III. 
Cf. “Study of the European Cosmetics Industry”, Global Insight (2007), Chapter III. 

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2.2. 

Problem identification 

The  Commission  has  identified  four  issues  to  be  addressed  in  a  simplification 
exercise:20

2.2.1.  Legal  unclarities/inconsistencies  and  burdensome  management  of  the  Cosmetics 

Directive 

a) Legal unclarities/inconsistencies 

The  53  amendments  over  a  span  of  more  than  30  years  have  led  to  numerous 
conflicting  provisions,  inconsistent  terminology  and  rules  appearing  in  the  wrong 
context. This is aggravated by the fact that the Cosmetics Directive:  

– 

– 

contains no list of definitions; and 

has  never  been  codified  (i.e.  all  the  amendments  have  never  been  formally 
incorporated into a single legal text).21 

Clarification  is  required  in  particular  as  to  the  notion  of  “person  responsible  for 
placing the cosmetic product on the market” and the scope of groups of substances, 
such  as  “UV-filter”.  Moreover,  the  public  consultation  revealed  that  a  number  of 
terms  used  in  the  Cosmetics  Directive  needed  clarification,  including  “minimum 
durability”,  “professional  use”,  “undesirable  effect”,  “traces”,  and  “rinse-off 
product”.22 In addition, the need of more coherent terms in the annexes, which is by 
and large a scientific and technical exercise, was stressed. 

Another  example  for  the  need  for  clarification  concerns  the  labelling  regime.  The 
relevant  provisions  of  the  Cosmetics  Directive23  have  been  amended  by  the  co-
legislator  several  times.  Some  provisions  now  appear  in  the  wrong  context  and 
render the text inconsistent. 

This lack of clarity leads to additional costs for businesses as well as for competent 
authorities. 

Costs for businesses 

It  is  very  difficult  to  quantify  the  costs  for  businesses  stemming  from  legal 
unclarities.  This  holds  particularly  true  for  the  cosmetics  sector.  In  the  public 
consultation24  stakeholders  attributed  this  to  the  fact  that  different  regulatory 
frameworks  apply  simultaneously  to  the  chemicals  employed  by  the  cosmetics 
industry.  These  laws  address  chemical  safety  from  different  perspectives,  such  as 
worker  protection,  transport,  environment,  consumer,  waste,  etc.  It  is  impossible  to 
“distil” the precise costs incurred from any single piece of legislation. Nevertheless, 

20 

21 

22 
23 
24 

Note  that  simplification  and  recast  address  the  same  issue,  i.e.  a  review  of  the  Cosmetics  Directive. 
Recast describes the legal technique, while simplification describes the broad policy aim. 
Note, however, that a consolidated version (i.e. an informal text incorporating all the amendments) was 
made available by the Office for Publications on 9 August 2006. 
A summary of the suggested items in the public consultation can be found in Annex 1. 
Art. 6 Cosmetics Directive. 
For a detailed summary of the responses, see Annex 1. 

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estimates  based  on  the  responses  submitted  during  the  public  consultation  suggest 
that greater legal certainty about various issues in the Cosmetics Directive could cut 
compliance costs by up to 10%. 

According to Commission research, total cost for compliance with the requirements 
of  the  Cosmetics  Directive  lies  between  0.5%  and  1%  of  the  annual  turnover  of  a 
cosmetic manufacturer.25  

Considering  a  yearly  EU-turnover  of  EU  cosmetics  industry  of  55  billion  EUR26, 
total costs of compliance for EU businesses is thus approx. 390-400 million EUR.27 
This  means  that  legal  unclarities  stemming  from  the  Cosmetics  Directive  cost  EU-
cosmetics businesses approx. 40 million EUR per year.  

Example:  The  Cosmetics  Directive  does  not  define  the  term  ‘placing  on  the  market’: 
Each  time  a  substance  is  banned/restricted  in  cosmetic  products  “placed  on  the 
market”,  there  is  considerable  legal  uncertainty:  Companies  have  to  consult  public 
authorities in order to know how this term is interpreted in their jurisdiction. In some 
cases, extensive discussion and consultation is needed in order to ensure the legality of a 
product in all Member States of the entire Community market. 

The public consultation confirmed that the share of SMEs in new product launches 
on the Community market is roughly 50%. Based on this figure, and considering that 
administrative  burdens  arise  usually  when  a  new  product  is  launched,  a  careful 
that  SMEs  bear  about  20  million  EUR  of  superfluous 
estimation  shows 
administrative burden stemming from legal uncertainties every year. 

Costs for national competent authorities 

Apart from the costs for businesses, legal uncertainties also lead to unnecessary costs 
for national authorities supervising correct application of the Cosmetics Directive by 
the industry. Research by the Commission suggests that it takes even small Member 
States approximately 3 person-years to give extensive explanations of the meaning of 
the various aspects of the Cosmetics Directive. These costs can be avoided and the 
resources redirected to market surveillance and in-market control. 

b) Complicated and burdensome management of the Cosmetics Directive 

Moreover,  some  aspects  of  the  management  of  the  Cosmetics  Directive  are  very 
complicated and burdensome without adding value. Examples are: 

•  The  burdensome  procedure  for  the  updating  of  the  inventory  of  cosmetic 
ingredients  used:  This  aspect  relates  in  particular  to  the  provisions  on  labelling: 
According to the Cosmetics Directive, the cosmetic cosmetic ingredients have to 
be  labelled  on  the  product.  To  avoid  the  need  for  translation,  an  “inventory  of 
ingredients” has been set up by the Commission, which lists “artificial” names of 
all  chemicals  which  are  of  interest  for  the  cosmetics  industry.  These  names, 
established at an international level, are independent of any national language and 

25 
26 
27 

Cf. “Impact of European Regulation on the EU Cosmetics Industry”, RPA (2007), Chapter 3.3.1. 
Cf. “Study of the European Cosmetics Industry”, Global Insight (2007), Chapter I. 
This includes administrative costs count of approx. 80 million EUR. For more details refer to annex 3. 

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do  not  need  to  be  translated  on  the  product  labelling.  However,  while  there  are 
constantly new chemicals for a potential use as cosmetic ingredient “discovered”, 
the update of the inventory is a very cumbersome procedure, involving translation 
of  the  description  of  the  chemical  and  its  scientific  name  and  Comitology 
procedure.  Translation  alone  of  these  highly  technical  aspects  into  22  languages 
takes several years. This is why there has been only one update of the inventory in 
the past 11 years;  

•  The complicated procedure for the development methods for analysis: Methods of 
analysis  are  required  to  assess  the  concentration  of  a  substance  contained  in  a 
preparation. Uniform methods of analysis are crucial for companies to have legal 
certainty  about  compliance  of  their  product  with  the  regulation  of  individual 
substances. At present, methods of analysis – a very technical matter – have to be 
adopted  as  Commission  Directives  under  Comitology  and  subsequently 
transposed by Member States. This procedure is very lengthy for an issue such as 
methods  of  analysis,  which  are  quickly  outdated.  Methods  of  analysis  in  this 
procedure  are  in  practice  very  often  useless.  Consequently,  since  1996,  no  new 
analytical method in the field of cosmetics was adopted; 

•  At present, the approx. 10-12 anti-poisoning centres are informed individually for 

the EU-wide launch of a product. 

Costs for businesses:

The cumbersome management of the Cosmetics Directive brings about considerable 
unnecessary costs for industry: The incomplete inventory obliges industry to label – 
in  order  to  be  compliant  with  the  Cosmetics  Directive  –  certain  ingredients  in  the 
national  language.  This  leads  to  considerable  additional  costs.  Industry  is  trying  to 
avoid  these  costs  by  labelling  international  “artificial”  names  which  are  not  yet 
contained  in  the  inventory.  In  the  responses  to  the  public  consultation,  the  need  to 
obtain  ingredient  names  from  other  sources  was  identified  as  one  of  the  most 
cumbersome  aspects  in  the  every-day  work  for  companies,  in  particular  for  SMEs 
which  have  only  limited  resources  for  regulatory  aspects  available.  Another  factor 
contributing  to  unnecessary  costs  is  the  lack  of  harmonised  up-to-date  analytical 
methods to assess compliance with the restrictions for ingredients. Finally, the need 
to  submit  information  to  several  anti-poisoning  centres  individually  leads  to 
important  increase  of  administrative  costs,  which  could  be  reduced  considerably: 
each  additional  notification  increases  costs  for  businesses  proportionally  (for  more 
details using the standard cost model, see below, 5.1.2.). 

Costs for national competent authorities

The difficulties created by the burdensome management of the Cosmetics Directive 
are also felt by national competent authorities: The incompleteness of the inventory 
makes  in-market  controls  of  products  and  their  ingredients  more  burdensome  and 
costly.  Moreover,  authorities,  in  their  in-market  control,  have  to  develop  their  own 
methods of analysis. This is costly, as it requires considerable technical expertise.  

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2.2.2. 

Incoherent and resource-intensive transposition without adding value 

The Cosmetics Directive provides for exhaustive harmonisation of the national rules 
on  the  packaging  and  labelling  of  cosmetic  products28  together  with  regulation  of 
ingredients  for  consumer  safety  reasons.  Member  States  may  not  adopt  additional 
rules in this area. Both the enacting terms of the Cosmetics Directive and the annexes 
to  it  are  highly  detailed  and  leave  little  room  for  manoeuvre  in  transposition  by 
Member States. 

Nevertheless,  the Cosmetics Directive and  subsequent amendments to it have to be 
transposed by Member States. This has lead to difficulties for EU businesses, as the 
national transpositions may be slightly divergent. Moreover, their date of entry into 
force may vary from country to country. Thus, at any one given time, labelling and 
ingredient restrictions can differ in the internal market.  

While it is true that these consequences are inherent in any EU legislation adopted in 
the form of a Directive, they are  particularly  apparent in the case of the Cosmetics 
Directive because it is: 

•  highly detailed; and 

•  frequently amended – in recent years up to five times a year. 

The  public  consultation  confirmed  that  each  non/maltransposition  of  amending 
Directives to the Cosmetics Directive in a single Member State creates considerable 
costs for EU-businesses without adding value in terms of safety.  

Example:  New  product  launches  are  often  preceded  by  lengthy  discussions  between 
technical managers and Member State authorities in order to track the implementation 
of changes to the Cosmetics Directive. 

Moreover,  it  reduces  the  benefits  of  an  internal  market  and  its  potential  for 
economies of scale. Transposition in 27 national law does not allow for Europe-wide 
product  launches  but  requires  the  staggering  of  launches:  Such  launch  is  only 
possible  once  all  27  Member  States  have  transposed  amendments  to  the  Cosmetics 
Directive into their national legal system. 

On  a  different  note,  it  has  to  be  stressed  that  transposing  highly  detailed  legal 
provisions  into  27  national  laws  (plus  monitoring  by  the  Commission)  creates  a 
heavy  and  costly  burden  for  public  authorities  without  adding  value  in  terms  of 
consumer safety. 

2.2.3.  Ensuring the safety of cosmetic products in the light of innovation 

As  explained  in  section  2.1.,  cosmetic  products  are  essentially  applied  chemical 
preparations.  These  substances  could  be  hazardous  and  pose  a  risk  to  consumer 
safety.  

28 

See  ECJ  cases  C-220/98  Lifting  ECR  2000  I-117,  ground  23;  C-150/88  Parfümerie-Fabrik  4711  v 
Provide ECR 1989 3891, ground 28; C-315/92 Verband Sozialer Wettbewerb v Clinique Laboratoires 
and Estée Lauder ECR 1994 I-317, ground 11. 

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All  available  statistics  suggest  that  the  number  of  adverse  reactions  to  cosmetic 
products  is  very  low.  For  example,  figures  from  the  German  industry  show 
approximately  1.14  undesirable  effects  per  1  million  units  of  cosmetic  products 
placed on the market. Older figures published in the 1970s by the Dutch authorities 
show an incidence rate of 3 cases per 1 million units of cosmetic products placed on 
the market.29 Considering that each year approximately 10 billion units of cosmetics 
are sold to final consumers in the EU, the incidence of undesirable effects lies in the 
range  of  approximately  10 000  to  20 000  per  year  in  the  EU.  Most  of  these 
undesirable effects are not “serious”, i.e. not “undesirable effects which have caused 
permanent or significant disability/incapacity, hospitalisation, congenital anomalies, 
immediate  vital  risk  or  death”.  According  to  figures  from  the  French  competent 
authority  AFSSAPS,  40  serious  undesirable  effects  were  notified  by  health 
professionals  in  2005.30  These  figures  were  very  similar  in  2006,  when  23%  of  all 
cases notified to AFSSAPS were considered serious. The RAPEX database recorded 
just  49  notifications  of  cosmetic  products  posing  a  “serious  risk”31  over  the  period 
January  2005-May  2007.  Most  “non-serious”  adverse  reactions  take  the  form  of 
minor allergic reactions and irritations. 

Moreover,  since  the  Cosmetics  Directive  entered  into  force  the  cosmetics  industry 
has had no major safety crisis, unlike, for example, the feed sector.  

On the other hand, ensuring and increasing the level of safety of cosmetic products is 
the  key,  in  particular  regarding  new  and  innovative  products.  Innovation  in  the 
cosmetics sector takes three forms: 

•  A constant change in product formulations: Even if the ingredients used in a given 
cosmetic  product  are  known,  they  are  constantly  applied  in  new  combinations, 
textures  and  matrixes.  Ingredients  –  albeit  known  –  may  pose  new  safety 
challenges when applied in other textures or for other uses. 

Example: Penetration of cosmetic ingredients depends on the texture of the product, its 
pH  and  its  mode  of  application.  Thus,  the  same  ingredient  may  have  different 
toxicological characteristics in different product types.  

•  Use  of  “new”  ingredients:  The  cosmetics  industry  is  constantly  on  the  quest  of 
new  ingredients  or  new  preparations  used  as  raw  material.  The  scale  of  this 
development  can  be  best  illustrated  by  the  attribution  of  new  international 
ingredient  names:  Essentially,  every  ingredient/raw  material  of  interest  for  the 
cosmetics  industry  is  attributed  an  international  ingredient  name:  Each  year, 
approx.  500  names  are  attributed,  i.e.  each  year,  500  new  ingredients/raw 
materials  are  used  in  cosmetic  products  placed  on  the  market  worldwide, 
including  in  the  EU.  Note,  however,  that  these  ingredients  are  not  necessarily 
“new” in terms of chemical molecule. Rather, these substances are often used in 
other  sectors  and  subsequently  “discovered”  for  the  use  in  a  cosmetic  product. 

29 
30 

31 

Keuringsdienst van Waren voor het Gebied Enschede, Cosmetica Report, 25 April 1982. 
A.  Pochet,  Actualités  réglementaires  relatives  aux  produits  cosmétiques,  Galénique  de  dermatologie, 
2007, 134:2. Note that these figures relate to France, the second-largest national market in the EU with 
a market share by volume of approximately 17% based on EU-15 (see Annex 2). 
Note that the definition of “serious risk” in RAPEX is not identical to the one in the French notification 
system.  

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Examples are “active” ingredients known in the pharmaceutical sector and applied 
in  concentrations  that  do  not  qualify  the  product  as  medicinal  product  as  the 
pharmacological, immunological or metabolic effect is insignificant.32 

•  Use of known ingredients in nanosizes: Future innovation is likely to be based on 
new physical characteristics of existing  substances: the most prominent example 
is the use of particles in micronised forms. Micronised particulars are presently in 
use  as  physical  UV-filters.33  As  such,  their  use  in  cosmetic  products  has  to  be 
authorised  by  the  European  Commission.  However,  other  uses  in  other  types  of 
cosmetic products cannot be excluded in the future.  

It is not possible to quantify – let alone to quantify in monetary terms – the impact of 
future innovation in the cosmetics sector on product safety and consumer health. 

However, it is clear that the cosmetics sector, which is in constant move, is going to 
pose increasingly safety-challenges in the future. The Commission has to follow-up 
this development carefully and to pro-actively respond to it for two reasons:  

•  The  cosmetics  sector  is  characterized  by  very  rapid  changes  of  product 
formulations. There is a constant quest by industry for new ingredients and new 
technologies; 

•  There  is  a  strong  public  interest  in  the  safety  cosmetic  products,  which  are 
essentially chemical preparations applied by every consumer (including children) 
every day. 

This holds even more true as the definition of “cosmetic product” in the EU is rather 
wide. A comparison with other jurisdiction reveals that, in the EU, relatively many 
products  fall  under  the  category  of  “cosmetic  products”  which  elsewhere  are 
considered as “over-the counter drugs” or “quasi drugs”. On the other hand, in those 
other  jurisdictions  the  requirements  for  “cosmetic  products”  are  in  some  cases 
relatively low, compared to the EU-regime. This concerns in particular provisions on 
product safety assessment, labelling, and the regulation on individual substances.34

Example 1: Mouth wash products and deodorants are usually cosmetic products in the 
EU,  but  regulated  as  “quasi-drugs”  in  Japan.  Anti-dandruff  shampoos,  sunscreen 
products and bleaching products are usually considered as cosmetic products in the EU, 
but regulated as “over the counter drugs” in the U.S. Anti-wrinkle and skin-bleaching 
products  are  usually  considered  as  cosmetic  products  in  the  EU,  but  regulated  as 
“functional cosmetics” (with a stricter regime) in South Korea.  

Example 2: The EU Cosmetics Directive regulates approx. 400 cosmetic ingredients in 
detail.  In  the  U.S.,  regulation  of  cosmetics  ingredients  is  very  limited,  amounting  to 
approx. 12 ingredients and a list of authorised colouring agents. 

32 

33 
34 

For  the  determination  of  the  borderline  „medicinal  product“  and  „cosmetic  product“  cf.  the  relevant 
guidance documents: http://ec.europa.eu/enterprise/cosmetics/html/cosm_borderline_docs.htm  
Physical UV-filter reflect radiation, while „chemical“ UV-filters act through absorption. 
Cf. “Cosmetics Legislation in the EU and Other Principal Markets with Special Attention to Borderline 
Products”, RPA (2004). 

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Apart from the innovation in this field, particular regard has to be paid to issues of 
sensitisation,  i.e.  allergic  reactions  to  certain  cosmetic  ingredients:  It  can  be 
estimated that approx. 60% of all undesirable effects are cases of allergic reactions.35 
Sensitisation is a significant pathology which affects the quality of life of consumers 
for  the  rest  of  their  lives.  While  safety  in  terms  of  sensitisation  seems  to  have 
improved  over  the  last  few  decades,  it  remains  a  major  challenge  in  the  field  of 
cosmetics.  This  was  also  stressed  by  some  contributions  during  the  public 
consultation. 

It  shall  be  stressed  that  the  new  chemicals  legislation,  the  REACH-Regulation 
1907/2006, does not address these issues: The Cosmetics Directive is lex specialis to 
REACH:  Aspects  of  human  health  risks  stemming  from  cosmetic  products  are 
excluded from the scope of the chemical safety assessment required under REACH. 

2.2.4.  Addressing  substances  classified  as  CMR  1  and  2  by  considering,  in  exceptional 

cases, safe exposure limits 

Carcinogenic, mutagenic and reprotoxic (“CMR”) substances are classified based on 
their intrinsic properties (“hazard”) without taking into account exposure, i.e. future 
use.  The  difference  between  hazard  and  risk  is  best  explained  with  an  example:  A 
lion  is  a  “hazard”  (i.e.  a  lion  as  such  is  dangerous  for  humans)  but  a  lion  is  not 
necessarily a “risk” (e.g. if it is in a guarded zoo, behind a fence, and well-fed). 

CMR  substances  are  categorised  into  3  categories,  “1”,  “2”  and  “3“  based  on  the 
degree of evidence of their carcinogenic, mutagenic or reprotoxic properties.36

According to the Cosmetics Directive37, CMR 1 and 2 substances are automatically 
banned  in  cosmetic  products.  CMR  3  substances  are  banned  unless  the  Scientific 
Committee, on the basis of exposure-data, has found that the substance is safe for use 
in cosmetics. 

The automatic ban without possibility of an exception for CMR 1 and 2 substances 
makes  regulation  of  cosmetics  dependent  on  a  hazard-classification  without 
considering exposure and actual use of the substance. This could lead to situations of 
incoherence between different legislative regimes for different products. A recent – 
but  not  the  only  –  example  is  ethanol:  Ethanol  (i.e.  alcohol)  is  widely  used  in 
cosmetic products. It was considered for classification as CMR 1 substance in 2006. 
The  dossier  is  pending.  A  classification  as  CMR  1  substance  would  lead  to  an 
automatic  ban  of  all  perfumes  (representing  over  10  billion  EUR  retail  value  per 
annum,  ie  15  %  of  value  of  all  cosmetics  placed  on  the  EU  market),  without  ever 
giving  the  possibility  to  prove  its  safe  use  in  cosmetic  products  based  on  exposure 
data. At the same time, ethanol-containing food and beverages would not be affected 
by  the classification and could hence be consumed  directly  while  being banned  for 
application on the skin in perfumes. 

35 

36 

37 

On the basis of undesirable effects notified in France to the responsible market surveillance authority in 
2005. 
Category 1: “Substances known to be carcinogenic to man”; Category 2: “Substances which should be 
regarded  as  if  they  are  carcinogenic  to  man”;  Category  3:  “Substances  which  cause  concern  for  man 
owing to possible carcinogenic effects but in respect of which the available information is not adequate 
for making a satisfactory assessment.“ 
Art. 4b Cosmetics Directive. 

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2.3. 

Community competence and subsidiarity  

The  Cosmetics  Directive  is  based  on  Art.  95  EC  Treaty.  It  aims  at  establishing  an 
internal  market  for  cosmetic  products  while  ensuring  a  high  level  of  protection  of 
consumers.  

Prior  to  the  adoption  of  the  Cosmetics  Directive,  the  provisions  laid  down  by  law, 
regulation or administrative action in force in the Member States differed from one 
Member State to another. These differences between these laws obliged the cosmetic 
industry  to  vary  their  production  according  to  the  Member  State  for  which  the 
products  are  intended.  Consequently,  the  different  national  rules  hindered  trade  in 
these  products  and,  as  a  result,  had  a  direct  effect  on  the  establishment  and 
functioning of the internal market. To respond to this, it was necessary to determine 
at  Community  level  the  regulations  which  must  be  observed  as  regards  the 
composition,  labelling  and  packaging  of  cosmetic  products.  This  objective  could 
only be achieved with a very limited efficiency at national level.  

This  rationale  is  still  valid  today:  Community  action  is  necessary  to  avoid  a 
fragmentation of the market and to ensure a high and equal level of protection of the 
European consumer.  

The  Cosmetics  Directive  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 and are in compliance with 
the principle of subsidiarity as established in Art. 5 EC Treaty. 

3. 

OBJECTIVES 

3.1. 

Preliminary remark: overall objectives 

By way of preliminary remark, it must be pointed out that several overall objectives 
are being pursued. These are: 

•  to maintain a high level of consumer safety: One major objective is that the high 

standard of safety set by the Cosmetics Directive must not be lowered; 

• 

to maintain the rules for phasing out animal testing: This simplification exercise is 
not going to propose any changes to the rules on animal testing which were added 
to the Cosmetics Directive by the “seventh amendment” in 2003 (see Article 4a, 
Article 6(3), second subparagraph, Article 7a(1)(h) and Article 9 of the Cosmetics 
Directive).  The  Commission  supports  these  rules.  Any  opening-up  of  this 
sensitive topic would distract attention from the primary aim of this simplification 
exercise.  

This objective was clearly underlined in the public consultation on the simplification 
exercise. It was also well understood: only five out of the 72 submissions addressed 
questions concerning animal testing, four of them merely in an auxiliary manner; 

•  to  smoothen  the  functioning  of  the  internal  market:  Adoption  of  the  Cosmetics 
Directive  in  1976  brought  about  real  improvements  for  the  free  circulation  of 
cosmetic  products  in  the  EU.  Still  today,  there  is  a  constant  increase  in  inter-

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Community trade. Industry is heavily relying upon the functioning of the internal 
market  for  these  products,  which  allows  for  economies  of  scale  and  thereby 
enhances competitiveness. This holds not only true for the big companies in this 
sector, but also for SMEs, who characterise the European cosmetics industry (cf. 
above, 2.1.).  

It is a crucial overall-objective for the Commission to further smooth the functioning 
of the internal market to allow companies to further exploit its potential. 

•  to ensure international alignment: Cosmetics is an international industry in which 

Europe is a very important player.  

The importance of international trade in this sector leads to a degree of “regulatory 
competition” between the different markets. In order to assess where EU legislation 
stands in the international context, in 2004 the Commission ordered a study to assess 
and  appraise  international  differences  in  regulation.  This  concluded  that  “the 
Cosmetics Directive, which combines a wide definition of cosmetics with clear and 
comprehensive requirements on safety testing, ingredients and labelling, provides a 
good basis for achieving further alignment, demonstrated by the number of countries 
and regions already modelling their approach upon it”.38

The “leadership” given by the Cosmetics Directive was also confirmed by numerous 
stakeholders  from  both  inside  and  outside  the  EU  in  the  public  consultation.  Asian 
and  South  American  countries  in  particular  have  modelled  their  regulations  on  the 
Cosmetics Directive. 

However, the above-mentioned study also stressed that it would be beneficial for EU 
companies  if  the  existing  international  divergences  between  regulations  were 
removed.  No  new  divergences  should  be  introduced.  Presently  EU  companies 
employ  approximately  1%  of  their  personnel  solely  on  assessing  divergences 
between the rules on labelling and other regulatory restrictions. For example, overall 
costs  for  duplication  of  effort  if  products  are  developed  for  both  the  US  and  EU 
markets are 25% higher than for developing products for only one of these markets. 
Moreover,  these  costs  mount  disproportionately  if  reformulation  of  a  complex 
formula is required. 

Therefore,  one  overall  objective  is  to  maintain  the  existing  convergence  with  other 
jurisdictions and to remove divergences, where possible. 

Apart  from  these  overall  objectives,  the  following  specific  objectives  are  being 
pursued by the Commission in this simplification exercise: 

3.2. 

Objective 1: Clear and coherent single legal text including facilitated managing 
of the Cosmetics legislation 

“Objective  1”  is  a  clear,  structured  and  coherent  legal  text  with  a  set  of  clear 
definitions  where  needed  (cf.  above,  2.2.1.)  and  a  facilitated  management  of  the 
Cosmetics Directive.  

38 

“Cosmetics  Legislation  in  the  EU  and  Other  Principal  Markets  with  Special  Attention  to  Borderline 
Products”, RPA (2004), p. 8. 

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In terms of facilitated management, “objective 1” includes: 

•  Facilitating  updates  of  the  inventory  of  cosmetic  ingredients  used  (cf.  above, 

2.2.1);  

•  Simplifying procedure to develop methods for analysis; and 

•  Simplifying submissions of information to anti-poisoning centres in the EU.  

A  set  of  clear  definition,  together  with  a  simplified  management  of  the  Cosmetics 
Directive, would have as overall impact a reduction of costs of compliance, including 
administrative costs, without compromising product safety. 

This objective was already set in 2004 in the “SLIM” exercise. The February 2004 
“Report  and  recommendations  reviewing  legislation  on  cosmetics”39  contains 
recommendations on how to address this. It was carefully considered by Commission 
staff during the impact assessment. 

3.3. 

Objective 2: Removing divergences between national law 

Objective  2  is  to  remove  any  divergences  in  transposition  in  the  different  Member 
States.  

The overall impact would be a better functioning internal market, thereby reducing 
costs for businesses by facilitating economies of scale for EU manufacturers.  

This  objective  has  not  been  considered  in  previous  revisions  of  the  Cosmetics 
Directive. 

3.4. 

Objective 3: Ensuring a high level of safety in cosmetic products in the light of 
innovation in the industry  

Objective 3 is a high level of safety in cosmetic products, in particular in the light of 
innovation in this sector. 

This objective includes considering experience with the shortcomings of the present 
system which is based on random ingredient-by-ingredient harmonisation by means 
of detailed legislation. 

The overall impact would be safe cosmetic products in the future, taking into account 
the specifics of each product and innovation in this sector.  

This  objective  has  been  pursued  in  several  amendments,  particularly  the  “sixth 
amendment”  to  the  Cosmetics  Directive  in  1993.40  The  “sixth  amendment” 
introduced the obligation to indicate the ingredients on the product label in order to 
facilitate  in-market  controls  plus  the  requirement  to  provide  a  product  information 
file.  This  was  a  consequence  of  the  awareness  that  it  was  neither  feasible  nor 

39 
40 

http://ec.europa.eu/internal_market/simplification/slim/2001-phase5_en.htm. 
Council Directive 93/35/EEC of 14 June 1993 (OJ L 151, 23.6.1993, p. 32). 

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necessary  to  establish  a  “cook  book”  which  would  regulate  every  substance 
employed in cosmetic products.41  

3.5. 

Objective  4:  Introducing  a  possibility  to  regulate  CMR  1,  2  substances  on  the 
basis of their actual risk 

Objective 4 is to have a possibility to address the problems set out under 2.2.4. which 
are  created  by  a  regulation  of  substances  used  in  cosmetics  based  on  a  hazard-
classification. 

This  objective  has  been  under  ongoing  discussion  since  the  introduction  of  the 
hazard-based  ban  of  CMR  1,  2  substances  in  the  “seventh  amendment”  to  the 
Cosmetics Directive, Directive 2003/15/EC. 

4. 

POLICY OPTIONS 

Different policy options in order to achieve each of the four objectives described in 
sections 3.2. to 3.4. are discussed below.42

4.1. 

Objective 1: Clear and coherent single legal text allowing easier management of 
the Cosmetics Directive 

Three  options  can  be  considered 
to  achieve  objective  1:  No  EU  action 
(section 4.1.1.), adoption of informal guidelines  by  the Commission to clarify legal 
provisions  (section  4.1.2.)  or  amending  the  text  of  the  Directive  itself  to  make  it 
clearer (section 4.1.3.). 

4.1.1.  Policy option 1 (discarded): No EU action 

The “no EU action” scenario cannot meet objective 1. In particular, it is not possible 
to rely on action by the Member States. The Cosmetics Directive is very detailed and 
provides for exhaustive regulation. It is therefore not possible for Member States to 
clarify the rules without being in breach of EU law. 

Therefore, this policy option was discarded at an early stage. 

41 

42 

Cf.,  for  exemple,  Commission  Working  document  XI/256/89-FR  of  March  1989,  p.  10 :  « Analyse 
critique du niveau actuel de protection de la santé et sécurité publique : La manière dont le principe de 
l’art. 2 susvisé fut concrétisé à ce jour semble assurer une fausse sécurité pour le citoyen. En effet, 13 
ans  après  son  adoption,  le  système  actuel  n’a  pas  encore  défini  toutes  les  catégories  des  listes  des 
substances  admises.  Les  substances  admises  ne  constituent  qu’une  partie  infime  (environ  300 
ingrédients  à  ce  jour)  de  l’ensemble  des  substances  employées  (estimées  entre  3000  et  8000).  La 
sécurité  du  produit  fini  n’est  plus  garantie. »  This  analysis  was  supported  by  Member  States.  For 
example  the  French  Republic  highlighted  in  a  responding  note  that  « le  système  des  listes  positives 
s’avère  comporter  un  certain  nombre  d’inconvénients:  fausse  sécurité  pour  le  consommateur  et  pour 
l’industriel  dans  la  mesure  où  l’évaluation  du  risque  ne  tient  compte  que  des  résultats  de  l’étude 
toxicologique des matières primaires et ne concerne pas les produits finis et leur champ d’application ; 
entrave  à  l’innovation  et  au  développement  de  l’industrie  car  inadapté  à  l’évolution  rapide  de  la 
technologie ; lenteur de la procédure d’inscription d’une substance. » 
An overview of the various objectives and policy options is set out in section 6.4. 

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4.1.2.  Policy option 2: Adoption of informal guidelines by the Commission 

Informal  guidelines  could  be  one  policy option to achieve objective 1 to the extent 
that  they  provide  real  legal  certainty  about  various  aspects  of  the  Cosmetics 
Directive. 

4.1.3.  Policy option 3: Amending the Cosmetics Directive 

A third policy option to achieve objective 1 is to amend the Cosmetics Directive with 
the aim of clarifying various aspects by: 

•  introducing a set of definitions;  

•  removing ambiguities and using identical terms in the legislation if the same thing 

is meant;  

•  putting the legal provisions in the right context;  

•  introducing tools that facilitate management of the cosmetics legislation for both 

companies and enforcing authorities; and 

•  reviewing the annexes to the Cosmetics Directive, in particular addressing double 

entries. 

Moreover, this policy-option would allow to (cf. above, 2.2.1.) 

•  simplify updates of the inventory of cosmetics ingredients;  

•  make use of standardisation bodies for the development of methods of analysis in 
the  future.  Standardising  bodies  may  deliver  faster  results  and  gather  more 
expertise; and 

•  simplify procedures for submission of information to anti-poison centres. 

4.2. 

Objective 2: Removing divergences between national laws 

4.2.1.  Policy option 1: No EU action 

In a “no policy change scenario” the situation would remain as described above.  

4.2.2.  Policy option 2: Turning the entire Cosmetics Directive into a Regulation 

The entire text of the Cosmetics Directive (i.e. enacting terms and annexes) could be 
turned into a Regulation. 

4.2.3.  Policy  option  3:  Redrafting  the  enacting  terms  as  a  Directive  and  turning  only  the 

annexes into a Regulation 

In  order  to  remove  divergences  between  the  national  transposing  laws,  one  policy 
option could be to redraft the enacting terms of the Cosmetics Directive more clearly 
and to turn only the annexes into a Regulation. 

EN 

21 

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Unlike  the  option  described  in  section  4.2.2.,  this  policy  option  would  split  the 
existing  text  of  the  Cosmetics  Directive  into  two  separate  legal  acts:  a  Directive 
(containing the enacting terms of the present Directive) and a Regulation (containing 
the annexes). The latter would be updated by further Regulations. 

4.3. 

Objective 3: Ensuring a high level of safety in cosmetic products in the light of 
innovation in the industry 

Various policy options may be considered to achieve objective 3:  

4.3.1.  Policy option 1: No EU action 

This option would not address objective 3 at EU level. It would leave the situation as 
it is. 

4.3.2.  Policy option 2: Non-binding guidelines and self-regulation 

A  second  option  could  be  to  rely  on  non-binding  guidelines  and  industry  self-
regulation in order to respond to upcoming safety challenges. 

4.3.3.  Policy  option  3:  Restricting  the  scope  of  the  Cosmetics  Directive  by  reviewing  the 

definition of “cosmetic product” 

A third policy option could be to restrict the scope of the Cosmetics Directive so that 
fewer products are regulated as cosmetics in the EU. They may then be covered by 
other  sectoral  legislation,  such  as  on  medicinal  products,  chemicals  or  biocidal 
products. Some of these arrangements require authorisation at European or national 
level prior to placing the products on the EU market. 

This  policy  option  can  be  described  as  that  chosen  in  several  Third  Countries, 
including the U.S.43  

4.3.4.  Policy option 4: Ex-ante authorisation for all cosmetic ingredients/products 

In order to ensure a risk assessment of every ingredient/product, one policy option is 
to  introduce  a  general  requirement  for  authorisation,  as  already  exists  in  the 
Community for medicinal products44 and novel foods.45

4.3.5.  Policy option 5: Introducing additional “positive lists” 

“Positive  lists” are  lists of substances  out  of  a specific group  which  are  allowed as 
ingredients  in  cosmetics  (hence  the  term  “positive”:  the  substances  in  the  group 
concerned must be listed “positively” before they can be allowed for use). As for the 
introduction of further “positive lists”, the Cosmetics Directive already contains three 

43 
44 

45 

Cf. above, 2.2.3. 
Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to medicinal products for human use. 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down  the  general  principles  and  requirements  of  food  law,  establishing  the  European  Food  Safety 
Authority and laying down procedures in matters of food safety. 

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22 

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“positive  lists”  for  colorants  (Annex  IV),  preservatives  (Annex  VI)  and  UV  filters 
(Annex VII). 

One policy option would be to extend the positive lists to other groups of substances. 

4.3.6.  Policy option 6: Sharpening the focus on manufacturer responsibility  

Another  option  would  be  to  sharpen  the  focus  on  manufacturer  responsibility  and 
how this is documented.  

There  are  already  a  number  of  elements  in  the  Cosmetics  Directive  which  aim  at 
ensuring that the manufacturer assesses the safety of the cosmetic product placed on 
the market. In this policy option, these would be strengthened. More specifically, this 
option could entail: 

–  bringing  the  safety  evaluation  by  the  manufacturer  of  the  finished  cosmetic 
the  standard 
products  (and 
recommended by the Scientific Committee for Consumer Products (see section (a) 
below); 

technical  documentation)  up 

the  related 

to 

–  making  in-market  control  and  cosmetovigilance  more  effective  (see  section  (b) 

below); and 

–  increasing requirements on notification (see section (c) below). 

(a) 

Bringing  the  safety  evaluation  by  the  manufacturer  of  the  finished 
cosmetic  products  (and  the  related  technical  documentation)  up  to  the 
standard  recommended  by  the  Scientific  Committee  for  Consumer 
Products46 

Today the Cosmetics Directive requires the manufacturer to assess the safety of the 
cosmetic  product  (based  on  an  assessment  of  the  toxicological  profile  of  the 
ingredients) and to document this in a product information file prior to placing it on 
the market.47  

However,  apart  from  a  very  general  description  of  this  requirement,  the  Cosmetics 
Directive  says  practically  nothing  about  the  standards  and  criteria  for  this  product 
safety  evaluation  and  how  it  has  to  be  documented.  The  only  point  of  reference  is 
Chapter  VI  of  the  guidelines  of  the  Scientific  Committee  for  Consumer  Products, 
which  addresses  the  safety  of  finished  cosmetic  products.48  In  this  chapter,  the 
Scientific Committee for Consumer Products (an advisory body for the Commission 
made  up  of  independent  experts)  sets  out  how,  in  its  view,  the  safety  of  a  finished 
cosmetic  product  should  be  assessed  by  the  person  responsible  for  placing  the 
product on the market. 

46 

47 
48 

Chapter VI of the “Notes of Guidance for Testing of Cosmetic Ingredients and their Safety Evaluation 
by the SCCP”, 6th revision, 19 December 2006. 
Article 7a(1) of the Cosmetics Directive. 
Chapter VI of the “Notes of Guidance for Testing of Cosmetic Ingredients and their Safety Evaluation 
by the SCCP”, 6th revision, 19 December 2006. 

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These suggestions of the scientific committee are currently largely ignored. Research 
conducted for the European Commission suggests that, presently, approx. 40% of all 
cosmetics safety evaluations of the finished product are considered as insufficient or 
incomplete by the competent authority.49 However, as there is a lack of specification 
of the content, competent authorities often refrain from taking action in these cases. 

A  minimum  standard  for  the  safety  assessment  of  the  finished  cosmetic  product 
would  include  the  toxicological  criteria  to  be  looked  at  and  the  minimum 
requirement for a substantiation of the reasoning supporting the safety of the product. 

(b)  Making in-market control and cosmetovigilance more effective  

Efficient targeted checks on products on the market and clear rules in cases of non-
compliance are the keys to safe cosmetics.  

Today the Cosmetics Directive provides no rules on administrative cooperation in in-
market  controls  and  cases  of  non-compliance.  In  terms  of  “cosmetovigilance”,  the 
Cosmetics Directive places an obligation on the manufacturer to keep a record, in the 
product information file, of all undesirable effects observed. 

These aspects could be strengthened by: 

–  a  mechanism  for  mutual  support  in  in-market  controls:  this  would  be  based  on 
bilateral requests from one competent authority (in the country where the product 
has  been  made  available)  to  another  (  in  the  country  where  the  product 
information file is located); and  

–  adding to the passive record-keeping obligatory active notification of the relevant 
competent  authority  by  the  person  responsible  for  placing  the  product  on  the 
market  of  all  serious  undesirable  effects  of  which  the  person  responsible  for 
placing the product on the market receives or should have received knowledge. 

(c) 

Increasing  notification  requirements 
authorities50 

to 

the  market 

surveillance 

In order to make in-market control more efficient, consideration could also be given 
to  increasing  the  number  of  addressees  notified  and  the  amount  of  information 
submitted prior to placing a cosmetic product on the EU market.  

Addressees: At present, the only competent authority which has to be notified is the 
authority  of  the  Member  State  where  the  product  is  manufactured/imported.51  The 
number of addressees could be extended to: 

–  the  competent  authorities  of  the  Member  State  where  the  product  is  made 

available to the final consumer; or  

49 
50 

51 

Cf. “Evaluation of the Cosmetics Directive” (GHK, 2007), Chapter 5.1. 
Note, that this notification is different from those to the anti-poison centres of some of the EU Member 
States. 
Article 7a(4) of the Cosmetics Directive. 

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24 

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–  all Member States, as a product placed on the Community market can potentially 

be made available to consumers in every Member State. 

Content:  Presently, 
is 
manufacture/importation. The scope of information could be extend  

to  be  notified 

information 

the  only 

the  place  of 

–  to the list of ingredients; or 

–  to the full quantitative and qualitative formula of the product.  

4.4. 

Objective  4:  Introducing  a  possibility  to  regulate  CMR  1,  2  substances  on  the 
basis of their actual risk 

4.4.1.  Policy option 1 – no EU action 

This policy option would not contribute to addressing the problem and has thus been 
discarded. 

4.4.2.  Policy option 2 – taking risk into consideration at the classification stage 

One  could  consider  already  at  the  stage  of  its  classification  the  risk  of  CMR  1,  2 
substances in view of different exposure scenarios in the various downstream uses. 

4.4.3.  Policy  option  3  –  giving  the  possibility  to  allow,  in  exceptional  cases,  the  use  of  a 

CMR 1, 2 substance provided that the substance is safe 

Policy  option  3  would  give  the  possibility  for  the  Commission  as  risk-manager  to 
regulate,  under  Comitology  procedure,  a  substance  classified  as  CMR  1  and  2. 
Various conditions would be introduced to ensure that this possibility does not lead 
to a regular risk-evaluation. Rather, this option would allow for risk-evaluation only 
in  specific  circumstances  were  a  hazard-based  ban  would  lead  to  incoherent 
situations (cf. section 2.2.4.). 

To  achieve  this,  the  conditions  for  use  of  a  CMR  1,  2  substances  would  be  the 
following: 

•  Evaluation of the safety of the substance by the SCCP after classification  of the 
substance as CMR 1, 2: This would ensure that the SCCP, in its safety-evaluation, 
takes into account the data which was the basis of the hazard-classification; 

•  The  substance  has  been  found  safe  by  the  SCCP,  in  particular  in  view  of 
exposure: This is the crucial element. While it is evident that a safety-evaluation 
has to consider the exposure to a substance, this is particularly relevant for CMR 
1, 2 substances which may have different intrinsic properties for different routes 
of exposure. 

•  In order to avoid a situation where the SCCP is systematically seized on the safety 
of  CMR  1,  2  substances,  two  additional  conditions  as  “gatekeeper”  would  be 
introduced: 

- 

The first condition would be that the substance is legally used in food or 
as  food  in  the  Community.  This  would  ensure  coherence  with  other 

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25 

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regulatory  systems  in  the  EU.  Moreover,  the  exposure  in  food  (ie.  in  a 
product intended to be ingested) is potentially higher than in cosmetics. 
Therefore, the use of a substance in food is a useful criteria to “open the 
path” towards a risk-assessment by the SCCP; 

- 

The second condition would be that there are no suitable alternatives for 
the substance in question available. 

It  is  important  to  note  that  these  two  conditions  would  not  contribute  to  safety  as 
such. Rather, they are mere “gatekeepers”: If these two conditions are fulfilled, the 
path towards a safety evaluation by the SCCP is opened. 

•  In order to ensure that misuse (which may lead to an different exposure and thus 
lead  to  a  risk)  is  prevented,  labelling  to  this  effect  would  be  obligatory.  It  is 
important to note that such a labelling would not be a labelling of hazard. Rather, 
it  would  concretise  the  general  rule  already  today  contained  in  the  Cosmetics 
Directive  aiming  at  avoiding  misuse  (and  thus  contributing  to  the  safety)  of 
cosmetic products. 

•  In addition, the substance would have to be regulated by the Commission as risk-
manager  in  the  Annexes  to  the  Cosmetics  Directive.  This  would  be  done  under 
Comitology  procedure  with  scrutiny,  ie.  involving  Member  States  and  European 
Parliament.  This  would  ensure  rigid  scrutiny  of  any  risk-management  measure 
taken by the Commission. 

•  Finally,  the  substance  would  have  to  be  re-evaluated  by  the  SCCP  at  the  latest 
after  5  years.  This  would  ensure  a  regular  safety  evaluation  of  the  substance  in 
view of evolving scientific knowledge. 

5. 

ANALYSIS OF IMPACT 

Commission 
likely  social,  economic  and 
environmental impact – be they direct or indirect – of the different policy options.52  

impact  assessments  analyse 

the 

With  regard  to  the  analysis  in  this  chapter,  it  must  be  stressed  that  it  is  not  an 
objective  of  the  recast  to  extend  the  scope  of  the  Cosmetics  Directive  to  issues  of 
environmental safety. Rather, in this respect, the objective was to maintain the status 
quo.  According  to  this  status  quo,  issues  of  environmental  safety  of  cosmetics 
ingredients  are  addressed  through  the  general  legal  framework  for  environmental 
risks stemming from chemicals.  

The  REACH-Regulation  1907/2006  has  just  recently  introduced  a  far-reaching 
reform of this legal framework. This reform has further strengthened environmental 
safety of chemicals used as cosmetic ingredients. For example: 

•  Suppliers of chemicals used as cosmetic ingredients will have to supply cosmetics 

manufacturer with information on environmental hazards; 

52 

Commission Impact Assessment Guidelines, pp. 4 and 5. 

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26 

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•  If the substance is produced/imported in quantities of over 10 tonnes per year per 
this  substance,  covering 
registrant,  a  chemical  safety  assessment 
environmental  risks,  will  have  to  be  performed  and  communicated  to  the 
cosmetics manufacturer; 

for 

•  Cosmetics  manufacturers  (i.e.  downstream  users)  will  be  under  an  obligation  to 
apply the recommended risk-reduction measures communicated by the supplier of 
the cosmetic ingredient;  

•  Moreover,  REACH  provides  for  the  possibility  to  subject  individual  substances 
employed  in  cosmetic  products  to  a  restriction  or  an  authorisation  procedure  in 
order to address issues of environmental safety. 

The  major  feature  of  REACH,  however,  is  its  cross-sectoral  nature:  The  various 
different applications of a substance, which may lead to an accumulation of exposure 
for the environment, are being looked at as a whole.  

Thus,  environmental  safety  issues  need  to  be  addressed  within  this  legislative 
framework. All efforts should now focus on the correct and efficient implementation 
of REACH.  

In  view  of  their  prominent  role  in  updates  of  the  impact  assessment  guidelines, 
administrative  costs  have  been  looked  at  in  particular  detail  in  this  analysis. 
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”.53 Note that this definition does not include the costs incurred by competent 
authorities  to  exercise  in-market  control.  Those  costs  are  considered  separately  in 
this chapter. 

5.1. 

Objective 1: Clear and coherent single legal text allowing easier management of 
the Cosmetics Directive 

5.1.1.  Policy option 2: Adoption of informal guidelines by the Commission 

On  the  positive  side,  informal  guidelines  are  flexible  instruments  and  allow  active 
participation by all stakeholders. This may lead to more workable results than legal 
definition  by  the  co-legislator.  Therefore,  to  date,  approximately  10  non-binding 
guidelines have been published by the Commission to explain different aspects of the 
Cosmetics  Directive.54  Almost  all  these  guidelines  are  a  consequence  of  unclear 
legislation and inconsistent use of legal terms. 

On  the  negative  side,  informal  guidelines  have  a  limited  impact  on  clarifying  legal 
terms. In order to reach a compromise with stakeholders, solutions are not always as 
satisfactory as they could be. Moreover, experience shows that drafting guidelines on 

53 
54 

Commission Impact Assessment Guidelines, Annex 10, p. 35. 
These  include guidelines on  the  term  “period  after opening-labelling”,  on  the  scope of  the  Cosmetics 
Directive, on the restriction to professional use, on claims referring to the absence of animal tests, on 
information  on  undesirable  effects  and  on  the  field  of  application  of  colorants.  Moreover,  the 
Commission is currently working on a guideline on the labelling of perfumery material. 

EN 

27 

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various aspects can take several years and thus ties up substantial resources. Finally, 
informal guidelines are non-binding and have only de facto, but no legal force. Legal 
force may, however, be required in critical cases. 

Moreover,  adoption  of  informal  guidelines  would  only  partly  address  objective  1. 
Many issues raised in the problem description are inherent in the text of the Directive 
which will have to be amended in order to solve them. For example, the complicated 
updating of the inventory of ingredients cannot be addressed by informal guidelines 
but only by substantial amendments to the enacting terms of the Cosmetics Directive. 

5.1.2.  Policy option 3: Amending the Cosmetics Directive 

On the positive side, a clear set of definitions and clarification of the legal provisions 
brings  legal  clarity  with  the  force  of  law.  This  would  yield  substantial  savings  for 
companies  on  regulatory  compliance,  including  administrative  costs.  A  careful 
estimate of potential savings for EU cosmetics businesses if legal uncertainties were 
removed suggests that these add up to approximately EUR 40 million per year (see 
section 2.2.1.). 

Moreover,  easier  management  of  the  Cosmetics  Directive  would  have  a  positive 
impact in terms of costs for both businesses and competent authorities. 

the  benefits  of  a  simplified  management  concerns 

One  example  for 
the 
communication  of  information  about  newly  launched  products  to  the  anti-poison 
centres  in  the  EU:  At  present,  the  economic  operator,  in  order  to  launch  a  product 
EU-wide, has to communicate a frame formulation of this item to these approx. 12-
15  different  anti-poison  centres.55  This  adds  to  the  notification  to  the  market 
is 
surveillance 
manufactured/imported.  Frequent  changes  of  product  formulations  (approx.  60.000 
products are reformulated or entirely new developed every year), create considerable 
administrative costs. In application of the standard cost model 

the  Member  State  where 

authority  of 

the  product 

Σ P x Q 
where P (for Price) = Tariff x Time 
and Q (for Quantity) = Number of entities concerned x Frequency 

these  costs  are  approx.  55  Mio  EUR  for  the  EU  cosmetics  industry.  These  costs 
could be reduced by approx. 80% to approx. 11 Mio. EUR (detailed assessment56 is 
set  out  in  Annexes  3  and  4),  if  the  communication  of  information  to  anti-poison 
centres was 

–  based on identical information for each Member State; 

–  submitted  centrally  in  electronic  form  through  one  portal  together  with  the 

information submitted to the market surveillance authority; and 

–  free of charge. 

55 

56 

Art. 7 (3) Cosmetics Directive; Note, that the notification to anti-poison centres must not be confused 
with the notification to surveillance authorities. 
In accordance with chapter 10 of the annexes to the Commission guidelines on impact assessment. 

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These costs are mainly linked to the launch of new product formulations. As approx. 
half of all product formulations placed each year on the EU-market stem from SMEs, 
it can be estimated that SMEs have a share of approx. 50% of these savings. 

A change of the notification system as set out above would require the creation of a 
single electronic portal for submission of information. Such a single portal would be 
set  up  and  maintained  by  the  European  Commission.  In  the  light  of  previous 
experiences  with  IT  support  tools  in  other  sectors,  the  costs  for  setting-up  such  an 
electronic single portal are estimated to be approx. EUR 110 000.57

Another  example  for  the  benefits  of  an  amendment  concerns  the  inventory  of 
ingredients.  The  inventory  of  ingredients  is  a  list  of  “artificial”  names  of  all 
chemicals which are of interest for the cosmetics industry. These international names 
are of high practical importance for product labelling: They are independent of any 
national  language  and  do  not  need  to  be  translated.  However,  while  there  are 
constantly  new  chemicals  for  a  potential  use  as  cosmetic  ingredient  “discovered” 
(approx. 500 per year), the update of the inventory is a very cumbersome procedure, 
involving translation of the description of the function and the chemical name of the 
substance  and  adoption  under  Comitology  procedure.  This  process  takes  several 
years.  This  is  why  there  has  been  only  one  update  of  the  inventory  in  the  past  11 
years: Today, 5 000 cosmetics ingredients of potential interest for the EU Cosmetics 
industry  are  not  listed  in  the  EU  inventory  of  ingredients.  For  these  ingredients, 
industry has to research a suitable internationally-recognised name. This creates costs 
for businesses, in particular for SMEs with limited resources for regulatory aspects, 
considerably.  These  costs  could  be  removed  if  the  inventory  was  updated  more 
regularly. Moreover, the overall objective of international convergence of regulation 
would  be  met,  as  the  ingredient’s  names  follow  are  identical  in  many  different 
regulatory systems worldwide. 

On  the  negative  side,  unless  its  clarity  and  impact  are  carefully  considered,  any 
amendment  to  the  Cosmetics  Directive  could  create  new  legal  uncertainties  and  is 
likely to bring about regulatory changes to which cosmetics businesses must adapt.  

5.1.3.  Comparison of options 

A  comparison  of  the  two  policy  options  (informal  guidelines  or  legal  amendment) 
reveals  that  an  amendment  is  preferable,  provided  that  it  takes  into  account  the 
stakeholders’ needs, previous experiences with existing guidelines and other existing 
Community  legislation  in  similar  fields.  This  has  also  been  suggested  by  several 
contributors during the public consultation.  

This approach would ensure legal certainty for issues that have been identified as key 
by  the  Commission,  Member  States  and  stakeholders.  At  the  same  time,  it  would 
reduce costs for compliance by 10%58 without compromising the overarching policy 
objectives. Moreover, certain measures facilitating the management of the Cosmetics 
Directive  would  bring  about  important  savings  for  EU-businesses.  One  example  is 

57 

58 

Cf. also the the ex-ante evaluation of implications for the Community budget in the legislative financial 
statement  submitted,  in  accordance  with  the  Manual  of  the  operating  procedures  of  the  Commission 
together with the Commission proposal. 
Cf. above, 2.2.1.a. 

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29 

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the cut of administrative costs for notification of products (be they re-formulations or 
entirely new developments). In application of the standard cost model 

Σ P x Q 
where P (for Price) = Tariff x Time 
and Q (for Quantity) = Number of entities concerned x Frequency 

these  costs  are  reduced59  by  80%  if  the  information  to  be  submitted  to  all  relevant 
anti-poison  centres  was  centralised  and  jointly  submitted  with  the  notification  to 
market surveillance authorities.

It is clear that an amended Cosmetics legislation may require cosmetics businesses to 
adapt to changes in the regulatory environment. Any change of the legal environment 
may  lead  to  additional  costs.  To  address  this,  the  challenge  for  the  Commission  as 
well as the Community legislator lies in combining  

•  a  careful  assessment  of  the  impact  of  any  change  as  compared  to  the  present 

situation; and 

•  a  sufficient  implementation  period  for  industry  in  order  to  react  to  legislative 

changes of the Cosmetics legislation. 

5.2. 

Objective 2: Removing divergences between national laws 

5.2.1.  Policy option 1: No EU action 

The Commission has considered this option. In particular, the Commission is aware 
that any new legislation could create new legal uncertainties and requires adaptation 
of the business environment. This adaptation is costly – in particular for SMEs when 
looking at costs on a per item basis.  

On  the  other  hand,  a  no  policy  change  scenario  would  mean  that  the  rules  on  the 
internal market would continue to differ without adding value. 

5.2.2.  Policy option 2: Turning the entire Cosmetics Directive into a Regulation 

On  the  positive  side,  a  Regulation  would  mean  Europe-wide  rules  that  would  be 
directly  applicable  without  any  need  for  transposition  in  the  national  laws  of  27 
Member States (as is the case with Directives). This would create a single identical 
legislative framework as the sole reference for operators on the entire internal market 
and address the difficulties described above. The public consultation also highlighted 
that  a  Regulation  would  ensure  uniform  interpretation  not  only  by  authorities,  but 
also by manufacturers. 

This  is  particularly  inherent  in  chemicals  legislation  which,  compared  with  other 
legislation, is highly prescriptive. Not surprisingly, today almost all the Directives on 
chemical safety have been, or are being, replaced by Regulations. Examples include 
the  Detergents  Directive 
the  Detergents  Regulation  648/2004 
73/404/EEC),  the  REACH  Regulation  1907/2006  (replacing  several  Directives  on 
chemical safety, including Directive 76/769/EEC) and the proposal for a Regulation 

(replacing 

59 

Cf. Annexes 3 and 4. 

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on  the  “Global  Harmonised  System”  of  classification  and  labelling  –  GHS 
(COM(2007) 355 final). 

An  important  positive  aspect  concerns  the  functioning  of  the  internal  market:  In 
particular from an industry perspective, removal of the need for transposition would 
enable  simultaneous  launches  of  new  products  on  the  entire  EU  market  instead  of 
staggering  launches  to  ensure  regulatory  compliance  in  specific  Member  States. 
Based on research conducted for the Commission60, it can be estimated that waving 
these  verifications  of  compliance  alone  would  save  40  person-hours  per  product 
formulation launched, thus amounting to savings of approx. 50 Mio EUR per year for 
EU businesses.  

Another  positive  aspect  concerns  access  to  the  law:  In  the  public  consultation, 
present practices of Member States to transpose the Cosmetics Directive in differing 
and unrelated pieces of legislation were severely criticised as onerous and costly. A 
Regulation would provide for one set of legal rules. 

At a more general level, in the light of various comments from stakeholders during 
the public consultation, two issues need clarification: 

–  first,  the  choice  of  the legislative technique has  no impact on the level  of  safety 
provided for by the Cosmetics Directive. In particular, it is wrong to assume that a 
Cosmetics  Directive  sets  only  minimum  standards  to  which  Member  States  can 
“add”.  This  is  not  the  case.  Today’s  Cosmetics  Directive  is  exhaustive,  and 
Member  States  may  not  adopt  additional  rules  on  labelling,  ingredients  and 
efficacy.  Turning  the  same  content  into  a  Regulation  would  have  no  impact  on 
this principle; 

–  second, the deadlines for implementation are independent of the choice of form of 
legislation.  When  setting  deadlines  for  implementation  of  amending  regulations, 
the  regulator  would  need  to  take  into  consideration  the  time  needed  today  for 
transposition into national law.  

On the negative side, EU legislation by means of Regulations removes the possibility 
for Member States to introduce EU law into their existing national law, which may 
be useful in terms of the coherence and comprehensiveness of the national regulatory 
system. 

5.2.3.  Policy  option  3:  Redrafting  the  enacting  terms  as  a  Directive  and  turning  only  the 

annexes into a Regulation 

On the positive side, reserving the legal form of a Regulation for the annexes to the 
Cosmetics Directive would make it possible to adapt the body of the Directive to the 
national  peculiarities  of  each  Member  State’s  legal  system.  During  the  public 
consultation some submissions argued that this was particularly relevant to SMEs.  

On  the  negative  side,  the  disparities  between  the  national  laws  implementing  the 
enacting  terms  would  persist.  While  the  enacting  terms  of  the  Cosmetics  Directive 
provide for detailed rules on labelling, etc., the (small) differences in the transposing 

60 

Cf. “Impact of European Regulation on the EU Cosmetics Industry” (RPA, 2007), chapter 4.2. 

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laws  of  Member  States  lead  to  considerable  increases  in  the  costs  for  businesses 
without adding value in terms of consumer safety.  

Rephrasing  these  details  in  the  same  type  of  legislation  is  not  conducive  to 
objective 2,  as  30  years’  experience  with  management  and  implementation  of  the 
Cosmetics Directive show.  

Moreover, in terms of the burden on national authorities, transposing highly detailed 
legal  provisions  in  27  national  laws  (plus  monitoring  by  the  Commission)  places  a 
heavy and costly burden on public authorities and regulators without adding value. 

5.2.4.  Comparison of the options 

This assessment of the impacts reveals that out of the three options (no EU-action – 
Regulation – re-drafted Directive) the option of a recast  in form of  a Regulation is 
preferable. It is the most effective option to reap the benefits from an internal market 
for  cosmetic  products.  At  the  same  time,  it  is  wrong  to  assume  that  a  Regulation 
would  lead  to  a  common  lowest  denominator  in  terms  of  consumer  protection: 
Already today, the Cosmetics Directive is exhaustive.  

It shall also be stressed here that it would be incorrect to assume that a Regulation 
would be less  accessible  for  stakeholders. A Regulation is obviously adopted in all 
official  EU  languages  and  rendered  public  like  in  any  national  official  journal. 
Therefore,  access  to  the  law  would  be  ensured  if  the  text  was  adopted  as  EU 
Regulation. 

5.3. 

Objective 3: Ensuring a high level of safety in cosmetic products in the light of 
innovation in the industry 

5.3.1.  Policy option 1: No EU action 

“No  EU  action”  would  mean  continuing  with  the  existing  mechanisms  to  address 
issues  concerning  the  safety  of  cosmetic  products,  mainly  by  regulating  individual 
ingredients. 

The Commission has considered this option. The Commission is well aware that EU 
action  in  this  field  could  create  new  regulatory  burdens.  Therefore,  it  is  crucial 
carefully to assess all the consequences of any proposed amendments. In particular, 
there  is  a  risk  that  any  changes  to  the  rules  on  product  labelling  could  lead  to 
considerable  costs  for  the  industry  stemming  from  the  need  for  new  label  artwork 
(which  is  particularly  expensive  for  aerosol  labelling),  printing  plates, repackaging, 
packaging write-offs, etc.  

Example: The need to relabel products outside the normal cycle of brand rotation leads 
to additional costs for SME’s of up to 50 000 EUR per product formulation.61

Therefore, no legislative changes may in some cases be preferable to those which are 
unreflected and disproportionate. 

61 

Cf. “Impact of European Regulation on the EU Cosmetics Industry” (RPA, 2007), chapter 3.2.3. 

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However,  as  set  out  above,  there  are  considerable  safety-challenges  lying  ahead 
which  need  to  be  addressed  today.  As  set  out  above  (2.2.3.),  it  is  not  possible  to 
quantify  or  calculate  the  costs  that  would  arise  if  these  future  challenges  are  not 
addressed.  Yet,  it  is  certain  that  this  damage  can  be  considerable,  both  in  terms  of 
public health as well as consumer trust in the safety of the products purchased on a 
daily basis. 

In  a  fast-moving  sector  as  the  cosmetic  one  it  is  not  possible  to  await  upcoming 
safety concerns. In particular, it is insufficient to continue relying on a “cook book 
approach” which relies heavily on a regulation “substance-by-substance” in annexes 
to the Cosmetics Directive, as originally envisaged by the Community legislator (cf. 
above,  2.1.).  Reliance  on  this  approach  has  serious  shortcomings,  especially  for 
innovative and complex products: 

•  first,  it  could be perceived as freeing industry  of its responsibility to ensure that 
substances and products are safe. Once a substance has been regulated in detail in 
the Cosmetics Directive, there is a risk that the industry might stop following up 
the  safety  aspects  related  to  this  substance.  This  responsibility  remains 
particularly crucial when it comes to combination of ingredients; 

•  second, there is a danger that, when engaging in detailed assessment of the safety 
of  a  specific  substance,  the  regulator  might  lose  sight  of  the  real  risks  posed  by 
cosmetic products placed on the Community market; 

•  third, the regulation of individual substances, which is practically the only tool to 
address safety concerns today, is an extremely lengthy process: The time between 
identification  of  a  substance  which  poses  a  potential  risk,  evaluation  of  the  risk, 
regulation  through  technical  adaptation  of  the  Cosmetics  Directive  and  actual 
changes  in  the  composition  of  the  product  sold  to  the  consumer  is  very  long 
(approximately five years). 

Therefore,  it  is  insufficient  to  continue  “business  as  usual”  and  to  consider 
regulation  of  individual  ingredients  the  first  choice  for  addressing  product 
safety issues. 

5.3.2.  Policy option 2: Non-binding guidelines, self-regulation 

Another option would be non-legislative measures and in particular the adoption of 
non-binding guidelines and self-regulation.  

The main difficulty of non-legislative regulation lies in its voluntary compliance and 
the  impossibility  for  competent  authorities  to  enforce  those  rules.  This  is  a  crucial 
aspect:  Recent  RAPEX  notifications  confirm  that  the  cosmetics  sector  is  prone  for 
“rough traders” who import low quality products into the EU. Incoherent compliance 
does not only put the consumer at risk – it also distorts competition to the detriment 
of compliant companies. 

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Thus, while non-legislative regulation may work well in markets characterised by an 
oligopolistic industry structure, it is less workable in the cosmetics sector, which is 
characterised by approx. 3800 EU-cosmetic producers and importers.62

Therefore, in order to ensure safety of all products placed on the market, and to avoid 
a distortion of competition between the players, it was considered crucial to ensure 
enforceability of these rules. 

Another  argument  is  based  on  historic  experience:  Already  today,  the  European 
industry  association  provides  guidance  for  the  safety  assessment  of  cosmetic 
products.63 Moreover, the “Notes of Guidance for the testing of cosmetic ingredients 
and  their  safety  evaluation”  of  the  Scientific  Committee  for  Consumer  Products 
address also the safety assessment of a finished cosmetic product.64

As  set  out  above  (1.1.),  despite  this  existing  support,  many  product  safety 
assessments  do  presently  not  live  up  to  the  standard  competent  authorities  would 
need for an efficient in-market control. 

Finally,  and  from  a  more  political  perspective,  there  is  still  a  critical  perception  in 
Europe towards non-legislative regulation. This aspect is particular important in the 
field  of  consumer  goods,  such  as  cosmetic  products.  A  recent  example  is  the 
Commission’s  experience  with  the  industry  guidelines  on  the  safe  use  of  fragrance 
material  (so-called  “IFRA-guidelines”).  Despite  these  guidelines,  there  has  been 
heavy political and public pressure on the Commission as regulator to adopt legally-
binding rules. The Commission, albeit hesitant, had to give way to this pressure and 
introduced these guidelines by way of a technical amendment into the Annexes to the 
Cosmetics Directive. 

5.3.3.  Policy  option  3:  Restricting  the  scope  of  the  Cosmetics  Directive  by  reviewing  the 

definition of “cosmetic product” 

Presently,  any  substance  which  exerts  a  non-insignificant  pharmacological, 
immunological  or  metabolic  effect  falls  within  the  scope  of  the  EU  legislation  on 
medicinal products. 

The impact of any reduction of the scope of the Cosmetics Directive would depend 
on the alternative regulation applied. Products which, following any such reduction 
would fall under the sectoral legislation on medicinal products or biocidal products 
would require authorisation at European or national level before they could be placed 
on the EU market. This should ensure that the efficacy and safety of these products 
are  verified,  but  it  would  have  a  huge  negative  impact  on  access  to  the  market  for 
innovative  or  reformulated  cosmetic  products.  Moreover,  this  option  would  be  a 
disproportionate  means  to  ensure  product  safety.  Experience  with  other  regulatory 
systems shows that the European approach of a wider definition of cosmetic products 
combined  with  stringent  rules  on  product  safety  is  better  suited  to  ensure  both 
innovation  and,  at  the  same  time,  a  high  level  of  protection.  One  example  is  the 
regulation  of  sunscreen  products:  these  are  usually  cosmetics  in  the  EU:  They  are 

62 
63 
64 

Cf. Annex 2. 
http://www.colipa.com/site/index.cfm?SID=15588&L0=15604&OBJ=15832  
Chapter 6 of the guidelines on the SCCP. 

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subject to rules on labelling and efficacy claims. Moreover, all UV-filter used have to 
be assessed by the SCCP and listed in the Annexes of the Cosmetics Directive by the 
Commission  as  risk-manager.  In  the  U.S.,  sunscreen  products  which  are  not 
addressed in the respective monograph have to undergo pre-market authorisation as 
“over the counter drug”. While the end-result is the same (i.e. the UV-filter used has 
been  assessed  by  the  authority),  the  U.S.  approach  delays  market  access,  creates 
additional costs for registration and acts as barrier for innovation in a product group 
relevant for safeguarding public health. 

Apart from that, applying different regulatory frameworks to products which – today 
–  all  fall  under  the  Cosmetics  Directive  would  increase  legal  uncertainty  about  the 
legislation applicable.  

This conclusion was confirmed by the public consultation. Virtually none of the 72 
contributions from stakeholders and Member States was in favour of any substantial 
rethinking of the scope of the Cosmetics Directive. 

5.3.4.  Policy option 4: Ex-ante authorisation for all cosmetic ingredients/products 

Ex ante authorisation of all cosmetic products or their ingredients could ensure a high 
level  of  product  safety.  However,  there  are  numerous  negative  aspects  to  this 
approach. It would be: 

•  disproportionate to the risk posed by cosmetic products: cosmetic products are not 
intended to be ingested, inhaled or injected. Exposure is thus very different from 
medicinal  products  and  novel  food.  Moreover,  cosmetic  products,  by  definition, 
must  have  no  more  than  an  insignificant  impact  on  the  metabolism.  Therefore, 
generally speaking, exposure to and the foreseeable risk stemming from cosmetic 
products  do  not  justify  a  regulatory  approach  similar  to  that  used  for  medicinal 
products and novel foods; 

•  highly burdensome both for regulators and for the industry, considering that every 
year the EU industry places approximately 60 000 new cosmetic formulations on 
the EU market; 

•  a hindrance to innovation and to new products entering the market. 

Finally,  ex-ante  authorisation  would  run  counter  to  all  international  regulatory 
systems worldwide. 

5.3.5.  Policy option 5: Introducing additional “positive lists” 

“Positive  lists”  indicate  which  substances  out  of  a  group  are  allowed  for  use  in 
cosmetic products.  

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Today  the  Cosmetics  Directive  provides  for  three  “positive  lists”  (for  UV  filters, 
colorants65  and  preservatives).  The  Commission  aims  to  extend  the  system  of 
positive lists to hair-dyeing substances.  

Policy option 4 would be to establish further positive lists in the Cosmetics Directive.  

Positive  lists  provide  for  maximum  harmonisation  of  cosmetic  ingredients  on  the 
Community  market  –  thereby  contributing  to  the  internal  market  for  cosmetic 
products.  Moreover,  they  create  a  degree  of  trust  as  the  SCCP  has  considered  the 
safety evaluation of these ingredients. 

Positive  lists  give  companies  strong  support,  as  they  provide  guidance  on  the  safe 
concentration  limits  for  substances.  SMEs  in  particular  do  not  have  their  own 
research  resources  but  rely  heavily  on  the  safety  restrictions  for  substances  on  the 
positive lists under the Cosmetics Directive. 

The  existing  positive  lists  under  the  Cosmetics  Directive  have  also  greatly 
contributed  to  international  alignment.  Many  regions  in  the  world  have  introduced 
positive lists for the same groups of ingredients as the EU. Often the substances on 
these lists are the same as in the EU. 

Despite these positive aspects, there are a number of arguments against adding new 
positive lists to the Cosmetics Directive. Many of these were voiced in the responses 
to the public consultation, which stressed that, rather than adding new positive lists, 
the  existing  positive  lists  should  be  better  managed.  This  includes  clarification  of 
their  scope  (e.g.  definition  of  “preservative”  and  “UV  filter”)  and  of  various 
restrictions contained therein (e.g. “field of applications” for colorants). 

The following negative aspects must be considered:  

First of all, the ingredient-by-ingredient approach does not in itself suffice to ensure 
product  safety,  as  it  takes  no  account  of  interactions  between  ingredients.  In 
particular, the responses to the public consultation stressed that substances can pose 
different toxicological risks, depending on the texture, matrix, pH value, solubility, 
etc.  of  the  final  preparation.  Positive  lists  tend  to  be  perceived  by  companies  as  a 
guarantee that the substance is safe under any circumstances. However, positive lists 
remain  substance-related  and  give  no  certainty  about  the  safety  of  the  final 
formulation. 

Another impact is on resources. This has been grossly underestimated in the past. As 
explained  in  section  2.1.,  the  original  approach  back  in  1976  was  to  establish  a 
“regulatory cook book” with restrictions for all chemical ingredients employed in the 
cosmetics  sector.  This  plan  has  failed.  Experience  has  shown  that  assessment  of 
individual  substances  ties  up  considerable  regulatory  resources.  Despite  over  30 
years of best efforts, today the Cosmetics Directive provides for detailed regulation 
of  “only”  approximately  300  chemical  substances  of  potential  interest  to  the 
cosmetics  industry.  Amending  the  Cosmetics  Directive  by  means  of  Commission 

65 

Presently this list is restricted to skin-colouring. Hair dyeing substances are excluded. However, in the 
framework of the hair dyes strategy the Commission aims at extending this positive list to hair dyeing 
substances. 

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Directives  on  each  ingredient  has  proved  too  lengthy,  burdensome  and  resource-
intensive.  The  time  between  identification  of  a  substance  which  poses  a  potential 
risk,  evaluation  of  the  risk,  regulation  by  means  of  technical  adaptation  of  the 
Cosmetics Directive and actual changes in the composition of the product sold to the 
consumer  is  very  long  (approximately  five  years).  The  Scientific  Committee  for 
Consumer  Products  (“SCCP”)  already  has  an  enormous  backlog,  with  almost  100 
opinions on the safety of individual substances pending.  

Another negative aspect is that the costs to businesses will be increased considerably 
without  necessarily  improving  the  safety  of  the  product  as  a  whole.  The  costs  of 
positive lists to industry stem from various sources, such as: 

•  compilation  of  the  evaluation  data  as  set  out  in  the  SCCP  guidelines.  The  data 
submitted  to  the  SCCP  are  put  together  by  the  industry.  The  SCCP  does  not 
perform  toxicological  tests,  but  only  reviews  the  results  and  the  conclusions 
drawn from them. The costs for industry to establish the necessary evaluation data 
range  from  EUR  100 000  to  EUR  1 000 000  per  substance.  However,  they  are 
usually borne by a consortium of companies to share these costs; 

•  delayed  market  access.  This  is  particularly  crucial  in  such  a  highly  innovative 

sector as cosmetics; 

•  loss  of  IP  protection.  Innovative  companies  cannot  economically  exploit  an  IP-
protected  molecule  on  the  EU  market  until  the  substance  has  been  evaluated  by 
the SCCP and listed by the regulator on a “positive list”. 

These important shortcomings had already been detected in the late 1980’s, when the 
legislator  started  to  turn  away  from  the  regulation  “ingredient-by-ingredient”  by 
introducing the requirement of a product information file (cf. above, 3.4.). 

5.3.6.  Policy option 6: Sharpening the focus on manufacturer responsibility 

As explained  in  sections 2.1. and 4.3.6., today the Cosmetics Directive is based on 
the  principle  of  manufacturer  responsibility.  This  is  supplemented  by  regulation  of 
individual substances used as cosmetics ingredients. 

Policy  option  6  envisages  sharpening  the  focus  on  manufacturer  responsibility  and 
surveillance  by  means  of  in-market  controls.  It  would  not  abolish  the  existing 
“positive  lists”  and  lists  of  prohibited  substances.  Instead,  it  would  strike  a  better 
balance  between  “manufacturer  responsibility”  and  “prescriptive  regulation  of 
individual ingredients” by placing greater emphasis on the former. 

Generally  speaking,  the  positive  side  of  strengthening  the  concept  of  manufacturer 
responsibility  lies  in  increasing  the  safety  of  cosmetic  products  placed  on  the 
Community  market,  without  necessarily  regulating  individual  substances.  Another 
positive aspect concerns the safety of new and innovative products. A sharper focus 
on manufacturer responsibility allows a rapid reaction to changes in the formulation 
of  cosmetic  products  -  not  only  if  new  ingredients  are  used,  but  also  for 
reformulations and for new matrices and textures. 

A  sharper  focus  on  in-market  controls  would  entail  a  series  of  complementary 
measures: 

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•  bringing  the  safety  evaluation  of  the  finished  cosmetic  products  in  which  the 
manufacturer  has  to  engage  prior  to  placing  a  product  on  the  market  (and  the 
related  technical  documentation)  up  to  the  standard  recommended  by  the 
Scientific Committee for Consumer Products (see section (a) below);  

•  making  in-market  control  and  cosmetovigilance  more  effective  (see  section  (b) 

below); and 

•  increasing requirements on notification (see section (c) below). 

The advantages and disadvantages of these different measures are discussed below: 

(a) 

Bringing  the  safety  evaluation  of  the  finished  cosmetic  products  by  the 
manufacturer  (and  the  related  technical  documentation)  up  to  the 
standard  recommended  by  the  Scientific  Committee  for  Consumer 
Products66 

On  the  positive  side,  clearer  requirements  for  safety  evaluations  would  allow 
assessing  the  safety  of  a  product  as  a  whole,  rather  than  its  individual  ingredients. 
This is particular relevant in the cosmetics sector, as many ingredients have different 
penetration  characteristics  depending  of  the  matrix  and  texture  they  are  used  in. 
Indeed,  as  shown  above,  it  has  been  a  misconception  in  the  early  phase  of  the 
Cosmetics  Directive  that  issues  of  safety  can  be  addressed  by  relying  mainly  on  a 
“cook  book”  of  individual  substances.  Rather,  it  is  at  least  equally  important  to 
comprehensively  assess  the  safety  of  a  product,  and  to  look  at  the  interactions, 
including  texture,  matrix,  ingredients  that  tend  to  weaken  the  skin  barrier,  etc.  The 
assessment of individual substances is not sufficient in this respect and can only be 
complementary. 

Another  positive  aspect  lies  in  the  possibility  for  competent  authorities  to  react 
quickly  to  safety-concerns  stemming  from  cosmetic  products  or  their  constituting 
ingredients. So far, the possibility to refer to the cosmetics safety assessment in order 
to assess the safety of a substance/product was limited. Research conducted for the 
Commission shows that the complete lack of a frame of reference in order to judge 
compliance with safety requirements has led to a situation where the means of choice 
to react to concerns has been a referral to the matter to the Commission, who would 
engage in a years-long evaluation of an individual ingredient. In the future, it will be 
easier  for  competent  authorities  to  turn  to  the  manufacturer  of  the  cosmetic  and  to 
verify  if  he  has  effectively  engaged  in  a  thorough  safety  evaluation  of  the  product, 
including  inter  alia  establishment  and  assessment  of  the  safety  of  individual 
ingredients where necessary. This allows for quick reactions to safety concerns in a 
sector,  which  is  characterised  by  constant  innovation  in  particular  through  re-
formulation, without the need to regularly address specific substances in the annexes 
of the Cosmetics Directive setting out banned/restricted uses. 

A  further  positive  aspect  concerns  effective  enforcement.  As  there  is  a  lack  of 
specification  of  the  extent  of  the  cosmetics  safety  assessment  of  the  cosmetics 
manufacturer,  competent  authorities  refrain  from  its  effective  enforcement.  Rather 
than verifying cosmetics safety assessment, Member States often limit themselves to 

66 

Chapter VI of the notes of guidance of the Scientific Committee for Consumer Products, 6th revision. 

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checking the composition and the labelling of a product. Research conducted for the 
Commission suggests that today, 2 700 cosmetics safety assessments are verified in 
the  EU  per  year.  This  compares  to  approx.  13 000  products/year  in  the  EU,  whose 
product formulations are checked against the detailed restriction of ingredients in the 
annexes to the Cosmetics Directive. A clarification about the requirements for safety 
assessments would help to intensify these controls. 

Moreover, strengthened requirements for safety evaluations by the manufacturer do 
not act as barrier to innovation as an introduction of additional positive lists would 
do (cf. 5.3.5.). This is crucial in a sector which can be characterised by rapid changes 
in product portfolio and ingredients used. 

On  the  negative  side,  strengthened  requirements  are  likely  to  raise  costs  for 
companies  who  have  so  far  neglected  the  need  for  a  robust  product  safety 
assessment. A “correct” cosmetics safety assessment requires in average approx. 240 
person-hours  for  an  entirely  new  product  formulation.  For  product  formulations 
which are merely adapted regarding one aspects of the product (for example, texture, 
another  colour  shade,  etc.)  the  person-hours  required  can  decrease  considerably: 
Updates of cosmetics safety assessment require in average approx. 30 person-hours. 

Moreover, it was highlighted during the public consultation that even SMEs handle 
in  average  60  product  formulations  per  company.  The  3%  non-SME’s  handle  in 
average  approx.  1 000  product  formulations  per  company.  While  the  non-SME’s 
replace or re-formulate approx. 30% of their formulations per annum, SME’s replace 
or re-formulate approx. 20% of their product formulations every year. 75% of all re-
formulations are slight changes to existing formulations which are due to 

- Change of supplier; 

- Slight change of matrix, texture, or a specific ingredient. 

information 

industry  consultation  and  a  Commission-study, 

the 
Based  on 
Commission estimates that a correct product safety assessment for a new formulation 
costs  in  average  approx.  15 000  EUR.  The  update  of  a  safety  assessment  for  a  re-
formulated product costs in average approx 1 800 EUR.67 Considering that each year 
approx.  45 000  products  are  re-formulated,  and  approx.  15 000  products  are  newly 
created,  this  amounts  to  costs  of  approx.  300  Mio  EUR  for  the  EU  cosmetics 
industry.  As  SMEs  count  for  approx.  50%  of  all  new  or  re-formulated  products 
placed on the EU market, it can be estimated that they also share about a half of these 
costs for compliance. 

It  is  important  to  stress  that  these  costs  are  no  new  costs.  Rather,  these  costs  are 
today’s  costs  for  a  robust  cosmetics  safety  assessment.  However,  as  stated  above, 
there  has  been  a  lack  of  compliance  with  the  obligation  to  undertake  a  cosmetics 
safety  assessment  –  in  particular  due  to  a  lack  of  clear  requirements  about  what 
information a cosmetics safety assessment should contain. If these requirements were 
specified,  costs  for  non-compliant  companies  would  rise.  It  is  difficult  to  quantify 
this rise in costs. A careful estimation would depart from the fact that approx. 40% of 
all  cosmetics  safety  assessments  are  considered  as  insufficient,  i.e.  they  lack 

67 

Cf. “Impact of European Regulation on the EU Cosmetics Industry” (RPA, 2007), pp. 29 et sequ. 

EN 

39 

   EN 

                                                 
information  considered  necessary  to  prove  the  safety  of  the  product  placed  on  the 
market. If one assumes that those safety information files are in average approx. 50% 
complete,  one  can  deduce  that  costs  for  non-compliant  companies  would  rise  by 
approx. 60 Million EUR compared to today. 

(b) 

Rendering in-market control and Cosmetovigilance more effective 

Strengthened in-market control 

On the positive side, a strengthened in-market control based on the possibility for the 
competent  authority  to  request  the  assessment  of  a  product  information  file  would 
greatly  ensure  safety  of  cosmetic  products  in  the  future.  This  was  also  largely 
confirmed in the responses to the public consultation. It was in particular pointed out 
that  in-market  surveillance  needs  strengthening  in  order  to  ensure  fair  competition 
vis-à-vis “rough traders” who deliberately run the risks of sanctions. 

On  the  negative  side,  strengthened  in-market  control  means  more  frequent  control. 
This,  in  turn  raises  administrative  costs.  According  to  research  carried  out  for  the 
Commission, the making-accessible of a product information file takes up approx. 10 
person-hours for the manufacturer/importer holding this file. In view of the present 
density of in-market controls (approx. 2700 controls of product information files in 
the EU per year), these administrative costs amount presently to approx. 1.6 million 
EUR  for  EU  cosmetic  businesses.  Any  increase  in  in-market  control  would  mount 
these costs proportionally.  

Strengthened cosmetovigilance 

In  terms  of  a  strengthened  cosmetovigilance,  the  concept  as  set  out  above  (4.3.6.) 
would  add  as  new  element  an  obligation  for  the  person  responsible  for  placing  the 
product  on  the  market  to  actively  report  all  serious  undesirable  effects  to  the 
competent authority of the Member State concerned (i.e. to the Member State where 
the  product  information  file  is  made  available  to  the  competent  authorities).  This 
Member State would then inform the other market surveillance authorities. 

A strengthened cosmetovigilance system along these lines would allow authorities of 
all Member States to detect rising safety-problems. 

On the negative side, reporting these events would constitute administrative costs of 
approx. EUR 1.5 Million per year for the EU cosmetics industry.68

(c) 

Increasing  notification  requirements 
authorities69 

to 

the  market 

surveillance 

In  terms  of  increase  of  notification  requirements,  its  impact  depends  largely  of  the 
extent of information to be notified and to whom.  

68 
69 

Cf. Annex 4. 
Note, that this notification is different from those to the anti-poison centres of some of the EU Member 
States. 

EN 

40 

   EN 

                                                 
Today,  the  Cosmetics  Directive  requires  the  manufacturer/importer  to  notify  the 
product and the place of manufacture/importation to the competent authority of that 
Member State. 

This requirement could be modified in various aspects: 

Addressees of notification: In terms of addressees of a notification, if the competent 
authorities  of  all  Member  States  were  to  be  notified,  (cf.  4.3.6.),  the  increase  of 
administrative  costs  would  be  essentially  27-fold.  However,  there  would  be  no 
additional  costs  if  the  notification  of  all  Member  States  was  done  jointly  by  one 
submission  through  one  electronic  portal.  Moreover,  costs  could  be  decreased 
considerably  if  the  notification  was  submitted  jointly  with  the  communication  of 
information  to  anti-poison  centres.  In  terms  of  efficacy,  this  solution  would  allow 
competent market surveillance authorities to gather information: 

-  that  a  certain  cosmetic  product  has  been  placed  on  the  Community  market  and 
where this was done for the first time;  

- some basic information about this product; and 

-  which  competent  market  surveillance  is  responsible  for  checking  the  cosmetics 
safety assessment.  

The alternative, i.e. a notification only of those Member States where the product is 
made  available  to  the  final  consumer  would  amount  to  a  tremendous  burden  for 
industry:  in  particular,  it  is  usually  not  possible  for  the  manufacturer  to  control  on 
which  national  territories  the  product  is  made  available  to  the  final  consumer. 
Therefore,  in  order  for  competent  authorities  to  have  a  complete  picture  of  the 
products  sold  on  its  territory  to  the  final  consumer,  the  notification  requirement 
would need to be extended to wholesalers and intra-EU traders. This would lead to a 
dramatic  increase  of  administrative  burdens  for  many  EU  businesses.  These 
additional costs are not proportionate to the improvement of market surveillance: In 
particular, even this extensive notification requirement would not as such effectively 
inhibit rough traders to market products which are not compliant with the Cosmetics 
Directive. 

Extent of notification: Today, the Cosmetics Directive requires only the product and 
the  place  of  manufacture/importation  to  be  notified.  If  the  concept  set  out  above 
(4.3.6.)  was  followed  (i.e.  notification  of  quantitative/qualitative  formula),  the 
increase of administrative costs would be very considerable: Considering that there 
are  approx.  60 000  re-formulated  or  newly  developed  products  on  the  EU  market 
every  year,  notification  of  their  quantitative/qualitative  formulas  would  lead  to 
additional  administrative  costs  in  the  range  of  22  Mio.  EUR  for  EU-industry.  This 
would be an increase  by approx.  25%  compared to today’s administrative costs  for 
EU cosmetics businesses.70  

70 

In  application  of  the  assumption  that  extensive  notification  of  a  new  formulation  requires  10  person-
hours  for  an  entirely  new  product  and  5  person-hours  for  a  re-formulated  product.  The  total 
administrative costs at present are approx. 80 Mio EUR (cf. Annexes 2, 3) 

EN 

41 

   EN 

                                                 
This  increase  in  costs  would  not  necessarily  lead  to  an  improvement  of  in-market 
control:  Rather,  national  competent  authorities  would  be  “flooded”  with 
notifications: The notification of 60 000 new or changed product formulations would 
mean  that  each  national  competent  authority  would  receive  in  average  240 
notifications per working day – i.e. one notification per every 2 minutes.71 It is not 
possible  for  competent  authorities  to  process  –  let  alone  screen  –  this  information. 
Therefore, the submitted quantitative/qualitative formula does not as such support in-
market control. It still requires competent authorities to verify on their territory if the 
product is made available there. In this respect, it is clearly sufficient to indicate the 
basic  information  in  order  to  identify  the  product  and  the  place  where  the  product 
information file is made accessible in the EU. 

Moreover, there is a risk that the notification of qualitative/quantitative formulas of 
product is being perceived as clearance for safety-considerations by the person who 
places the product on the market. 

Finally, in practical terms the notification of a quantitative/qualitative formula bears 
the  risk  of  an  enormous  “data-cemetery”  with  millions  of  outdated  datapoints  –  a 
notified list of substances alone would lead to approx. 3 000 000 data-entries. 

5.3.7.  Comparing the options 

A comparison of these impacts reveals that out of the six options (no action – non-
binding guidelines – restricting scope – ex-ante authorisation – more positive lists – 
focus on manufacturer responsibility) the first option is not supportive to reach this 
objective.  Options  3,  4  and  5  would  lead  to  an  important  increase  in  regulatory 
burden for businesses, without necessarily contributing to the safety of the product. 
Moreover,  it  would  run  counter  experiences  in  the  past  and  in  other  regulatory 
systems. 

With regard to policy option 5, this does not mean that the existing positive lists in 
the  Cosmetics  Directive  should  be  scrapped:  These  positive  lists  have  certainly 
contributed to some degree to product safety. Abolishing them could be perceived as 
“rendering products less safe”. Moreover, it would destroy over 30 years of efforts to 
harmonise rules on certain ingredients which have caused safety concerns in the past. 

Policy  option  6  is  best  suited  to  achieve  objective  3.  It  would  ensure  safety  of 
cosmetic products without negative impact on innovation and on new developments 
as it would permit turning to the detailed regulation of individual ingredients only as 
ultima ratio.  

It  is  important  to  stress  that  option  6  is  not  a  change  in  paradigm  of  cosmetics 
regulation in the EU. Already today the Cosmetics Directive is based on the principle 
of  manufacturer  responsibility.  This  encompasses  in  particular  the  obligation  to 
assess the safety of the final product and to document this. However, while this point 
is crucial, it has been neglected by Community legislation, which has so far largely 
built on the concept of a prescriptive legislation “ingredient by ingredient”. In other 
words,  the  elements  set  out  in  option  6  exist  already  but  would  be  strengthen  to 

71 

On the basis of an 8-hours working day. 

EN 

42 

   EN 

                                                 
better  balance-out  the  two  elements  “manufacturer  responsibility”  and 
“descriptive regulation of individual ingredients”. 

Within  option  6,  several  measures  have  been  considered  (cf.  section  5.3.6.):  In  the 
light  of  the  arguments  put  forward,  the  approach  to  follow  shall  be  a  strengthened 
role of the cosmetics safety assessment, a better system of administrative cooperation 
and cosmetovigilance and a more far-reaching notification requirement as far as the 
addressees are concerned. 

Regarding  the  cosmetics  safety  assessment,  this  might  raise  costs  for  those 
companies whose products have so far not been sufficiently supported with such an 
assessment.  As  set  out  above  (5.3.6.a.),  establishing  a  cosmetics  safety  assessment 
means an increase in costs for regulatory compliance for companies, which have so 
far  neglected  their  obligation  to  self-assess  the  safety  of  their  products  and  to 
document  this.  According  to  Commission  research,  about  40%  of  the  cosmetics 
safety assessment made available to competent authorities in the framework of their 
in-market  control  are  not  sufficiently  robust,  ie.  They  lack  information  or  do  not 
sufficiently set out the reasoning supporting the safety of the product. Based on that 
figure, it can be estimated, that this increase in costs is approx. 60 Million EUR for 
EU cosmetics industry. 

However, there are a number of points to be considered: 

•  First  of  all,  the  rules  for  the  cosmetics  safety  assessment  would  be  sufficiently 
flexible and generic to not introduce disproportionate requirements: In particular, 
it is totally wrong to assume that a cosmetics safety assessment would consist of a 
“tick-box”  of  various  tests  to  be  executed.  This  would  go  contrary  all  overall 
objectives  set  out  above,  including  maintaining  the  rules  on  animal  testing  and 
international alignment. Information would be fundamentally different from risk-
assessment data for an individual cosmetic ingredient submitted to the Scientific 
Committee  for  Consumer  Products.  Rather,  the  cosmetics  safety  assessment 
would be a substantiated reasoning based on a large variety of information such as 
historical data, published data, communicated information from suppliers and read 
across data from other substances or preparations.  

•  Secondly, there are several aspects which mitigate costs related to the cosmetics 

safety assessment: For example,  

- REACH is going to ease access to information on chemicals as more information is 
going to be passed on from the chemical’s industry to the downstream user.72 This 
should  greatly  help  to  assess  the  toxicological  safety  of  the  finished  cosmetic 
products  in  a  strengthened  cosmetics  safety  assessment.  While  there  is  some 
uncertainty as to the portion of cosmetic ingredients falling within the scope of the 
REACH-  registration  (i.e.  produced/imported  in  quantities  >1  ton  per  year  per 
manufacturer/importer), figures available to the Commission suggest that about 70% 
of all cosmetic ingredients are  going to be  affected by the registration/information-

72 

Note,  that  the  obligation  to  pass  on  safety-data  on  ingredients  to  the  cosmetics  manufacturer  is 
independent from the obligation to assess the safety for the specific use in cosmetic products. The latter 
aspect  is  not  covered  by  REACH.  In  this  respect,  the  Cosmetics  Directive  is lex  specialis  (cf.  above, 
2.1.). 

EN 

43 

   EN 

                                                 
obligation of REACH, as they are produced by one or some manufacturers/importers 
in quantities >1 ton per year; 

-  the  Regulation  would  provide  for  sufficient  timelines  for  industry  to  implement 
requirements  for  a  cosmetics  safety  assessment.  As  products  are  re-formulated 
frequently, a sufficient timeline to implement the requirements for a cosmetics safety 
assessment allows for reduction of costs for compliance. 

If, despite these aspects, there is an increase in costs for regulatory compliance, this 
can be justified with the need to ensure safe products and a possibility to document 
this in in-market controls. 

In  terms  of  administrative  costs  of  a  Cosmetovigilance  system  as  discussed  above 
(5.3.6.), it has to be stressed that an active reporting system for serious undesirable 
effects greatly improves efficacy of in-market control by all competent authorities in 
the entire internal market. Against this background, a rise in administrative costs for 
businesses  in  the  scale  of  EUR 1.5 Mio.  per  year  is  justified  by  the  need  for 
competent authorities to be informed of emerging risks to consumer safety through 
cosmetic products.  

Considering a strengthened notification requirement, the arguments brought forward 
above  (5.3.6.c.)  support  extending  the  scope  of  addressees  to  all  competent 
authorities  in  the  internal  market  –  provided  that  this  is  done  through  a  centralised 
portal  in  order  to  not  increase  administrative  costs.  In  terms  of  content,  additional 
bureaucratic  burdens  in  form  of  a  rise  of  administrative  costs  by  approx.  25%  (cf. 
above, 5.3.6.c.) cannot be justified by a slight increase of effectiveness of in-market 
controls.  

5.4. 

Objective  4:  Introducing  a  possibility  to  regulate  CMR  1,  2  substances  on  the 
basis of their actual risk 

5.4.1.  Policy option 2 – taking risk into consideration at the classification stage 

The difficulty of objective 4 lies in the danger that the public – who is not necessarily 
familiar with the concept of “hazard” and “risk” – perceives it as “rendering products 
less  safe”.  Therefore,  the  positive  aspect  of  policy  option  2  would  be  that  the 
provisions  on  CMR  1,  2  substances  in  the  Cosmetics  Directive  would  not  be 
amended. 

However, there are a number of negative aspects linked to this policy option: 

The  classification  system  for  chemicals  in  the  EU  is  based  on  hazard.  It  is  not 
intended  to  assess  a  risk.  Rather,  this  aspect  (which  requires  consideration  of 
different exposure scenarios) is covered by downstream legislation. 

Thus, if one wanted to address issues of risk at the classification stage, it would mean 
a complete overhaul of the regulatory systems for chemicals in the EU. The negative 
impact  would  be  even  greater,  as  the  classification  system  is  currently  being 
harmonised on a global level.73

73 

„Global Harmonised System“, GHS. 

EN 

44 

   EN 

                                                 
Indeed,  it  would  be  wrong  to  “blame”  the  upstream  legislation  of  hazard 
classification for inconsistent results in downstream legislation. This aspect has been 
well summarised by the UK, Sweden and Portugal in a declaration made during the 
vote  on  the  2nd  adaptation  to  technical  progress  of  the  dangerous  preparations 
Directive:  “[t]he  proposal  [for  an  amendment  to  the  dangerous  preparations 
Directive]  may  create  unforeseen  and  unintended  problems  with  downstream 
legislation.  Specifically,  we  believe  that  [the  amendment  to  provisions  on 
classification] will in turn trigger the requirements of the Seveso Directive (Directive 
96/82  as  amended  by  Directive  2003/105/EC),  which  is  concerned  with  the 
prevention of major chemical accidents at fixed installations. […] This is not a fault 
of the classification sytems under Directive 67/548/EEC or Directive 1999/45/EC but 
the way the classification system is used to trigger application of Directive 96/82/EC. 
We  therefore  request  the  Commission  to  address  the  unintended  consequences  for 
downstream legislation with particular reference to Directive 96/82/EC.”74

5.4.2.  Policy  option  3  –  giving  the  possibility  to  allow,  in  exceptional  cases,  the  use  of  a 

CMR 1, 2 substance provided that the substance is safe 

This  policy  option  would  allow  the  use  of  a  CMR  1,  2  substance  under  very  strict 
conditions provided that the use of the substance is safe. 

In  particular,  the  requirements  set  out  in  policy  option  3  ensure  that  there  is  no 
persistent recourse to the Scientific Committee for the safety-evaluation of CMR1, 2 
substances. Rather, this would be done only in exceptional cases. 

In addition, the use of substances classified as CMR 1 or 2 would only be allowed if 
their safety has been clearly and unequivocally established. 

Moreover,  as  set  out  in  policy  option  3,  a  labelling  aiming  at  the  prevention  of 
misuse  (which  may  lead  to  a  different  exposure  and  thus  to  a  risk)  would  be 
obligatory. 

On the negative side, it has to be stressed, that the submission of a safety dossier to 
the  Scientific  Committee  means  additional  costs  for  the  submitting  party,  usually 
industry.  These  costs  may  be  in  average  approx.  500.000  EUR.  However,  they  are 
often borne by a consortium. Moreover, the obligatory labelling to avoid misuse of a 
product contributes to administrative costs (ie labelling). 

5.4.3.  Comparing the options 

A  comparison  of  these  impacts  reveals  that  policy  option  3  is  preferable.  It  builds 
upon  the  well-established  classification  system  but  allows,  in  exceptional  cases, 
some  flexibility  for  the  regulator.  This  flexibility  can  only  be  exercised  if  the 
substance  is  safe,  is  used  in  food,  does  not  have  suitable  alternatives  and  has  been 
regulated by the Commission under Comitology procedure with scrutiny. 

74 

Declaration fo the minutes – vote on 4 November 2005 on the 2nd adaptation to technical progress of the 
dangerous preparations Directive (1999/45/EC). 

EN 

45 

   EN 

                                                 
The  increase  in  administrative  costs  for  the  submission  of  the  safety  files  is  an 
unavoidable  consequence  and  can  be  justified  by  the  strength  and  benefits  of  this 
option. 

6. 

SYNERGIES, OVERVIEW 

6.1. 

Synergies of the preferred options 

The  predefined  structure  of  impact  assessment  requires  looking  at  the  various 
impacts of different options separately. However, it should be pointed out that there 
are synergies between the four favoured policy options.  

This  relates  in  particular  to  the  impact  of  the  options  chosen  for  objective  1  and 
objective  2  in  order  to  attain  objective  3:  One  can  expect  that  clear  rules  in  an 
amending legal text, together with the adoption of the recast as Regulation, improve 
also  compliance  with  the  provisions  aim  at  safeguarding  a  high  level  of  consumer 
safety. 

6.2. 

Summary of impact on administrative costs of the policy options for objectives 
1- 4 

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”.75

In its assessment of the impacts of the various policy options to reach objectives 1-4, 
the  Commission  has  in  particular  considered  the  impact  on  costs  defined  as 
“administrative costs”. 

This assessment shows that: 

•  Communication of information to anti-poison centres are going to be reduced by 

approx. 80%;  

•  “Objective  3”  can  be  achieved  with  a  minimal  increase  of  administrative  costs 

(Cosmetovigilance and increased market surveillance); 

In  sum,  administrative  costs  would  be  reduced  by  50%  as  compared  to  today.

75 

Commission impact assessment Guidelines, Annex 10, p. 35. 

EN 

46 

   EN 

                                                
 
Impact  of  policy  options  to  reach  objectives  1-4  on  administrative  costs  as 
compared to option “No EU action” 

Objective 

Policy option  

Final choice 

1 

2 

2 

(cid:56) 

3 

(cid:57) 

2 

(cid:57) 

3 

(cid:56) 

2 

(cid:56) 

3 

(cid:56) 

3 

4 

(cid:56) 

5 

(cid:56) 

6 

(cid:57) 

4 

2 

(cid:56) 

3 

(cid:57) 

Labelling requirements 

= 

= 

Notification 
requirements 

= 

(cid:216) 
(80%, 
ie. 45 
Mio 
EUR) 

(cid:216) 
(10%, 
i.e. 2 
Mio 
EUR) 

= 

= 

(cid:215) 

= 

= 

= 

= 

= 

= 

= 

= 

= 

= 

= 

= 

= 

= 

Making safety file 
available upon  
request by competent 
authority 

= 

= 

= 

= 

(cid:220) 
(50%
, ie. 
1.6 
Mio 
EUR
) 

= 

= 

= 

Submitting file for 
safety evaluation by 
SCCP 

= 

= 

= 

= 

= 

(cid:215) 

(cid:215) 

(cid:215) 

Reporting of 
undesirable events 
(“cosmetovigilance”) 

= 

= 

= 

= 

= 

= 

= 

= 

(cid:220) 
(50%
, ie. 
1.6 
Mio 
EUR
) 

= 

= 

(cid:222) 
(20%
, ie. 1 
Mio. 
EUR
) 

= 

(cid:220) 
(depe
nding 
on 
the 
numb
er of 
CMR 
subst
ances 
conc
erned
) 

(cid:220) 
(ie. 
1.5 
Mio 
EUR
) 

= 

= 

EN 

47 

   EN 

 
6.3. 

Overview 

The final policy choices for the four objectives pursued by the Commission can be 
summarised as: 

–  Amendment  to  the  Cosmetics  Directive  in  order  to  clarify  legal  terms  and  to 

facilitate its management; 

–  Re-cast of the Cosmetics Directive as a whole as Regulation; 

–  Strengthening  the  focus  on  manufacturer  responsibility  through  the  three 
components 
in-market 
control/improved Cosmetovigilance and extension of the notification requirement 
to all competent authorities; 

assessment”, 

strengthened 

“cosmetics 

safety 

–  Introducing a possibility, under strict conditions, to regulate CMR 1, 2 substances 

on the basis of their actual risk. 

EN 

48 

   EN 

Overview: objectives and policy options, final choices 

Objectiv
e 

Policy 
options  

Final 
choice 

Positive impacts 

Negative impacts 

1 

1 

2 

3 

1 

discarded 

(cid:56) 

(cid:57) 

(cid:56) 

2 

2 

(cid:57) 

No  effect,  unless  breach 
of  EU  law  by  Member 
States 

Flexibility; 
input 

easier 

expert 

Less effective 

More effective 

Less flexibility 

Avoids 
legislative 
possibly new costs 

unforeseeable 
changes  with 

No effect 

effective, 

as 
no 
Very 
required; 
transposition 
Savings for industry without 
compromising 
safety; 
Allows  for  fully  exploiting 
economies  of  scale  in  the 
internal market 

Less  possibility  to  adopt 
EC-rules  to  national  legal 
system 

3 

(cid:56) 

Existing  legal  systems  in 
Member 
remain 
States 
partly untouched 

Less effect 

3 

1 

(cid:56) 

No increase in costs 

2 

(cid:56) 

Flexibility 

3 

(cid:56) 

4 

(cid:56) 

the 

Depending  of 
regime: 
control,  which  allows 
some  cases 
safety/efficacy checks  

legal 
pre-marketing 
in 
for  official 

Pre-marketing 
allows 
safety/efficacy  check 

control 
official 
for 

for 

to 
Missed  opportunity 
improve  shortcoming  of 
the  existing 
regulatory 
system to ensure safety of 
cosmetic  products  in  the 
future 

Enforcement, risk of non-
compliance  and  negative 
perception 

Disproportionate 
measure; High burden for 
industry; increase of legal 
uncertainty 

Disproportionate;  High 
burden  for  industry  and 
regulators 

EN 

49 

   EN 

 
every product 

5 

(cid:56) 

Targeted approach to certain 
groups of substances 

6 

1 

2 

4 

(cid:57) 

in 

Increase 
Relatively 
increase 
costs 
compliance;  positive 
innovation; 
market control 

safety; 
moderate 
for 
for 
facilitated 

in 

discarded 

No effect 

(cid:56) 

No  need  to  address  issue  in 
Cosmetics Directive 

3 

(cid:57) 

Allows  addressing  the  issue 
the 
without 
principal rule that CMR 1, 2 
substances are banned 

changing 

Disproportionate,  High 
burden  for  industry  and 
regulators;  Does 
not 
consider  safety  of  final 
product 

Costs  of  compliance  for 
safety 
and 
assessment 
cosmetovigilance 

Would  require  overhaul 
internationally-
of 
classification 
accepted 
system 

increase 
Slight 
administrative costs 

in 

The  data  available  supports  these  policy  choices.  There  is  only  a  slight  increase  in 
regulatory burden which is off-balanced through  

–  reductions  in  administrative  costs  by  approx.  50%  as  compared  to  the 
administrative costs for EU-businesses today. The bulk of these saving result from 
changes  to  the  rules  of  communication  of  information  to  anti-poison  centres  as 
well as to market surveillance authorities which allow savings of approx. 80% as 
compared to costs of today’s information system; 

–  better functioning of the Internal market; and 

–  increase in product safety for the consumer. 

Several  elements  in  the  re-cast  provide  for  the  basis  to  improve  international 
regulatory  alignment,  such  as  the  possibility  of  a  swift  update  of  the  inventory  of 
ingredients. 

Moreover,  several  accompanying  measures  facilitate  compliance:  This  includes  in 
particular the ongoing work on an informal platform of enforcing authorities in order 
to  strengthen 
the  practical 
in-market  control  and  guidance  documents  for 
implementation  of  the  strengthened  requirements  for  cosmetics  safety  assessment 
and its documentation. 

EN 

50 

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7. 

MONITORING AND EVALUATION 

The proposal, once adopted, is going to be implemented in close cooperation with all 
stakeholders  concerned.  To  this  end,  the  working  party  “cosmetic  products”  has 
provided for a valuable forum in the past and is going to be used in the future. 

Monitoring of the policy will be done through the platform for market surveillance 
which  is  currently  being  set  up  by  the  Commission.  This  platform  brings  together 
competent  authorities  and  allows  for  practical  considerations  which  the  new  policy 
might raise. 

In  order  to  measure  progress,  in  particular  with  regard  to  improvements  of  product 
safety, the Commission is going to assess on a biannual basis 

•  The number of product information files checked by competent authorities in in-
market control and the compliance-rate with the minimum requirements set out in 
the recast legal act; and 

•  The  number  and  nature  of  the  serious  undesirable  events  notified  in  accordance 

with the mechanisms envisaged in the proposed Regulation. 

*** 

EN 

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ANNEX 1 - Synthesis of public consultation 

This annex shall resume the various replies to the public consultation document and discuss 
the most relevant ones. The structure of the summary is going to follow grosso modo that of 
the public consultation document. The public consultation document is not reproduced in this 
synthesis document. The text is available in DE, FR and EN on the “Cosmetics”-website of 
the Commission.76

1. 

General Comments 

Generally  speaking,  the  re-cast/simplification  of  the  Cosmetics  Directive  was 
welcomed by all submissions. However, it was also pointed out that any legislative 
change brings about new legal uncertainties (and, in particular for SME’s, new costs) 
and that a thorough impact assessment was necessary. The Commission agrees that 
frequent changes of the regulatory requirements should be avoided. It is aware that 
any  review  should  be  comprehensive  enough  to  pre-empt  a  re-opening  of  the 
discussion  a  few  years  later.  Indeed,  section  3  of  the  public  consultation  document 
has to be seen against this background. 

The  need  to  look  also  at  the  international  impact  of  changes  to  the  Cosmetics 
Directive was stressed by many submissions. 

Many  submissions  –  including  industry  submissions  –  emphasised  that  reduced 
administrative  and  regulatory  burden  must  not  lead  to  a  reduction  of  consumer 
safety. 

Several submissions stressed the importance and success of self-regulation and non-
binding guidelines in this sector. Particular reference was made to the guidelines of 
the international fragrance organisation IFRA. 

Some  submissions  suggested  looking  closely  at  existing  chemicals  and  food 
regulation.  The  re-cast  of  the  EU  Detergents  Directive  was  characterised  as  a 
successful  simplification  initiative.  Previous  work  of  the  SLIM-working  group  was 
widely endorsed. 

The public consultation did not bring about much quantifiable data. The Commission 
regrets this. Several submissions pointed at the difficulty for a company to assess the 
“legal  basis”  for  regulatory  and  administrative  costs,  as  the  chemical  sector  is 
covered  by  a  plethora  of  regulations  looking  at  identical  business  and  production 
processes from different perspectives (e.g. worker protection, transport, environment, 
consumer, waste, etc.). 

The few quantifications delivered in the submissions are all taken up explicitly in this 
synthesis report. 

2. 

Directive vs. Regulation (item 3 public consultation document) 

76 

http://ec.europa.eu/enterprise/cosmetics/html/cosm_simpl_dir_en.htm  

EN 

52 

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A vast majority of the submission supported the re-cast of the enacting terms and the 
annexes  to  the  Cosmetics  Directive  as  Regulation  (i.e.  option  1  in  item  3  of  the 
public consultation document). It was argued that only this option 1 would 

–  effectively  reduce  discrepancies  in  national  legislations  (very  concrete  examples 

were given in several submissions),  

–  tackle “double banking” and “gold plating”; and  

–  allow for identical entry into force of amendments. 

It  was  stressed  that  the  (illegal)  practice  of  “gold  plating”,  combined  with  relaxed 
enforcement in Member States, was in particular a problem for companies who try to 
comply  with  (transposed)  EU-regulation  throughout  the  EU.  These  companies  are 
disadvantaged vis-à-vis “rough-traders” who are willing to run the risk of sanctions 
in a particular Member State. 

It was also repeatedly stressed that sufficient implementation time for amendments is 
needed. Clarity of the term “placing on the market” was crucial.  

Some  submissions  argued  that  option  2  would  better  take  national  practices  into 
account,  which  was  favourable  for  SME’s;  however,  this  argument  was  not  further 
substantiated. 

Two  submissions  argued  that  a  Directive  was  preferable  as  it  allowed  only  for 
minimum-standards.  The  Commission  would  like  to  stress  that  this  view  is  wrong. 
Already  today,  the  Cosmetics  Directive  is  exhaustive.  Member  States  cannot  adopt 
additional rules to those in the Cosmetics Directive. Also, unlike suggested by some 
submissions, the rules for the language of labelling are independent of the choice of 
the legal instrument. 

3. 

Issues/concepts  and  terms  needing  clarification  (items  1  and  4  public  consultation 
document) 

The  number  of  issues/concepts  and  legal  terms  which  need  to  be  defined  and 
clarified  according  to  the  submissions  amounts  to  almost  one  hundred.  The 
Commission stresses that it is not possible to follow-up every suggested clarification. 
However,  some  concepts  and  terms  very  repeatedly  outlined  as  having  created 
difficulties in application and thus raising costs for compliance without contributing 
to product safety. These includes: 

–  “Placing on the market”: Most submissions supported the equation of putting into 
stock with placing on the market. Others supported the notion of the first making-
available of the product. 

–  “Person  responsible  for  placing 

the  market”  (including 
considerations  of  the  role  of  other  economic  operators,  such  as  the  company  in 
charge  of  marketing  and  sub-contracted  producers):  The  peculiarity  of  the 
cosmetics  sector  –  which  heavily  relies  on  mandated  and  sub-contracted 
production – was stressed by many submissions; 

the  product  on 

–  The concept of single access point to the product information file; 

EN 

53 

   EN 

–  Cooperation in in-market controls; 

–  Traces and the conditions for their acceptance, incl. thresholds;  

–  Notification: Extent of information required; 

–  Safeguard  clause:  Uncertainties  about  scope  (one  product,  product  line,  product 

group?); 

–  Labelling:  The  importance  of  clarity  on  the  rules  of  labelling  was  stressed.  The 
rules  for  “period-after-opening”  were  particularly  criticised.  It  was  suggested  to 
skip them or to change them according to the respective Commission-guidelines. 
The  minimum-durability-date  was  also  addressed  by  many  submissions, 
advocating the possibility to label this information with an hourglass. Other issues 
discussed  were  the  term  “decorative  cosmetics”  and  the  rules  on  the  +/-,  the 
labelling  of  the  address  (extent  of  detail  varies  in  the  national  laws)  and  the 
possibility to highlight the address where the safety file is made available. 

The  Commission  agrees  that  the  rules  on  labelling  are  confuse.  However,  the 
Commission is very hesitant in changing the rules on labelling in substance without a 
thorough assessment of this impact, as costs of labelling are a particularly important 
factor for administrative costs in particular for SME’s. 

Other concept/terms for which more explanation was suggested include: hazard/risk, 
and “leave on”/”rinse-off” products (in particular for bath-products). 

The  incoherent  use  of  the  terms  “cosmetic  product”,  “finished  cosmetic  product”, 
“cosmetic ingredient” “product”, etc. was criticized. Some submissions suggested a 
clear  differentiation  between  individual  product  and  “product  line”  (i.e.  batch). 
Annex I to the Cosmetics Directive in the present form was described as being out of 
date, incoherent with the definition of “cosmetic product” and even superfluous. 

While  the  difficulty  was  stressed  to  quantify  the  costs  for  these  uncertainties,  one 
submission  from  a  smaller  Member  State  suggested  that  the  time  spent  by  an 
authority to explain unclear terms amounted to three man-years. 

4. 

Inventory (item 7 of the public consultation document) 

Virtually  all  submissions  characterised  a  simplified  update  of  the  inventory  as 
important  measure  to  facilitate  application  of  the  Cosmetics  Directive,  and  reduce 
costs without compromising product safety. In terms of content of the inventory and 
its  translation,  several  submissions  stressed  that  the  translation  of  the  introductory 
part of the inventory was sufficient. The bad quality of the translation of the chemical 
names  was  highlighted.  The  Commission  agrees  that  verification  of  the  translated 
names  in  23  languages  is  an  impossible  task.  Many  submissions  suggested  that 
listing the INCI-name (not “CTFA-name”) and CAS-no. was sufficient. 

Many  submissions  stressed  the  need  to  maintain  some  key  elements  of  the  present 
system, such as: 

–  Transparency and free accessibility to the inventory; 

EN 

54 

   EN 

–  No  linking  of  the  inventory  to  safety  checks  (which  would  lead  to  a  pre-market 

authorisation “through the backdoor”); 

–  Participation  of  the  regulator  in  the  process  of  granting  international  names,  in 

particular for botanical names. 

Some submissions questioned whether an informal inventory could be made legally 
binding.  

The need to inform explicitly Member State authorities about any update was raised. 

The possibility to use IT-tools was raised.  This  would  allow  for  swift  yearly  or  bi-
annual updates.  

The importance of short names, in particular for allergens, was stressed. 

5. 

Notification (item 12 of the public consultation document) 

Practically all submissions confirmed the legal uncertainty surrounding the (national 
transpositions of) the notification requirements. It was stressed that this uncertainty 
raised  administrative  costs  without  adding  value:  For  example,  in  Poland,  alone, 
180.000  products  are  currently  notified.  As  repeated  notification  is  sometimes 
necessary, this amounts to approx. 540.000 notifications in this Member State alone. 

It was suggested that each enterprise employs in average one person full-time during 
three  days  to  do  the  notification  for  a  formulation.  Other  costs  stem  from  fees  for 
registration  or  fees  for  subsequent  acknowledgement  receipts  by  the  competent 
authority. 

There  was  remarkable  agreement  amongst  all  submissions  about  the  features 
required for a re-shaped notification system. This should be: 

–  Centralised (“single notification”);  

–  Based on a simple IT-tool; and 

–  Not leading to a pre-authorisation. 

In terms of content, there was widespread agreement that the notification should be  

–  Based on a frame-formula as already applied in some Member States (eg. UK, IE, 

SE); and 

–  Cover  the  names  and  nature  of  the  relevant  persons  and  their  name/type  of 

product. 

It is remarkable that even some industry submissions spoke in favour of quite some 
information  to  be  submitted  in  the  notification.  This  may  be  explained  with  the 
interest  of  some  companies  to  use  notification  requirements  in  order  to  control 
parallel trade. Other businesses stressed that quick market developments make overly 
descriptive notifications burdensome. Different views were expressed on the need to 
indicate the place of production. However, the Commission considers this helpful to 
control the respect of good manufacturing practices when producing in the EU. 

EN 

55 

   EN 

One submission spoke in favour of a differentiated system for EU-domestic vis-à-vis 
imported products. The possibility of a voluntary system (as in the U.S.), at least in 
the early phase, was raised. 

No submission agreed with the suggestion in the public consultation document that 
the notification requirement can contribute to combating counterfeit. 

6. 

Simplifying  annexes  of  substances  (items  5  and  6  of  the  public  consultation 
document) 

Many submissions discussed extensively potential for simplifying the annexes. In the 
Commission’s  view  this  shows  the  practical  importance  of  the  annexes  and  the 
restrictions set out therein. 

Many  submissions  argued  that  –  rather  than  re-arranging  annexes,  it  was  more 
important to  

–  clarify the terminology used therein: for example, it was argued that the “fields of 
application” of colorants could be reduced to two instead of four categories. The 
interpretation of column c in Annex III was discussed as well as the definition of 
“UV-filter”; 

–  remove substances which are unrelated to cosmetics (in particular the list of CMR 
substances  in  Annex  II,  which  is  a  mere  “copy-paste”  of  the  chemicals 
legislation); 

–  Identify substances better (in particular with CAS no and INCI name); 

–  develop an IT-tool to search the annexes; and 

–  address multiple entries of the same substance in different annexes. 

6.1. 

No regulation of ingredients according to their intended function 

Many  submissions  criticised  the  approach  proposed  in  the  public  consultation 
document.  While  the  merits  of  the  idea  were  acknowledged,  there  was  widespread 
agreement  that  one  cannot  consider  cosmetic  ingredients  without  their  intended 
function, for the following reasons: 

–  Possible multi-functions; 

–  Ingredients may have a function only beyond a certain concentration; and 

–  Exposure is closely linked to function. 

It  was  argued  that  giving  up  the  concept  of  intended  function  would  lead  to  more 
legal  insecurity  and  thus  to  more  rather  than  less  costs  and  would  run  counter 
international as well as EU (cf. Biocidal products Directive) practice. 

On the other hand, many submissions acknowledged that the criteria of the “intended 
function”  has  lead  to  legal  uncertainties  in  the  past.  Several  submission  spoke  in 
favour of linking regulation of substances to hazard and exposure rather than to the 
intended function. 

EN 

56 

   EN 

Other  submissions  suggested  to  refer  to  “usual  function”,  “prevailing  function”  or 
“expected functionality”. 

The Commission would like to remind that starting point of its consideration was an 
attempt to  

–  avoid “loopholes” in the system, i.e. “escaping” the need for “positive listing” by 

arguing with subjective motivations of the formulator; 

–  avoid double-listing of one substance in different annexes: All restrictions of the 
same  substance  should  be  listed  at  the  same  place  to  avoid  contradictory 
provisions. 

Interestingly,  in  particular  regarding  the  second  point,  virtually  all  submissions 
agreed that this is a confusing feature in the Cosmetics Directive today.  

The  Commission  is  going  to  assess  how  these  aims  can  be  pursued  taking  into 
account the comments submitted in the public consultation. 

6.2. 

Re-organising annexes 

Many  submissions  opposed  a  re-organisation  of  the  annexes,  arguing  that  their 
system  works  well  and  is  easily  understood.  An  important  argument  referred  to 
international alignment: it was stressed that the annexes as presently presented in the 
Cosmetics Directive have “model character” and are used worldwide. Re-organising 
them would put this model-character at risk.  

With  regard  of  the  suggestion  in  the  public  consultation  document  to  arrange  all 
regulated  substances  in  one  list,  it  was  argued  that  the  relevant  substances  would 
“disappear”  amongst  the  many  banned  substances.  In  this  context,  one  submission 
reminded that currently, out of the many hundred substances listed in Annex II, only 
approx.  20%  are  actually  relevant  for  the  cosmetics  industry.  Another  interesting 
argument concerned public perception: It was argued that the present organisation of 
the annexes can be easily explained to the public, policy-makers and media. 

On the other hand, there was a plethora of proposals how the annexes could be re-
organised. This includes, apart from a “single list”: 

–  Re-grouping in two annexes: negative and positive/restricted; 

–  Re-grouping in three annexes: positive, negative and restricted/provisional; 

–  Differentiation between substances listed in annex II because of lack of data and 

substances listed there because of their risk for consumer safety; 

–  Abolishing  all  positive  lists  and  replacing  this  by  a  well-supervised  system  of 

manufacturer responsibility. 

The  need  of  an  electronic  tool  to  navigate  in  the  annexes  was  stressed.  The 
Commission is indeed currently working on such a database. 

7. 

Introducing/strenghthening “New-approach” elements  

EN 

57 

   EN 

The suggestion in the public consultation document to strengthen and introduce some 
elements of “new approach” legislation in the Cosmetics Directive found particular 
interest by the interested parties. Some submissions argued that the “new approach” 
philosophy would not work in the cosmetics field, as  

–  Causality between a harm and a product is more difficult to establish in the field 

of toxicology then, say, in case of harms through mechanical hazard; and  

–  Product  withdrawal  is  not  realistic  in  a  sector  where  products  are  used  off 

(quickly). 

Therefore, these submissions argued that cosmetics legislation should continue to be 
modelled after chemical’s legislation rather than new approach legislation. 

It  was  also  pointed  out  that  standardization  is  not  as  quick  and  swift  as  sometimes 
suggested.  The  fear  that  standardization  leads  to  reduced  consumer  protection  than 
descriptive legislation was voiced. 

It  was  pointed  out  that  the  “CE-mark”  –  a  particular  feature  of  “new  approach” 
legislation  –  would  lead  to  increased  costs  and  bureaucracy  for  the  cosmetics 
industry. 

The  Commission  would  like  to  point  out  that  many  elements  typical  for  “new 
approach”  legislation  can  already  today  be  found  in  the  Cosmetics  Directive.  This 
includes 

–  Manufacturer  responsibility  for  the  safety  of  the  products  placed  on  the  market 

(cf. below, 7.1.); 

–  Technical documentation supporting the safety of the product (cf. below, 7.2.); 

–  In-market control of regulatory compliance (cf. below, 7.3.). 

In  the  public  consultation  document  the  Commission  wanted  to  assess  how  these 
elements  can  be  strengthened  to  avoid  recurrence  to  the  regulation  of  individual  as 
means of choice and to restrict this inflexible and resource-intensive tool to peculiar 
cases. In this respect, the submissions confirmed that improvements are possible. 

7.1. 

Clarifying manufacturer responsibility (item 8 of the public consultation document) 

Most  submissions  pointed  out  that  the  concept  of  manufacturer  responsibility  was 
already  well  understood  in  the  EU.  Uncertainties  about  role  and  responsibilities 
concern  rather  other  actors,  such  as  safety  assessor,  sub-contracted  producers,  and 
professional users. 

On  the  other  hand,  it  was  admitted  that  clarification  can  be  useful,  in  particular  in 
order to explain the EU-regulatory system in third countries. 

7.2. 

Strengthening  product  safety  assessment  (item  9  of  the  public  consultation 
document) 

EN 

58 

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This issue was rightly considered as a crucial element of the re-cast. The submissions 
rightly identified a strengthened product safety assessment as a key issue in order to 
turn  away  from  descriptive  legislation  as  means  of  choice  to  address  the  safety  of 
cosmetic products. 

(1) 

General observations 

Practically  all  submissions  agreed  on  the  importance  of  the  cosmetics  safety 
assessment and its documentation for the safety of the product placed on the market. 
The  vast  bulk  of  submission  concurred  that  the  present  provision  in  the  Cosmetics 
Directive are insufficient, fail to give guidance and do not reflect the complexity of 
the  exercise.  Concrete  minimum  requirements  and  standards  how  to  set  out  the 
“reasoning” of a safety assessment should be established. It was pointed out that this 
would  help  to  look  closer  at  toxicological  characteristics  of  substances  in  their 
matrix/texture  and  at  combination  of  substances  –  thereby  addressing  the  actual 
toxicological risk stemming from a cosmetic product. 

Many submissions stressed that a strengthened safety assessment should not 

–  Run counter the animal testing provisions;  

–  Rise  regulatory  burden:  It  was  emphasised  that  costs  for  businesses  to 
establish/maintain product dossiers can be high. For example, one SME reported 
that it had to handle (ie establish, update, keep accessible) already today approx. 
330 product information files; and 

–  Lead to a “tick-box” approach consisting of simply listing a number of obligatory 

tests for each ingredient contained in a product. 

Moreover, practically all submissions stressed the necessity to continue to look (also) 
at  individual  substances  and  that  a  product  safety  assessment  cannot  in  all  cases 
substitute a detailed assessment of an individual substance by the risk-assessor. 

It  was  also  pointed  out  that  the  concept  of  “adequate  safety  substantiation”  is  a 
common  feature  of  the  regulation  in  other  jurisdictions  too  and  that  guidance  for 
cosmetics safety assessments exists already in other regions. 

(2) 

Content of the cosmetics safety assessment 

Many submissions discussed the possible content of a strengthened cosmetics safety 
assessment and the product information file.  

There was widespread concern amongst industry that a cosmetics safety assessment 
may lead  to a “tick-box” reasoning. To avoid this, the Commission’s attention was 
drawn to existing guidelines of various industry associations as well as provisions in 
transposing national laws. In this respect, most submissions pointed out that existing 
test  catalogues  to  assess  the  toxicological  safety  of  individual  substances  as 
contained  in  chemicals  legislation  are  not  suitable  for  establishing  a  catalogue  of 
criteria  for  a  cosmetics  safety  assessment.  The  difference  between  the  two 
approaches (substance safety – product safety) was stressed. 

EN 

59 

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Submissions  highlighted 
to  address  exposure  data, 
Information/data  on  sensitisation,  stability  of  raw  material,  microbiological  criteria, 
impact  on  renewal  of  the  epidermis,  transdermal  water  loss,  and  experiences  from 
previous formulations. 

in  particular 

the  need 

The  possibility  to  introduce  additional  requirements  for  micronised  particles  was 
raised. 

Almost  all  submissions  agreed  that,  apart  from  a  legal  description,  detailed 
guidelines were necessary. 

(3) 

Origin of data/qualification of safety assessor 

Several  submissions  highlighted 
the  safety  assessor 
(qualification,  experience)  and  stressed  that  requirements  differ  in  the  Member 
States. The idea of a “register” of recognised safety assessors was raised in particular 
by some submissions from competent authorities and Member States. 

important  role  of 

the 

The  importance  of  a  passing-on  of  relevant  data  downstream  to  the  cosmetics 
producer was stressed.  

(4) 

Access to product information file 

Many  submissions  raised  the  question  of  access  to  product  information  file.  The 
notion  “readily  available”,  as  currently  contained  in  the  Cosmetics  Directive,  was 
discussed. Many submissions highlighted the importance of the concept of a “single 
point of access” which should be further clarified in the Cosmetics Directive as this 
principle is not always respected in practice.  

Some  submissions  raised  the  need  for  a  possibility  to  “forward”  requests  by 
competent authorities for access to the product information file. In this respect, the 
difficult position for sub-producers was highlighted: These do not want to give away 
their know-how to the contractor. On the other hand, the contractor does not want to 
indicate another producer on its label. 

(5) 

Other remarks 

The  idea  of  a  standardised,  formalised  and  signed  “declaration  of  conformity”  was 
raised  by  some  contributions.  It  was  stressed  that  it  is  important  to  refer  to  all 
ingredients  with  INCI-name:  too  often,  competent  authorities  are  faced  with  a 
cosmetics safety assessment referring to a “mass” of many substances to which the 
manufacturer had only added some perfume etc. The importance of good laboratory 
Practices  (“GLP”)  was  stressed.  However,  some  submissions  underlined  that  GLP 
cannot be a prerequisite to every test submitted in the cosmetics safety assessment. 

The importance of enforcement was stressed – in particular, rules for cases where the 
product  information  file  is  incomplete  are  needed.  In  this  respect,  there  were 
warnings  that  capacities  of  enforcing  authorities  should  not  be  over-estimated. 
Cooperation and trust between Member State authorities was necessary to verify the 
cosmetics safety assessment as contained in the product information file.  

EN 

60 

   EN 

7.3. 

Strengthened  in-market  control,  cosmetovigilance  (items  10  and  11  of  the  public 
consultation document) 

The  need  for  quick  reactions  of  competent  authorities  was  stressed,  as  cosmetic 
products  use  off  relatively  quickly.  Implementation  and  market  surveillance  should 
be stepped up – not at least to discourage “rough traders” who bring the sector as a 
whole  in  discredit.  There  was  agreement  that  cooperation  between  competent 
authorities should  be enhanced. While legal provisions certainly help, this is also a 
matter of resources in the Member States. 

It  was  pointed  out  that  non-compliance  can  have  different  degrees  (labelling  – 
translation etc.) and that responses have to be proportionate. 

Many submissions pointed out that the General Product Safety Directive provides for 
efficient  rules  for  product  withdrawal  and  that  a  parallel  system  for  cosmetic 
products should be avoided. 

Concerning cosmetovigilance, practically all submissions stressed the importance to 
follow-up  closely  developments  in  (serious)  undesirable  effects.  However,  it  was 
emphasised that  

–  a situation should be avoided where each Member States mounts its own system, 
with  own  definitions  and  requirements.  The  work  of  the  Council  of  Europe  was 
referred to frequently as suitable basis for improvements in the EU; and 

–  any  information  requirement  about  undesirable  effects  should  be  restricted  to 
serious cases. Otherwise, the system would become too heavy and unmanageable.  

Some submissions queried what would happen with reported information. A central 
register  was  suggested.  It  was  also  suggested  to  make  it  available  to  ingredient 
manufacturers and independent safety-assessors. On the other hand, the importance 
of confidentiality of reported data was stressed. 

The idea of a yearly industry report was raised.  

7.4. 

Turning  to  regulation  of  individual  substances  only  as  “last  resort”  (item  13  of  the 
public consultation document) 

Many submissions queried how a strengthened cosmetics safety assessment (and its 
enforcement  in  the  market)  would  relate  to  the  existing  system  of  regulating 
individual substances in the annexes to the Cosmetics Directive. 

While  many  submissions  agreed  that  only  significant  matters  should  go  before  the 
SCCP and regulated by the legislator, most submissions also stressed the importance 
of  this  work,  as  in  particular  SME’s  did  not  have  the  expertise  and  resources  to 
undertake safety assessments of individual substances. Moreover, national authorities 
may not be sufficiently independent from their national industries. 

There was widespread fear that disagreement over the completeness or conclusions 
of a cosmetics safety assessment would lead automatically to a general regulation of 
a  substance  based  on  the  information  contained  therein.  It  was  stressed  that  a 
product-specific  cosmetics  safety  assessment  cannot  justify  risk-management 

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measures  for  this  ingredient  in  general  on  Community  level.  Moreover,  a  situation 
where  one  substance  is  evaluated  repeatedly  by  different  Member  States  should  be 
avoided. 

With  regard  to  the  interface  of  cosmetics  safety  assessment  and  the  work  of  the 
SCCP, it was suggested to implicate the SCCP in order to ensure the functioning of 
the internal market in case where competent authorities of different Member States 
disagree about the appropriateness of the cosmetics safety assessment. 

8. 

Strengthening safety in view of innovative products 

The  public  consultation  document  raised  also  the  question  on  safety  of  new  and 
innovative  products.  While  this  is  not  a  matter  of  simplification  stricto  sensu,  the 
Commission felt that this point needed to be addressed in the light of the peculiarities 
of cosmetic products, which are essentially applied chemical preparations. 

8.1. 

General remarks 

The  vast  majority  of  the  submissions  pointed  out  that  –  all  in  all  –  the  regulatory 
principles in the Cosmetics Directive have been successful in ensuring a high level of 
safety  of  products  placed  on  the  Community  market.  So  far,  there  has  not  been  – 
unlike in other sectors - a failure of the system. It was stressed that industry statistics 
show  a  rate  of  approx  1  undesirable  effect  per  1  million  units  cosmetic  products 
placed on the Community market. 

There  was  also  widespread  disagreement  with  the  equation  “innovation  =  new 
chemical ingredient = higher risk”. Rather, innovation in this sector is not necessarily 
linked to a new ingredient  (but also to new composition,  new  delivery  mechanism, 
new texture, etc. Moreover, in the case of “new” ingredients their properties may be 
well  known  from  other  sectors.  Therefore,  all  cosmetic  products  –  independent  if 
they  are  “innovative”  or  not  -  should  be  dealt  with  within  the  same  regulatory 
framework. 

All  submissions  agreed  that  many  issues  presented  for  discussion  in  the  public 
consultation  document  do  already  add  on  in  terms  of  ensuring  consumer  safety. 
Moreover,  it  was  pointed  out  that  REACH  is  going  to  bring  about  further 
improvement in supply of toxicological data to cosmetic manufacturers. 

On the other hand, some submissions pointed out that – within the existing system – 
there should be more consideration of  

–  Micronised particles; 

–  Cumulative toxicity; 

–  Sensitisation; 

–  “Active” ingredients in “borderline” cosmetic products. 

One submission suggested a substitution obligation for CMR substances. 

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It  was  also  suggested  to  look  at  incoherencies  of  cosmetics  legislation  with  other 
chemicals or other consumer product legislation, such as toys legislation, as well as 
food legislation. 

One  submission  proposed  that  total  exposure,  including  exposure  to  chemical 
through food, should be looked at more closely by the SCCP. 

8.2. 

No risk-benefit analysis (item 15 of the public consultation document) 

Practically  all  submissions  concurred  that  the  regulatory  paradigm  for  cosmetic 
products – unlike pharmaceutical products – is not based on risk-benefit reasoning. 
There was also agreement that similar terms should be used for “safety” throughout 
the Cosmetics Directive. 

However, the term “uncompromised safety” as introduced in the public consultation 
document  was  widely  criticised  as  suggesting  a  “zero  risk”  requirement.  In  this 
context, it was pointed out that “zero risk” was impossible to attain and that it was 
rather about a minimisation of risk to the largest-possible extent. 

It  was  also  suggested  that,  rather  than  discussing  terminology,  risk-management 
approaches should be reviewed, for example concerning allergies. In this respect, the 
question  was  raised  whether  consumers  should  be  allowed  to  enter  consciously  a 
risk, provided that they are sufficiently informed. 

8.3. 

Dealing  with  data  shortage  –  “no  data  –  no  market”  (item  16  of  the  public 
consultation document) 

All submissions agreed that any cosmetic product placed on the EU market should be 
sufficiently supported with information proving the safety of the product. 

However,  many  submissions  pointed  out  that  the  correct  paradigm  would  be  “no 
safety assessment – no market” or “no valid/robust information – no market” rather 
than “no data – no market”. The latter would lead to a “tick-box approach” for safety 
assessment  of  finished  products  with  very  negative  consequences  in  particular  for 
SME’s  using  natural  ingredients  or  ingredients  which  have  been  in  use  for  a  very 
long time. 

A  robust  explanation/justification  was  characterized  as  crucial.  In  this  respect, 
historical experience and “read-across” were highlighted as acceptable methods – in 
particular  for  so-called  “natural”  substances.  The  Commission  agrees  but  stresses 
that this reasoning cannot be valid for endpoints such as carcinogenicity. 

Regarding  REACH,  some  submissions  reminded  that  the  registration  requirements 
only applies to substances produced/imported in quantities of >1 ton/manufacturer or 
importer.  Another  submission  reported  that  it  expects  over  70%  of  the  substances 
purchased to be within the REACH registration obligation. 

8.4.  More  recurrence  to  “positive  lists”  (items  17  and  18  of  the  public  consultation 

document) 

(1) 

General remarks 

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The vast majority opposed the idea of setting up additional “positive list” or giving 
the  Commission  the  mandate  to  do  this.  It  was  pointed  out  that  –  rather  than 
establishing new positive lists – the existing ones should be better administered. This 
concerns in particular annex IV (colorants). 

It  was  also  stressed  that  additional  positive  lists  go  against  international  alignment 
and  that  the  process  establishing  these  is  costly  and  lengthy.  In  particular,  positive 
lists  make  it  difficult  for  companies  to  exploit  innovation  –  albeit  patented.  In  this 
respect, the possibility of a “bonus” in patent protection – as is the case for medicinal 
products – was raised. On the other hand, the usefulness of the existing positive lists, 
in particular for SME’s, was stressed. 

(2) 

Sunset clause 

An  automatic  review  of  substances  listed  positively  was  opposed  by  the  large 
majority  of  submissions.  Again,  it  was  argued  that  it  was  more  about  good  risk-
management  than  legal  changes.  Review  of  substances  should  be  based  on  sound 
scientific justification (for example, new toxicological data), rather than a calendar-
date. 

It was also pointed out that a sunset-clause may be counterproductive if it leads to a 
“shelving” of new scientific information. 

On  the  other  hand,  some  submissions  confirmed  that  the  advancement  of  technical 
and  toxicological  knowledge  make  it  necessary  more  often  than  it  is  presently  the 
case  to  re-view  a  positively-listed  substance.  In  this  respect,  the  importance  of 
cosmetovigilance was highlighted. 

9. 

International alignment (item 2 of the public consultation document) 

Many  industry  submissions  pointed  out  that  the  Cosmetics  Directive  had  lost  its 
“model function” due to the changes introduced in the 7th amendment: This concerns 
not  only  animal  testing,  but  also  fragrance-labelling,  period-after-opening  and 
hazard-based regulation of substances. 

Despite  this,  many  submissions  stressed  that  the  Cosmetics  Directive  is  still  an 
important reference worldwide and that the simplification should not further deepen 
the gap between it and other jurisdictions. In this respect, the Commission was urged 
to look into trade-effects of all amendments it intends to propose. 

Many industry submissions pointed at the need of international alignment. In terms 
of costs, the concrete example was given of 1% of the personnel of an SME which is 
necessary  to  deal  with  regulatory  differences.  It  was  stressed  that  many  SME’s 
heavily depend on exports to third countries constituting up to 50% of their turnover. 
Concerning regulatory alignment, the following areas were raised: 

–  Aligned  common  ingredient  names:  it  was  stressed  repeatedly  that  this  would 

bring about important savings; 

–  Aligned substances regulation: in particular concerning colorants. It was stressed 
that  costs  mount  disproportionally,  if  re-formulation  of  complex  formula  is 
required; 

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–  Issues of borderlines and acceptable claims for products; 

–  Use of international bodies, such as ISO; 

–  Cooperation in risk-assessment. 

The possibility of strengthening international alignment and cooperation through an 
industry-regulator dialogue was raised. 

10. 

Other issues raised 

Several  issues  were  raised  by  the  submissions  which  were  not  part  of  the  public 
consultation document. 

10.1.  Definition of cosmetic product, scope 

Virtually no submission argued in favour of a substantial change of the definition of 
“cosmetic  product”  in  the  EU.  Some  submissions  suggested  as  additional  cosmetic 
function  “contributing  to  personal  well-being”  or  to  clarify  the  meaning  of  the 
cosmetic function “protect and maintain”. One submission suggested a clarification 
of the word “skin” and an explicit exclusion of body-parts affected by “diseases”. 

One submission suggested covering cosmetic articles, too. 

Some submissions suggested including in the scope of the Cosmetics Directive risks 
to  the  environment.  The  Commission  would  like  to  point  out  that  this  aspect  is 
currently addressed by the general chemical safety law of the EU and that there is no 
intention to change this. 

Some submissions suggested including issues of occupational chemicals safety into 
the  scope  of 
the  SLIM-
the  Cosmetics  Directive,  as  also  suggested 
recommendations.  It  was  stressed  that  in  particular  labelled  warnings  do  not 
sufficiently take this aspect into account. 

in 

10.2.  Animal testing 

Albeit  explicitly  excluded  from  the  scope  of  this  re-cast,  a  small  number  of 
submissions  addressed  the  issue  of  animal  testing.  This  concerned  in  particular 
clarification  of  the  amendments  in  the  “7th  amendment”  such  as  the  term 
“alternative”  method  and  the  scope  of  the  ban  of  animal  testing  (incl.  the  question 
whether efficacy testing was covered). 

10.3.  Analytical methods 

The importance of harmonised analytical methods for industry as well as competent 
authorities was stressed. The use of standardising bodies was suggested. 

10.4. 

Efficacy 

Some  submissions  asked  for  a  stronger  regulatory  focus  on  efficacy  of  cosmetic 
products. This concerns in particular claims such as “natural”, “bio”, “fragrance free” 
and “preservative free“. The use of standardisation in this area was suggested. 

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10.5.  Risk assessment 

Many  submissions  highlighted  the  importance  of  the  role  of  the  SCCP’s,  stressing 
that  its  work  was  closely  followed  by  regulators  and  industry  worldwide.  It  was 
argued  that  the  process  should  be  improved  and  rendered  more  transparent,  incl. 
possibilities  for  industry  to  collaborate  closer  with  the  SCCP  and  to  discuss 
submissions. Procedural tools to avoid bit-by-bit delivery of data were asked for. 

Some  submissions  contemplated  a  “decentralised”  risk  assessment  system,  the 
possibility  for  Member  States  to  review  SCCP-opinions  or  mandate  for  risk-
assessment by the newly-created European Chemicals Agency in Helsinki. 

10.6.  Miscellaneous 

One  submission  suggested  a  difference  to  be  made  between  “industrial  cosmetics” 
and “consumer cosmetics”. 

One submission criticized the dynamic references in the Cosmetics Directive, which 
render readability more difficult.  

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66 

   EN 

ANNEX 2 - Description of European cosmetics industry and EU cosmetics market 

The  purpose  of  this  annex  lies  in  describing  the  European  cosmetics  industry  to  the  extent 
necessary  to  assess  administrative  costs  and  other  costs  for  compliance  stemming  from  the 
Cosmetics Directive before and after re-cast. 

The data contained in this annex stems from a variety of sources, including: 

•  A study contracted by the Commission in 2004: “Cosmetics Legislation in the EU and 
Other Principal Markets with Special Attention to so-called Borderline Products” 

•  A  study  contracted  by  the  Commission  in  2006:  “Description  of  the  EU  cosmetics 

industry” 

•  A study contracted by the Commission in 2006: “Impact of EU regulation on consumer 

safety” 

•  A study contracted by the Commission in 2006: “Impact of EU regulation on industry’s 

competitiveness” 

•  Data obtained from EUROSTAT 

•  Data obtained from COLIPA 

•  The market size of the EU is approx. 60 billion EUR. 

•  The  yearly  EU-turnover  of  EU  cosmetics  industry  is  approx.  70  billion  EUR.  Of  these, 

approx. 55 billion EUR are generated on the Community market. 

•  There are approx. 3.800 cosmetics producers in the EU. Out of these77: 

–  approx. 80% companies (i.e. approx. 3000) have less than 19 employees; 

–  approx 9% companies (i.e. approx. 350) have 20-49 employees; 

–  approx. 8% companies (i.e. approx. 300) have 50-249 employees; 

–  approx. 3% companies (i.e. approx. 100) have more than 250 employees. 

Thus, 97% of cosmetic producers in the EU are SME’s. These SME employ approx. 90.000 
persons in the EU. 

•  SMEs  handle  in  average  approx.  60  product  formulations.  The  3%  non-SMEs  handle  in 
average  approx.  1000  product  formulations.  While  in  average  approx.  30%  of  their 
formulations  are  completely  replaced  or  re-formulated  every  year,  SMEs  re-formulate  in 
average approx. 20% per annum.  

•  There are approx. 300.000 product formulations made available to the final user on the EU 
market  by  EU  companies.  Out  of  these,  approx.  60.000  are  reformulations  or  newly 

77 

These figures are based on more generic figures stemming from the 3-digit NACE 245 code. 

EN 

67 

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developed  each  year.  Approx.  75%  of  these  re-formulations  (i.e.  approx.  45.000)  are 
largely based on existing product formulations. 

•  Total costs of compliance with the Cosmetics Directive lies between 0.5% and 1% of the 
annual  turnover  of  a  cosmetic  manufacturer,  i.e.  approx.  390  million  EUR.  Of  these, 
approx.  80-90  million  EUR  are  administrative  costs,  while  approx.  300  million  EUR  are 
other  costs  of  compliance  –  in  particular  establishing  a  product  information  file  with  a 
cosmetics safety assessment. 

•  Establishing  a  safety  assessment  for  a  new  product  formulation  requires  approx.  240 

person-hours. This amounts to costs of compliance of approx. 220 million EUR. 

•  Establishing  a  safety  assessment  for  a  re-formulation  on  the  basis  of  an  existing  product 
formulation  requires  in  average  approx.  30  person-hours.  This  amounts  to  costs  of 
compliance of approx. 80 million EUR. 

•  The costs for a dossier submitted to the SCCP for listing a new cosmetic ingredient in a 

“positive list” in the annexes to the Cosmetics Directive is approx. 500.000 EUR. 

•  The product notification fees vary between 0 to 36 EUR per product formulation notified, 

depending on the transposing laws and regulations in the different Member States. 

•  The average tariff per person-hour in the field of regulatory compliance with the Cosmetics 

Directive is approx. 60 EUR. 

•  Each  year,  competent  authorities  verify  approx.  2700  safety  files  of  cosmetic  products 

placed on the EU market. 

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Volume of intra-EU27 cosmetics trade:78

1999

2000

2001

2002

2003

2004

2005

2006

Shaving preparations and toiletries

Preparations for oral & dental hygiene

Preparations for use on the hair

Beauty & make-up preparations for the skin; manicure and pedicure preparations

Perfumes & toilet waters

Value of intra-EU27 cosmetics trade:79

s
e
n
n
o
t
d
n
a
s
u
o
h
T

2,500

2,000

1,500

1,000

500

0

s
o
r
u
E
n
o

i
l
l
i

B

16.0

14.0

12.0

10.0

8.0

6.0

4.0

2.0

0.0

1999

2000

2001

2002

2003

2004

2005

2006

Shaving preparations and toiletries

Preparations for oral & dental hygiene

Preparations for use on the hair

Beauty & make-up preparations for the skin; manicure and pedicure preparations

Perfumes & toilet waters

78 
79 

Source: Eurostat. 
Source: Eurostat. 

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EN 

70 

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ANNEX 3 – Assessment of the administrative costs of the Cosmetics Directive (before re-cast)  
(NB: to facilitate the understanding, the table differs between SMEs and non-SMEs)

Council Directive 76/768 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) 

Tariff
(€ per 
hour) 

Time 
(hour) 

Price
(per 
action 
or 
equip) 

Freq  
(per 
year): 
above 
SME; 
below: 
non-SME 

Nbr  
of  
entities:
above 
SME; 
below: 
non-
SME 

Total nbr
of  
actions
above 
SME; 
below: 
non-SME 

Total  
cost 
above SME; 
below: non-
SME (Mio €) 

Regulatory 
origin 
(%) 

No. 

Ass. 
Art. 

Orig. 
Art. 

Type of obligation 

Target group 

i 

e 

i 

e

Int 

EU 

Nat  Reg 

1  6§1 

Labelling - new product 

Familiarising with the information 
obligation 

Cosmetics industry 

60

10 

600

2  6§1 

Labelling -  
reformulated product 

Familiarising with the information 
obligation 

Cosmetics industry 

60

3 

180

3  7§3 

Notification anti-poison centre 
 - new product 

Filling forms and tables 

Cosmetics industry 

60

10 

600

4  7§3 

Notification anti-poison centre  
- reformulated product 

Filling forms and tables 

Cosmetics industry 

60

5 

300

5  7a§4 

Notification competent authority  
- new product 

Filling forms and tables 

Cosmetics industry 

60

10 

600

6  7a§4 

Notification competent authority  
- reformulated product 

Filling forms and tables 

Cosmetics industry 

60

5 

300

7  7a§1 

8  4§1 

Making safety file available upon  
request by competent authority 

Submitting file for safety evaluation 
to SCCP 

Inspecting and checking 
(including assistance to inspection 
by public authorities) 

Cosmetics industry 

60

10 

600

Producing new data 

Cosmetics industry 

500.000

3

75

9

3.700

11.100

100

7.500

3.700

33.300

6,7

4,5

6

100% 

100% 

225

100

22500

4,05

3

75

3.700

11.100

100

7500

9

3.700

33.300

6,7

4,5

10

225

100

22.500

6,75

3

3.700

11.100

75

9

100

7500

3.700

33.300

6,7

4,5

10

225

100

22.500

6,75

20%  80% 

20%  80% 

20%  80% 

20%  80% 

2700

10

1,62

100% 

5 

100% 

Total administrative costs (Mio €)

83,77 (incl. notification: 55,9) 

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ANNEX 4 – Assessment of the administrative costs of the Cosmetics Directive (after re-cast) 
(NB: to facilitate the understanding, the table differs between SMEs and non-SMEs)

Re-cast Council Directive 76/768 of 27 July 1976 on the approximation of the laws of the Member States relating to 
cosmetic products 

Tariff 
(€ per 
hour) 

Time 
(hour)

Price
(per 
action 
or 
equip) 

Freq 
(per 
year): 
above 
SME; 
below: 
non-
SME) 

Nbr  
of  
entities:above 
SME; 
below: non-
SME 

Total 
nbr 
of  
actions
above 
SME; 
below: 
non-
SME 

Total 
cost 
above 
SME; 
below: 
non-
SME 
(Mio €) 

No. 

Ass. 
Art. 

Orig. 
Art. 

Type of obligation 

Target 
group 

i 

e 

i 

e

Regulatory 
origin 
(%) 

Int

EU  Nat  Reg 

1 

2 

3 

4 

5 

6 

80 
81 

EN 

Labelling - new product 

Familiarising with the information obligation 

Cosmetics 
industry 

60 

9

540

Labelling -  
reformulated product 

Familiarising with the  
information obligation 

Cosmetics 
industry 

60 

   2,7

160

3

75

9

3.700

11.100

100

7.500

3.700

33.300

225

100

22.500

Centralised electronic  
notification (anti-poison centre and 
competent authority) - new product 

Filling forms and tables 

Centralised electronic 
notification (anti-poison centre and 
competent authority) - reformulated 
product 

Filling forms  
and tables 

Cosmetics 
industry 

60 

Cosmetics 
industry 

60 

3

2

3

75

9

180

120

3.700

33.300

225

100

22.500

3.700

11.100

100

7.500

1,35

6

4

5,3

3,6

2

  100% 

  100% 

  100% 

4

2,7

  100% 

Making safety file available upon  
request by competent authority 

Inspecting and checking (including assistance to 
inspection by public authorities) 

Cosmetics 
industry 

60 

10

600

5.400

3,24

  100% 

Submitting file for  
safety evaluation to SCCP80

Producing new data 

Cosmetics 
industry 

500000

881

4

  100% 

This would include the submission of product safety files supporting the use of CMR 1, 2 substances to the SCCP (cf. objective 4). 
The Commission assumes that, in the framework of a stronger focus on  in-market control and cosmetics safety assessment by the manufacturer, the number of dossiers 
submitted to the SCCP is going to reduce by approx. 20%. 

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7 

Reporting serious  
undesirable effects (cosmetovigilance) 

Active reporting of serious undesirable events 

Cosmetics 
industry 

60 

   100

6000

250

1,5

  100% 

Total administrative costs (Mio €) 

37,69 

(incl. notification: 
10,05) 

This means: Reduction of administrative costs by approx. 50% from approx. 83 Mio EUR to approx. 37.5 Mio EUR; Reduction of costs for notifications by 80% from 
approx. 56 Mio EUR to approx. 10 Mio. EUR. 

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ANNEX 5 – Summary of the Cosmetics Directive 

A cosmetic product is any substance or preparation intended to be placed in contact with the 
various external parts of the human body 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,  and/or  correcting  body  odours,  and/or  protecting  them  or  keeping  them  in 
good  condition.  Such  products,  listed  in  the  Annex  (illustrative  list),  must  not  be  liable  to 
cause damage to human health when they are applied under normal conditions of use.  

The  Cosmetics  Directive  provides  for  exhaustive  rules  in  terms  of  packaging,  labelling  and 
chemical safety for the internal market. 

1. 

Product information file/Market surveillance 

Cosmetic products are not subject to pre-market approval. Rather, the manufacturer/importer 
has  to  assess  the  safety  of  the  product.  The  safety  is  then  checked  in  in-market  controls  by 
competent authorities.  

The manufacturer/importer must keep product information and safety information available to 
the competent monitoring authority.  

2. 

Notification to the competent authority 

The manufacturer/importer has to notify the product and the place of manufacture or of initial 
importation to the competent authority of that Member State. 

Moreover, he has to notify approx. 12 anti-poison centres in several Member States. 

3. 

Labelling 

Containers and/or packaging must bear, in indelible, easily legible and visible characters inter 
alia: 

•  the  name  or  trade  name  and  address  or  registered  office  of  the  manufacturer  or  of  the 

person responsible for marketing the cosmetic product within the Community;  

•  particular precautions for use; and 

•  the list of ingredients. 

This  information  is  to  be  labelled  in  the  national  or  official  language  or  languages  of  the 
respective Member State. 

With regard to the list of ingredients, Member States may require these to be labelled with the 
name contained in the inventory, as published by the Commission.  

4. 

Ingredients/composition 

The  Directive  sets  out  a  list  of  substances  which  cannot  be  included  in  the  composition  of 
cosmetic  products  (Annex  II)  and  a  list  of  substances  which  cosmetic  products  may  not 
contain, outside the restrictions and conditions laid down (Annex III).  

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The  Directive  also  contains  “positive  lists”  for  colorants  (Annex  IV),  preservatives  (Annex 
VI) and UV filters (Annex VII). Concerning these groups of ingredients, only the substances 
listed in the respective annex are allowed for use in cosmetics in the EU. 

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ANNEX 

6 

– 

Impact 

assessment  board 

opinion 

of 

31  August 

2007 

EUROPEAN COMMISSION 

IMPACT ASSESSMENT BOARD 

Brussels, 31 August 2007 

D(2007) 7617 

Opinion

Title

Impact  Assessment  on  simplification  of  the  “Cosmetics 
Directive” – Directive 76/768/EEC 

(Draft of 18 July 2007) 

Lead DG

DG ENTR 

Impact Assessment Board Opinion 

(A) Context 

Simplification of Council Directive 76/768/EEC of 27 July 1976 on the approximation of 
the laws of the Member States relating to cosmetic products (the “Cosmetics Directive”) 
was  first  announced  in  the  2005  Commission  Communication  “Implementing  the 
Community  Lisbon  programme:  A  strategy  for  the  simplification  of  the  regulatory 
environment” and is therefore part of the simplification rolling programme 2005-2008.  

(B) Positive aspects 

The IA report is well structured and clearly written. It provides a good overview of the 
relevant Cosmetics Directive issues and contains a very comprehensive synthesis of the 
public consultation. 

(C) Main recommendations for improvements 

The recommendations below are listed in order of descending importance. Some more technical comments 
have been transmitted to the author DG.  

General recommendations: The IA report would benefit from a clearer presentation 
of expected costs and benefits, especially in the context of the simultaneous effects of 
simplification of the regulatory environment for producers and improved safety for 
consumers  through  better  implementation.  The  following  recommendations  were 
accepted by DG ENTR in the Board meeting. 

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(1) The calculation of the costs of "correct cosmetics safety assessments" should be 
presented in the proper perspective. In the present text it is not sufficiently clear that 
these  costs  are  incurred  by  the  industry  under  the  preferred  option  and  are  not  purely 
additional,  but  must  be  seen  against  the  aggregate  costs  in  the  current  situation, 
characterised  by  lack  of  clarity  and  transparency  and  the  absence  of  uniformity  across 
Member States. The report should highlight whether the introduction of a uniform safety 
regime  across  the  EU  would  actually  produce  considerable  cost  savings  for  bona  fide 
producers while it should also explain whether the effective overall safety levels could be 
raised. 

(2) It should be clarified whether the desired improvement of cosmetics safety will 
be achieved without the adoption of more stringent requirements. In view of the dual 
objective to simplify the regulatory environment without compromising existing levels of 
consumer  protection,  the  IA  report  should  spell  out  whether  improved  security  will  be 
entirely  accounted  for  by  greater  transparency  and  higher  compliance  rates  or  also 
through the imposition of more stringent de facto requirements.  

(3)  The  overall  simplification  benefits  of  this  initiative  should  be  better  presented. 
Given that the initiative is part of the Commission's simplification programme, the likely 
simplification  benefits  should  be  presented  as  clearly  as  possible,  including  possible 
gains from simplification of the labelling regime. 

(4)  The  international  context  should  be  better  explained.  The  IA  report  should 
incorporate  a  comparison  of  the  EU  regulatory  regime  with  the  situation  in  third 
countries.  It  should  also  refer  to  consultations  that  have  taken  place  in  the  context  of 
existing regulatory dialogues with the US and other countries.  

(D) Procedure and presentation 

It appears that all necessary procedural elements have been complied with, although the 
report should state more clearly whether the minimum consultation standards were met. 
With  regard  to  the  presentation,  the  IA  report  should  aim  to  more  closely  respect  the 
maximum length of 30 pages (excluding annexes) 

IAB scrutiny process 

Reference number 

2007/ENTR/002 

Author DG 

ENTR- F - 3 

External expertise used 

No  

Date of Board Meeting 

29 August 2007 

Date of adoption of Opinion 

31 August 2007 

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