REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Review of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with regard to substances with endocrine-disrupting properties
Date: 2018-11-07
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: animal health, chemical product, cosmetic product, disease prevention, endocrine disruptor, market approval, plant health control, plant health product, product safety, public health

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 7.11.2018 COM(2018) 739 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Review of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with regard to substances with endocrine-disrupting properties  
 
 
1.  INTRODUCTION 

This report presents the Commission's review of Regulation (EC) 1223/2009 of the European 
Parliament  and  of  the  Council  of  30  November  2009  on  cosmetic  products1  (the  Cosmetics 
Regulation) with regard to substances with endocrine-disrupting properties pursuant to Article 
15(4) of that Regulation2. 

For  the  purpose  of  this  review,  substances  with  endocrine-disrupting  properties  (endocrine 
disruptors)  are  chemical  substances  that  alter  the  functioning  of  the  endocrine  system  and 
negatively affect the health of humans and animals3.  

On 15 June 2016 the Commission presented draft Regulations on criteria to identify endocrine 
disruptors in the field of plant protection products and biocides4. The criteria put forward were 
based  on  the  definition  of  the  World  Health  Organisation  International  Programme  on 
Chemical Safety (WHO/ IPCS5). The WHO defines an endocrine disruptor as ʻan exogenous 
substance or mixture that alters function(s) of the endocrine system and consequently causes 
adverse health effects in an intact organism, or its progeny, or (sub)populationsʼ.  

These  criteria  which  are  in  practice  equivalent  in  terms  of  content  for  biocides  and  plant 
protection  products  were  adopted  by  the  Commission  by  Regulations  of  4  September  2017 
and 19 April 20186. Although these  criteria do not  have direct  legal  consequences  for other 
areas of EU law than the areas of plant protection products and biocides, they should be taken 
into  account,  as  far  as  possible,  for  the  purposes  of  the  present  review  of  the  Cosmetics 
Regulation.  

2.  RESTRICTION  OF  SUBSTANCES  UNDER  THE  COSMETICS  REGULATION  AND  IN  OTHER 

SECTORS 

1 OJ L 342, 22.12.2009, p. 59. 
2 When Community or internationally agreed criteria for identifying substances with endocrine-disrupting 
properties are available, or at the latest on 11 January 2015, the Commission shall review this Regulation with 
regard to substances with endocrine-disrupting properties. 
3 Commission Communication ʻtowards a comprehensive European Union framework on endocrine disruptorsʼ. 
4 Draft Commission Regulations C(2016) 3751 projet and C(2016) 3752 projet and Communication from the 
Commission to the European Parliament and the Council on endocrine disruptors and the draft Commission acts 
setting out scientific criteria for their determination in the context of the EU legislation on plant protection 
products and biocidal products  
(https://ec.europa.eu/health/sites/health/files/endocrine_disruptors/docs/com_2016_350_en.pdf). 
5 World Health Organisation International Program on Chemical Safety, Global assessment of the state-of-the-

science of endocrine disruptors, 2002, WHO/PCS/EDC/02.2. 

6 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the 
determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European 
Parliament and Council, OJ L 301, 17.11.2017, p. 1 (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1510927786692&uri=CELEX:32017R2100) and Commission Regulation (EU) 2018/605 
of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the 
determination of endocrine disrupting properties, OJ L 101, 20.4.2018, p. 33 (https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:32018R0605). 

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In order to ensure a high level of protection of human health, the Cosmetics Regulation lays 
down a system of restrictions on the use of certain substances in cosmetics7.  

Certain  categories  of  ingredients  (i.e.  colorants,  preservatives  and  UV-filters)  can  only  be 
used  in  cosmetic  products  if  they  have  been  authorised  through  their  inclusion  in  the 
respective positive lists of the Cosmetics Regulation (Annexes IV, V and VI to the Cosmetics 
Regulation).  Other  ingredients  can  be  used  in  cosmetics  without  authorisation.  If  there  are 
identified  risks  to  human  health,  ingredients  can  be  prohibited  or  restricted  from  use  in 
cosmetics (Annexes II and III to the Cosmetics Regulation).  

These Annexes may be amended by the Commission in case of potential risk to human health8 
or for adaptation to technical and scientific progress9. 

The inclusion of substances in these Annexes is preceded by a scientific risk assessment by an 
independent  scientific  committee,  the  Scientific  Committee  on  Consumer  Safety  (SCCS). 
More generally, the SCCS provides opinions on health and safety risks (chemical, biological, 
mechanical and other physical risks) of non-food consumer products (e.g. cosmetic products 
and  their  ingredients,  toys,  textiles,  clothing,  personal  care  and  household  products)  and 
services  (e.g.  non-permanent  tattooing,  artificial  sun  tanning).  The  SCCS,  in  the  risk 
assessment procedure for substances used as cosmetic ingredients, considers also the exposure 
assessment  for  specific  vulnerable  groups,  such  as  children  and  pregnant  women.  This  is 
critical since cosmetic products are consumer products used by every citizen every day. 

Specific  rules  under  Article  15  of  the  Cosmetics  Regulation  apply  to  the  use  in  cosmetic 
products of substances which have been classified as carcinogenic, mutagenic or toxic for the 
reproduction (CMR) under Regulation (EC) No 1272/200810 on the Classification, Labelling 
and  Packaging  of  substances  and  mixtures.  CMR  substances  of  category  1A  or  1B11  and  of 
category 212 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall in principle be 
prohibited  from  use  in  cosmetics  based  on  their  CMR  classification  due  to  their  hazardous 
properties13 and inserted in the relevant Annex of the Cosmetics Regulation. 

However  this  general  prohibition  may  be  subject  to  certain  derogations  (either  as 
authorisation or restriction) if certain conditions are fulfilled, including a favourable opinion 
by the SCCS. 

The  Cosmetics  Regulation  does  not  have  any  specific  provisions  for  endocrine  disruptors. 
When  a  substance  identified  or  considered  as  a  potential  endocrine  disruptor  has  been  also 
classified as a CMR, then Article 15 shall apply and the substance shall be banned unless a 

7 Chapter IV of the Cosmetics Regulation. 
8 Article 31(1) of the Cosmetics Regulation. 
9 Article 31(2) of the Cosmetics Regulation. 
10 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, p. 1. 
11 Known or presumed CMR substance. 
12 Suspected CMR / substance of concern. 
13 Article 15 of the Cosmetics Regulation. 

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derogation to the ban is granted subject to the strict requirements laid down in Articles 15(1) 
(opinion by the SCCS) and 15(2) (compliance with food safety requirements of the General 
Food Law, use limited to specific product category, lack of availability of suitable alternative 
substances, evaluation and positive opinion by the SCCS as regards the safe use in cosmetics 
products).  For  cases  where  the  identified  or  potential  endocrine  disrupting  substance  is  not 
classified as a CMR, its use in cosmetics follows the general provisions of Article 31 of the 
Cosmetics Regulation which requires a scientific opinion of the SCCS. 

Chemical  substances  with  adverse  effects  to  the  environment  are  taken  care  of  under  the 
REACH  Regulation14  where  they  can  be,  for  example,  subjected  to  authorisations  or 
restrictions15. This includes chemical substances with endocrine-disrupting properties used in 
cosmetics  which  can  be  subject  to  regulatory  measures  under  REACH  if  they  have  adverse 
effects on the environment16. 

Different  regulatory  approaches  exist  in  different  pieces  of  EU  law  on  endocrine  disruptors 
depending  on  the  specificities  of  each  sector17.  For  example,  in  the  EU  Food  Contact 
Materials Regulation18, like in the Cosmetics Regulation, no specific provisions for endocrine 
disruptors  are  laid  down:  where  necessary,  in  order  to  address  potential  risks  for  human 
health, the Commission can adopt measures banning or restricting the use of substances used 
in  food  contact  materials  based  on  a  scientific  risk  assessment  which  takes  account  of  the 
requirements of the sectoral legislation. 

In  the  areas  of  biocides  and  plant  protection  products,  the  legislator  expressly  decided  that 
endocrine  disruptors,  including  those  that  are  not  classified  as  CMRs,  should  not  be,  in 
principle, approved with limited possibilities of derogation. Under REACH, substances with 
endocrine disrupting properties may be identified as substances of very high concern (SVHC); 
the  latter  may  be  identified  as  SVHC  on  a  case  by  case  basis  provided  there  is  scientific 
evidence of probable serious effects to human health or the environment which give rise to an 
equivalent  level  of  concern  to  CMRs  (categories  1A/1B)  or  persistent,  bioaccumulative  and 
toxic  (PBT)  or  very  persistent  and  very  bioaccumulative  (vPvBs).  The  new  Regulation  on 
medical  devices19  aims  at  ensuring  that  when  used  the  benefit  of  the  use  of  endocrine 
disruptors in the devices is higher than the potential risk of their use. This applies to medical 

14 Regulation (EC) No 1907/2006 of the European Parliament and the Council of 18 December 2006 concerning 
the registration, evaluation, authorisation and restriction of chemicals (REACH), OJ L 396, 30.12.2006, p. 1. 
15 For example, REACH restricts the use of nonylphenol, used as a surfactant, in cosmetic products (point 46(a) 
of Annex XVII to REACH). 
16 Up to now, 9 substances have been identified under REACH as endocrine disruptors with adverse effects to 
the environment. 
17 Commission Communication ʻtowards a comprehensive European Union framework on endocrine disruptorsʼ.  
18 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC, OJ L 338, 13.11.2004, p. 4 (https://eur-lex.europa.eu/legal-
content/EN/TXT/?qid=1539937344962&uri=CELEX:32004R1935). 
19 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, 
amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and 
repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L 117, 5.5.2017, p. 1 (https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745). 

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devices  that  are  invasive  and  come  into  direct  contact  with  the  human  body,  administer 
medicines  and  body  liquids  and  the  use  of  endocrine  disruptors  in  such  devices  shall  be 
justified. 

3.  SAFETY ASSESSMENT OF COSMETIC INGREDIENTS BY THE SCCS 

a.  SCCS' METHODOLOGY FOR SAFETY ASSESSMENT 

The  SCCS  is  mandated  by  the  Commission  to  perform  the  safety  assessment  of  substances 
used in cosmetic products, including CMR substances and nanomaterials20.  

Relevant  information  on  the  different  aspects  of  testing  and  safety  evaluation  of  cosmetic 
substances  in  Europe  is  presented  in  the  SCCS  Notes  of  Guidance  for  Testing  of  Cosmetic 
Ingredients  and  Their  Safety  Evaluation  (SCCS  Notes  of  Guidance).  They  are  designed  to 
provide  guidance  to  public  authorities  and  to  the  cosmetic  industry  in  order  to  improve 
harmonised compliance with the Cosmetics Regulation. 

The  SCCS  Notes  of  Guidance  are  regularly  revised  and  updated  in  order  to  incorporate  the 
progress  of  scientific  knowledge  in  general,  and  the  experience  gained  in  particular,  in  the 
field of testing and safety evaluation of cosmetic ingredients21. 

b.  SCCS' APPROACH TO THE SAFETY ASSESSMENT OF ENDOCRINE DISRUPTORS 

The SCCS has set out its specific approach to the safety assessment of endocrine disruptors in 
its  Memorandum  on  Endocrine  Disruptors  (SCCS/1544/14)  of  16  December  2014.  In  that 
document the SCCS endorsed, in  accordance with  the European Food Safety Authority (the 
EFSA)22  and  the  ʻEndocrine  Disruptors  Expert  Advisory  Groupʼ  convened  by  the 
Commission's Joint Research Centre (JRC)23,  the above-mentioned WHO/IPCS definition of 
an endocrine disruptor.  

In its Memorandum,  the SCCS has  supported the conclusions of the EFSA that  ʻ[endocrine 
disruptors] can […] be treated like most other substances of concern for human health and 
the environment, i.e. be subject to risk assessment and not only to hazard assessmentʼ. EFSA 
has also found that ʻlevels of concern are not determined exclusively by risk assessment but 
also by protection goals set by the risk managementʼ.  

The  SCCS'  position  to  the  safety  assessment  of  endocrine  disruptors  as  described  in  the 
Memorandum was confirmed in the 9th revision of the SCCS Notes of Guidance24 of 25 April 

20 Articles 15, 16 and 31 of the Cosmetics Regulation. 
21 Last update: SCCS/1564/15, 9th revision of 25 April 2016. 
22 EFSA (2013), Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for 
identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated 
by these substances on human health and the environment, EFSA Journal 2013;11(3):3132. 
23 Munn S., Goumenou M-P., Key scientific issues relevant to the identification and characterisation of 
endocrine disrupting substances - Report of the Endocrine Disrupters Expert Advisory Group (ED EAG). JRC-
IHCP 2013. [29 pp.]DOI: 10.2788/8659 (online). Retrieved from: 
http://publications.jrc.ec.europa.eu/repository/bitstream/JRC79981/lbna25919enn.pdf. 
24 SCCS/1564/15, 9th revision of 25 April 2016. 

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2016. The SCCS pointed out that this approach is in line with its past and present practices 
with regard to a safety assessment for substances with endocrine-disrupting properties. 

The SCCS and its predecessors, the Scientific Committee on Consumer Products (the SCCP) 
and  the  Scientific  Committee  on  Cosmetic  Products  and  Non-Food  Products  Intended  for 
Consumers,  have  indeed  already  evaluated  cosmetic  ingredients  suspected  of  having 
endocrine-disrupting  properties.  Examples  of  ingredients  on  which  the  SCCS  and  its 
predecessors  delivered  such  scientific  opinions  are  several  parabens25  (which  are  cosmetic 
preservatives),  triclosan26  (used  as  a  preservative  and  deodorant),  homosalate27  (used  in 
sunscreens as UV-filter but also for its skin conditioning properties), benzophenones (mainly 
used to  protect  cosmetics  from  the effects  of UV-light), the UV-filters  4-methylbenzylidene 
camphor and 3-benzylidene camphor28, melatonin29 (used as an antioxidant), resorcinol30 (hair 
dye)  and  cyclomethicone31  (which  has  various  functions  such  as  antistatic,  softening  and 
smoothing the skin or hair conditioning).  

These  opinions  illustrate  the  type  of  data  used  for  ensuring  a  scientific  evaluation  of 
substances suspected to have endocrine disrupting properties32. Conclusions are made whether 
endocrine/hormonal  activities  are  linked  to  the  critical  endpoint  for  assessing  the  safety  of 
these  substances  for  consumers,  including  vulnerable  groups  such  as  children  when 
applicable. They confirm that the SCCS can perform a risk assessment of these substances for 
use in cosmetics in accordance with the current SCCS methodology. 

These  opinions  show  that  the  scientific  concerns  with  regard  to  the  endocrine-disrupting 
properties of substances can be addressed in the safety assessment of the SCCS (subject to the 
limitations linked to the animal testing ban for cosmetics33), as in the case of certain parabens 
which  are  used  as  preservatives  in  cosmetics.  The  SCCS  carried  out  a  case-by-case  safety 
assessment of the different parabens. While the safety for use in cosmetics of certain types of 
parabens34 has been confirmed by the SCCS, the SCCS could not rule out the risk for human 
health  of  other  categories  of  parabens35.  Based  on  the  SCCS  safety  assessment,  the 
Commission took the appropriate measures to restrict or ban the use of certain parabens where 
there was a potential risk for human health, including the use of some parabens in products 

25 SCCP/1017/06, SCCP/1183/08, SCCS/1348/10, SCCS/1446/11, SCCS/1514/13. 
26 SCCP/1192/08 and SCCS/1414/11. 
27 SCCP/1086/07. 
28 SCCNFP/0483/01 and SCCS/1513/13. 
29 SCCS/1315/10. 
30 SCCS/1270/09. 
31 SCCS/1241/10. 
32 Data from in vitro studies suitable to detect different hormonal activities were reviewed together with data 
from in vivo studies relevant for detection of related developmental and reproductive toxicity as well as 
information on human exposure resulting from the use of these substances. 
33 Article 18(1) of the Cosmetics Regulation. 
34 Methylparaben, ethylparaben, propylparaben and butylparaben 
35 Isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and pentylparaben 

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designed for application on the nappy area of children under the age of three; while the use of 
other parabens was confirmed as safe.36  

Consequently,  substances  identified  as  endocrine  disruptors  are  currently  subject  to  the 
general safety assessment of the SCCS. They are treated like substances of concern for human 
health and are subject to case-by-case regulatory action based on the general requirements of 
the legislation which are aimed at ensuring product safety.  

4.  AVAILABLE EVIDENCE FOR THE IDENTIFICATION OF ENDOCRINE DISRUPTORS 

To  support  the  impact  assessment  performed  by  the  Commission  in  the  field  of  plant 
protection  products  and  biocides37,  a  screening  study  of  available  evidence  on  chemical 
substances  for  their  potential  identification  as  endocrine  disruptors  was  performed  by  an 
external  contractor  and  published  on  30  June  201638.  The  methodology39  for  the  screening 
was developed by the JRC. 

The  study  was  carried  out  to  estimate  the  number  and  the  identity  of  the  chemicals  which 
would be potentially identified as endocrine disruptors under different options for criteria to 
identify  endocrine  disrupting  properties.  The  substances  screened  were  overall  about  600 
chemicals,  including  almost  all  approved  active  substances  in  the  EU  for  use  in  plant 
protection products  and  biocidal  products,  plus  a subset of chemicals  falling under REACH 
Regulation, the Cosmetics Regulation and the Water Framework Directive. 

The  results  of  the  screening  study  do  not  constitute  scientific  evaluations  of  individual 
substances  which  need  to  be  specifically  carried  out  under  the  respective  chemical 
legislations,  in  particular  the  Cosmetics  Regulation.  It  would  thus  be  erroneous  to  consider 
that  the  substances  listed  in  the  results  of  this  study  are  considered  as  endocrine  disruptors 
within the meaning of the EU legislation. 

Therefore the results of the screening study cannot be used as such for a regulatory decision 
and need to be confirmed40 through a critical review and a re-assessment of the data. 

Within the screening exercise performed, the analysis of the 51 substances used as cosmetics 
ingredients41 has shown that, according to the methodology applied, the large majority has not 
been identified as potentially having endocrine-disrupting properties. However this outcome 
may result from the lack of evidence for endocrine-disrupting properties in the subset of the 
51 substances examined rather than negative evidence. 

36 Commission Regulation (EU) No 358/2014 of 9 April 2014 amending Annexes II and V to Regulation (EC) 
No 1223/2009 of the European Parliament and of the Council on cosmetic products, OJ L 107, 10.4.2014, p. 5 
and Commission Regulation (EU) No 1004/2014 of 18 September 2014 amending Annex V to Regulation (EC) 
No 1223/2009 of the European Parliament and of the Council on cosmetic products, OJ L 282, 26.9.2014, p. 5. 
37 https://ec.europa.eu/health/sites/health/files/endocrine_disruptors/docs/2016_impact_assessment_en.pdf   
38 http://ec.europa.eu/health/endocrine_disruptors/docs/2016_impact_assessment_study_en.pdf 
39http://publications.jrc.ec.europa.eu/repository/bitstream/JRC101950/jrc%20screening%20methodology%20for
%20ed%20impact%20assessment%20%28online%29.pdf 
40 See the disclaimer on the front page of the screening methodology and the screening report. 
41 Initially forty-five substances, including the category of parabens of which seven were analysed. 
(http://ec.europa.eu/health/endocrine_disruptors/docs/impactassessment_chemicalsubstancesselection_en.pdf). 

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Among  the  seven  cosmetic  substances  identified  as  potentially  having  endocrine-disrupting 
properties and the three for which the results were inconclusive42, half is already banned and 
listed  in  Annex  II  to  the  Cosmetics  Regulation  (ʻlist  of  substances  prohibited  in  cosmetic 
productsʼ) or will be prohibited as CMR substances. 

The remaining few substances identified as potentially having endocrine-disrupting properties 
are  not  covered  by  an  existing  or  ongoing  prohibition.  The  next  steps  regarding  those 
substances are presented in Section 5. 

In  addition  to  these  51  substances,  some  substances  were  not  specifically  screened  for 
cosmetics in  the  context  of the study but  are actually  also  used in  cosmetics and have been 
identified as potentially having endocrine-disrupting properties.  

An  example  is  triclosan,  subject  to  a  non-approval  decision43  under  the  Biocidal  Products 
Regulation44  for  its  use  in  product-type  1  –  human  hygiene  disinfecting  product  (e.g.:  hand 
disinfectant) due to unacceptable risks for the environment. In 2014, the Commission already 
implemented a restriction to the use of triclosan as a preservative in cosmetics, following the 
scientific opinions of the SCCP45 and of the SCCS46. This was a result of the opinions of the 
SCCP and the SCCS which considered that the continued use of triclosan as a preservative at 
the previously  allowed  maximum  concentration limit  of 0.3 % in  all cosmetic products  was 
not  safe  for  the  consumer  because  of  the  magnitude  of  the  aggregate  exposure  taking  into 
account the concerns related to endocrine disruption.  

The Commission is aware of the ongoing debate on potential endocrine-disrupting properties 
of triclosan. As soon as new scientific data47 on possible adverse effects of triclosan on human 
health become available, the Commission will assess the next steps to be taken based on such 
data. 

5.  CONCLUSIONS AND PROPOSED NEXT STEPS  

As  regards  environmental  aspects,  chemical  substances  with  adverse  effects  to  the 
environment  are  taken  care  of  under  REACH  where  they  can  be,  for  example,  subjected  to 
authorisations  or  restrictions.  Therefore  chemical  substances  with  endocrine-disrupting 
properties  impacting  on  the  environment  which  are  used  in  cosmetics  can  be  subject  to 
regulatory measures under REACH. 

42 Limited or no relevant data available. 
43 Commission Implementing Decision (EU) 2016/110 of 27 January 2016 not approving triclosan as an existing 
active substance for use in biocidal products for product-type 1, OJ L 21, 28.1.2016, p. 86. 
44 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the 
making available on the market and use of biocidal products, OJ L 167, 27.6.2012, p. 1. 
45 SCCP/1192/08 and SCCS/1414/11. 
46  Commission Regulation (EU) No 358/2014 of 9 April 2014 amending Annexes II and V to Regulation (EC) 
No 1223/2009 of the European Parliament and of the Council on cosmetic products, OJ L 107, 10.4.2014, p. 5. 
47 The Member State Committee under REACH, after having carried out a substance evaluation of triclosan, has 
decided to ask registrants of triclosan to provide further data on endocrine disruption (Decision from 19. 
September 2014 on Substance Evaluation pursuant to article 46(1) of Regulation (EC) No 1907/2006). 
(https://echa.europa.eu/documents/10162/c58c17a8-d00f-4327-853e-2b3d66ffad9e)  

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As  regards  health  aspects,  in  contrast  to  CMRs,  the  Cosmetics  Regulation  does  not 
specifically  lay  down  any  regulatory  consequences  for  endocrine  disruptors.  However 
substances  identified  or  considered  as  potential  endocrine  disruptors  which  have  been 
classified  as  CMRs  are  to  be  banned  under  Article  15  unless  a  specific  derogation  is  fully 
justified and scientifically approved by the SCCS. For substances other than CMRs which are 
identified or considered  to  be potential endocrine disruptors, the provisions of Article 31 to 
prohibit or restrict their use would apply following a risk assessment where there is a potential 
risk  to  human  health  identified,  as  shown  in  the  examples  of  triclosan  and  parabens.  In  the 
risk  assessment  procedure  for  substances  used  as  cosmetic  ingredients,  the  SCCS  considers 
also  the  exposure  assessment  for  specific  vulnerable  groups,  such  as  children  and  pregnant 
women. This is critical since cosmetic products are consumer products used by every citizen 
every day. 

Therefore,  the  Cosmetics  Regulation  provides  the  adequate  tools  to  regulate  the  use  of 
cosmetic substances that present a potential risk for human health and to take the appropriate 
regulatory  measures  based  on  a  scientific  assessment  of  available  data  concerning  human 
health. 

Mindful  of  the  different  approaches  taken  in  relevant  pieces  of  EU  legislation  to  address 
endocrine  disruptors  in  different  sectors,  the  experience  collected  since  the  entry  into 
application  of  the  Cosmetics  Regulation  has  not  revealed  elements  which  would  justify 
deviating from the regime designed by the legislator to address the safety concerns related to 
the use of endocrine disruptors in cosmetics. 

The  cornerstone  of  the  existing  legislative  framework  is  the  scientific  risk  assessment  of 
cosmetic ingredients carried out by the SCCS. The SCCS has confirmed that it can assess the 
safety  of  cosmetic  ingredients  with  respect  to  their  endocrine-disrupting  activity,  subject  to 
the restrictions imposed by the animal testing ban for cosmetic products. Substances identified 
as  endocrine  disruptors  are  treated  like  substances  of  concern  for  human  health  and  are 
subject to case-by-case regulatory action based on the general requirements of the legislation 
which are aimed at ensuring product safety.  

When  the  SCCS  safety  assessment  concludes  to  a  risk  to  human  health  of  substances 
considered  as  potential  endocrine  disruptors,  the  Commission  is  in  a  position  to  take  the 
appropriate measures to ban or restrict the use of such substances in cosmetics on a case by 
case basis. Such action has already been taken in the past, as shown in the above-mentioned 
examples  and  will  continue  in  the  future.  The  Commission  will  establish  by  the  1st  Quarter 
2019 a priority list of potential endocrine disruptors that are not already covered by the bans 
laid  down  in  the  Cosmetics  Regulation48.  In  order  to  prepare  the  assessment  of  such 
substances,  the  Commission  will  launch  calls  for  data  addressed  to  Member  States, 
stakeholders  and  academia.  Upon  receipt  of  such  data,  the  Commission  will  mandate  the 
SCCS  to  evaluate  the  substances  in  the  shortest  delay.  On  that  basis,  the  Commission  will 
take the appropriate action to ban or restrict the use of the different substances in cosmetics.  

48 Substances prohibited from use in cosmetic products and specific prohibitions applicable to CMR substances. 

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The Commission will further analyse the efficiency, effectiveness and coherence between the 
different risk-management approaches to endocrine disruptors laid down in EU law, including 
the  Cosmetics  Regulation,  as  stated  in  the  Commission  Communication  ʻtowards  a 
comprehensive  European  Union  framework  on  endocrine  disruptorsʼ  which  announces  the 
launch of a cross-sectoral Fitness Check on endocrine disruptors. 

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