REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on product claims made based on common criteria in the field of cosmetics
Date: 2016-09-19
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: advertising, advertising malpractice, consumer information, cosmetics industry, labelling, market approval, market supervision, marketing standard, single market

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 19.9.2016  COM(2016) 580 final   REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on product claims made based on common criteria in the field of cosmetics  
 
 
1. 

INTRODUCTION 

The European cosmetics industry is a dynamic and competitive sector. Each year, about 25 % 
of  cosmetic  products  on  the  European  market  are  new.  Europe  is  the  global  leader  in 
cosmetics, with a EUR 77 billion total retail market size. It exports one-third of all cosmetic 
products sold worldwide. 

Cosmetics  encompass  a  very  wide  spectrum  of  products  in  a  variety  of  product  categories, 
ranging from shampoos, fragrances and hair colours to sunscreens, toothpaste and deodorants. 
Considering the high number of cosmetic products available on the EU market (more than 1 
million  different  products),  it  is  very  important  to  provide  consumers  with  specific, 
understandable  and  reliable  information,  substantiated  using  generally  accepted  methods,  to 
enable them to  make  informed choices and compare  products to  find the ones  that best suit 
their needs. 

Product  claims  and  advertising  are  essential  tools  for  informing  consumers  about 
characteristics and qualities and help them choose the products that best suit their needs and 
expectations. Today, virtually every cosmetic product placed on the EU market bears a  type 
of communication which falls into the scope of product claims. 

Product claims are also marketing tools used by the cosmetic companies to distinguish their 
products  from  the  competitors,  thus  they  might  contribute  to  the  functioning  of  the  internal 
market and to stimulating innovation and competition among companies. 

For  cosmetic  product  claims  to  meet  their  purposes  adequately,  it  is  important  to  have  an 
efficient framework in place which ensures that they are fair and do not mislead consumers, 
taking into account the context and the marketing tools (irrespective of whether it is printed 
material,  a  TV  advertisement  or  using  any  kind  of  new  media  such  as  internet  or  smart 
phones) in which such claims are shown. 

To achieve this, competent authorities in charge of market surveillance must be able to easily 
verify all claims based on harmonised common criteria at EU level. The Commission adopted 
common criteria by Regulation (EU) 655/2013 (the Claims Regulation)1, for the justification 
of claims made in relation to cosmetic products. In addition, Regulation (EC) No 1223/2009 
(the  Cosmetics  Regulation)2  requires  the  Commission  to  submit  by  11  July  2016  to  the 
European Parliament and the Council a report regarding the use of claims on the basis of the 
common criteria adopted. 

The main objective of this report is to assess the legal compliance of cosmetics-related claims 
with the common criteria adopted and to specify the corrective measures that the Commission 
and Member States intend to take in cases of non-compliance. 

1   Regulation (EU) No 655/2013 of 10 July 2013 laying down common criteria for the justification of claims 

used in relation to cosmetic products, OJEU L 190/31 of 11.7.2013. 

2   Regulation  (EC)  No  1223/2009  of  the  European  Parliament  and  the  Council  of  30  November  2009  on 

cosmetic products, OJEU L 342/59 of 22.12.2009. 

2 

 
 
                                                            
2. 

EU  LEGISLATION  APPLICABLE  TO  CLAIMS  MADE  IN  RELATION  TO  COSMETIC 
PRODUCTS 

2.1.  Article 20 of the Cosmetics Regulation 

Claims  made  in  relation  to  cosmetic  products  (cosmetic  claims)  are  voluntary  marketing 
messages  used  by  economic  operators  in  the  labelling,  marketing  or  advertising  of  their 
products.  According  to  Article  20  of  the  Cosmetics  Regulation,  cosmetic  claims  are  text, 
names, trademarks, pictures and figurative or other signs that explicitly or implicitly convey 
product  characteristics  or  functions  in  the  labelling,  making  available  on  the  market  and 
advertising  of  cosmetic  products.  They  do  not  include  mandatory  information  required  for 
cosmetic products, e.g. by Article 19 of the Cosmetics Regulation on product labelling. 

Article  20  requires  claims  not  be  used  to  imply  that  cosmetic  products  (as  defined  under 
Article 2(1)(a) of the Cosmetics Regulation) have characteristics and functions which they do 
not have. 

However, Article 20 does not cover all claims made in relation to the marketing of cosmetic 
products.  For  instance,  claims  which  are  not  related  to  the  product’s  characteristics  and 
functions  and  which  do  not  fall  under  the  Cosmetics  Regulation  (e.g.  claims  related  to 
packaging or to pricing) are covered by other EU legislation, such as Directive 2005/29/EC on 
business-to-consumer  unfair  commercial  practices  (UCPD)3  and  Directive  2006/114/EC  on 
misleading and comparative advertising (MCAD) 4.  

Accordingly, for the purposes  of this report, the term ‘cosmetic claims’ only  refers to those 
claims falling under the scope of Article 20 of the Cosmetics Regulation. 

The  adoption  of  common  criteria  for  cosmetic  claims  was  the  most  important  step  of  the 
implementation  of  Article  20  of  the  Cosmetics  Regulation5.  They  were  published  in  the 
Claims Regulation on 11 July 2013 and entered into force immediately6. 

2.2.  The common criteria for the justification of cosmetic claims  

The  main  objective  of  the  common  criteria  is  to  guarantee  a  high  level  of  protection  for 
consumers,  in  particular  from  misleading  cosmetic  claims.  The  common  criteria  provide  an 
EU-level  framework  for  companies,  give  Member  States’  competent  authorities  a  much 
stronger legal basis for in-market control decisions, and should therefore be the reference for 

3   Directive  2005/29/EC  of  the  European  Parliament  and  of  the  Council  of  11  May  2005  concerning  unfair 

business-to-consumer commercial practices in the internal market, OJEU L 149/22 of 11.6.2005. 

4   Directive  2006/114/EC  of  the  European  Parliament  and  of  the  Council  of  12  December  2006  concerning 

misleading and comparative advertising, OJEU L 376/21 of 27.12.2006. 

6  

5   The common criteria were developed by the sub-working group on claims set up under the Working Group 
on  Cosmetic  Products  with  the  aim  of  implementing  Article  20  of  the  Cosmetics  Regulation.  The  sub-
working  group  is  chaired  by  the  Commission  and  consists  of  representatives  of  Member  States,  the 
cosmetics  industry,  including  small-  and  medium-sized  enterprises  (SMEs),  and  European  Consumer 
Organisation BEUC. 
In order to ensure the harmonised application of the common criteria, the Commission and the sub-working 
group  on  claims  also  developed  legally  non-binding  guidelines,  which  are  available  on  the  Commission’s 
website  (http://ec.europa.eu/growth/sectors/cosmetics/legislation/index_en.htm).  Annex  I  to  the  guidelines 
provides  a  detailed  description  of  the  common  criteria  set  out  by  the  Claims  Regulation,  including 
illustrative and non-exhaustive examples of claims. Annex II includes best practices specifically related to 
the type of evidential support used for the justification of cosmetic claims. 

3 

 
 
                                                            
any  further  analysis.  Competent  authorities  can  verify  cosmetic  claims  much  more  easily 
when they use the common criteria. 

The  common  criteria  apply  to  claims  in  the  form  of  text,  names,  trademarks,  pictures  and 
figurative  or  other  signs  that  explicitly  or  implicitly  convey  product  characteristics  or 
functions  in  the  labelling,  making  available  on  the  market  and  advertising  of  cosmetic 
products. They apply to any claim, irrespective of the medium or type of marketing tool used, 
the product functions claimed, and the target audience.  

The  six  common  criteria  are  legal  compliance,  truthfulness,  evidential  support,  honesty, 
fairness and informed-decision making. 

2.3.  Horizontal EU legislation applicable to cosmetic claims 

2.3.1. Relationship between the Cosmetics Regulation and the UCPD 

The  Cosmetics  Regulation  and  Directive  2005/29/EC  on  business-to-consumer  unfair 
commercial practices have a similar objective, to protect consumers from misleading claims, 
and the latter may apply in a complementary manner to cosmetic claims, to the extent these 
qualify as a commercial practice within the meaning of the UCPD.   

The provisions of the Cosmetics Regulation prevail as lex specialis over the UCPD where the 
specific aspects of unfair commercial practices are regulated by the former. That principle is 
clearly established in the UCPD, which provides in its Article 3.4 that in the case of conflict 
with ‘other Community rules regulating specific aspects of unfair commercial practices’ the 
latter  shall  prevail  and  apply  to  those  specific  aspects.  That  principle  is  further  clarified  in 
recital 10 of the UCPD which states that the ‘Directive accordingly applies only in so far as 
there  are  no  specific  Community  law  provisions  regulating  specific  aspects  of  unfair 
commercial practices, such as information requirements and rules on the way the information 
is presented to the consumer’7. 

With the adoption of the common criteria and their accompanying guidelines, the Cosmetics 
Regulation  is  a  more  precise,  detailed  and  sector-specific  framework  under  which  cosmetic 
claims within the scope of Article 20 are to be primarily assessed. 

2.3.2. Relationship between the Cosmetics Regulation and the MCAD 

The  purpose  of  Directive  2006/114/EC  on  misleading  and  comparative  advertising  is  to 
protect  traders  from  misleading  advertising  and  to  set  out  the  conditions  under  which 
comparative  advertising  is  permitted.  While  the  MCAD  may  in  specific  cases  cover  similar 
practices  to  those  addressed  under  the  UCPD,  the  assessment  of  such  practices  under  the 
MCAD focuses on their impact on competitors. 

Article  20  of  the  Cosmetics  Regulation,  for  its  part,  does  not  distinguish  between  the 
protection of consumers and that of competitors.    

Although  recital  51  of  the  Cosmetics  Regulation  emphasises  the  need  to  protect  consumers 
from misleading claims, the scope of Article 20 is not limited to the protection of consumers. 
‘Fairness’  has  been  included  in  the  common  criteria  as  a  key  principle  aimed  at  protecting 
competitors’ interests and fair trading. 

7   See  also  Section  3.3.3  on  the  implementation/application  of  Directive  2005/29/EC  on  unfair  commercial 

practices, SEC(2009) 1666 final, p.54. 

4 

 
 
                                                            
However, while encompassing similar objectives, the scope of the MCAD is broader than that 
of  Article  20  of  the  Cosmetics  Regulation  and  is  not  limited  to  products’  function  and 
characteristics.  The  MCAD  may  address  any  advertising  used  to  promote  the  supply  of 
products. 

2.4.  Self-regulation for cosmetic claims 

Self-regulation  has  been  a  long-standing  practice  in  the  field  of  advertising,  with  the  three 
main  parties  in  the  advertising  industry  (advertisers,  agencies  and  media)  working  together 
and committing to specific rules and codes of practice and conduct. These codes are entrusted 
to  advertising  Self-Regulatory  Organisations  (SROs),  who  are  responsible  for  their 
establishment, review, application and enforcement. 

The  Commission’s  Better  Regulation  Package8  refers  to  self-regulatory  tools  as  being 
important and complementary to regulatory tools. It endorses, as a benchmark, the principles 
of good practice of self-regulation and co-regulation established by the European Commission 
Community  of  Practice  for  Self-  and  Co-Regulation9.  Self-regulation  is  also  enshrined  in 
legislation, e.g. Article 2(f) of the UCPD. 

Self-regulatory systems help industry provide an additional level of consumer protection  by 
building consumer trust in brands through the promotion of responsible advertising. 

In 2012, the European cosmetic products association Cosmetics Europe developed a Charter 
and  Guiding  Principles  on  Responsible  Advertising  and  Marketing  Communications 
(C&GPs)10  regarding  advertising  of  cosmetic  products  in  the  EU.  The  C&GPs  are  being 
gradually implemented in national advertising codes, to the extent relevant. 

In  line  with  the  commitments  undertaken  in  the  C&GPs,  a  first  monitoring  exercise  was 
carried  out  in  2015  by  the  European  Advertising  Standards  Alliance  (EASA)  across  six 
European  countries:  France,  Hungary,  Italy,  Poland,  Sweden  and  UK.  A  total  of  1 861 
advertisements  (including  577  television  and  1 284  print  advertisements)  of  cosmetic 
products, broadcast/published in September 2014, March 2015 and June 2015, were analysed 
by  SROs.  The  EASA  report11  indicates  a  level  of  compliance  with  all  relevant  advertising 
codes  and  laws  of  91  %,  as  well  as  with  the  common  criteria  of  91  %;  it  thus  shows  the 
cosmetics industry’s commitment to responsible advertising.  

Whilst self-regulation does not replace regulation, the C&GPs apply beyond the national and 
European legal and regulatory framework. They complement the list of common criteria with 
additional provisions which address societal concerns.   

3.  MEMBER STATES’ MARKET SURVEILLANCE ACTION ON COSMETIC CLAIMS 

3.1.  Introduction 

Article 22 of the Cosmetics  Regulation states that Member States  must  monitor compliance 
with the Regulation via in-market controls of the cosmetic products made available on the EU 

8  The  European  Commission’s  Better  Regulation  Package,  13.04.2016:  http://ec.europa.eu/smart-

regulation/index_en.htm. 

9   https://ec.europa.eu/digital-agenda/best-practice-principles-better-self-and-co-regulation. 
10   https://www.cosmeticseurope.eu/publications-cosmetics-europe-

association/guidelines.html?view=item&id=87. 

11   Cosmetics Europe and the European Advertising Standards Alliance: Cosmetics Advertising Audit, 2015. 

5 

 
 
                                                            
market. In July 2014, the Commission sent a letter to all Member States inviting them to carry 
out  market  surveillance  controls  on  cosmetic  claims.  It  requested  Member  States  to 
communicate the results of their controls by 31 December 2015. 

In order to obtain the right input for its report, the Commission requested that Member States' 
market surveillance authorities take the following principles into account: 

1. Purpose 

The  market  surveillance  action  should  be  conducted  in  the  context  of  Article  20  of  the 
Cosmetics  Regulation,  namely  focusing  on  the  use  of  claims  on  the  basis  of  the  common 
criteria.  The  action  should  apply  to  cosmetic  products  after  clarifying  any  borderline  issues 
with medical devices or medicinal products. 

Due  to  the  wide  scope  of  Article  20,  priority  will  be  given  in  the  Commission  report  to 
cosmetics claims where their non-compliance with the common criteria could have a possible 
negative impact on the consumer's health. 

Competent  authorities  of  each  Member  State  must  have  integrated  the  common  criteria  and 
the  accompanying  guidance  in  their  control  practices  and  must  use  them  as  a  tool  to  check 
whether claims could potentially mislead the consumer. 

2. Scope  

The claims verified should cover all forms (text, signs, symbols, etc.) and vehicles (on-pack 
labels, television advertising, print advertising, etc.) for communicating claims. They should 
not be limited to on-pack text claims. 

3. Time-frame  

The time-span during which in-market controls linked to market surveillance action should be 
carried out should be one calendar year (to allow coverage of seasonal products). 

4. Methodology 

Competent authorities should report to the Commission the total number of controls, as well 
as the number of non-compliant claims. 

In  case  of  on-pack  claims  not  complying  with  the  common  criteria,  it  should  be  checked 
whether the common criteria were applicable at the time when the product was placed on the 
market i.e. whether the product was placed on the market before or after 11 July 2013. 

In  cases  of  suspected  non-compliance,  the  responsible  person  should  be  contacted  for  an 
explanation and relevant reporting should be provided. 

Contributions  were  received  from  21  Member  States,  showing  that  national  public  health 
authorities  used  the  common  criteria  and  related  guidelines  to  assess  the  compliance  of 
cosmetic claims. Since the implementation of the Cosmetics Regulation, the common criteria 
are  regularly  used  for  market  surveillance,  including  when  the  responsible  person  or 

6 

 
 
distributor  places  a  product  on  the  market.  Some  Member  States  also  used  additional  EU 
guidance documents12.   

In  addition  to  the  EU  guidelines  on  cosmetic  claims,  some  Member  States  introduced 
additional national guidelines with more detailed instructions and interpretations to take into 
account  specific  social,  cultural  and  linguistic  context,  within  the  framework  established  at 
EU level.   

The necessity to take account of the national context is particularly relevant for assessing the 
average  consumer’s  understanding  of  the  messages  communicated  through  certain  product 
claims. Moreover, ethical criteria such as taste and decency are not included in the EU legal 
framework  and  are  exclusively  addressed  under  the  laws  of  the  Member  States,  and  their 
assessment depends on each Member State’s specific linguistic, social and cultural context13. 

Some  countries  focused  more  on  certain  common  criteria,  such  as  ‘legal  compliance’, 
‘truthfulness’,  ‘evidential  support’  and  ‘honesty’.  Others  analysed  in  depth  only  the  ‘legal 
compliance’, ‘fairness’ and ‘informed decision making’ criteria. Due to difficulties in certain 
cases with accessing the product information files from responsible persons that were not in 
the  same  country,  some  criteria,  such  as  ‘truthfulness’,  ‘evidential  support’  and  ‘honesty’, 
were only partially verified. 

The emphasis of inspection in all Member States  was on health claims as it was advised by 
the Commission to focus on claims that might pose a health risk to the consumer in case they 
are non-compliant and misleading and thus have a negative impact on consumer's health. 

3.2.  Methodology used by the Member States authorities 

Market  surveillance  bodies  of  the  Member  States  focused  primarily  on  assessing  products 
available on their national markets. 

Checks  were  carried  out  either  as  part  of  regular  market  surveillance  or  as  specific  on-site 
checks  in  preparation  of  the  drafting  of  this  report.  Most  Member  States  visited  the 
distributors, responsible persons, manufacturing sites, retail locations, e-shops and wholesale 
units involved. Several Member States examined importers’ and exporters’ sites as well.  

Member  States  examined  claims  found  on  various  media  (television,  radio,  general  and 
specialised press, online), packaging, promotional leaflets, brochures, magazines and websites 
(websites of certain brands, health websites). Selected social media targeting different groups 
of  consumers  were  also  taken  into  account.  Member  States  also  sampled  products  sold  in 
pharmacies and parapharmacies. 

Most samples used for the analysis represented products containing the following categories 
of claims: 

  claims characterising ingredients (e.g. ‘anti-ageing’); 

  claims related to the product’s efficacy (e.g. a skin cream with a sun protection factor); 

12   Such as the Manual on the scope of application of the Cosmetics Regulation (EC) No 1223/2009 (Article 
2(1)(a)), version 1.0 (November 2013) or the Guidance document on the demarcation between the Cosmetic 
2001/83: 
Products 
http://ec.europa.eu/growth/sectors/cosmetics/products/borderline-products/index_en.htm. 
the  UCPD,  as  well  as  section  1.6  of 
implementation/application of UCPD, SEC(2009) 1666 final, p. 12. 

the  Commission  Guidance  on 

13   See  Recital  7  of 

the  Medicinal 

Directive 

Directive 

Products 

76/768 

and 

the 

7 

 
 
                                                            
  claims highlighting the absence of substances (e.g. ‘free from perfume’); 

  claims  addressing  skin  compatibility  of  the  product  (e.g.  ‘hypoallergenic’,  ‘for 

sensitive or atopic skin’); 

  claims  addressing  health  or  additional  benefits  other  than  the  cosmetic  purpose  (e.g. 

sunscreens or intimate hygiene products). 

Member States reviewed the product information files, safety evaluation documents, and the 
claims  on  the  products  themselves,  such  as  text,  images,  symbols,  brand  names  and 
denominations.  Samples  were  also  analysed  scientifically  to  examine  the  presence  of  an 
ingredient that was claimed to be present or absent. 

Some  Member  States  also  monitored  the  notifications  of  serious  undesirable  effects  under 
Article 23 of the Cosmetics Regulation, and the Rapid Alert System (RAPEX)14.  

3.3.  Results of market surveillance carried out by Member States 

According to the contributions from 21 Member States, 38995 cosmetic claims were analysed 
in total in 2014 and 2015. There were 3730 non-compliant claims out of 38995 (10 %). The 
percentage  of  compliance  and  non-compliance  varies  significantly  according  to  the  type  of 
product distribution. In some Member States, up to 70 % of non-compliant claims were found 
online, only 17 % were found on the actual product, and 13 % were found in brochures.   

3.3.1.  Product performance  

16  out  of  the  21  Member  States  that  replied  stated  that  they  found  cases  where  ‘evidential 
support’ and ‘honesty’ criteria were breached in products claiming a function that could not 
be supported with  sufficient evidence,  with the available studies  lacking reproducibility and 
scientific strength.  This was also the case for claims highlighting the function  of one  of the 
substances  to  be  the  function  of  the  final  product.  Due  to  the  low  concentration  of  the 
substance in the product, its effectiveness could not been achieved and evidential support for 
the  function  claimed  by  the  manufacturer  was  considered  insufficient.  For  example,  such 
products claimed to have a sun protection effect or not to contain any allergens. These claims 
were considered to be dishonest. 

3.3.2.  Medicinal properties, claims of treatment ability and therapeutic effects 

10  Member  States  found  claims  stating  a  cosmetic  product’s  medicinal  effect,  breaching  a 
number  of  criteria  such  as,  ‘informed-decision  making’,  ‘honesty’,  ‘evidential  support’  and 
‘legal  compliance’.  They  highlighted  increased  difficulties  to  distinguish  and  classify 
borderline products, i.e. whether a product is a cosmetic or a medicine or a medical device. 

The  common  criteria  must  only  be  used  once  the  product  has  been  determined  to  be  a 
cosmetic  product  under  Article  2  of  the  Cosmetics  Regulation15.  Otherwise,  there  is  a  risk 
that,  for  example,  products  are  wrongly  concluded  to  be  non-compliant  cosmetics,  when  in 

14   The  Rapid  Alert  System  (RAPEX)  makes  it  possible  for  31  European  countries  and  the  Commission  to 
quickly  exchange  information  about  dangerous  non-food  products  posing  a  risk  to  consumer  health  and 
safety: http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/index_en.htm. 

15   A cosmetic product is any substance or mixture intended to be placed in contact with the external parts of 
the  human  body  (epidermis,  hair  system,  nails,  lips  and  external  genital  organs)  or  with  the  teeth  and  the 
mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, 
changing their appearance, protecting them, keeping them in good condition or correcting body odours. 

8 

 
 
                                                            
fact they are medical devices or medicine. Consequently, market surveillance checks should 
only be carried out for cosmetic products, after any borderline issues with medical devices or 
medicinal products have been resolved.  

Most Member States identified claims with a medicinal effect as being the most dangerously 
misleading  claims  for  consumers.  Believing  that  a  cosmetic  product  has  therapeutic  effects 
and medicinal properties could lead consumers to delay seeing their doctor and follow their 
own treatment. Such misleading claims included therapeutic effects on skin, blood circulation, 
deeper tissue, muscles, joints, veins or adipose tissue, anti-inflammatory function, and healing 
properties.  Products  claimed  to  have  medicinal  functions  or  curative  or  biocidal  effects, 
although the responsible person could not give evidence to support this. 

3.3.3.  Free from authorised ingredients 

10  Member  States  raised  the  issue  of  the  ‘fairness’  criterion  being  breached  in  the  claims 
checked because of the denigration of authorised ingredients. Such claims include for instance 
‘free from parabens’ or ‘free from aluminium’. 

20 %  of  the  monitored  cosmetic  products  had  a  ‘free  from’  claim  and  many  of  them  were 
‘parabens  free’.  This  claim  is  attractive  for  marketing  purposes  because  of  the  media 
attention.  However,  Member  States  considered  that  it  is  against  the  ‘fairness’  criterion 
because it denigrates legally authorised ingredients. 

On  the  other  hand,  many  Member  States  stated  that  claims  addressing  the  absence  of 
ingredients  such  as  alcohol,  essential  oils  or  soap  were  considered  to  be  compliant  as  it  is 
essential for the consumer to be able to choose to avoid these ingredients for specific reasons 
such as religion or allergies. 

3.3.4.  Free from banned ingredients 

Some  Member  States  notified  that  cases  of  claims  highlighting  the  absence  of  prohibited 
ingredients  and  claims  mentioning  the  respect  of  EU  quality  standards  and  ‘good 
manufacturing  practices’  were  considered  non-compliant,  breaching  the  ‘legal  compliance’ 
criterion. Such claims can create confusion for consumers and increase competition with other 
manufacturers who also comply with the Cosmetics Regulation but do not make this clear. 

3.3.5.  Hypoallergenic claims 

7 Member States reported cases of ‘hypoallergenic’ claims without supporting documents or 
evidence. Some national authorities notified claims made about hair dyes, according to which 
the  dyes  contained ingredients  that guaranteed or  offered  protection  from  skin  problems  (or 
reduced  the  risk  of  allergy)  during  the  colouring  process.  These  products  nonetheless 
contained resorcinol and para-phenylenediamine, which are well known allergens. Claims that 
attempt  to  underestimate  the  risks  of  allergic  reactions  associated  with  the  use  of  hair  dyes 
pose a risk to human health and may prevent consumers from making an informed choice to 
use the product. 

3.3.6.  Claims on the presence/absence of ingredients although they were not found/found in 

the product 

5  Member  States  reported  cases  of  absence  of  ingredients  mentioned  in  a  product  claim, 
which breaches the ‘truthfulness’ criterion. 

9 

 
 
3.3.7. 

‘Not tested on animals’ and the rabbit logo 

4 Member States found cases of non-compliance with the ‘evidential support’ criterion when, 
although  products  were  claiming  to  be  ‘not  tested  on  animals’  through  the  presence  of  the 
rabbit logo or text, the responsible person did not have evidence of this for all the cosmetic 
components.  Since  2013,  the  Cosmetics  Regulation  prohibits  using  cosmetics  or  substances 
tested on animals as part of the final cosmetic product.   

3.4.  Corrective action in cases of non-compliance 

According  to  the  contributions  received  from  Member  States,  a  wide  variety  of  corrective 
actions  were  carried  out  in  reaction  to  non-compliance  of  claims  with  the  common  criteria. 
The most frequently reported corrective actions were: 

  Written  advice  to  the  responsible  person,  importer  or  manufacturer,  ordering  and 
prohibiting sales until the product complies with the requirements. This measure was 
also taken for e-shops selling non-compliant cosmetic products. 

  Request to the responsible person to modify the claim in the advertisement not only on 

the product but also in the media and on the internet. 

  Order for the responsible person to retroactively carry out skin-compatibility tests for 

a specific target group. 

 

Instruction to the responsible person to conduct new studies to get enough evidence to 
retroactively support the claims. 

  Financial sanctions imposed in some Member States. 

  For erroneous translations, request to correct the labelling. 

  Reminder of the law or injunction to responsible persons. 

  Ensuring that the labelling is corrected through repeated market surveillance actions or 
the reception of relevant documentary evidence before accepting the products back on 
the market. 

4. 

CONCLUSIONS 

The existing European regulatory framework for claims and advertising of cosmetic products 
is very comprehensive and ensures a high level of consumer protection. At the same time, it 
enables the European cosmetics industry to be competitive within the EU and in the world. 

Based on Member States’ contributions to this report, 90 % of analysed cosmetic claims were 
found compliant with the common criteria set out in Regulation (EU) 655/2013. 

It  should  be  noted  that  the  common  criteria  should  only  be  applied  to  products  which  fall 
under  the  definition  of  a  cosmetics  product  under  the  Cosmetics  Regulation,  and  for  which 
any  borderlines  issues  with  medical  devices  or  medicinal products  have  been  resolved.  It  is 
for Member States to decide on a case-by-case basis whether a product is a cosmetic or not.   

Most  non-compliant  claims  were  found  to  be  misleading  as  regards  the  function  and 
performance of the cosmetic product. Furthermore, as also mentioned in the difficulties faced 
by  the  national  authorities  whilst  controlling  claims  on  cosmetic  products,  it  was  not  clear 
how  to  regulate  the  ‘hypoallergenic’  claim  and  the  ‘free-from  (an  authorised  ingredient)’ 

10 

 
 
claim. Such a claim is considered to be denigrating as it is giving a negative impression to the 
consumer about an authorised and scientifically proven safe ingredient. 

All Member States that contributed to this report concurred that there is a need to clarify the 
‘free from’ and ‘hypoallergenic’ claims. This could be done through the existing sub-working 
group on claims and ad hoc technical documents on the two issues. 

11