REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the use of nanomaterials in cosmetics and on the review of Regulation (EC) No 1223/2009 on cosmetic products as regards nanomaterials
Date: 2021-07-22
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: approximation of laws, chemical product, consumer information, cosmetic product, health risk, labelling, nanotechnology, product safety

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 22.7.2021  COM(2021) 403 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the use of nanomaterials in cosmetics   and   on the review of Regulation (EC) No 1223/2009 on cosmetic products as regards nanomaterials   
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on the use of nanomaterials in cosmetics  

and  

on the review of Regulation (EC) No 1223/2009 on cosmetic products as regards  
nanomaterials  

TABLE OF CONTENTS 

Glossary .................................................................................................................................................. 2 

Introduction ............................................................................................................................................. 3 

SECTION 1 – STATUS REPORT ON THE USE OF NANOMATERIALS IN COSMETIC 
PRODUCTS ............................................................................................................................................ 4 

1.1.  The provisions governing nanomaterials in the Cosmetics Regulation ........................... 4 

1.2.  Notification procedure of the nanomaterials placed on the EU market .......................... 5 

1.3. 

1.4. 

Inventory of the nanomaterials present on the EU market ............................................... 8 

Safety assessment of nanomaterials used in cosmetic products ........................................ 9 

1.5.  Assessment methods ............................................................................................................ 11 

International cooperation and regulatory harmonisation in the field of nanomaterials 

1.6. 
in cosmetic products ....................................................................................................................... 12 

1.7.  Main findings Section 1 ...................................................................................................... 13 

SECTION 2 – REVIEW OF THE PROVISIONS CONCERNING NANOMATERIALS ................. 14 

2.1. 

Purpose of the review .......................................................................................................... 14 

2.2.  Definition of “nanomaterial” in the Cosmetics Regulation ............................................. 14 

2.3.  Notification process for nanomaterials ............................................................................. 16 

2.4. 

Scientific assessment of nanomaterials and regulatory measures .................................. 18 

2.5.  Labelling of cosmetics containing nanomaterials and consumer awareness ................. 19 

2.6.  Main conclusions ................................................................................................................. 20 

1 

 
 
 
 
 
 
 
 
Glossary 

Cosmetics Regulation  Regulation (EC) No 1223/2009 of the European Parliament and of 

the Council of 30 November 2009 on cosmetic products 

CPNP 

ECHA 

EU 

EUON 

ICCR 

INCI 

Cosmetic Products Notification Portal  

European Chemicals Agency 

European Union 

European Union Observatory for Nanomaterials 

International Cooperation on Cosmetics Regulation 

International Nomenclature of Cosmetic Ingredients 

Responsible person 

Legal or natural person designated in the EU in accordance with 
Article 4 of the Cosmetics Regulation 

REACH (Regulation)  Regulation (EC) No 1907/2006 of the European Parliament and of 

the Council of 18 December 2006 concerning the Registration, 
Evaluation, Authorisation and Restriction of Chemicals 

SCCS 

Scientific Committee on Consumer Safety  

2 

 
 
 
 
INTRODUCTION 
Nanomaterials  consist  of  very  small  particles1  that  cannot  be  observed  by  the  human  eye. 
These materials are present in nature, such as in beach sand and milk (natural colloids), but 
they are also manufactured and added to consumer products to provide specific properties. 

The  very  small  size  of  nanomaterials  provides  special  physical  and  chemical  properties: 
nanomaterials  may  change  colour  compared  to  their  macroform  or  may  gain  antioxidant 
properties.  However,  the  small  size  can  also  influence  the  hazard  properties  of  a  specific 
nanomaterial.  Some  of  the  nanoforms  of  substances  could  thus  potentially  present  intrinsic 
hazards not displayed in their non-nano form. 

Cosmetic  products  containing  nanomaterials  must  follow  specific  regulatory  provisions  for 
nanomaterials,  and  every  day,  approximately  10  new  such  cosmetic  products  are  placed  on 
the  EU  market;  this  represents  only  small  fraction  (between  1.2%  and  1.5%)  of  the  total 
number of new products (see Paragraph 1.2).  

Regulation  (EC)  No  1223/2009  (hereinafter  the  “Cosmetics  Regulation”)  addresses  the 
specificities inherent to nanomaterials used in cosmetic products: Article 16 provides an ad-
hoc regime that applies to cosmetic products that contain nanomaterials, as described more in 
detail in Section 1. 

Pursuant to Article 16 (10) and (11) of the Cosmetics Regulation, the Commission is required 
to submit to the European Parliament and the Council an annual status report on the use of 
nanomaterials in cosmetic products and to review the provisions concerning nanomaterials of 
this Regulation. 

This  document  aims  to  implement  the  provisions  mentioned  above  and  is  structured  as 
follows: 

  Section 1  – Status  Report on developments  in  the use of nanomaterials  in  cosmetic 

products (Article 16 (10) (b)); 

  Section  2  –  Review  of  the  Provisions  Concerning  Nanomaterials  of  the  Cosmetics 

Regulation (Article 16 (11). 

1  
or an internal structure, on the scale from 1 to 100 nm (nano-meter).   

Article 2(1)(k) of the Cosmetics Regulation refers to a material with one or more external dimensions, 

3 

 
 
                                                           
SECTION  1  –STATUS  REPORT  ON  THE  USE  OF  NANOMATERIALS 

IN COSMETIC PRODUCTS 

1.1.  The provisions governing nanomaterials in the Cosmetics Regulation 

The  Cosmetics  Regulation  provides  a  specific  regime  governing  cosmetic  products  that 
contain  nanomaterials,  defined  in  Article  2(1)(k)  of  this  Regulation  as  “an  insoluble  or 
biopersistant and intentionally manufactured material with one or more external dimensions, 
or an internal structure, on the scale from 1 to 100 nm””. 

In  particular,  Article  16(1)  clarifies  that  “[for]  every  cosmetic  product  that  contains 
nanomaterials,  a  high  level  of  protection  of  human  health  shall  be  ensured”  and  the 
subsequent  paragraphs  in  Article  16  govern  the  procedures  that  apply  to  cosmetic  products 
that contain nanomaterials:  

1.  cosmetic products with nanomaterials are subject to a specific notification procedure, 
“[i]n addition to the notification under Article 13, products containing nanomaterials 
shall be notified to the Commission by the responsible person by electronic means six 
months  prior  to  being  placed  on  the  market  […]”  (Article  16(3)  of  the  Cosmetics 
Regulation). The notification submitted by the applicant shall include the information 
listed in Article 16(3) of the Cosmetics Regulation; 

2.  in the event that the Commission has concerns regarding the safety of a nanomaterial, 
the Commission shall, without delay, request the SCCS (the Scientific Committee for 
Consumer Safety)2 to give its opinion on the safety of this nanomaterial for use in the 
relevant categories of cosmetic products and on the reasonably foreseeable exposure; 
3.  the  SCCS  shall  deliver  its  opinion  within  six  months  of  the  Commission's  request. 
Where  the  SCCS  finds  that  any  necessary  data  is  lacking,  the  Commission  shall 
request  the  responsible  person  to  provide  such  data  within  an  explicitly  stated 
reasonable time, which shall not be extended; 

4.  SCCS  shall  deliver  its  final  opinion  within  six  months  of  submission  of  additional 

data;  

5.  Article  16(6)  of  the  Cosmetics  Regulation  eventually  provides  that:  “[taking]  into 
account the opinion of the SCCS, and where there is a potential risk to human health, 
including when there is insufficient data, the Commission may amend Annexes II and 
III”3. 

Article 16(2) provides that the provisions of this Article do not apply to nanomaterials used 
as  colorants,  UV-filters  or  preservatives  regulated  under  Article  14  of  the  same  Cosmetics 
Regulation,  unless  expressly  specified4,  since  they  are  already  subject  to  specific  ex  ante 
authorisation requirements.  

Annexes II and III of the Cosmetics Regulation provide, respectively, the list of “substances prohibited 

The SCCS is an expert body that provides independent scientific advice to the European Commission 

2  
on the safety of non-food consumer products, including cosmetic products. 
3  
in cosmetic products” and the list of restrictions to the use of substance (“List of substances which cosmetic 
products must not contain except subject to the restrictions laid down”). 
4  
accordance with the conditions laid down in the relevant Annex (IV; V or VI). 

In accordance with Article 14 of the Cosmetics Regulation, these nanomaterials can only be used in 

4 

 
 
 
 
 
                                                           
1.2.  Notification procedure of the nanomaterials placed on the EU market  

Article 13 of the Cosmetics Regulation  provides that, prior to placing a cosmetic product on 
the market, the responsible person shall submit, by electronic means, specific information on 
that  cosmetic  product  to  the  Commission  (including  the  presence  of  nanomaterials  when 
relevant). This notification requirement is carried out via the Cosmetic Product Notification 
Portal5 (CPNP). 

The data extracted from the CPNP provide valuable information on cosmetic products: every 
day  about  800  new  cosmetic  products  are  notified  and  placed  on  the  EU  market  (almost 
290.000 cosmetics were notified in 2019). 

Article 16(3) of the Cosmetics Regulation provides that, in addition to the notification under 
Article 13, cosmetic products that contain nanomaterials shall be notified to the Commission 
by  the  responsible  person,  by  electronic  means,  six  months  prior  to  being  placed  on  the 
market. Hence, the CPNP also contains a separate module for cosmetic products containing 
nanomaterials.  

The  notification  shall  include  the  information  listed  in  Article  16(3)  of  the  Cosmetics 
Regulation.  In  case  of  ingredients  used  to  colour,  preserve  or  as  UV–filter  and  listed  in 
Annexes  IV,  V  or  VI  as  nanomaterials,  the  notification  under  Article  16  does  not  apply; 
nevertheless,  the  general  notification  requirement  under  Article  13  would  continue  to  be 
applicable.  

Therefore,  the  notifications  submitted  under  Article  13  to  CPNP  allow  assessing  the  total 
amount of cosmetic products containing nanomaterials. 

Considering  the  data  collected  from  the  CPNP,  it  is  possible  to  assess  how  the  use  of 
nanomaterials  in  cosmetic  products  has  evolved  over  time.  In  particular,  since  the 
establishment of the CPNP for nanomaterials (period 2013 - 2020) a total of: 

  over 2.5 million cosmetic products have been placed on the EU market;  
  37  647  cosmetic  products  were  notified  with  nanomaterials  (in  accordance  with 

Article 13 procedure), this corresponds to about 1.5% of all notifications; 

  1 445 notifications were made in accordance with Article 16 procedure. 

More specifically, Table 1 below provides an overview of the submitted CPNP notifications 
received for the period 2016 – 2020: 

Year 

2020 

2019 

Article 13 
Notifications 

Article 16 
Notifications 

3 444 

3 926 

137 

175 

5   See https://ec.europa.eu/growth/sectors/cosmetics/cpnp_en 

5 

 
 
 
 
                                                           
2018 

2017 

2016 

3 557 

3 626 

3 556 

200 

131 

265 

Table  1:  2016-2020  CPNP  notifications  on  cosmetic  products  containing  nanomaterials  (both  Article  13  and 
Article 16 notifications).  

This  corresponds  to  an  average  of  about  3  620  new  products  containing  nanomaterials  per 
year  that  are  notified  on  the  CPNP  (data  2016-2020):  every  day,  about  10  new  cosmetic 
products containing nanomaterials are placed on the EU market. 

The use of nanomaterials in cosmetic products is limited (1.5% of all products) and seems 
to be rather stable over the past five years (2016-2020). 

Nanomaterials  used  as  colorants,  preservatives  or  UV  filters  and  listed,  respectively,  in  the 
Annexes  IV,  V  and  VI  to  the  Cosmetics  Regulation  are  not  subject  to  the  notification 
requirements  under  Article  16  of  that  Regulation,  since  they  are  already  subject  to  the  pre-
market  authorisation  regime.  Their  presence  can  be,  however,  retrieved  via  the  general 
notifications submitted in accordance with Article 13 of the Cosmetics Regulation. 

There  are  five  nanomaterials  included  in  the  Annexes  IV,  V  and  VI  to  the  Cosmetics 
Regulation (see Table 2): 

Annex 

INCI 

CAS number 

IV (Colorants) 

Carbon Black (nano) 

1333-86-4/7440-44-0 

V (Preservatives) 

- 

Methylene Bis-Benzotriazolyl 
Tetramethylbutylphenol (nano) 

VI (UV Filters) 

Titanium Dioxide (nano) 

- 

103597-45-1 

13463-67-7/1317-70-
0/1317-80-2 

Tris-biphenyl triazine (nano) 

Zinc Oxide (nano) 

31274-51-8 

1314-13-2 

Table 2: Nanomaterials included in the Annexes to the Cosmetics Regulation 

In 2020, 3 444 notifications were submitted under Article 13 of the Cosmetics Regulation for 
nanomaterials  listed  in  the  Annexes  IV,  V  and  VI;  for  all  other  nanomaterials  only  137 
notifications were made in accordance with Article 16 of the Cosmetics Regulation.  

The figures above confirm that the vast majority of the nanomaterial notifications are related 
to  authorised  uses  of  colorants  and/or  UV  filters  (currently  there  are  no  authorized 
nanomaterials with a preservative function listed in Annex V nor notified in the CPNP); only 

6 

 
 
a  minority  of  all  notifications  are  not  related  to  such  uses  (in  2020,  137  notifications 
corresponding to about 3.9% of all notifications of that year).  

Most  of  the  cosmetic  products  containing  nanomaterial  ingredients  are  related  to 
ingredients with a colorant or UV filter function (about 96% of notifications in 2020). 

The four most used chemical substances, accounting for over 70% of all CPNP nanomaterial 
notifications, are: 

  Titanium Dioxide 
  Silica Dimethyl Silylate, Silane, dichlorodimethyl-, reaction products with silica  
  Carbon Black nano (CI 77266)  
  Silica. 

The most common product  categories6 associated with  a cosmetic containing nanomaterials 
are: 

1.  Sun protection; 
2.  Nail varnish/Nail make up; 
3.  Oxidative hair care; 
4.  Foundation; 
5.  Lip care products and lipstick. 

Significant  differences  were  found  on  the  percentage  of  cosmetic  products  containing 
nanomaterials in different countries. Table 3 below provides an overview of notifications in 
the five EU countries with the highest number of total CPNP notifications (France, Germany, 
Italy,  Spain  and  Poland).  It  is  plausible  to  assume  that  this  divergence  may  result  from 
differences  in  the  implementation  by  national  authorities  and/or  economic  operators  of  the 
nanomaterials definition and, consequently, of the relevant notification obligations. 

Country of 
the 
responsible 
person 

Total CPNP 
notifications 

CPNP 
notifications for 
Nanomaterials 

Percentage of 
notifications for 
Nanomaterials in 
that country 

Country contribution to 
total EU notifications for 
nanomaterials  

France 

328 041 

16 459 

Germany 

291 269 

Italy 

Spain 

528 340 

315 850 

Poland 

123 966 

4 326 

4 569 

2 550 

2 463 

5.0% 

1.5% 

0.9% 

0.8% 

2.0% 

Table 3: CPNP notifications in the five largest EU countries 

43.7% 

11.5% 

12.1% 

6.7% 

6.5% 

There  is  a  significant  difference  in  the  percentage  of  cosmetic  products  containing 
nanomaterials  notified  in  the  five  EU  countries  with  the  highest  number  of  total  CPNP 

6 The reported five uses account for about 64% of all Nanomaterials notifications. 

7 

 
 
                                                           
notifications  (from  0.8%  up  to  5%)  and  in  the  country’s  contribution  to  the  total  EU 
notifications of nanomaterials (from 6.5% (Poland) to 43.7% (France)). 

1.3. 

Inventory of the nanomaterials present on the EU market  

To  improve  transparency,  the  Commission  has  published  two  catalogues  of  nanomaterials 
used in cosmetic products placed on the EU market, as notified through the CPNP. Article 16 
(10) requires that this information concerns all nanomaterials used in cosmetic products – not 
only those notified under Article 16, but  also those used as colorants,  preservatives or UV-
filters. 

The  Commission  published  the  first  catalogue  in  June  2017  (“2017  Catalogue”  with  data 
collected until end of 2016)7. The second version was issued in 2019 (“2019 Catalogue” with 
data collected until end of 2018)8. 

The catalogues include a list of International Nomenclature of Cosmetic Ingredients (INCI) 
names  of  nanomaterials  used  in  cosmetics,  as  notified  in  CPNP.  The  catalogue  further 
specifies into nanomaterials used as colorants, as UV-filters and other nanomaterials notified 
under Article 16 of the Cosmetics Regulation.  

It is important to highlight that the Catalogue is based on the information provided solely by 
the  responsible  person  and  there  is  no  validation  of  the  quality  of  the  information.  The 
responsible person holds the responsibility for the content of the notification. For this reason, 
the  catalogue  is  for  information  only  and  does  not  represent  a  list  of  authorised 
nanomaterials. 

A comparison of both catalogues issued with a two years interval allows identifying trends in 
the  use  of  nanomaterials  in  cosmetics.  Apart  from  illustrating  the  market  trends,  it  also 
reflects rectification of incorrect listing of substances as nanomaterials: 

  The  2017  Catalogue  contains  43  entries  (even  though  some  nanomaterials  appear 
there multiple times in their different functions – i.e. as colorants, UV-filters and other 
functions).  

  The  2019  Catalogue  contains  29  entries  (titanium  dioxide  and  zinc  oxide  are  listed 

twice as both colorants and UV-filters).  

The total  amount of cosmetic ingredients  qualifying as nanomaterials  has declined over the 
observed period from 43 to 29.  

In order to explain this difference, it is relevant in particular to assess the colorants category: 

  The  2017  Catalogue  contains  12  nanomaterial  substances  notified  in  CPNP  as 
Colorants; however, only one substance (Carbon black nano) is present in the related 
Annex IV (only colorants listed in Annex IV can be used for this purpose as cosmetic 
ingredients).  

7   Catalogue of nanomaterials used in cosmetic products placed on the market – version 1. Available at: 

https://ec.europa.eu/docsroom/documents/38164 

8   Catalogue of nanomaterials used in cosmetic products placed on the market – version 2. Available at: 

https://ec.europa.eu/docsroom/documents/38284 

8 

 
 
                                                           
 

In the 2019 Catalogue there are only 3 nanomaterial substances notified in CPNP as 
Colorants  (Carbon black, Titanium oxide and Zinc oxide);  Titanium oxide and  Zinc 
oxide  are  not  authorized  for  colouring  purposes  but  are  inserted  in  Annex  VI  as 
authorized UV filters in nanomaterial form. 

Furthermore, two nanomaterial substances from the list of UV-filters9 and six from the list of 
nano-substances with other functions10 were removed. Nano-copper, Gold and Silver moved 
from nano-colorants to nanomaterials with other functions. 

The above seems to support the finding that many notifications on nanomaterials included 
in  the  2017  first  catalogue  were  made  by  mistake  or  as  a  precaution  and  that  the  2019 
Catalogue represents a more accurate picture of the market. For instance, Titanium dioxide 
and Zinc oxide are not authorized as colorants in Annex IV and, therefore, should not have 
been notified for colouring purposes.  

The differences between the nanomaterial definitions in the Cosmetics Regulation and in the 
Commission  Recommendation  of  18  October  2011  on  the  definition  of  nanomaterial 
(2011/696/EU)  (“Commission  Recommendation  on  the  definition  of  nanomaterial”)11  (see 
Section 2) might be at the origin of some difficulties encountered by economic operators in 
the past in implementing some notifications obligations.  

Overall, there are no “new” chemical substances, qualifying as nanomaterials, featured in the 
2019 Catalogue that had not already appeared in some form (e.g. used in a different category 
of cosmetics) in the 2017 Catalogue.  

1.4. 

Safety assessment of nanomaterials used in cosmetic products  

As mentioned in Section 1.1, Article 16(4) of the Cosmetics Regulation provides that in the 
event  that  the  Commission  has  concerns  regarding  the  safety  of  a  nanomaterial,  it  shall, 
without delay, request the SCCS to give its opinion on the safety of such nanomaterial for use 
in the relevant categories of cosmetic products and on the reasonably foreseeable exposure. 

The SCCS must deliver its opinion within six months of the Commission's request. Where the 
SCCS  finds  that  any  necessary  data  is  lacking,  the  Commission  requests  the  responsible 
person to provide such data within an explicitly stated reasonable time, which should not be 
extended. 

The SCCS has to deliver its final opinion within six months of submission of additional data. 

9   Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine; Ethylhexyl Methoxycinnamate. 
10   Cellulose; Platinum powder; Retinol; Sapphire Powder; Tin Oxide; Tocopheryl Acetate. 
11 The Cosmetics Regulation provides a sector specific definition of “nanomaterial” in Article 2(1)(k): “an 
insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an 
internal structure, on the scale from 1 to 100 nm”.  
The 2011 Commission Recommendation provides the following definition of nanomaterial by: “Natural, 
incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an 
agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external 
dimensions is in the size range 1 nm-100 nm”. 

9 

 
 
                                                           
In accordance with Article 16(5) of the Cosmetics Regulation, the Commission may also, at 
any time, consult the SCCS in accordance with the procedure described above in case safety 
concerns arise.  

Following the mandates provided by the Commission12, in the last 10 years, SCCS issued 
over 20 opinions and guidance documents13 on nanomaterials used in cosmetic products14. 

The  draft  conclusions  of  the  SCCS  are  subject  to  public  consultation  and,  once  finalised, 
constitute  the  scientific  basis  for  the  Commission  decision  to  amend  the  Annexes  to  the 
Cosmetics Regulation.  

The assessment conducted by the SCCS on the safety of a nanomaterial is, therefore, mainly 
based  on  the  information  provided  by  the  notifier,  both  in  the  original  notification  (Article 
16(2)  and  Article  16(3)  of  the  Cosmetics  Regulation)  and  in  the  additional  information 
requested by the SCCS, as applicable, pursuant to Article 16(4) of the Cosmetics Regulation. 

Normally the SCCS should conclude whether a safe use of a nanomaterial can be established, 
including  with  relevant  limitations  or  restrictions,  as  applicable.  However,  in  some  cases 
SCCS  might  not  be  in  a  position  to  conclude  on  the  safety.  This  might  be  due  to  the 
insufficient information/data, as submitted to the SCCS by the applicants and/or as available 
in scientific literature. 

the  most  recent  (2015 

to  2020)  SCCS  opinions  on  CPNP-notified 
Considering 
nanomaterials, the majority are inconclusive. In particular, in seven out of ten opinions, the 
SCCS could not conclude on the safety of the relevant nanomaterial based on the information 
available  in  the  CPNP  system  or  when  the  responsible  persons  were  requested  to  provide 
clarification or additional information/data.  

Finally, it should be noted that the availability of data on specific nanomaterial substances 
could improve in the future via the implementation of the REACH Regulation. In fact, the 
Commission  adopted  nano-specific  clarifications  and  new  provisions  for  REACH 
registrants15.  The  proposed  amendments  (applicable  since  1st  January  2020)  require 
characterisation of nanoforms of substances (i.e. nanomaterials in their different forms). They 
also clarify REACH information requirements with regard to nanomaterials and are expected 
to  over  time  increase  the  availability  of  related  data  (e.g.  through  updates  of  REACH 
registration dossiers). 

12   See https://ec.europa.eu/health/scientific_committees/consumer_safety/requests_en  
13   See Guidance on the safety assessment of nanomaterials in cosmetics; SCCS/1611/19 – 30-31 October 2019; 
Checklists for Nanomaterials in Cosmetics; Revision of the memorandum on Relevance, Adequacy and 
Quality of Data in Safety Dossiers on Nanomaterials, SCCS/1524/13 – 12 December 2013 – revision of 27 
March 2014 

14   The final SCCS opinions are public and can be consulted at 

https://ec.europa.eu/health/scientific_committees/consumer_safety/opinions_en#fragment2 

15   On 3 December 2018 the Commission adopted Commission Regulation (EU) 2018/1881 to modify REACH 
Annexes I, III and VI-XII, introducing nano-specific clarifications and new provisions in the chemical safety 
assessment (Annex I), registration information requirements (Annex III and VI-XI) and downstream user 
obligations (Annex XII). 

10 

 
 
                                                           
1.5.  Assessment methods   

The  assessment  whether  a  particulate  material  is  a  nanomaterial  or  not  according  to  the 
definition  of  nanomaterial  in  the  Cosmetics  Regulation  often  requires  that  specific 
measurements  (e.g.  to  confirm  the  size  range)  are  carried  out,  as  well  as  to  duly  consider 
additional  elements  of  the  definition  (e.g.  insolubility,  intentionality  of  the  manufacturing, 
etc.).  The  assessment  of  the  risks  associated  with  nanomaterials  also  requires  specific 
considerations. 

Recital 30 of the Cosmetics Regulation provides that:  

is 

there 

the  risks  associated  with 
“At  present, 
nanomaterials.  In  order  to  better  assess  their  safety  the  SCCS  should  provide 
guidance  in  cooperation  with  relevant  bodies  on  test  methodologies  which  take  into 
account specific characteristics of nanomaterials”.  

information  on 

inadequate 

The Cosmetics Regulation acknowledged, therefore, that, at the moment of its adoption there 
was “inadequate information on the risks associated with nanomaterials” and mandated the 
SCCS to adopt a guidance on test methodologies to assess their risks. Such guidance has been 
adopted  by  the  SCCS  in  2012  (“Guidance  on  the  Safety  Assessment  of  Nanomaterials  in 
Cosmetics”,  SCCS/1484/12)  and  it  was  followed  by  a  SCCS  Memorandum  on  Relevance, 
Adequacy and Quality of Data in Safety Dossiers on Nanomaterials (SCCS/1524/13).  

The  Guidance  was  originally  adopted  in  2012  and  was  revised  in  201916  to  reflect  new 
scientific  findings  and  update  data  requirements,  such  as  the  animal  testing  ban  that  has 
meanwhile come into force and requires obtaining data from alternative methods17. 

The  current  Guidance  on  the  Safety  Assessment  of  Nanomaterials  in  Cosmetics  takes  into 
account specific characteristics of nanomaterials and details various safety considerations to 
be taken into account (such as physicochemical characterisation, exposure assessment, hazard 
identification  and  dose-response  characterisation  and  risk  assessment).  Checklists  for  the 
applicants’ dossiers are also available18.  

In addition, the EU Joint Research Centre (JRC) issued in 2019 a Report on Identification of 
nanomaterials  through  measurements19,  which  addresses  identification  of  nanomaterials 
according  to  the  Commission  Recommendation  on  the  definition  of  nanomaterial.  Even  if 
there is no full coherence between the 2011 Commission Recommendation on the definition 
of  nanomaterial  and  the  definition  of  “nanomaterial”  in  the  Cosmetics  Regulation,  the  JRC 
report  contains  useful  elements  on  the  analytical  methodologies  to  be  followed.  Relevant 
information  can  also  be  retrieved  on  the  ECHA  Guidance  “Appendix  for  nanoforms 

16 Guidance on the Safety Assessment of Nanomaterials in Cosmetics, SCCS/1611/19, as revised in October 
2019. Available at: 
https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_233.pdf 
17 https://ec.europa.eu/health/sites/health/files/scientific_committees/docs/citizens_guidance_nano_en.pdf 
18   See Checklists for Nanomaterials in Cosmetics section in the: Checklists for Applicants submitting dossiers 
on Cosmetic Ingredients to be evaluated by the SCCS, SCCS/1588/17, as revised in May 2018. Available at: 
https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_210.pdf  

19   See https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/identification-

nanomaterials-through-measurements 

11 

 
 
 
 
 
                                                           
applicable  to  the  Guidance  on  Registration  and  Substance  Identification”  (December 
2019)20. 

1.6. 

International  cooperation  and  regulatory  harmonisation 
nanomaterials in cosmetic products  

in  the  field  of 

The  EU  is  the  first  jurisdiction  to  have  regulated  the  use  of  nanomaterials  in  cosmetics  in 
order to ensure their safety for human health. However, using nanotechnology to improve the 
performance of cosmetic products is a global trend not limited to EU. Some other countries 
followed this approach by adopting a regulatory framework specifically covering the use of 
nanomaterials in cosmetics21. 

Contrary  to  this,  other  jurisdictions  did  not  adopt  specific  regimes  reflecting  the  distinct 
chemical and biological characteristics of nanomaterials (e.g. United States, Australia, Brazil, 
Canada and Japan22). 

Efforts  towards  harmonisation  of  the  “nanomaterial”  definition  and  alignment  on  the  nano-
specific safety assessment is ongoing at a number of international fora23. Therefore, when the 
ICCR  (International  group  of  cosmetics  regulatory  authorities  from  Brazil,  Canada,  the 
European  Union,  Japan  and  the  United  States)24  was  established  in  2007,  the  use  of 
nanotechnology  in  cosmetics  was  considered  as  one  of  six  priority  areas  for  international 
cooperation25.  Since  then,  steps  are  being  taken  to  find  a  common  approach  towards 
nanomaterials in cosmetics. 

In  its  standardisation  efforts,  ICCR  worked  toward  a  consensus  on  safety  approaches  to 
nanomaterials  in  cosmetics and to  harmonise experimental procedures.  It  has issued reports 
on standard nanoparticle detection and characterisation methods, followed by the latest report 
on safety approaches to nanomaterials in cosmetics26.  

As the notion of “nanomaterial” varies among different jurisdictions, already in its first report 
on nanotechnology, the  ICCR invited the cosmetic industry to  develop  common definitions 

20 See https://echa.europa.eu/documents/10162/13655/how_to_register_nano_en.pdf/f8c046ec-f60b-4349-492b-
e915fd9e3ca0   
21   By way of example, New Zealand has a notification and labelling requirement comparable to those in the EU 
Cosmetic Regulation. In Israel and South Korea, nanomaterials are also regulated – specific requirements are 
in place to verify the safety of a cosmetic product containing nanomaterial ingredients and the use of 
nanomaterials in the product has to be indicated on the product label.  

22   Report of the ICCR Working Group: Safety Approaches to Nanomaterials in Cosmetics. Annex 2: 

Regulatory Considerations relating to nanomaterials in cosmetics (2013). Available at: https://www.iccr-
cosmetics.org//downloads/topics/2013-11_safety_approaches_to_nanomaterials_in_cosmetics.pdf  

23   See e.g. the standardisation work of the Technical Committee 229 on Nanotechnologies of the International 

Standardization Organization (ISO) (https://www.iso.org/committee/381983.html).  

24   International Cooperation on Cosmetics Regulation (ICCR) is a voluntary international group of cosmetics 
regulatory authorities from Brazil, Canada, the European Union, Japan and the United States. see the ICCR 
website available at: https://www.iccr-cosmetics.org/. 

25   ICCR-2. Association Panel Report Nanotechnology in Cosmetics of October 31, 2008. Available at: 

https://www.iccr-cosmetics.org/files/2814/3350/5427/2008-
10_Association_Panel_Report_on_Nanotechnology_in_Cosmetics.pdf.  

26   ICCR. Report of the ICCR Working Group on the Safety Approaches to Nanomaterials in Cosmetics. 

ICCR/NANOSAFETY1/R/FINAL/. 2013. Available at: https://www.iccr-
cosmetics.org//downloads/topics/2013-11_safety_approaches_to_nanomaterials_in_cosmetics.pdf 

12 

 
 
                                                           
for nanotechnology in the field of cosmetics27. In the interim, the ICCR’s Ad Hoc Working 
Group on Nanotechnology identified a set of criteria to help determine if a specific substance 
used  in  cosmetics  is  considered  “nanomaterial”  based  on  set  criteria  and  methods  of 
detection.  

The ICCR working definition28 is broadly aligned with the definition in Article 2(1)(k) of the 
Cosmetics  Regulation,  thus  defines  a  nanomaterial  as  a  substance  which,  amongst  other 
criteria, is of the size 1 to 100 nanometres. Similarly to the Cosmetics Regulation, the ICCR 
also does not include the nanoparticles emerging naturally or incidentally in the nanomaterial 
definition.  

1.7.  Main findings Section 1 

  On average, 10 new cosmetic products containing nanomaterials are placed on the 
EU  market  every  day;  this  is  only  a  fraction  of  the  800  new  cosmetic  products 
notified daily in CPNP. Overall, the use of nanomaterials concerns a rather limited 
number  of  all  cosmetic  products  (about  1.5%  of  the  total)  and  has  been  rather 
stable over the last five years. 

  Most  of  the  cosmetic  products  notified  in  the  CPNP  correspond  to  nanomaterials 

with a colorant or UV-filter function. 

  There  are  differences  in  the  percentage  of  newly  notified  cosmetic  products 
containing  nanomaterials  among  EU  countries  (from  0.8%  to  5.5%)  as  well  as  in 
the share of the overall notifications of nanomaterials (from 6.5% to 43.7%). 

  The  2019  Commission  catalogue  of  nanomaterials  represented  a  rather  accurate 
picture  of  the  market,  albeit  with  the  inherent  limitations  stemming  from  the 
notification process.  

  Most  of  the  SCCS  opinions  on  the  safety  of  CPNP-notified  nanomaterials  were 
inconclusive due to  the lack of or insufficient  data.  Therefore, there is  a need for 
responsible persons to provide information as accurate as possible when notifying 
nanomaterials which are present in cosmetic products. 

27   Ibid., p. 2. 
28   “For purposes of the International Cooperation on Cosmetic Regulation, a substance used in a cosmetic is 
considered a nanomaterial if it is an insoluble ingredient, intentionally manufactured, with one or more 
dimensions in the realm of 1 to 100 nanometers in the final formulation and is sufficiently stable and 
persistent in biological media to allow for the potential of interaction with biological systems.” 
see: https://www.iccr-cosmetics.org/files/2814/3350/5840/2010-
07_Nanotechnology_in_Cosmetics_Criteria_and_Methods_for_Detection.pdf. (See the Association Panel 
Report Nanotechnology in Cosmetics, ibid, p. 5). 

13 

 
 
 
 
 
                                                           
SECTION 2 – REVIEW OF THE PROVISIONS CONCERNING NANOMATERIALS 

2.1.  Purpose of the review 

As  mentioned  in  Section  1.1,  Article  16(11)  of  the  Cosmetics  Regulation  provides  that  the 
Commission  shall  “regularly  review 
this  Regulation  concerning 
nanomaterials in the light of scientific progress and shall, where necessary, propose suitable 
amendments to those provisions”29. 

the  provisions  of 

The  current  review  intends  to  assess  whether  the  provisions  of  the  Cosmetics  Regulation 
concerning  nanomaterials  are  still  fit  for  purpose  in  the  light  of  technical  and  scientific 
progress, including the information shared in Section 1 of this document.  

In particular, four main elements of the provisions governing nanomaterials in the Cosmetics 
Regulation are assessed in the light of technical and scientific progress: 

1.  Definition of “nanomaterial” 
2.  Notification of nanomaterials 
3.  Scientific assessment of nanomaterials 
4.  Labelling of cosmetic products containing nanomaterials 

2.2.  Definition of “nanomaterial” in the Cosmetics Regulation 

In 2009, when the Cosmetics Regulation was adopted, an internationally agreed definition of 
nanomaterials was not yet available. The Cosmetics Regulation acknowledged, therefore, that 
there was a lack of consensus on a definition of nanomaterials at EU and international level 
and thus expressly envisaged the possibility to review and update its related provisions. 

In this respect, Recital 29 of the Cosmetics Regulation provides that: 

“The  use  of  nanomaterials  in  cosmetic  products  may  increase  with  the  further 
development  of  technology.  In  order  to  ensure  a  high  level  of  consumer  protection, 
free  movement  of  goods  and  legal  certainty  for  manufacturers,  it  is  necessary  to 
develop a uniform definition for nanomaterials at international level. The Community 
should endeavour to reach an agreement on a definition in appropriate international 
fora.  Should  such  an  agreement  be  reached,  the  definition  of  nanomaterials  in  this 
Regulation should be adapted accordingly.” 

The Cosmetics Regulation currently provides a sector-specific definition30 of “nanomaterial” 
in  Article  2(1)(k):  “an  insoluble  or  biopersistant  and  intentionally  manufactured  material 
with one or more external  dimensions, or an internal structure, on the scale from 1 to  100 
nm”. 

29 The need to review the provisions on nanomaterials of the Cosmetics Regulation is also reflected in Recital 
(31)  “The  Commission  should  regularly  review  the  provisions  on  nanomaterials  in  the  light  of  scientific 
progress”. 
30   Other sectorial nanomaterial definitions are provided in EU: for instance, the Novel Food Regulation 

(Regulation 2015/2283 Article 3 (f): https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32015R2283&from=en) and in the Biocidal Products Regulation 
(Regulation 528/2012 Article 3(z) Reg. https://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32012R0528&from=en) 

14 

 
 
                                                           
Therefore, when establishing the nanomaterial status of a cosmetic ingredient, the following 
main elements must be considered: 

Insolubility or biopersistence 
Intentional manufacture 

 
 
  One or more external dimensions on the scale from 1 to 100 nm. 

A more horizontal definition of nanomaterials  became available after the publication of the 
Cosmetics  Regulation  with  the  Commission  Recommendation  of  2011  on  the  definition  of 
nanomaterial 31: 

“Natural, incidental or manufactured material containing particles, in an unbound state or 
as  an  aggregate  or  as  an  agglomerate  and  where,  for  50%  or  more  of  the  particles  in  the 
number size distribution, one or more external dimensions is in the size range 1 nm-100 nm.” 

It is worth noting that the cross-sectorial REACH Regulation applies the 2011 Commission 
Recommendation on the definition of nanomaterial32. 

There are two main differences between the two definitions: the threshold of the particle size 
distribution and the concept of natural, incidental or engineered nanomaterial. 

1.  Particle  size  distribution  –  the  absence  of  a  threshold  of  the  size  distribution  in  the 
Cosmetics Regulation should be regarded with caution. In fact, considering that most 
of  the  materials  are  not  mono-modal  in  size  (i.e.  not  all  particle  dimensions  are  the 
same) and that no size distribution is requested, this could create unwanted situations 
(i.e. the detection of one single particle of a cosmetic ingredient in the scale from 1 to 
100 nm could cause the applicability of the nanomaterial classification)33. This is also 
somewhat  confirmed  by  the  2019  SCCS  “Guidance  on  the  Safety  Assessment  of 
Nanomaterials in Cosmetics” that acknowledged the 50% distribution size threshold 
in  the  2011  Commission  Recommendation  and  suggested  that  “it  should  be  kept  in 
view by the Applicants when assessing the safety” of a substance used in a cosmetic 
product. 

2.  Incidental and intentional– similarly, the concept of “intentionally manufactured” of a 
nanomaterial  used  in  a  cosmetic  product  is  difficult  to  be  established  only  based  on 
analytical  test  methods.  The  “intention”  is  something  that  goes  beyond  an  objective 
and measurable fact. 

The differences between the Cosmetics Regulation definition and the Recommendation create 
some  discrepancies  across  different  sectors  concerning  the  classification  of  materials  as 
nanomaterials (i.e. some materials are considered nanomaterials under REACH and not under 

31   The general relevance of this definition is clarified in point 1 of the Recommendation: “Member States, the 

Union agencies and economic operators are invited to use the following definition of the term ‘nano-
material’ in the adoption and implementation of legislation and policy and research programmes 
concerning products of nanotechnologies.” 

32   See COMMISSION REGULATION (EU) 2018/1881 of 3 December 2018  
33   Some authors argued that the nanomaterials definition in Cosmetics Regulation refers implicitly to a 

significant size distribution. Miernicki, M., Hofmann, T., Eisenberger, I. et al. Legal and practical challenges 
in classifying nanomaterials according to regulatory definitions. Nat. Nanotechnol. 14, 208–216 (2019). 
https://doi.org/10.1038/s41565-019-0396-z  

15 

 
 
 
                                                           
the  Cosmetics  Regulation),  which  might  generate  questions  and  divergent  approaches 
amongst Competent Authorities and economic operators (see footnote 32).  

Further to the divergence mentioned above, it is important to underline that as mentioned in 
Section  1.4,  following  adaptations  of  the  REACH  annexes34,  it  is  expected  that  REACH 
registrants will soon start to produce new data on the safety of nanomaterials and update their 
registration dossier. Such data would be based on the nanomaterials definition provided in the 
2011 Recommendation.  In order to  fully  exploit the new scientific data from the cosmetics 
regulatory  perspective  (e.g.  in  the  safety  assessment  of  specific  nanomaterials  used  in 
cosmetics by SCCS), it could be beneficial to adopt the same nanomaterial definition also for 
cosmetic products.  

The  possibility  of  aligning  the  nanomaterial  definition  of  the  Cosmetics  Regulation  with 
the  2011  Commission  Recommendation  and  its  planned  future  update  should  be 
thoroughly assessed in order to evaluate its potential effects. 

Furthermore, the EU Chemicals Strategy for Sustainability published on 14 October 202035, 
has identified several elements also relevant for the cosmetic sector, including the revision of 
the  horizontal  definition  of  nanomaterials  by  2021  (such  a  revision  will  follow  the  Better 
Regulation  rules,  including  public  consultation).  In  particular,  and  in  order  to  allow  a 
coherent approach across the EU acquis, it is provided that the Commission will “review the 
definition  of  nanomaterial  and  ensure  its  coherent  application  across  legislation  using 
legally binding mechanisms”36. The cosmetics definition of nanomaterials might, therefore, 
be adapted to the upcoming revised general definition to be presented in 2021. 

2.3.  Notification process for nanomaterials 

As mentioned in Section 1.1, further to the notification obligations that apply to all categories 
of  cosmetic  products  under  Article  13  of  the  Cosmetics  Regulation,  Article  16(3)  provides 
specific  notification  obligations  applying  to  cosmetics  products  that  contain  nanomaterials. 
Therefore, cosmetic products containing nanomaterials are subject not only to the notification 
under Article 13, but also to the notification under Article 16:  

“For every cosmetic product that contains nanomaterials, a high level of protection of human 
health  shall  be  ensured.  In  addition  to  the  notification  under  Article  13,  cosmetic  products 
containing  nanomaterials shall  be notified to  the Commission  by the responsible person  by 
electronic means six months prior to being placed on the market […].”37 

Following  the  notification  and  the  relevant  information  made  available  via  the  CPNP,  the 
Commission may request the SCCS to give its opinion on the safety of such nanomaterial for 
use  in  the  relevant  categories  of  cosmetic  products  and  on  the  reasonably  foreseeable 

34   See COMMISSION REGULATION (EU) 2018/1881 of 3 December 2018 of 3 December 2018 amending 

Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, 
Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III, VI, VII, VIII, 
IX, X, XI, and XII to address nanoforms of substances. 

35  Communication on “Chemicals Strategy for Sustainability - Towards a Toxic-Free Environment” 
(COM(2020) 667 final). 
36   Communication on “Chemicals Strategy for Sustainability - Towards a Toxic-Free Environment” 
(COM(2020) 667 final), Page 17. 
37   Article 16(3) of the Cosmetics Regulation 

16 

 
 
                                                           
 
 
exposure conditions. On the basis of SCCS findings and if there is a potential risk, including 
when  there  is  insufficient  data,  the  Commission  can  prohibit  or  restrict  the  use  of  such  a 
nanomaterial  in  cosmetic  products  (see  Section  1.1  and  Article  16  (4)  to  (6)  Cosmetics 
Regulation). 

There are a few important elements to be highlighted in this respect: 

  First, Article 16 states that ‘in the event that the Commission has concerns regarding 
the safety of a nanomaterial, the Commission shall, without delay, request the SCCS 
to  give  its  opinion  on  the  safety  of  such  nanomaterial…’.  The  identification  of 
concerns by the Commission might require special scientific consideration in order to 
fully implement  this provision. For that reason, the Commission  has requested from 
the  SCCS  to  draft  a  priority  list  based  on  relevant  concerns  for  the  notified 
nanomaterials as published in the 2019 catalogue38. 

  Second,  it  is  evident  from  Article  16  that  it  is  not  the  nanomaterial  itself  that  is 
notified  to  the  Commission  via  CPNP,  but  each  cosmetic  product  containing  the 
relevant  nanomaterial.  However,  the  safety  assessment  is  carried  out  at  ingredient 
level by SCCS (see next Paragraph). This observation has some direct consequences, 
since the same nanomaterial ingredient can be used in multiple applications by many 
responsible  persons.  Thus,  the  Commission  and  SCCS  need  to  check  numerous 
notifications containing similar or the same information (especially in the case where 
the same responsible person is notifying multiple products). It should be noted that in 
the  last  three  years  over  500  CPNP  notifications  were  made  under  Article  16 
notification procedure. Although this process is a time consuming exercise, it must be 
concluded in a relatively short period of time (6 months). 

  Third, the current approach does not  appear optimal for the economic operators that 
need  to  plan  in  advance  their  business  activities.  A  cosmetic  product  notified  under 
Article 16 can be marketed after the period of six months, regardless of whether the 
safety assessment has been concluded or not. The expiry of this period in fact does not 
mean per se that the nanomaterial was approved nor that it may not be regulated in the 
future. Contrary to the substances authorised under Annexes IV to VI, the expiry of 
the 6 months ‘standstill period’ does not necessarily result in a conclusive assessment 
on the safety of the concerned products. 

The notification process of the nanomaterial and, in particular, its duration and the effect 
of the expiry of the deadline provided in the Cosmetics Regulation would  deserve special 
further analysis in order to consider possible improvements and adaptations in light of the 
experience gained so far. 

38 See the Commission’s mandate to SCCS “Request for a scientific advice on the safety of nanomaterials in 
cosmetics” adopted by written procedure by SCCS on 5 February 2020, available at: 
https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs2016_q_044.pdf 

17 

 
 
 
                                                           
2.4. 

Scientific assessment of nanomaterials and regulatory measures 

The approach followed in the nanomaterials assessment39 is based on a preliminary screening 
of CPNP notifications operated by the Commission on the basis of a potential concern. Once 
such a concern has been identified, the SCCS is mandated to issue an opinion on the safety of 
the nanomaterial.  Based  on the SCCS opinion and where there is  a potential  risk to  human 
health,  the  Commission  may  act  by  prohibiting  or  restricting  such  nanomaterial  via  the 
modification of Annexes II or III. 

With  over  7  years  since  the  applicability  date  of  the  nanomaterials  notification,  experience 
shows  that  the  application  of  the  Article  16  has  revealed  some  aspects  which  should  be 
further analysed in order to strengthen the safety assessment of nanomaterials.  

As reported in Section 1, a total of 1 445 notifications were submitted to CPNP under Article 
16  for  new  cosmetic  products  containing  nanomaterials.  The  establishment  of  concerns  for 
specific  nanomaterials  has  to  be  carried  out  by  the  Commission  on  the  basis  of  the 
information provided within each notification. This is challenging from an administrative and 
scientific point of view, in particular, in the absence of specific information/data on the safety 
of those nanomaterials used. 

Following the preliminary screening by the Commission, the SCCS issued 10 opinions on the 
safety  of  the  CPNP-notified  nanomaterials  in  the  last  five  years  (2015-2020).  Seven  out  of 
these ten SCCS opinions were inconclusive due to lack of data, therefore the SCCS could not 
provide  any  conclusions  on  whether  these  nanomaterials  are  safe  for  use  and  under  which 
conditions.  

On  one  hand,  the  lack  of  conclusive  SCCS  opinions  indicating  a  potential  risk  for  human 
health  hampers  the  ability  of  the  Commission  to  proceed  with  regulatory  measures.  On  the 
other hand, the responsible persons are allowed to place their products on the market once the 
6-months are lapsed, irrespective of the SCCS outcome. 

The  current  situation  is  expected  to  improve  to  a  certain  extent  with  the  publication  of  the 
2021  scientific  advice  on  the  safety  of  nanomaterials  in  cosmetics40  by  the  SCCS.  The 
identification  of  safety  concerns  within  this  scientific  advice,  after  the  previously 
inconclusive  SCCS  Opinions  specifically  for  three  groups  of  nanomaterials,  may  pave  the 
way to the adoption of regulatory measures. In addition, the SCCS advice proposes a scoring 
system that will help the Commission in the screening phase and during the selection of the 
materials most likely to cause concerns. Furthermore, new data from the REACH registration 
dossiers on the safety of nanomaterials are expected to become available in the coming years 
(see  Paragraph  2.3)  that  may  further  contribute  to  the  safety  assessment  of  cosmetic 
ingredients. 

Nevertheless, further improvements might be examined to also address other features of the 
current system, such as the disproportionate number of notifications per single nanomaterial 
to be checked and the lack of reassurance on the safety of the concerned products in case of 
inconclusive SCCS opinion.  

39 Article 16 notification process and SCCS role are discussed in Par. 1.3.  
40   The scientific advice SCCS/1618/20 is available 

https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_239.pdf  

18 

 
 
                                                           
At the same time it is important to recall that the Cosmetics Regulation has already in place a 
well-functioning  “authorisation  process”  whereby  the  safety  of  an  ingredient  has  to  be 
demonstrated via a dedicated dossier submission by the applicant to the SCCS for evaluation.  
Only  substances  that  were  assessed  and  found  safe  are  listed  in  Annexes  IV,  V  and  VI 
(Article 14 Cosmetics Regulation).  

The possibility to extend the authorisation system for nanomaterials (as provided in Article 
14 of the Cosmetics Regulation) beyond colorants,  preservatives and  UV Filter)  could  be 
further explored. 

2.5.  Labelling of cosmetics containing nanomaterials and consumer awareness 

In  order  to  inform  consumers  about  the  composition  of  a  specific  product,  every  cosmetic 
product has to indicate the list of its ingredients in indelible and visible lettering either on its 
container  or  packaging41.  Furthermore,  when  it  comes  to  cosmetic  products  including 
nanomaterials, the Cosmetics Regulation further extends the labelling obligation:  

“All ingredients present in the form of nanomaterials shall be clearly indicated in the list of 
ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.” 
(Article 19(1)(g) of the Cosmetics Regulation).  

This labelling applies to all cosmetic products containing nanomaterials, regardless whether 
they  are  subject  to  the  nanomaterial  notification  under  Article  16,  or  the  authorization 
procedure  as  colorants,  preservatives  or  UV-filters  under  Article  14(1)(c),  (d)  and  (e) 
respectively.  In  the  consumer  product  sector,  only  cosmetic  products  have  a  specific 
labelling requirement on the presence of nanomaterials42. 

The label should indicate all ingredients in  INCI nomenclature and the ingredients in nano-
size should be followed by a word ‘nano’ in brackets (e.g. Titanium dioxide(nano)). As with 
other  ingredients,  also  nano-ingredients  should  be  listed  in  the  descending  order  of  weight 
compared to other ingredients in the product43. 

With  regard  to  consumer  perception  of  nano-enabled  cosmetic  products,  it  remains  unclear 
how  the  above  ‘nano’  labelling  facilitates  the  consumer  awareness  about  the  cosmetic 
products containing nanomaterials and their buying behaviour. However, interesting findings 
were  published  in  2020  by  a  study  conducted  for  the  European  Union  Observatory  for 
the  Public’s  Perception  of 
Nanomaterials 
Nanomaterials and How Their Safety Is Perceived in the EU”44. This report found that almost 
9 out of 10 respondents, from a representative number of EU citizens from different Member 
States, consider it important to be informed when buying a product containing nanomaterial.  

(EUON)  and  ECHA  “Understanding 

The study also showed that if consumers were presented with clear information that a product 
contains nanomaterials, the majority would take a cautious stand of either not buying such a 
product,  or  decide  based  on  the  category  of  the  product.  The  negative  or  rather  negative 

41   See Article 19 (1)(g) of the Cosmetics Regulation.  

19 

 
 
                                                           
 
 
 
attitude  towards  nanomaterials  was  clearly  linked  to  the  level  of  knowledge  of  respondents 
about  nanomaterials.  The lower the level  of knowledge about  nanomaterials, the less likely 
the  respondent  is  to  buy  a  product  containing  nanomaterials.  Furthermore,  as  a  general 
observation, consumers tended to be more aware of the use of nanomaterials when it came to 
cosmetics than with a number of other surveyed areas.  

Finally, it should be recalled that the use of digital technologies to purchase consumer goods, 
and  cosmetic  products  in  particular,  has  increased  significantly  (e.g.  during  the  Covid-19 
health  crisis).  This  provides  novel  challenges  and  opportunities  that  deserve  to  be  further 
explored. For instance,  market  control of on-line purchase can be  challenging;  on the other 
hand, digital means can contribute to a more effective and targeted communication to the user 
of  cosmetic  products  (e.g.  an  electronic  label  could  also  include  information  on  the  use  of 
cosmetic ingredients qualifying as nanomaterials). 

Most  EU  citizens  considers  important  to  be  informed  on  the  presence  of  nanomaterials 
when they purchase a product (as required by the Cosmetics Regulation) and the potential 
use of digital technologies should also further explored to that extent.  

2.6.  Main conclusions 

This  review  has  assessed  whether  the  provisions  of  the  Cosmetics  Regulation  concerning 
nanomaterials  are  still  fit  for  purpose  in  the  light  of  technical  and  scientific  progress.  In 
particular,  the  review  has  focused  on  the  definition  of  ‘nanomaterial’,  the  notification  of 
nanomaterials, the scientific assessment of nanomaterials, as well as the labelling of cosmetic 
products containing nanomaterials.  

As regards the definition, this review has highlighted the differences between the definition 
of nanomaterials in the Cosmetics Regulation and the 2011 Commission Recommendation on 
the  definition  of  nanomaterial.  This  was  also  recognised  in  the  EU  Chemicals  Strategy  for 
Sustainability,  where  a  revision  of  the  horizontal  definition  of  nanomaterials  by  2021  was 
announced.  Aligning  the  nanomaterial  definition  of  the  Cosmetics  Regulation  with  a 
horizontal definition could increase coherence between legislation but should be thoroughly 
assessed in order to evaluate its potential effects. 

Shortcomings have been identified in the notification of nanomaterials. For instance, while 
the safety assessment is carried out at ingredient level, notifications are made at product level. 
Furthermore, the timeline for assessment is relatively short and does not appear optimal for 
economic  operators  that  need  to  plan  their  business  activities  in  advance.  Therefore,  the 
effectiveness of the current notification process  of nanomaterials via the Cosmetic Products 
Notification Portal (CPNP) merits  specific attention, in  particular the duration and effect  of 
the expiry of the deadline as laid out in the Cosmetics Regulation. 

The  scientific  safety  assessment  of  nanomaterials  could  be  strengthened,  in  particular  as 
experience  has  shown  that  the  majority  of  the  completed  assessments  by  the  Scientific 
Committee  on  Consumer  Safety  were  inconclusive  due  to  lack  of  data.  While  the  current 
situation is expected to improve to a certain extent through improved implementation, further 
improvements  could  be  explored,  such  as  the  possibility  to  extend  to  nanomaterials  the 
existing  authorisation  system,  as  provided  in  Article  14  of  the  Cosmetics  Regulation  for 
colorants, preservatives and UV Filter, which works well. 

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Finally, as regards labelling, as most EU citizens consider it important to be informed about 
the presence of nanomaterials in products they buy, digital labelling could be considered to 
complement and further improve the labelling of nanomaterials in cosmetic products.  

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