EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes IV and VI to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council on cosmetic products  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes IV and VI to Regulation (EC) No 1223/2009  of the European 
Parliament and of the Council on cosmetic products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the 
Council of 30 November 2009 on cosmetic products1, and in particular Article 31 (2) thereof,  
After consulting the Scientific Committee on Consumer Safety,  
Whereas:  
(1) The Scientific Committee on Cosmetic Products and Non -Food Products intended for 
Consumers, subsequently replaced by the Scientific Committee on Consumer Products 
("SCCP"), pursuant to Commission Decision 2004/210/EC2, subsequently replaced by 
the Scientific Committee on Consumer Safety ("SCCS"), pursuant to Commission 
Decision 2008/721/EC3, delivered an opinion on 25 June 20034, in which it stated that, 
in general, Zinc Oxide may be considered as a non -toxic substance, including when 
used in cosmetic products. However, the potential for absorption by inhalation was not 
considered and the SCCP expressed concern on the safety of micronized Zinc Oxide, 
due to the lack of a reliable safety dossier on that substance. Following requests for 
clarification by the Commission, the SCCP5 confirmed that the use of the non -nano 
Zinc Oxi de in cosmetic products was safe up to a maximum concentration of 25% and 
that adequate data should be submitted for the risk assessment of Zinc Oxide in nano 
form.  
(2) The SCCS was requested to perform a safety assessment of Zinc Oxide in nano form 
and delive red an opinion on 18 September 20126, followed by an addendum of 23 July 
20137. The SCCS concluded, on the basis of available evidence, that the use of Zinc 
Oxide nanoparticles with the characteristics as indicated, at a concentration up to 25% 
as a UV -filter in sunscreens, can be considered not to pose a risk of adverse effects in 
humans after dermal application. In addition, the SCCS indicated that there is no 
evidence for the absorption of Zinc Oxide nanoparticles through skin and via the oral 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 OJ L 66, 04.03.2004, p.45.  
3 OJ L 241,10.09.2008, p.21.  
4 SCCNFP/0649/03, http://ec.europa.eu/health/ph_risk/committees/sccp/documents/out222_en.pdf . 
5 SCCP/0932/05, http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_00m.pdf  , 
SCCP/1147/07 , http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/ sccp_o_123.pdf  and 
SCCP/1215/09, http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_167.pdf . 
6 SCCS/1489/2012 Revision of 11 December 2012, 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_103.pdf . 
7 SCCS/1518/13 Revision of 22 April 2014, 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_137.pdf .  
EN 3   EN route. In the Margin of Safety calculation, the calculation of the exposure to Zinc 
Oxide nanoparticles results in acceptable Margin of Safety for both the oral and 
dermal routes.  The SCCS later confirmed  that Zinc Oxide nano may be used in other 
cosmetic products  than sunscreens,  intended for dermal application . 
(3) The characteristics indicated by the SCCS in its opinion concern the physico -chemical 
properties of the material  (such as purity, structure and physical appearance, particle  
number  size distribution and wate r solubility)  and whether it is uncoated or coated 
with specific chemicals. Other cosmetic ingredients can be used as coatings as long as 
they are demonstrated to the SCCS to be safe and do not affect the particle properties 
related to behaviour and/or tox icological effects, compared to the nanomaterials 
covered in the relevant SCCS opinion. Therefore, t he Commission considers that these  
physic o-chemical properties and requirements regarding coatings should be reflected 
in Regulation (EC) No 1223/2009 .  
(4) The SCCS also considered that, on the basis of available information, the use of Zinc 
Oxide nanoparticles in spray products cannot be considered safe. In addition, the 
SCCS indicated, in a further opinion of 23 September 2014 for clarification of the 
meaning of the term “sprayable application/products” for the nano forms of Carbon 
Black CI 77266, Titanium Dioxide and Zinc Oxide8, that its concern is limited to spray 
products that could lead to exposure of the consumer’s lungs to nano Zinc Oxide by 
inhalation.  The SCCS also indicated that non -nano Zinc Oxide has similar toxic 
effects to nano Zinc Oxide, as far as lung toxicity after inhalation is concerned.  
(5) In light of the SCCS opinions mentioned above, the Commission considers that Zinc 
Oxide in non -nano form s hould be authorized for use as a UV-filter in cosmetic 
products ; Zinc Oxide in nano form (according to the SCCS’s specifications), should be 
authorized for use as a UV -filter in cosmetic  products , according to the specifications . 
Both forms of the substanc e should be authorized at a maximum concentration of 
25%, except in applications that may lead to exposure of the end user’s lungs by 
inhalation.     
(6) Carbon Black is authorized as a colorant in cosmetics under entry 126 of Annex IV to 
Regulation (EC) No 12 23/2009. The SCCS carried out a risk assessment of Carbon 
Black (nano) and adopted an opinion on 12 December 20139, in which it concluded 
that the use of Carbon Black in its nano -structured form (with a primary particle size 
of 20 nm or larger) at a concen tration up to 10% as a colorant in cosmetic products 
does not pose any risk of adverse effects in humans after application on healthy, intact 
skin. However, an eye irritation potential cannot be excluded.  
(7) Moreover, the SCCS indicated, and clarified in the above -mentioned opinion on 
“sprayable applications/products” of 23 September 2014, that  the opinion on Carbon 
Black (nano) does not apply to applications that might lead to exposure of the 
consumer’s lungs to Carbon Black nanoparticles by inhalation.  
(8) The SCCS conclusions apply to Carbon Black (nano) with a defined  purity and 
impurity profile . Furthermore, t he purity criteria set out for non -nano Carbon Black 
are no longer up -to-date and should be removed, as Commission Directive 95/45/EC 
laying down specif ic purity criteria concerning colours for use in foodstuffs10 was 
                                                 
8 SCCS/1539/14 23 September 2014  Revision of 16 December 2014  
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_163.pdf    
9 SCCS/1515/13 Revision of 27 March 2014, 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_144.pdf . 
10 OJ L 226, 22.9.1995, p. 1 .  
EN 4   EN repealed by Commission Directive 2008/128/EC laying down specific purity criteria 
concerning colours for use in foodstuffs11. Those criteria should be replaced by the 
criteria applicable to Ca rbon Black (nano).  
(9) In light of the SCCS opinions mentioned above, the Commission considers that 
Carbon Black (nano) (according to the SCCS’s specifications) should be authorized 
for use as a colorant in cosmetic products at a maximum concentration of 10%, except 
in applications that may lead to exposure of the end user’s lungs by inhalation .  
(10) Taking into account that the use of nanomaterials can improve the efficiency of UV -
filters and enhance the performance of certain colorants, the Commission considers 
that Annexes IV and VI to Regulation (EC) No 1223/2009 should be amended for the 
purpose of adapting them to technical and scientific progress.  
(11) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Cos metic Products,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes IV and VI to Regulation (EC) No 1223/2009 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker  
 
                                                 
11 OJ L 6, 10.1.2009, p. 20.