EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex IV 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 Annex IV 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(1) thereof,  
Whereas:  
(1) Zinc oxide is authorised as a colorant in cosmet ic products  under  entry 144 of Annex 
IV to Regulation (EC) No 1223/2009.  
(2)  In its opinion of 18 September 20122, which was revised in 23 September 20143, the 
Scientific Committee on Consumer Safety (SCCS) concluded that the use of  zinc 
oxide is safe when us ed as colorant , in its uncoated non -nano form,  in cosmetics for 
dermal application. However,  the SCCS also considered that  in view of the lung 
inflammation induced by zinc oxide particles after inhalation, the use of zinc oxide in 
cosmetic products that ma y result in exposure of the consumer’s lungs to zinc oxide by 
inhalation was of concern.  
(3) In light of the SCCS opinions, the use of zinc oxide as a colorant , in its uncoated non -
nano form,  in cosmetic products  should be restricted to those applications whic h may 
not lead to exposure of the end -user's lungs by inhalation.  
(4) Annex IV to Regulation (EC) No 1223/2009 should therefore be amended 
accordingly.  
(5) The industry should be allowed a reasonable period of time to make the necessary 
adjustments to product form ulations in view of their placing on the market and for the 
withdrawal of non -compliant products from the market.  
(6) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Cosmetic Products,  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS/1489/12 Revision of 11 December 2012, 
http://ec.europa.eu/health/scie ntific_committees/consumer_safety/docs/sccs_o_103.pdf  
3 SCCS/1539/14 Revision of 25 June 2015, 
http://ec.europa.eu/health/scientific_committees/consumer_sa fety/docs/sccs_o_163.pdf  EN 3   EN HAS ADOPTED T HIS REGULATION:  
Article 1  
Annex IV to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this 
Regulation.  
Article 2  
From (please insert date – six months after entry into force of this Regulation) only cosmetic 
products which comply wi th this Regulation shall be placed on the Union market.  
From (please insert date – nine months after entry into force of this Regulation) only cosmetic 
products which comply with this Regulation shall be made available on the Union market.  
Article 3  
This R egulation 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