EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of 
the Council on cosmetic products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex V 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 pr oducts1, and in particular Article 31(2) thereof,  
Whereas:  
(1) The substance 4 -(3-ethoxy -4-hydroxyphenyl)butan -2-one (CAS Number 569646 -79-
3), which has been assigned the name Hydroxyethoxyphenyl Butanone (HEPB) under 
the International Nomenclature of Cosmeti c Ingredients, is used as a cosmetic 
preservative and as a skin conditioning agent. It is currently not listed in Regulation 
(EC) No 1223/2009.  
(2) The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 7 
April 20172 that, under an agg regate exposure scenario, HEPB  can be considered safe 
when used as a preservative in rinse off, oral care and leave -on cosmetic products at a 
maximum concentration of 0,7 %. The SCCS also concluded that more evidence 
would be needed to exclude eye irritati on.  
(3) Following concerns raised by several Member States on HEPB as a potential eye 
irritant  and additional scientific data submitted by the applicant , the SCCS concluded 
in its opinion of 5 March 20193 that, under an aggregate exposure scenario, the use of 
HEPB as a preservative in rinse -off, oral care and leave -on cosmetic products at a 
maximum concentration of 0 ,7 % is safe with regard to eye irritation.   
(4) In light of the opinions mentioned above  and in order to take into account technical 
and sc ientific progress , HEPB should be allowed for use as a preservative in rinse off, 
oral care and leave -on cosmetic products at a maximum concentration of 0,7  % in 
ready for use preparation .  
(5) Regulation (EC) No 1223/2009 should therefore be amended according ly.  
(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 (Scientific Committee on Consumer Safety), Opinion on Ethylzingerone - 
‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 , SCCS/1582/16, 7 April 2017   
3 SCCS (Scientific Committee on Consumer Safety), Opinion on Ethylzingerone - 
‘Hydroxyethoxyphenyl Butanone’ (HEPB) - Cosmetics Europe No P98 – Submission II eye irritation, 
preliminar y version of 21 December 2018, final version of 5 March 2019, SCCS/1604/18  EN 2  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex V to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to t his 
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 S tates.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER