COMMI SSION REGUL ATION (EU) 2019/1858 
of 6 November 2019 
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 EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regar d to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on 
cosmetic products (1), and in particular Article 31(2) thereof, 
Whereas: 
(1) The substance 4-(3-etho xy-4-hydro xyphenyl)butan-2-one (CA S Number 569646-79-3), which has been assigned 
the name Hydro xyetho xyphenyl Butanone (HEPB) under the Internati onal Nomenclature of Cosmetic Ingredients, 
has the function of preser vative and skin conditioning. It is currently not listed in Regulation (EC) No 1223/2009. 
(2) The Scientific Committ ee on Consumer Safety (SCCS) concluded in its opinion of 7 Apr il 2017 (2) that, under an 
aggregat e exposure scenar io, HEPB can be considered safe when used as a preser vative in rinse off, oral care and 
leav e-on cosmetic products at a maximum concentration of 0,7 %. The SCCS also concluded that more evidence 
would be needed to exclude eye irritation. 
(3) Following concer ns raised by several Member States on HEPB as a poten tial eye irritant and additional scientific data 
submitted to it by the applicant, the SCCS concluded in its opinion of 5 Marc h 2019 (3) that, under an aggregat e 
exposure scenar io, the use of HEPB as a preser vative in rinse-off, oral care and leav e-on cosmetic products at a 
maximum concentration of 0,7 % is safe with regard to eye irritation. 
(4) In light of the opinions mentioned abov e and in order to take into account technical and scientifi c progress, HEPB 
should be allowed for use as a preser vative in rinse off, oral care and leav e-on cosmetic products at a maximum 
concentration of 0,7 % in ready for use preparation. 
(5) Regulation (EC) No 1223/2009 should theref ore be amended according ly. 
(6) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Cosmetic Products, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Annex V to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation. 
(1)OJ L 342, 22.12.2009, p. 59. 
(2)SCCS (Scientific Committee on Consumer Safet y), Opinion on Ethylzing erone — ‘Hydro xyetho xyphenyl Butanone’ (HEPB) — 
Cosmetics Europe No P98, SCCS/1582/16, 7 Apr il 2017. 
(3)SCCS (Scientific Committee on Consumer Safet y), Opinion on Ethylzing erone — ‘Hydro xyetho xyphenyl 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 Offi cial Jour nal of the European Union 7.11.2019                                                                                                                                           L 286/7   Article 2 
This Regulation shall enter into force on the twentieth day followi ng 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, 6 November 2019.  
For the Commission 
The President 
Jean-Claude JUNCKER     EN Offi cial Jour nal of the European Union L 286/8                                                                                                                                           7.11.2019   ANNEX 
In Annex V to Regulation (EC) No 1223/2009, the following entr y is added:                                                                
Reference number Substance Identificat ion Conditions Wording of conditions 
of use and warnings 
Chemical name/INN Name of Common 
Ingredients Glossar y CAS number EC number Product type, Body 
parts Maximum 
concentration in 
ready for use 
preparation Other  
a b c d e f g h i 
‘60 4-(3-etho xy-4-hy ­
droxyphen yl)bu­
tan-2-one Hydro xyetho xy­
pheny l Butanone 569646-79-3 933-435-8  0,7 %’     EN Offi cial Jour nal of the European Union 7.11.2019                                                                                                                                           L 286/9