EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2017) 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 products1, and in particular Article 31(1) thereof,   
Whereas:  
(1) The substance Biphenyl -2-ol, and its salts, which have been assigned the names o -
phenylphenol, MEA o -phenylphenate, potassium o -phenylphenate and sodium o -
phenylphenate under the International N omenclature of Cosmetics Ingredients (INCI), 
are currently allowed as preservatives in cosmetic products at a concentration up to 0,2 
% (as phenol) in ready for use preparation. The substance Biphenyl -2-ol, and its salts 
are currently listed in entry 7 of Annex V to Regulation (EC) No 1223/2009.  
(2) The Scientific Committee on Consumer Safety  (SCC S) concluded in its opinion of 25 
June 2015, later revised on 15 December 20152, that o -phenylphenol as a preservative 
with a maximum concentration of 0,2 % in leave -on cosmetic products is not safe for 
the consumer. Also, in view of further exposures including non -cosmetic uses, the 
SCCS found that the maximum concentration of o -phenylphenol in leave -on cosmetic 
products should be lowered to 0,15 %. For rinse -off cosm etic products, the SCCS 
found that a maximum concentration of 0,2 % can be considered safe. The SCCS 
finally concluded that there might be a potential of injury to the vision system  
attributable to o -phenylphenol .  
(3) In light of the opinion  of the SCCS and in view of the potential risk to human health 
arising from the use of this substance, the use of o -phenylphenol as a preservative in 
leave -on cosmetic products should be allowed up to a maximum concentration of 0,15 
%. In addition, contact  with eyes  should be avoided . 
(4) Annex  V to Regulation (EC) No 1223/2009 should therefore be amended  accordingly.  
(5) The industry should be allowed a reasonable period of time to adapt to the new 
requirements by  making the necessary adjustments to product formu lations  to ensure 
that only products complying with those requirements are placed on the market. The 
industry should also be allowed a reasonable period of time to withdraw products 
which do not comply with the new requirements from the market .  
(6) The measur es provided for in this Regulation are in accordance with the opinion of the 
Standing C ommittee on Cosmetic Products,  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS/1555/15: http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_177.pdf   
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 this 
Regulation .  
Article 2 
From [date = 6 months after the date of entry into force] cosmetic products containing  
Biphenyl -2-ol and not  comply ing with the conditions laid down in this Regulation shall not be 
placed on the Union market.   
 
From [date = 9 months after the date of entry into force] cosmetic products  containing  
Biphenyl -2-ol and not  comply ing with the conditions laid down in this Regulation shall not be 
made available on the Union market.   
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Point ( 1) of the Annex shall apply from [date = 9 months after the date of entry into force].  
This Regulation shall be binding in its entirety and directly applicable in all M ember States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER