EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2018) 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 Nomenclature  of Cosmetics Ingredients (INCI), 
are currently allowed as preservatives in cosmetic products with a maximum 
concentration of 0,2 % (as phenol) in ready for use preparation  under entry 7 of Annex 
V to Regulation (EC) No 1223/2009.  
(2) The Scientific Committee  on Consumer Safety (SCCS) concluded in its opinion of 25 
June 2015, revision of  15 December 2015 ,2 as regards the use of o-phenylphenol as a 
preservative , that a maximum concentration of 0,2 % in leave -on cosmetic products is 
not safe , while  a maximum concentration of  0,15 %  in such products can be 
considered safe , and that a maximum concentration of 0,2 % in rinse -off cosmetic 
products is considered safe . The SCCS also concluded that there might be a potential 
of injury to the vision system attributable to o -phenylphenol.  
(3) Following concerns raised by several Member States regarding the use of MEA  o-
phenylphenate, potassium o-phenylphenate and sodium o-phenylphenate, the SCCS 
indicated  in an addendum to the above -mentioned opinion , adopted on  21-22 February 
2018 ,3 that the same conclusions on the safe use levels of o -phenylphenol cannot be 
applied as such to sodium o -phenylphenate, potassium o -phenylphenate or MEA o -
phenylphenate. The SCCS stated that sodium o -phenylphenate, potassium o -
phenyl phenate and MEA o -phenylphenate may have potentially more potent toxic 
effects than o -phenylphenol due to greater skin penetration.  The SCCS  concluded that 
a potential risk to human health from the use of these substances as preservatives in 
cosmetic produ cts cannot be excluded .  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS (Scientific Committee on Consumer Safety), Opinion  on o -Phenylphenol, Sodium o -
phenylphenate and Potassium o -phenylphenate, 25 June 2015,  SCCS/1555/15, revision of 15 December 
2015  
3 SCCS (Scientific Committee on Consumer Safety), Addendum to the scientific opinion on the use as 
preservative of o -Phenylphenol, Sodium ophenylphenate and Potassium o -phenylphenate 
(SCCS/1555/15)  Here: the use as preservative of Sodium o -phenylphenate, Potassium o -phenylphenate, 
MEA o -Phenylphenate 21 -22/02/2018, SCCS/1597/18  EN 2  EN (4) In light of the above -mentioned SCCS opinion s and in view of the potential risk to 
human health arising from the use of th ose substances, the use of o -phenylphenol as a 
preservative should be allowed with a maximum concentration of  0,15 %  in leave -on 
and 0,2 % in rinse -off cosmetic products . In addition, it should be indicated  that 
contact with eyes should be avoided . The use  of sodium o -phenylphenate, potassium 
o-phenylp henate and MEA o -phenylphenate as preservatives should not be allowed .  
(5) Annex  V to Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(6) The industry should be allowed a reasonable period of time to adapt to the new 
requirements by making the necessary adjustments to product formulations 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.  
(7) The measures provided for in t his Regulation are in accordance with the opinion of the 
Standing Committee on Cosmetic Products,  
HAS ADOPTED THIS REGULATION:  
Article 1  
In Annex  V to Regulation (EC) No 1223/2009 , entry 7  is replaced by the text set out in  the 
Annex to this Regulation .  
Article 2  
1. From [date = 6 months after the date of entry into force] cosmetic products containing 
Biphenyl -2-ol and not complying 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 complying with the conditions laid down in this Regulation shall not be 
made available on the Union market.  
2. From [date = 6 months after the date  of entry into force] cosmetic products containing  
Sodium 2 -biphenylate , Potassium 2 -biphenylate  or 2-aminoethan -1-ol; 2 -phenylphenol  as 
preservatives  shall not be placed on the Union market.   
From [date = 9 months after the date of entry into force] cosm etic products  containing  
Sodium 2 -biphenylate , Potassium 2 -biphenylate  or 2-aminoethan -1-ol; 2 -phenylphenol  as 
preservatives  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 . 
Article 1 shall apply from [date = 6 months after the date of entry into force].  
This Regulation shall be binding i n its entirety and directly applicable in all Member States.  
 EN 3  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER