EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION REGULATION (EU) No …/..  
of XXX  
amending Annex II 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 II 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 Scientific Committee on Consumer Safety  (SCCS) concluded in its opinion of 
26–27 June 20122 that 3- and 4 -(4-Hydroxy -4-methylpentyl) cyclohex -3-ene-1-
carbaldehyde (HICC),  with the INCI name of Hydroxyisohexyl 3 -Cyclohexene 
Carboxaldehyde,  2,6-Dihydroxy -4-methyl -benzaldehyde (atranol)  and 3-Chloro -2,6-
Dyhydroxy -4-methyl -benzaldehyde (chloroatranol)  should not be used in cosmetic 
products as they are the fragrance allergens  which caused the highest number of 
contact allergies cases in past years . 
(2) Consequently, there is a potential risk to human healt h and those substances should 
therefore be prohibited in cosmetic products.   
(3) It is appropriate to provide for reasonable periods of time in order for the industry to 
adapt to the new prohibitions and for this reason no longer  place on the market and 
withd raw from  the market products concerned which contain one or more of the 
prohibited substances . When determining those periods of time, due account should 
also be taken of the potential risk of those products to human health.   
(4) In particular, t he exceptional ly complex and lengthy procedure for fragrance 
reformulation  and consumers’ concerns over the change of the olfactory properties of 
fragrances should be reflected in longer than usual duration of the deadline given to 
the industry for adjustments of produc ts. Manifestations of contact allergies to 
fragrances are normally confined to skin.  Consumers with contact allergy to 
fragrance allergens often are aware that they cannot tolerate scented products on their 
skin and therefore can avoid them.   
(5) Annex II to Regulation (EC) No 1223/2009 should therefore be amended 
accordingly.  
(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/1459/11 . EN 3   EN  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex  II to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this 
Regulation .  
Article 2 
From  [date = 2  years  after the date of entry into force ] cosmetic products containing one or 
more of the substances prohibited by this Regulation shall not b e placed on the Union market .   
From  [date = 4 years  after the date of entry into force] cosmetic products containing one or 
more of the substances prohibited by this Regulation shall be withdrawn from  the Union 
market .  
Article 3  
This Regulation shall ent er 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