EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and 
of the Council on cosmetic products   EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and 
of the Council on cosmetic products  
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 Nov ember 2009 on cosmetic products1, and in particular Article 31(1) thereof,  
Whereas:  
(1) Several Member States have recently indicated safety  problems in relation to the use 
of peanut oil , its extracts and its derivatives in cosmetic products . Concerns have bee n 
raised that sensitisation to peanuts might be induced through skin exposure to peanut 
oil through the use of cosmetic products .  
(2) The Scientific  Committee on Consumer Safety  ("SCCS") acknowledged those 
concerns in its revised opinion of 23 September 20142. In th at opinion, the SCCS 
concluded that there are insufficient data to define a safe level of skin exposure in the 
non-sensitised population . However, in view of the documented safe levels of oral 
intake of peanut protein in sensitised individuals and i n view of the industry’s 
capability to refine peanut oil to protein level s of 0,5 ppm  or below , that value can be 
accepted as the maximum allowable concentration in (refined) peanut oil , its extracts 
and its derivatives used in cosmetic products .  
(3) Several Member States have also indicated safety problems in relation to cosmetic 
products containing hydrolysed wheat protein. A number of cases of contact urticaria 
provoked by such cosmetic products, followed by anaphylactic shock after the 
ingestion of food co ntaining wheat proteins, have been reported.   
(4) In its revised opinion of 22 October 20143 the SCCS consider ed the use of hydrolysed 
wheat proteins in cosmetic products safe for consumers, provided that the maximum 
molecular weight average of the peptides in  hydrolysates is 3,5 kDa.  
(5) In light of the opinions given by the SCCS , the use of cosmetic products containing 
peanut oil, its extracts and its derivatives and the use of cosmetic products containing 
hydrolysed wheat proteins present a potential risk to human health. In order to ensure 
the safety of such cosmetic  products for hum an health, it is appropriate to set a 
maximum concentration of 0,5 ppm for peanut  protein in peanut oil, its extracts and its 
derivatives used in cosme tic products and to restrict the molecular weight average of 
the peptides in hydrolysed wheat protein used in cosmetic products to a maximum of 
3,5 kDa.  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS/1526/14 . 
3 SCCS/1534/14 . EN 3   EN (6) The industry should be allowed a reasonable period of time to adapt to the new 
requirements by making the necessary adjustments to their product formulations  to 
ensure that only products complying with those re quirements are placed on the market. 
The industry should also be allowed a reas onable period of time to withdraw products  
which do not comply with the new requirements from the market .   
(7) Annex III to Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(8) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing Committee on Cosmetic Products,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this 
Regulation.  
Article 2 
From [date = 9 months after the date of entry into force] cosmetic products which do not 
comply with the requirements introduced by this Regulation shall not be placed on the Union 
market.  
From [date = 12 months after the date of entry into force] cosmetic products which do not 
comply with the requirements introduced by this Regulation shall be withdrawn from 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 . 
This Regulation sha ll be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker