Commission Regulation (EU) 2017/2228 of 4 December 2017 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
Date: 2017-12-04
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: approximation of laws, consumer information, cosmetic product, groundnut oil, health risk, product safety, vegetable protein, wheat




L_2017319EN.01000201.xml










5.12.2017   


EN


Official Journal of the European Union


L 319/2








            COMMISSION REGULATION (EU) 2017/2228
of 4 December 2017
         
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 November 2009 on cosmetic products (1), 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 been 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 2014 (2). In that opinion, the SCCS concluded that there are insufficient data to define a safe level of skin exposure in the non-sensitised population. It added that, however, in view of the documented safe levels of oral intake of peanut proteins in sensitised individuals and in view of the industry's capability to refine peanut oil to protein levels 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 proteins. A number of cases of contact urticaria provoked by such cosmetic products, followed by anaphylactic shock after the ingestion of food containing wheat proteins, have been reported.












(4)


In its revised opinion of 22 October 2014 (3) the SCCS considered 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 human health, it is appropriate to set a maximum concentration of 0,5 ppm for peanut proteins in peanut oil, its extracts and its derivatives used in cosmetic products and to restrict the molecular weight average of the peptides in hydrolysed wheat proteins used in cosmetic products to a maximum of 3,5 kDa.












(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 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)


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 25 September 2018 cosmetic products containing one or more of the substances restricted by this Regulation and not complying with the restrictions laid down in this Regulation shall not be placed on the Union market.
From 25 December 2018 cosmetic products containing one or more of the substances restricted by this Regulation and not complying with the restrictions 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.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 4 December 2017.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 342, 22.12.2009, p. 59.

(2)  SCCS/1526/14.

(3)  SCCS/1534/14.




ANNEX
In Annex III to Regulation (EC) No 1223/2009, in the table, the following two entries are added:














Reference number


Substance identification


Restrictions


Wording of conditions of use and warnings




Chemical name/INN


Name of Common Ingredients Glossary


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




‘X



Peanut oil, extracts and derivatives


Arachis Hypogaea Oil


8002-03-7


232-296-4


 


 


Maximum concentration of peanut proteins: 0,5 ppm (*1)



 




Arachis Hypogaea Seedcoat Extract


8002-03-7


232-296-4




Arachis Hypogaea Flour


8002-03-7


232-296-4




Arachis Hypogaea Fruit Extract


8002-03-7


232-296-4




Arachis Hypogaea Sprout Extract


 


 




Hydrogenated Peanut Oil


68425-36-5


270-350-9




Peanut Acid


91051-35-3


293-087-1




Peanut Glycerides


91744-77-3


294-643-6




Peanut Oil PEG-6 Esters


68440-49-3


 




Peanutamide MEA


93572-05-5


297-433-2




Peanutamide MIPA


 


 




Potassium Peanutate


61789-56-8


263-069-8




Sodium Peanutamphoacetate


 


 




Sodium Peanutate


61789-57-9


263-070-3




Sulfated Peanut Oil


73138-79-1


277-298-6





Y



Hydrolyzed wheat protein


Hydrolyzed Wheat Protein


94350-06-8 / 222400-28-4 / 70084-87-6 / 100209-50-5


305-225-0


 


 


Maximum molecular weight average of the peptides in hydrolysates: 3,5 kDa (*2)’


 




309-358-5







(*1)  From 25 September 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be made available on the Union market.

(*2)  From 25 September 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be made available on the Union market.