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
EU Regulation 2017/2228 · Adopted 4 December 2017 · Extends to United Kingdom
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 productsf1, 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 2014f2. 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 2014f3 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:
Annotations to the whole text
Footnotes
- f1
- f2
-
SCCS/1526/14.
- f3
-
SCCS/1534/14.
Contents
1
Annex III to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
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.
3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Signature
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
In Annex III to Regulation (EC) No 1223/2009, in the table, the following two entries are added:
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.
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.
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 ppmf1 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 kDaf2’ 309-358-5