# L_2017319EN.01000201.xml

| 5.12.2017 | EN | Official Journal of the European Union | L 319/2 |
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5.12.2017

EN

Official Journal of the European Union

L 319/2

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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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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. |
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(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, |
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(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

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

1

(2)  SCCS/1526/14.

2

(3)  SCCS/1534/14.

3

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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 |

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

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(*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.

*1

(*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.

*2

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