# L_2017036EN.01003701.xml

| 11.2.2017 | EN | Official Journal of the European Union | L 36/37 |
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11.2.2017

EN

Official Journal of the European Union

L 36/37

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COMMISSION REGULATION (EU) 2017/238

of 10 February 2017

amending Annex VI 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) | The Scientific Committee on Consumer Safety (‘SCCS’), concluded in its opinion of 16 December 2008 (2) that the use of Benzophenone-3 as a UV-filter at a concentration of up to 6 % w/w in cosmetic sunscreen products and up to 0,5 % w/w in all types of cosmetic products to protect the formulation does not pose a risk to human health, apart from its contact allergenic and photoallergenic potential. |
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(1)

The Scientific Committee on Consumer Safety (‘SCCS’), concluded in its opinion of 16 December 2008 (2) that the use of Benzophenone-3 as a UV-filter at a concentration of up to 6 % w/w in cosmetic sunscreen products and up to 0,5 % w/w in all types of cosmetic products to protect the formulation does not pose a risk to human health, apart from its contact allergenic and photoallergenic potential.

| (2) | Consequently, the current maximum concentration of 10 % w/w for Benzophenone-3 used as a UV-filter in cosmetic products should be decreased to 6 % w/w. |
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(2)

Consequently, the current maximum concentration of 10 % w/w for Benzophenone-3 used as a UV-filter in cosmetic products should be decreased to 6 % w/w.

| (3) | Regulation (EC) No 1223/2009 should therefore be amended accordingly. |
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(3)

Regulation (EC) No 1223/2009 should therefore be amended accordingly.

| (4) | The application of the new maximum concentration should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted six months from the entry into force of this Regulation to take the necessary measures to place on the market compliant products and to stop making available products already placed on the market that do not comply with the new maximum concentration. |
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(4)

The application of the new maximum concentration should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted six months from the entry into force of this Regulation to take the necessary measures to place on the market compliant products and to stop making available products already placed on the market that do not comply with the new maximum concentration.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products, |
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(5)

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 VI to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall apply from 3 September 2017.

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, 10 February 2017.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  SCCP 1201/08.

2

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ANNEX

In Annex VI to Regulation (EC) No 1223/2009, entry 4 is replaced by the following:

| Reference number | Substance identification | Conditions | Wordings of conditions of use and warnings |
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| Chemical name/INN/XAN | 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 |
| ‘4 | 2-Hydroxy-4-methoxybenzophenone/Oxybenzone | Benzophenone-3 | 131-57-7 | 205-031-5 | | 6 % | Not more than 0,5 % to protect product formulation | Contains Benzophenone-3 (1)’ |

Reference number

Substance identification

Conditions

Wordings of conditions of use and warnings

Chemical name/INN/XAN

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

‘4

2-Hydroxy-4-methoxybenzophenone/Oxybenzone

Benzophenone-3

131-57-7

205-031-5

6 %

Not more than 0,5 % to protect product formulation

Contains Benzophenone-3 (1)’

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