# L_2007101EN.01001101.xml

| 18.4.2007 | EN | Official Journal of the European Union | L 101/11 |
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18.4.2007

EN

Official Journal of the European Union

L 101/11

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COMMISSION DIRECTIVE 2007/22/EC

of 17 April 2007

amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes IV and VI thereto to technical progress

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,

After consulting the Scientific Committee on Consumer Products,

Whereas:

| (1) | The Scientific Committee on Cosmetic and Non-Food Products intended for consumers, replaced by the Scientific Committee on Consumer Products, (SCCP), by Commission Decision 2004/210/EC (2), delivered an opinion regarding the safe use of the preservative iodopropynyl butylcarbamate (IPBC) in cosmetic products concluding that the daily bioavailable intake of iodine from cosmetic products should not exceed 20 % of the recommended daily intake of 150 μg and that IPBC should not be used in oral hygiene and lip care products. |
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(1)

The Scientific Committee on Cosmetic and Non-Food Products intended for consumers, replaced by the Scientific Committee on Consumer Products, (SCCP), by Commission Decision 2004/210/EC (2), delivered an opinion regarding the safe use of the preservative iodopropynyl butylcarbamate (IPBC) in cosmetic products concluding that the daily bioavailable intake of iodine from cosmetic products should not exceed 20 % of the recommended daily intake of 150 μg and that IPBC should not be used in oral hygiene and lip care products.

| (2) | Considering that the list of preservatives authorised in cosmetic products should not be too limited, but that the exposure to iodine from IPBC should not be too high, the existing entry 56 to Annex VI should be amended accordingly. |
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(2)

Considering that the list of preservatives authorised in cosmetic products should not be too limited, but that the exposure to iodine from IPBC should not be too high, the existing entry 56 to Annex VI should be amended accordingly.

| (3) | Sodium iodate and colorant CI 45425 contain iodine and are currently respectively listed under Annex VI as authorised preservative and under Annex IV as authorised colorant. In view of the absence of interest from stakeholders to defend the use of these substances and the opinion of the SCCP regarding the necessity to reduce the exposure to iodine from cosmetic products, the authorisations should be withdrawn. |
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(3)

Sodium iodate and colorant CI 45425 contain iodine and are currently respectively listed under Annex VI as authorised preservative and under Annex IV as authorised colorant. In view of the absence of interest from stakeholders to defend the use of these substances and the opinion of the SCCP regarding the necessity to reduce the exposure to iodine from cosmetic products, the authorisations should be withdrawn.

| (4) | Directive 76/768/EEC should therefore be amended accordingly. |
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(4)

Directive 76/768/EEC should therefore be amended accordingly.

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

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes IV and VI to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.

Article 2

Member States shall take all necessary measures to ensure that from 18 October 2008 no cosmetic products which fail to comply with this Directive are placed on the market by Community manufacturers or by importers established within the Community.

Member States shall take all necessary measures to ensure that those products are not sold or disposed of to the final consumer after 18 April 2009.

Article 3

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 18 January 2008 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 4

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 17 April 2007.

For the Commission

Günter VERHEUGEN

Vice-President

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(1)  
  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2007/17/EC (OJ L 82, 23.3.2007, p. 27).

1

(2)  
  OJ L 66, 4.3.2004, p. 45.

2

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ANNEX

Directive 76/768/EEC is amended as follows:

| (1) | In part 1 of Annex IV, colouring agent CI 45425 is deleted. |
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(1)

In part 1 of Annex IV, colouring agent CI 45425 is deleted.

| (2) | Part 1 of Annex VI is amended as follows:






  (a) | reference number 10 is deleted; |
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(2)

Part 1 of Annex VI is amended as follows:

(a)

reference number 10 is deleted;

| (b) | reference number 56 is replaced by the following:









  Reference number | Substance | Maximum authorised concentration | Limitations and requirements | Conditions of use and warnings which must be printed on the label |
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| a | b | c | d | e |
| ‘56 | iodopropynyl butylcarbamate
  (IPBC)
  3-iodo-2-propynylbutylcarbamate
  CAS No: 55406-53-6 | (a) | rinse-off products: 0,02 % |

(b)

reference number 56 is replaced by the following:

Reference number

Substance

Maximum authorised concentration

Limitations and requirements

Conditions of use and warnings which must be printed on the label

a

b

c

d

e

‘56

iodopropynyl butylcarbamate

(IPBC)

3-iodo-2-propynylbutylcarbamate

CAS No: 55406-53-6

(a)

rinse-off products: 0,02 %

| (b) | leave-on products: 0,01 %, except in deodorants/antiperspirants: 0,0075 % |
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(b)

leave-on products: 0,01 %, except in deodorants/antiperspirants: 0,0075 %

Not to be used in oral hygiene and lip care products

| (a) | Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoo |
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(a)

Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoo

| (b) | — | Not to be used in body lotion and body cream (*1) |
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(b)

—

Not to be used in body lotion and body cream (*1)

| — | Not to be used in preparations for children under three years of age |
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—

Not to be used in preparations for children under three years of age

| (a) | “Not to be used for children under three years of age” (*2) |
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(a)

“Not to be used for children under three years of age” (*2)

| (b) | “Not to be used for children under three years of age” (*3) |
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(b)

“Not to be used for children under three years of age” (*3)

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(*1)  Concerns any products aimed to be applied on a large part of the body.

(*2)  Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age.

(*3)  Solely for products which might be used for children under three years of age.’

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