Lexploria

4.4.2008

EN

Official Journal of the European Union

L 93/13

COMMISSION DIRECTIVE 2008/42/EC

of 3 April 2008

amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III 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,

Whereas:

(1)

On the basis of the IFRA (International Fragrance Association) Code of Practice, the Scientific Committee on Consumer Products (SCCP) (2), identified substances used as fragrance compounds in cosmetic products for which some restrictions should be provided.

(2)

Considering that whatever the function of these substances in cosmetic products is, it is the exposure to these substances which should be considered. Therefore, the restrictions should not be limited to the use of the identified substances as fragrance compounds in cosmetic products.

(3)

However, sensitisation would not exist when the substance is used in oral products. Therefore, in order to ensure consistency, as some of these substances are authorised as flavouring substances by Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996 (3), these restrictions should not apply to substances listed under this register.

(4)

In the light of the opinions of the SCCP, it is necessary to amend the restrictions related to the identified substances which are already listed in Annex III to Directive 76/768/EEC under entries 45, 72, 73, 88 and 89. Furthermore, it is appropriate to include in that Annex those identified substances which are not yet listed with their respective restrictions, as well as, for consistency, substances belonging to the same family identified in Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products (4).

(5)

Benzyl alcohol being listed twice in Annex III part 1, under reference numbers 45 and 68, the content of entry 68 as well as the new restrictions should be included in entry 45.

(6)

Following clarification by the SCCP regarding Peru balsam, entry 1136 of Annex II should be amended.

(7)

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

(8)

In order to ensure a smooth progression from the existing formulae of cosmetic products to formulae which comply with the requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.

(9)

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 II and III of 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 products which fail to comply with this Directive are not sold or disposed of to the final consumer after 4 October 2009.

Article 3

1. Member States shall adopt and publish, by 4 October 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 4 April 2009.

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, 3 April 2008.

For the Commission

Günter VERHEUGEN

Vice-President

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2008/14/EC (OJ L 42, 16.2.2008, p. 43).

(2) OJ L 66, 4.3.2004, p. 45. Decision as amended by Decision 2007/263/EC (OJ L 114, 1.5.2007, p. 14).

(3) OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision 2006/252/EC (OJ L 91, 29.3.2006, p. 48).

(4) OJ L 132, 1.6.1996, p. 1. Decision as amended by Decision 2006/257/EC (OJ L 97, 5.4.2006, p. 1).

ANNEX

Directive 76/768/EEC is amended as follows:

(1)

In Annex II, reference number 1136 is replaced by the following: ‘Exudation of Myroxylon pereirae (Royle) Klotzch (Peru balsam, crude); CAS No 8007-00-9) when used as fragrance ingredient’.

(2)

Part 1 of Annex III is amended as follows:

(a)

reference number 68 is deleted;

(b)

reference numbers 45, 72, 73, 88 and 89 are replaced by the following:

Reference number

Substance

Restrictions

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

Field of application and/or use

Maximum authorised concentration in the finished cosmetic product

Other limitations and requirements

a

b

c

d

e

f

‘45

Benzyl alcohol (1)

CAS No 100-51-6

(a)

Solvent

(b)

fragrance/aromatic compositions/their raw materials

(b)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

—

0,001 % in leave-on products

—

0,01 % in rinse-off products

72

Hydroxycitronellal

CAS No 107-75-5

(a)

Oral products

(a) (b)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

—

0,001 % in leave-on products

—

0,01 % in rinse-off products

(b)

Other products

(b)

1,0 %

73

Isoeugenol

CAS No 97-54-1

(a)

Oral products

(a) (b)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

—

0,001 % in leave-on products

—

0,01 % in rinse-off products

(b)

Other products

(b)

0,02 %

88

d-Limonene

CAS No 5989-27-5

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

—

0,001 % in leave-on products

—

0,01 % in rinse-off products

Peroxide value less than 20 mmoles/L (2)

89

Methyl 2-octynoate

CAS No 111-12-6

(a)

Oral products

(a) (b)

The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:

—

0,001 % in leave-on products

—

0,01 % in rinse-off products

Methyl heptine carbonate

(b)

Other products

(b)

0,01 % when used alone

When present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)

(c)

The following reference numbers 103 to 184 are added:

Reference number

Substance

Restrictions

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

Field of application and/or use

Maximum authorised concentration in the finished cosmetic product

Other limitations and requirements

a

b

c

d

e

f

‘103

Abies alba cone oil and extract

CAS No 90028-76-5