Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)

• Published date: 25 April 2013
• Official Gazette Publication: Official Journal of the European Union, L 114, 25 April 2013

2013R0344 — EN — 15.05.2013 — 000.001

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This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B COMMISSION REGULATION (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance) (OJ L 114, 25.4.2013, p.1)

Corrected by:

►C1 Corrigendum, OJ L 142, 29.5.2013, p. 10 (344/2013)

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▼B

COMMISSION REGULATION (EU) No 344/2013

of 4 April 2013

amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

(Text with EEA relevance)

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, paragraphs 1 and 2, thereof,

Whereas:

(1) Regulation (EC) No 1223/2009 is to apply from 11 July 2013 and will replace Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ( 2 ). However, in order to ensure a smooth transition, economic operators are allowed to place on the market cosmetic products which comply with Regulation (EC) No 1223/2009 before the date of application of that Regulation.

(2) The Annexes to Regulation (EC) No 1223/2009 reflect the advancement of science at the time of the adoption of the proposal for that Regulation by the Commission on 5 February 2008. Since then, the Annexes to Directive 76/768/EEC have been amended several times.

(3) Several of the amendments to the Annexes to Directive 76/768/EEC aimed to address potential risks to human health and therefore introduced the necessary measures to protect public health. Both for the sake of legal clarity and, as there is an option to comply with Regulation (EC) No 1223/2009 before 11 July 2013 as an alternative to compliance with Directive 76/768/EEC, it is therefore necessary to amend the Annexes to Regulation (EC) No 1223/2009 as well, with a view to ensuring a high level of protection of public health.

(4) Also, a number of the amendments to the Annexes to Directive 76/768/EEC adapted those Annexes to technical and scientific progress, while protecting public health. As a result, the Annexes to Directive 76/768/EEC are now better adapted to technical and scientific progress than those of Regulation (EC) No 1223/2009. It is thus necessary to introduce those amendments in the Annexes to Regulation (EC) No 1223/2009 as well.

(5) In some cases, the substances have not been assigned with internationally recognised nomenclatures as the International Nomenclature of Cosmetic Ingredients (INCI). However, they are identified by their perfuming names. It is therefore appropriate to indicate the perfuming names in column c of Annex III (Name of Common Ingredients Glossary).

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

(7) 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

Annexes II, III, V and VI to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 11 July 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

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ANNEX

(1) Annex II to Regulation (EC) No 1223/2009 is amended as follows:

(a) The entry concerning reference number 167 is replaced by the following:

‘167 4-Aminobenzoic acid and its esters, with the free amino group 150-13-0 205-753-0’

(b) The entry concerning reference number 450 is replaced by the following:

‘450 Verbena essential oils (Lippia citriodora Kunth.) and derivatives other than absolute when used as a fragrance ingredient 8024-12-2 285-515-0’

(c) The entry concerning reference number 1136 is replaced by the following:

‘1136 Exudation of Myroxylon pereirae (Royle) Klotzsch (Peru balsam, crude) when used as a fragrance ingredient 8007-00-9 232-352-8’

(d) Entries for the following reference numbers are added:

‘1329	4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine and its hydrochloride salt (Basic Violet 14; CI 42510) when used as a substance in hair dye products	3248-93-9 / 632-99-5 (HCl)	221-832-2 / 211-189-6 (HCl)
1330	4-(2,4-Dihydroxyphenylazo)benzensulphonic acid and its sodium salt (Acid Orange 6; CI 14270) when used as substance in hair dye products	2050-34-2 / 547-57-9 (Na)	218-087-0 / 208-924-8 (Na)
1331	3-Hydroxy-4-(phenylazo)-2-naphthoic acid and its calcium salt (Pigment Red 64:1; CI 15800) when used as a substance in hair dye products	27757-79-5 / 6371-76-2 (Ca)	248-638-0 / 228-899-7 (Ca)
1332	2-(6-Hydroxy-3-oxo-(3H)xanthen-9-yl)benzoic acid; Fluorescein and its disodium salt (Acid Yellow 73 sodium salt; CI 45350) when used as a substance in hair dye products	2321-07-5 / 518-47-8 (Na)	219-031-8 / 208-253-0 (Na)
1333	4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) and its disodium salt (CI 45370) when used as a substance in hair dye products	596-03-2 / 4372-02-5 (Na)	209-876-0 / 224-468-2 (Na)
1334	2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43), its disodium salt (Acid Red 87; CI 45380) and its aluminium salt (Pigment Red 90:1 Aluminium lake) when used as a substance in hair dye products	15086-94-9 / 17372-87-1 (Na) / 15876-39-8 (Al)	239-138-3 / 241-409-6 (Na) / 240-005-7 (Al)
1335	Xanthylium, 9-(2-carboxyphenyl)-3-((2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt and its sodium salt (Acid Violet 9; CI 45190) when used as a substance in hair dye products	10213-95-3 / 6252-76-2 (Na)	— / 228-377-9 (Na)
1336	3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) and its sodium salt (Acid Red 95; CI 45425) when used as a substance in hair dye products	38577-97-8 / 33239-19-9 (Na)	254-010-7 / 251-419-2 (Na)
1337	2′,4′,5′,7′-Tetraiodofluorescein, its disodium salt (Acid Red 51; CI 45430) and its aluminium salt (Pigment Red 172 Aluminium lake) when used as a substance in hair dye products	15905-32-5 / 16423-68-0 (Na) / 12227-78-0 (Al)	240-046-0 / 240-474-8 (Na) / 235-440-4 (Al)
1338	1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) and its dihydrochloride salts (2,4-Diaminophenol HCl) when used as a substance in hair dye products	95-86-3 / 137-09-7 (HCl)	202-459-4 / 205-279-4 (HCl)
1339	1,4-Dihydroxybenzene (Hydroquinone), with the exception of entry 14 in Annex III	123-31-9	204-617-8
1340	[4-[[4-Anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) when used as a substance in hair dye products	2580-56-5	219-943-6
1341	Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) when used as a substance in hair dye products	4548-53-2	224-909-9
1342	Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)- N5,O6]ferrate(3-); (Acid Green 1; CI 10020) when used as a substance in hair dye products	19381-50-1	243-010-2
1343	4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) and its salts when used as a substance in hair dye products	2051-85-6	218-131-9
1344	4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) and its salts when used as a substance in hair dye products	6535-42-8	229-439-8
1345	1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) and its salts when used as a substance in hair dye products	2814-77-9	220-562-2
1346	3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) and its salts when used as a substance in hair dye products	6535-46-2	229-440-3
1347	N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) and its salts when used as a substance in hair dye products	6410-41-9	229-107-2
1348	Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) when used as a substance in hair dye products	3564-21-4	222-642-2
1349	Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) when used as a substance in hair dye products	6417-83-0	229-142-3
1350	Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) when used as a substance in hair dye products	915-67-3	213-022-2
1351	2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) when used as a substance in hair dye products	5102-83-0	225-822-9
1352	2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) when used as a substance in hair dye products	6706-82-7	229-754-0
1353	1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) when used as a substance

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