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)
Modified by
  • Regulation (EC) No 1223/2009 of the European Parliament and of the Councilof 30 November 2009on cosmetic products(recast)(Text with EEA relevance), 32009R1223, December 22, 2009
Corrected by
  • Corrigendum to 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, 32008L0042R(02), May 24, 2008
Commission Directive 2008/42/ECof 3 April 2008amending 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 productsOJ 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)., 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)OJ L 66, 4.3.2004, p. 45. Decision as amended by Decision 2007/263/EC (OJ L 114, 1.5.2007, p. 14)., 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 1996OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision 2006/252/EC (OJ L 91, 29.3.2006, p. 48)., 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 productsOJ L 132, 1.6.1996, p. 1. Decision as amended by Decision 2006/257/EC (OJ L 97, 5.4.2006, p. 1)..(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 1Annexes II and III of Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
Article 2Member 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 31.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 4This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 5This Directive is addressed to the Member States.
nullANNEXDirective 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:
As a preservative, see Annex VI, Part 1, No 34.This limit applies to the substance and not to the finished cosmetic product."
Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the label
Field of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirements
abcdef
"45Benzyl alcoholCAS 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 products0,01 % in rinse-off products
72HydroxycitronellalCAS 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 products0,01 % in rinse-off products
(b)Other products(b)1,0 %
73IsoeugenolCAS 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 products0,01 % in rinse-off products
(b)Other products(b)0,02 %
88d-LimoneneCAS No 5989-27-5The 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 products0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L
89Methyl 2-octynoateCAS 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 products0,01 % in rinse-off products
Methyl heptine carbonate(b)Other products(b)0,01 % when used aloneWhen 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 %)
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As a preservative, see Annex VI, Part 1, No 34.This limit applies to the substance and not to the finished cosmetic product."(c)The following reference numbers 103 to 184 are added:
This limit applies to the substance and not to the finished cosmetic product.The sum of those substances used in combination should not exceed the limits given in column d."
Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the label
Field of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirements
abcdef
"103Abies alba cone oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L
104Abies alba needle oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L
105Abies pectinata needle oil and extractCAS No 92128-34-2Peroxide value less than 10 mmoles/L
106Abies sibirica needle oil and extractCAS No 91697-89-1Peroxide value less than 10 mmoles/L
107Abies balsamea needle oil and extractCAS No 85085-34-3Peroxide value less than 10 mmoles/L
108Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8Peroxide value less than 10 mmoles/L
109Pinus mugo leaf and twig oil and extractCAS No 90082-72-7Peroxide value less than 10 mmoles/L
110Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1Peroxide value less than 10 mmoles/L
111Pinus nigra leaf and twig oil and extractCAS No 90082-74-9Peroxide value less than 10 mmoles/L
112Pinus palustris leaf and twig oil and extractCAS No 97435-14-8Peroxide value less than 10 mmoles/L
113Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0Peroxide value less than 10 mmoles/L
114Pinus pumila leaf and twig oil and extractCAS No 97676-05-6Peroxide value less than 10 mmoles/L
115Pinus species leaf and twig oil and extractCAS No 94266-48-5Peroxide value less than 10 mmoles/L
116Pinus cembra leaf and twig oil and extractCAS No 92202-04-5Peroxide value less than 10 mmoles/L
117Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6Peroxide value less than 10 mmoles/L
118Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9Peroxide value less than 10 mmoles/L
119Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1Peroxide value less than 10 mmoles/L
120Thuja Occidentalis Stem OilCAS No 90131-58-1Peroxide value less than 10 mmoles/L
1213-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)Peroxide value less than 10 mmoles/L
122Cedrus atlantica wood oil and extractCAS No 92201-55-3Peroxide value less than 10 mmoles/L
123Cupressus sempervirens leaf oil and extractCAS No 84696-07-1Peroxide value less than 10 mmoles/L
124Turpentine gum (Pinus spp.)CAS No 9005-90-7Peroxide value less than 10 mmoles/L
125Turpentine oil and rectified oilCAS No 8006-64-2Peroxide value less than 10 mmoles/L
126Turpentine, steam distilled (Pinus spp.)CAS No 8006-64-2Peroxide value less than 10 mmoles/L
127Terpene alcohols acetatesCAS No 69103-01-1Peroxide value less than 10 mmoles/L
128Terpene hydrocarbonsCAS No 68956-56-9Peroxide value less than 10 mmoles/L
129Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7Peroxide value less than 10 mmoles/L
130Terpene terpenoids sinpineCAS No 68917-63-5Peroxide value less than 10 mmoles/L
131α-TerpineneCAS No 99-86-5p-Mentha-1,3-dienePeroxide value less than 10 mmoles/L
132γ-TerpineneCAS No 99-85-4p-Mentha-1,4-dienePeroxide value less than 10 mmoles/L
133TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-dienePeroxide value less than 10 mmoles/L
134Acetyl hexamethyl indanCAS No 15323-35-0(a)Leave-on products(a)2 %
1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone(b)Rinse-off products
135Allyl butyrateCAS No 2051-78-72-Propenyl ButanoateLevel of free allyl alcohol in the ester should be less than 0,1 %
136Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoateLevel of free allyl alcohol in the ester should be less than 0,1 %
137Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl CyclohexaneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %
138Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-CyclohexanepropanoateLevel of free allyl alcohol in the ester should be less than 0,1 %
139Allyl heptanoateCAS No 142-19-82-Propenyl heptanoateLevel of free allyl alcohol in the ester should be less than 0,1 %
140Allyl caproateCAS No 123-68-2Allyl hexanoateLevel of free allyl alcohol in the ester should be less than 0,1 %
141Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoateLevel of free allyl alcohol in the ester should be less than 0,1 %
142Allyl octanoateCAS No 4230-97-12-Allyl caprylateLevel of free allyl alcohol in the ester should be less than 0,1 %
143Allyl phenoxyacetateCAS No 7493-74-52-Propenyl PhenoxyacetateLevel of free allyl alcohol in the ester should be less than 0,1 %
144Allyl phenylacetateCAS No 1797-74-62-Propenyl BenzeneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %
145Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3Level of free allyl alcohol in the ester should be less than 0,1 %
146Allyl cyclohexyloxyacetateCAS No 68901-15-5Level of free allyl alcohol in the ester should be less than 0,1 %
147Allyl isoamyloxyacetateCAS No 67634-00-8Level of free allyl alcohol in the ester should be less than 0,1 %
148Allyl 2-methylbutoxyacetateCAS No 67634-01-9Level of free allyl alcohol in the ester should be less than 0,1 %
149Allyl nonanoateCAS No 7493-72-3Level of free allyl alcohol in the ester should be less than 0,1 %
150Allyl propionateCAS No 2408-20-0Level of free allyl alcohol in the ester should be less than 0,1 %
151Allyl trimethylhexanoateCAS No 68132-80-9Level of free allyl alcohol in the ester should be less than 0,1 %
152Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate)0,002 %This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)
153AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one0,1 %
154Myroxylon balsamum var pereirae. extracts and distillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru)0,4 %
1554-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde0,6 %
156Cuminum cyminum fruit oil and extractCAS No 84775-51-9(a)Leave-on products(b)Rinse-off products(a)0,4 % of Cumin oil
157cis-Rose ketone-1CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone)(a)Oral products
(b)Other products(b)0,02 %
158trans-Rose ketone-2CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone)(a)Oral products
(b)Other products(b)0,02 %
159trans-Rose ketone-5CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone)0,02 %
160Rose ketone-4CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)(a)Oral products
(b)Other products(b)0,02 %
161Rose ketone-3CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone)(a)Oral products
(b)Other products(b)0,02 %
162cis-Rose ketone-2CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone)(a)Oral products
(b)Other products(b)0,02 %
163trans-Rose ketone-1CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone)(a)Oral products
(b)Other products(b)0,02 %
164Rose ketone-5CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one0,02%
165trans-Rose ketone-3CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone)(a)Oral products
(b)Other products(b)0,02 %
166trans-2-hexenalCAS No 6728-26-3(a)Oral products
(b)Other products(b)0,002 %
167l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-dienePeroxide value less than 20 mmoles/L
168dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene)Peroxide value less than 20 mmoles/L
169PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al(a)Oral products
(b)Other products(b)0,1 %
170IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate0,1 %
171Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde0,5 %
1723-methylnon-2-enenitrileCAS No 53153-66-50,2 %
173Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate(a)Oral products
(b)Other products(b)0,002 % when used aloneWhen present in combination with methyl heptine 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 %)
174Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate(a)Oral products
(b)Other products(b)0,3 %
175PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide(a)Oral products
(b)Other products(b)0,01 %
176IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol0,5 %
1772-Hexylidene cyclopentanoneCAS No 17373-89-6(a)Oral products
(b)Other products(b)0,06 %
178Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one(a)Oral products
(b)Other products(b)0,002 %
179p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde0,2 %
180Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax)0,6 %
181Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax)0,6 %
182Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN)All cosmetic products, with the exception of oral products(a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 %
183Commiphora erythrea engler var. glabrescens engler gum extract and oilCAS No 93686-00-10,6 %
184Opopanax chironium resinCAS No 93384-32-80,6 %
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This limit applies to the substance and not to the finished cosmetic product.The sum of those substances used in combination should not exceed the limits given in column d."