Directive 76/768/EEC is amended as follows:
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’.
Part 1 of Annex III is amended as follows:
reference number 68 is deleted;
reference numbers 45, 72, 73, 88 and 89 are replaced by the following:
a As a preservative, see Annex VI, Part 1, No 34. | |||||
b This limit applies to the substance and not to the finished cosmetic product.’ | |||||
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 alcohola 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:
| ||
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:
| ||
(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:
| ||
(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:
Peroxide value less than 20 mmoles/Lb | |||
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:
| ||
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 %) |
The following reference numbers 103 to 184 are added:
a This limit applies to the substance and not to the finished cosmetic product. | |||||
b The sum of those substances used in combination should not exceed the limits given in column d.’ | |||||
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 | Peroxide value less than 10 mmoles/La | |||
104 | Abies alba needle oil and extract CAS No 90028-76-5 | Peroxide value less than 10 mmoles/La | |||
105 | Abies pectinata needle oil and extract CAS No 92128-34-2 | Peroxide value less than 10 mmoles/La | |||
106 | Abies sibirica needle oil and extract CAS No 91697-89-1 | Peroxide value less than 10 mmoles/La | |||
107 | Abies balsamea needle oil and extract CAS No 85085-34-3 | Peroxide value less than 10 mmoles/La | |||
108 | Pinus mugo pumilio leaf and twig oil and extract CAS No 90082-73-8 | Peroxide value less than 10 mmoles/La | |||
109 | Pinus mugo leaf and twig oil and extract CAS No 90082-72-7 | Peroxide value less than 10 mmoles/La | |||
110 | Pinus sylvestris leaf and twig oil and extract CAS No 84012-35-1 | Peroxide value less than 10 mmoles/La | |||
111 | Pinus nigra leaf and twig oil and extract CAS No 90082-74-9 | Peroxide value less than 10 mmoles/La | |||
112 | Pinus palustris leaf and twig oil and extract CAS No 97435-14-8 | Peroxide value less than 10 mmoles/La | |||
113 | Pinus pinaster leaf and twig oil and extract CAS No 90082-75-0 | Peroxide value less than 10 mmoles/La | |||
114 | Pinus pumila leaf and twig oil and extract CAS No 97676-05-6 | Peroxide value less than 10 mmoles/La | |||
115 | Pinus species leaf and twig oil and extract CAS No 94266-48-5 | Peroxide value less than 10 mmoles/La | |||
116 | Pinus cembra leaf and twig oil and extract CAS No 92202-04-5 | Peroxide value less than 10 mmoles/La | |||
117 | Pinus cembra leaf and twig extract acetylated CAS No 94334-26-6 | Peroxide value less than 10 mmoles/La | |||
118 | Picea Mariana Leaf Oil and Extract CAS No 91722-19-9 | Peroxide value less than 10 mmoles/La | |||
119 | Thuja Occidentalis Leaf Oil and Extract CAS No 90131-58-1 | Peroxide value less than 10 mmoles/La | |||
120 | Thuja Occidentalis Stem Oil CAS No 90131-58-1 | Peroxide value less than 10 mmoles/La | |||
121 | 3-Carene CAS No 13466-78-9 3,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) | Peroxide value less than 10 mmoles/La | |||
122 | Cedrus atlantica wood oil and extract CAS No 92201-55-3 | Peroxide value less than 10 mmoles/La | |||
123 | Cupressus sempervirens leaf oil and extract CAS No 84696-07-1 | Peroxide value less than 10 mmoles/La | |||
124 | Turpentine gum (Pinus spp.) CAS No 9005-90-7 | Peroxide value less than 10 mmoles/La | |||
125 | Turpentine oil and rectified oil CAS No 8006-64-2 | Peroxide value less than 10 mmoles/La | |||
126 | Turpentine, steam distilled (Pinus spp.) CAS No 8006-64-2 | Peroxide value less than 10 mmoles/La | |||
127 | Terpene alcohols acetates CAS No 69103-01-1 | Peroxide value less than 10 mmoles/La | |||
128 | Terpene hydrocarbons CAS No 68956-56-9 | Peroxide value less than 10 mmoles/La | |||
129 | Terpenes 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 1 CAS No 65996-98-7 | Peroxide value less than 10 mmoles/La | |||
130 | Terpene terpenoids sinpine CAS No 68917-63-5 | Peroxide value less than 10 mmoles/La | |||
131 | α-Terpinene CAS No 99-86-5 p-Mentha-1,3-diene | Peroxide value less than 10 mmoles/La | |||
132 | γ-Terpinene CAS No 99-85-4 p-Mentha-1,4-diene | Peroxide value less than 10 mmoles/La | |||
133 | Terpinolene CAS No 586-62-9 p-Mentha-1,4(8)-diene | Peroxide value less than 10 mmoles/La | |||
134 | Acetyl hexamethyl indan CAS 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 | ||||
135 | Allyl butyrate CAS No 2051-78-7 2-Propenyl Butanoate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
136 | Allyl cinnamate CAS No 1866-31-5 2-Propenyl 3-Phenyl-2-propenoate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
137 | Allyl cyclohexylacetate CAS No 4728-82-9 2-Propenyl Cyclohexaneacetate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
138 | Allyl cyclohexylpropionate CAS No 2705-87-5 2-Propenyl 3-Cyclohexanepropanoate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
139 | Allyl heptanoate CAS No 142-19-8 2-Propenyl heptanoate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
140 | Allyl caproate CAS No 123-68-2 Allyl hexanoate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
141 | Allyl isovalerate CAS No 2835-39-4 2-Propenyl 3-Methyl-butanoate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
142 | Allyl octanoate CAS No 4230-97-1 2-Allyl caprylate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
143 | Allyl phenoxyacetate CAS No 7493-74-5 2-Propenyl Phenoxyacetate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
144 | Allyl phenylacetate CAS No 1797-74-6 2-Propenyl Benzeneacetate | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
145 | Allyl 3,5,5-trimethylhexanoate CAS No 71500-37-3 | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
146 | Allyl cyclohexyloxyacetate CAS No 68901-15-5 | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
147 | Allyl isoamyloxyacetate CAS No 67634-00-8 | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
148 | Allyl 2-methylbutoxyacetate CAS No 67634-01-9 | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
149 | Allyl nonanoate CAS No 7493-72-3 | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
150 | Allyl propionate CAS No 2408-20-0 | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
151 | Allyl trimethylhexanoate CAS No 68132-80-9 | Level of free allyl alcohol in the ester should be less than 0,1 % | |||
152 | Allyl heptine carbonate CAS 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) | ||
153 | Amylcyclopentenone CAS No 25564-22-1 2-Pentylcyclopent-2-en-1-one | 0,1 % | |||
154 | Myroxylon balsamum var pereirae. extracts and distillates CAS No 8007-00-9 Balsam Peru oil, absolute and anhydrol (Balsam Oil Peru) | 0,4 % | |||
155 | 4-tert.-Butyldihydrocinnamaldehyde CAS No 18127-01-0 3-(4-tert-Butylphenyl)propion-aldehyde | 0,6 % | |||
156 | Cuminum cyminum fruit oil and extract CAS No 84775-51-9 | (a)Leave-on products(b)Rinse-off products | (a)0,4 % of Cumin oil | ||
157 | cis-Rose ketone-1b CAS 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 % | ||||
158 | trans-Rose ketone-2b CAS 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 % | ||||
159 | trans-Rose ketone-5b CAS No 39872-57-6 (E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one (Isodamascone) | 0,02 % | |||
160 | Rose ketone-4b CAS No 23696-85-7 1-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) | (a)Oral products | |||
(b)Other products | (b)0,02 % | ||||
161 | Rose ketone-3b CAS No 57378-68-4 1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one (Delta-Damascone) | (a)Oral products | |||
(b)Other products | (b)0,02 % | ||||
162 | cis-Rose ketone-2b CAS No 23726-92-3 1-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one (cis-β-Damascone) | (a)Oral products | |||
(b)Other products | (b)0,02 % | ||||
163 | trans-Rose ketone-1b CAS No 24720-09-0 1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one (trans-α-Damascone) | (a)Oral products | |||
(b)Other products | (b)0,02 % | ||||
164 | Rose ketone-5b CAS No 33673-71-1 1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one | (b)0,02 % | |||
165 | trans-Rose ketone-3b CAS No 71048-82-3 1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one (trans-delta-Damascone) | (a)Oral products | |||
(b)Other products | (b)0,02 % | ||||
166 | trans-2-hexenal CAS No 6728-26-3 | (a)Oral products | |||
(b)Other products | (b)0,002 % | ||||
167 | l-Limonene CAS No 5989-54-8 (S)-p-Mentha-1,8-diene | Peroxide value less than 20 mmoles/La | |||
168 | dl-Limonene (racemic) CAS No 138-86-3 1,8(9)-p-Menthadiene; p-Mentha-1,8-diene (Dipentene) | Peroxide value less than 20 mmoles/La | |||
169 | Perillaldehyde CAS No 2111-75-3 p-Mentha-1,8-dien-7-al | (a)Oral products | |||
(b)Other products | (b)0,1 % | ||||
170 | Isobergamate CAS No 68683-20-5 Menthadiene-7-methyl formate | 0,1 % | |||
171 | Methoxy dicyclopentadiene carboxaldehyde CAS No 86803-90-9 Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde | 0,5 % | |||
172 | 3-methylnon-2-enenitrile CAS No 53153-66-5 | 0,2 % | |||
173 | Methyl octine carbonate CAS No 111-80-8 Methyl 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 %) | ||||
174 | Amylvinylcarbinyl acetate CAS No 2442-10-6 1-Octen-3-yl acetate | (a)Oral products | |||
(b)Other products | (b)0,3 % | ||||
175 | Propylidenephthalide CAS No 17369-59-4 3-Propylidenephthalide | (a)Oral products | |||
(b)Other products | (b)0,01 % | ||||
176 | Isocyclogeraniol CAS No 68527-77-5 2,4,6-Trimethyl-3-cyclohexene-1-methanol | 0,5 % | |||
177 | 2-Hexylidene cyclopentanone CAS No 17373-89-6 | (a)Oral products | |||
(b)Other products | (b)0,06 % | ||||
178 | Methyl heptadienone CAS No 1604-28-0 6-Methyl-3,5-heptadien-2-one | (a)Oral products | |||
(b)Other products | (b)0,002 % | ||||
179 | p-methylhydrocinnamic aldehyde CAS No 5406-12-2 Cresylpropionalde-hyde p-Methyldihydrocinnamaldehyde | 0,2 % | |||
180 | Liquidambar orientalis Balsam oil and extract CAS No 94891-27-7 (styrax) | 0,6 % | |||
181 | Liquidambar styraciflua balsam oil and extract CAS No 8046-19-3 (styrax) | 0,6 % | |||
182 | Acetyl hexamethyl tetralin CAS No 21145-77-7 CAS No 1506-02-1 1-(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: hydro alcoholic products: 1 % fine fragrance: 2,5 % fragrance cream: 0,5 % (b)rinse-off products: 0,2 % | ||
183 | Commiphora erythrea engler var. glabrescens engler gum extract and oil CAS No 93686-00-1 | 0,6 % | |||
184 | Opopanax chironium resin CAS No 93384-32-8 | 0,6 % |