http://www.legislation.gov.uk/id/eudr/2008/42

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 alcohol5
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/L6
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 %)
As a preservative, see Annex VI, Part 1, No 34.
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 alcohol5 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/L6
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 %)
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:

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/L7
104
Abies alba needle oil and extract
CAS No 90028-76-5
Peroxide value less than 10 mmoles/L7
105
Abies pectinata needle oil and extract
CAS No 92128-34-2
Peroxide value less than 10 mmoles/L7
106
Abies sibirica needle oil and extract
CAS No 91697-89-1
Peroxide value less than 10 mmoles/L7
107
Abies balsamea needle oil and extract
CAS No 85085-34-3
Peroxide value less than 10 mmoles/L7
108
Pinus mugo pumilio leaf and twig oil and extract
CAS No 90082-73-8
Peroxide value less than 10 mmoles/L7
109
Pinus mugo leaf and twig oil and extract
CAS No 90082-72-7
Peroxide value less than 10 mmoles/L7
110
Pinus sylvestris leaf and twig oil and extract
CAS No 84012-35-1
Peroxide value less than 10 mmoles/L7
111
Pinus nigra leaf and twig oil and extract
CAS No 90082-74-9
Peroxide value less than 10 mmoles/L7
112
Pinus palustris leaf and twig oil and extract
CAS No 97435-14-8
Peroxide value less than 10 mmoles/L7
113
Pinus pinaster leaf and twig oil and extract
CAS No 90082-75-0
Peroxide value less than 10 mmoles/L7
114
Pinus pumila leaf and twig oil and extract
CAS No 97676-05-6
Peroxide value less than 10 mmoles/L7
115
Pinus species leaf and twig oil and extract
CAS No 94266-48-5
Peroxide value less than 10 mmoles/L7
116
Pinus cembra leaf and twig oil and extract
CAS No 92202-04-5
Peroxide value less than 10 mmoles/L7
117
Pinus cembra leaf and twig extract acetylated
CAS No 94334-26-6
Peroxide value less than 10 mmoles/L7
118
Picea Mariana Leaf Oil and Extract
CAS No 91722-19-9
Peroxide value less than 10 mmoles/L7
119
Thuja Occidentalis Leaf Oil and Extract
CAS No 90131-58-1
Peroxide value less than 10 mmoles/L7
120
Thuja Occidentalis Stem Oil
CAS No 90131-58-1
Peroxide value less than 10 mmoles/L7
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/L7
122
Cedrus atlantica wood oil and extract
CAS No 92201-55-3
Peroxide value less than 10 mmoles/L7
123
Cupressus sempervirens leaf oil and extract
CAS No 84696-07-1
Peroxide value less than 10 mmoles/L7
124
Turpentine gum (Pinus spp.)
CAS No 9005-90-7
Peroxide value less than 10 mmoles/L7
125
Turpentine oil and rectified oil
CAS No 8006-64-2
Peroxide value less than 10 mmoles/L7
126
Turpentine, steam distilled (Pinus spp.)
CAS No 8006-64-2
Peroxide value less than 10 mmoles/L7
127
Terpene alcohols acetates
CAS No 69103-01-1
Peroxide value less than 10 mmoles/L7
128
Terpene hydrocarbons
CAS No 68956-56-9
Peroxide value less than 10 mmoles/L7
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/L7
130
Terpene terpenoids sinpine
CAS No 68917-63-5
Peroxide value less than 10 mmoles/L7
131
α-Terpinene
CAS No 99-86-5
p-Mentha-1,3-diene
Peroxide value less than 10 mmoles/L7
132
γ-Terpinene
CAS No 99-85-4
p-Mentha-1,4-diene
Peroxide value less than 10 mmoles/L7
133
Terpinolene
CAS No 586-62-9
p-Mentha-1,4(8)-diene
Peroxide value less than 10 mmoles/L7
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-18
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-28
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-58
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-48
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-38
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-28
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-18
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-58
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-38
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/L7
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/L7
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 alone
When 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 %
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.’