LegalizeThe Cosmetic Products (Safety) (Amendment No. 2) Regulations 2008
Made: 30th September 2008
Laid before Parliament: 2nd October 2008
Coming into force: 4th April 2009
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Citation, commencement and interpretation
1
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Amendment to the Principal Regulations
2
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SCHEDULE
PART 1
| Reference number | Substance | Restrictions | Restrictions | Restrictions | Conditions of use and warnings which must be printed on the label |
|---|---|---|---|---|---|
| Reference number | Substance | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | Conditions of use and warnings which must be printed on the label |
| a | b | c | d | e | f |
| 45 | Benzyl alcohol (*) CAS No 100-51-6 | (a) Solvent | |||
| 45 | Benzyl alcohol (*) CAS No 100-51-6 | (b) fragrance/ aromatic compositions/their raw materials | (b) The presence of the substance must be indicated in the list of ingredients referred to in regulation 12(2) 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 regulation 12(2) when its concentration exceeds: — 0.001% in leave-on products — 0.01% in rinse-off products | ||
| 72 | Hydroxycitronellal CAS No 107-75-5 | (b) Other products | (b) 1.0% | (a) (b) The presence of the substance must be indicated in the list of ingredients referred to in regulation 12(2) when its concentration exceeds: — 0.001% in leave-on products — 0.01% in rinse-off products | |
| 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 regulation 12(2) when its concentration exceeds: — 0.001% in leave-on products — 0.01% in rinse-off products | ||
| 73 | Isoeugenol CAS No 97-54-1 | (b) Other products | (b) 0.02% | (a) (b) The presence of the substance must be indicated in the list of ingredients referred to in regulation 12(2) when its concentration exceeds: — 0.001% in leave-on products — 0.01% in rinse-off products | |
| 88 | d-Limonene CAS No 5989-27-5 | The presence of the substance must be indicated in the list of ingredients referred to in regulation 12(2) when its concentration exceeds: — 0.001% in leave-on products — 0.01% in rinse-off products | |||
| 88 | d-Limonene CAS No 5989-27-5 | Peroxide value less than 20 mmoles/L (**) | |||
| 89 | Methyl 2-octynoate CAS No 111-12-6 Methyl heptine carbonate | (a) Oral products | (a) (b) The presence of the substance must be indicated in the list of ingredients referred to in regulation 12(2) when its concentration exceeds: — 0.001% in leave-on products — 0.01% in rinse-off products | ||
| 89 | Methyl 2-octynoate CAS No 111-12-6 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%) | (a) (b) The presence of the substance must be indicated in the list of ingredients referred to in regulation 12(2) when its concentration exceeds: — 0.001% in leave-on products — 0.01% in rinse-off products | |
| () As a preservative, see Schedule 6, Part 1, No 34. (*) This limit applies to the substance and not to the finished cosmetic product | () As a preservative, see Schedule 6, Part 1, No 34. (*) This limit applies to the substance and not to the finished cosmetic product | () As a preservative, see Schedule 6, Part 1, No 34. (*) This limit applies to the substance and not to the finished cosmetic product | () As a preservative, see Schedule 6, Part 1, No 34. (*) This limit applies to the substance and not to the finished cosmetic product | () As a preservative, see Schedule 6, Part 1, No 34. (*) This limit applies to the substance and not to the finished cosmetic product | () As a preservative, see Schedule 6, Part 1, No 34. (*) This limit applies to the substance and not to the finished cosmetic product |
PART 2
| Reference number | Substance | Restrictions | Restrictions | Restrictions | Conditions of use and warnings which must be printed on the label |
|---|---|---|---|---|---|
| Reference number | Substance | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | Conditions of use and warnings which must be printed on the label |
| a | b | c | d | e | f |
| 103 | Abies alba cone oil and extract CAS No 90028-76-5 | Peroxide value less than 10 mmoles/L (*) | |||
| 104 | Abies alba needle oil and extract CAS No 90028-76-5 | Peroxide value less than 10 mmoles/L (*) | |||
| 105 | Abies pectinata needle oil and extract CAS No 92128-34-2 | Peroxide value less than 10 mmoles/L (*) | |||
| 106 | Abies sibirica needle oil and extract CAS No 91697-89-1 | Peroxide value less than 10 mmoles/L (*) | |||
| 107 | Abies balsamea needle oil and extract CAS No 85085-34-3 | Peroxide value less than 10 mmoles/L (*) | |||
| 108 | Pinus mugo pumilio leaf and twig oil and extract CAS No 90082-73-8 | Peroxide value less than 10 mmoles/L (*) | |||
| 109 | Pinus mugo leaf and twig oil and extract CAS No 90082-72-7 | Peroxide value less than 10 mmoles/L (*) | |||
| 110 | Pinus sylvestris leaf and twig oil and extract CAS No 84012-35-1 | Peroxide value less than 10 mmoles/L (*) | |||
| 111 | Pinus nigra leaf and twig oil and extract CAS No 90082-74-9 | Peroxide value less than 10 mmoles/L (*) | |||
| 112 | Pinus palustris leaf and twig oil and extract CAS No 97435-14-8 | Peroxide value less than 10 mmoles/L (*) | |||
| 113 | Pinus pinaster leaf and twig oil and extract CAS No 90082-75-0 | Peroxide value less than 10 mmoles/L (*) | |||
| 114 | Pinus pumila leaf and twig oil and extract CAS No 97676-05-6 | Peroxide value less than 10 mmoles/L (*) | |||
| 115 | Pinus species leaf and twig oil and extract CAS No 94266-48-5 | Peroxide value less than 10 mmoles/L (*) | |||
| 116 | Pinus cembra leaf and twig oil and extract CAS No 92202-04-5 | Peroxide value less than 10 mmoles/L (*) | |||
| 117 | Pinus cembra leaf and twig extract acetylated CAS No 94334-26-6 | Peroxide value less than 10 mmoles/L (*) | |||
| 118 | Picea Mariana Leaf Oil and Extract CAS No 91722-19-9 | Peroxide value less than 10 mmoles/L (*) | |||
| 119 | Thuja Occidentalis Leaf Oil and Extract CAS No 90131-58-1 | Peroxide value less than 10 mmoles/L (*) | |||
| 120 | Thuja Occidentalis Stem Oil CAS No 90131-58-1 | Peroxide value less than 10 mmoles/L (*) | |||
| 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/L (*) | |||
| 122 | Cedrus atlantica wood oil and extract CAS No 92201-55-3 | Peroxide value less than 10 mmoles/L (*) | |||
| 123 | Cupressus sempervirens leaf oil and extract CAS No 84696-07-1 | Peroxide value less than 10 mmoles/L (*) | |||
| 124 | Turpentine gum (Pinus spp.) CAS No 9005-90-7 | Peroxide value less than 10 mmoles/L (*) | |||
| 125 | Turpentine oil and rectified oil CAS No 8006-64-2 | Peroxide value less than 10 mmoles/L (*) | |||
| 126 | Turpentine, steam distilled (Pinus spp.) CAS No 8006-64-2 | Peroxide value less than 10 mmoles/L (*) | |||
| 127 | Terpene alcohols acetates CAS No 69103-01-1 | Peroxide value less than 10 mmoles/L (*) | |||
| 128 | Terpene hydrocarbons CAS No 68956-56-9 | Peroxide value less than 10 mmoles/L (*) | |||
| 129 | Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 88, 167 and 168 of Part 1 of this Schedule CAS No 65996-98-7 | Peroxide value less than 10 mmoles/L (*) | |||
| 130 | Terpene terpenoids sinpine CAS No 68917-63-5 | Peroxide value less than 10 mmoles/L (*) | |||
| 131 | α-Terpinene CAS No 99-86-5 p-Mentha-1,3-diene | Peroxide value less than 10 mmoles/L (*) | |||
| 132 | γ-Terpinene CAS No 99-85-4 p-Mentha-1,4-diene | Peroxide value less than 10 mmoles/L (*) | |||
| 133 | Terpinolene CAS No 586-62-9 p-Mentha-1,4(8)-diene | Peroxide value less than 10 mmoles/L (*) | |||
| 134 | Acetyl hexamethyl indan CAS No 15323-35-0 1,1,2,3,3,6-Hexamethylindan- 5-yl methyl ketone | (a) Leave-on products | (a) 2% | ||
| 134 | Acetyl hexamethyl indan CAS No 15323-35-0 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-Methylbutanoate | 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)propionaldehyde | 0.6% | |||
| 156 | Cuminum cyminum fruit oil and extract CAS No 84775-51-9 | (a) Leave-on products | (a) 0.4% of Cumin oil | ||
| 156 | Cuminum cyminum fruit oil and extract CAS No 84775-51-9 | (b) Rinse-off products | |||
| 157 | cis-Rose ketone-1 (**) 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 | |||
| 157 | cis-Rose ketone-1 (**) CAS No 23726-94-5 (Z)-1-(2,6,6-Trimethyl- 2-cyclohexen-1-yl)-2- buten-1-one (cis-α-Damascone) | (b) Other products | (b) 0.02% | ||
| 158 | trans-Rose ketone-2 () 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 | |||
| 158 | trans-Rose ketone-2 () CAS No 23726-91-2 (E)-1-(2,6,6-Trimethyl- 1-cyclohexen-1-yl)-2- buten-1-one (trans-β-Damascone) | (b) Other products | (b) 0.02% | ||
| 159 | trans-Rose ketone-5 () 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-4 (**) CAS No 23696-85-7 1-(2,6,6-Trimethylcyclohexa- 1,3-dien-1-yl)-2-buten-1-one (Damascenone) | (a) Oral products | |||
| 160 | Rose ketone-4 (**) CAS No 23696-85-7 1-(2,6,6-Trimethylcyclohexa- 1,3-dien-1-yl)-2-buten-1-one (Damascenone) | (b) Other products | (b) 0.02% | ||
| 161 | Rose ketone-3 (**) CAS No 57378-68-4 1-(2,6,6-Trimethyl-3- cyclohexen-1-yl)-2- buten-l-one (Delta-Damascone) | (a) Oral products | |||
| 161 | Rose ketone-3 (**) CAS No 57378-68-4 1-(2,6,6-Trimethyl-3- cyclohexen-1-yl)-2- buten-l-one (Delta-Damascone) | (b) Other products | (b) 0.02% | ||
| 162 | cis-Rose ketone-2 (**) CAS No 23726-92-3 1-(2,6,6-Trimethyl-l-cyclohexen- 1-yl)-2- buten-l-one (cis-β-Damascone) | (a) Oral products | |||
| 162 | cis-Rose ketone-2 (**) CAS No 23726-92-3 1-(2,6,6-Trimethyl-l-cyclohexen- 1-yl)-2- buten-l-one (cis-β-Damascone) | (b) Other products | (b) 0.02% | ||
| 163 | trans-Rose ketone-1 (**) CAS No 24720-09-0 1-(2,6,6-Trimethyl-2- cyclohexen-1-yl)-2- buten-l-one (trans-α-Damascone) | (a) Oral products | |||
| 163 | trans-Rose ketone-1 (**) CAS No 24720-09-0 1-(2,6,6-Trimethyl-2- cyclohexen-1-yl)-2- buten-l-one (trans-α-Damascone) | (b) Other products | (b) 0.02% | ||
| 164 | Rose ketone-5 (**) CAS No 33673-71-1 1-(2,4,4-Trimethyl-2- cyclohexen-1-yl)-2- buten-l-one | 0.02% | |||
| 165 | trans-Rose ketone-3 (**) CAS No 71048-82-3 1-(2,6,6-Trimethyl-3- cyclohexen-1-yl)-2- buten-l-one (trans-delta-Damascone) | (a) Oral products | |||
| 165 | trans-Rose ketone-3 (**) CAS No 71048-82-3 1-(2,6,6-Trimethyl-3- cyclohexen-1-yl)-2- buten-l-one (trans-delta-Damascone) | (b) Other products | (b) 0.02% | ||
| 166 | trans-2-hexenal CAS No 6728-26-3 | (a) Oral products | |||
| 166 | trans-2-hexenal CAS No 6728-26-3 | (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/L (*) | |||
| 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/L (*) | |||
| 169 | Perillaldehyde CAS No 2111-75-3 p-Mentha-1,8-dien-7-al | (a) Oral products | |||
| 169 | Perillaldehyde CAS No 2111-75-3 p-Mentha-1,8-dien-7-al | (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 | |||
| 173 | Methyl octine carbonate CAS No 111-80-8 Methyl non-2-ynoate | (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 | |||
| 174 | Amylvinylcarbinyl acetate CAS No 2442-10-6 1-Octen-3-yl acetate | (b) Other products | (b) 0.3% | ||
| 175 | Propylidenephthalide CAS No 17369-59-4 3-Propylidenephthalide | (a) Oral products | |||
| 175 | Propylidenephthalide CAS No 17369-59-4 3-Propylidenephthalide | (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 | |||
| 177 | 2-Hexylidene cyclopentanone CAS No 17373-89-6 | (b) 0.01 % | (b) 0.06% | ||
| 178 | Methyl heptadienone CAS No 1604-28-0 6-Methyl-3,5-heptadien-2-one | (a) Oral products | |||
| 178 | Methyl heptadienone CAS No 1604-28-0 6-Methyl-3,5-heptadien-2-one | (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. | () 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. | () 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. | () 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. | () 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. | () 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. |
Signed
Gareth Thomas — Minister of State for Trade and Consumer Affairs — 30th September 2008
Explanatory note
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Footnotes
[^f00001]: 1987 c.43. Section 11(1) has been amended by S.I. 2005/1803, and section 11(5) has been amended by S.I. 2008/960.
[^f00002]: S.I. 2008/1284, as amended by SI2008/2173.
Editorial notes
[^key-b15d2703891c79c3b37e7c32e01e0d7c]: Regulations revoked (11.7.2013) by The Cosmetic Products Enforcement Regulations 2013 (S.I. 2013/1478), reg. 1(2), Sch. 1 (with reg. 6(5))
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