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S.I. No. 370/2008 - European Communities (Cosmetic Products) (Amendment) (No. 2) Regulations 2008

S.I. No. 370 of 2008

EUROPEAN COMMUNITIES (COSMETIC PRODUCTS) (AMENDMENT) (No. 2) REGULATIONS 2008

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 23rd September, 2008.

I, MARY HARNEY, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), and for the purpose of giving effect to Commission Directive 2008/14/EC 1 of 15 February 2008 and Commission Directive 2008/42/EC 2 of 3 April 2008, hereby make the following regulations:

1. These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment) (No. 2) Regulations 2008.

2. The collective citation “the European Communities (Cosmetic Products) Regulations 2004 to 2008” includes these Regulations.

3. (1) In these Regulations, “Principal Regulations” mean the European Communities (Cosmetic Products) Regulations 2004 ( S.I. No. 870 of 2004 ), as amended.

(2) (a) A reference in these Regulations to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other Regulations is intended.

(b) A reference in these Regulations to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.

(c) A reference in these Regulations to a Schedule is to a Schedule to these Regulations, unless it is indicated that reference to some other Regulations is intended.

4. Subject to Regulations 6 and 7, Regulation 4(1) of the Principal Regulations is amended by the addition to the definition of “Directive” of references to the following Commission Directives:

“2008/14/EC and 2008/42/EC”.

5. Subject to Regulations 6 and 7, the Schedules to the Principal Regulations are amended in the manner set out in the Schedules to these Regulations.

6. (1) Subject to paragraph (2), the provisions of these Regulations, insofar as such provisions relate to Commission Directive 2008/14/EC and the requirements of Schedule 1, shall come into operation on 16 November 2008.

(2) Insofar as cosmetic products fail to comply with the provisions and requirements referred to in paragraph (1), the prohibition on sales and disposals to the final consumer shall not come into operation until 16 February 2009.

7. (1) Subject to paragraph (2), the provisions of these Regulations, insofar as such provisions relate to Commission Directive 2008/42/EC and the requirements of Schedule 2, shall come into operation on 4 April 2009.

(2) Insofar as cosmetic products fail to comply with the provisions and requirements referred to in paragraph (1), the prohibition on sales and disposals to the final consumer shall not come into operation until 4 October 2009.

8. The European Communities (Cosmetic Products) (Amendment) Regulations 2008 ( S.I. No. 6 of 2008 ) are amended by substituting for Regulation 2 the following Regulation:

“2. These Regulations shall be construed as one with the European Communities (Cosmetic Products) Regulations 2004 to 2007 and may be cited together with those Regulations as the European Communities (Cosmetic Products) Regulations 2004 to 2008.”

9. The European Communities (Cosmetic Products) (Amendment) Regulations 2008 are amended in Regulation 10 by substituting “March” for “January”.

SCHEDULE 1

In Part 1 of Schedule 3 to the Principal Regulations, the following entry for glyoxal is added:

Restrictions

Reference No

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

‘102

Glyoxal Glyoxal (INCI)CAS No 107-22-2EINECS No 203-474-9

100mg/kg’

SCHEDULE 2

1. In Schedule 2, substance 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 schedule 3 is amended as follows:

(a) reference number 68 is deleted;

(b) reference numbers 45, 72, 73, 88 and 89 are replaced by the following:

Restrictions

Reference No

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(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(b) Other products

(b) 1.0%

(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

73

Isoeugenol CAS No 97-54-1

(a) Oral products(b) Other products

(b) 0,02 %

(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

88

d-LimoneneCAS 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 productsPeroxide value less than 20 mmoles/L (**)

89

Methyl 2-octynoate CAS No 111-12-6Methyl heptine carbonate

(a) Oral products(b) Other products

(b) 0,01 % when used aloneWhen present in combination with methyl octane carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octane 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 Article 6(1)(g) 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.’

(c) the following reference numbers 103 to 184 are added:

Restrictions

Reference No

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 ExtractCAS No 90028-76-5

Peroxide value less than 10 mmoles/L (*)

104

Abies alba needle oil and ExtractCAS No 90028-76-5

Peroxide value less than 10 mmoles/L (*)

105

Abies pectinata needle oil and ExtractCAS 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 extractCAS No 90082-72-7

Peroxide value less than 10 mmoles/L (*)

110

Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1

Peroxide value less than 10 mmoles/L (*)

111

Pinus nigra leaf and twig oil and extractCAS No 90082-74-9

Peroxide value less than 10 mmoles/L (*)

112

Pinus palustris leaf and twig oil and extractCAS No 97435-14-8

Peroxide value less than 10 mmoles/L (*)

113

Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0

Peroxide value less than 10 mmoles/L (*)

114

Pinus pumila leaf and twig oil and extractCAS No 97676-05-6

Peroxide value less than 10 mmoles/L (*)

115

Pinus species leaf and twig oil and extractCAS No 94266-48-5

Peroxide value less than 10 mmoles/L (*)

116

Pinus cembra leaf and twig oil and extractCAS No 92202-04-5

Peroxide value less than 10 mmoles/L (*)

117

Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6

Peroxide value less than 10 mmoles/L (*)

118

Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9

Peroxide value less than 10 mmoles/L (*)

119

Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1

Peroxide value less than 10 mmoles/L (*)

120

Thuja Occidentalis Stem OilCAS No 90131-58-1

Peroxide value less than 10 mmoles/L (*)

121

3-CareneCAS No 13466-78-93,7,7-Trimethyl-bicyclo[4.1.0]hept-3-ene(Isodiprene)

Peroxide value less than 10 mmoles/L (*)

122

Cedrus atlantica wood oil and ExtractCAS No 92201-55-3

Peroxide value less than 10 mmoles/L (*)

123

Cupressus sempervirens leaf oil and extractCAS 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 OilCAS 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 acetatesCAS No 69103-01-1

Peroxide value less than 10 mmoles/L (*)

128

Terpene hydrocarbonsCAS 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 167, 168 and 88 of this Schedule 3, Part 1CAS No 65996-98-7

Peroxide value less than 10 mmoles/L (*)

130

Terpene terpenoids sinpineCAS No 68917-63-5

Peroxide value less than 10 mmoles/L (*)

131

-Terpinene CAS No 99-86-5p-Mentha-1,3-diene

Peroxide value less than 10 mmoles/L (*)

132

-TerpineneCAS No 99-85-4p-Mentha-1,4-diene

Peroxide value less than 10 mmoles/L (*)

133

TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene

Peroxide value less than 10 mmoles/L (*)

134

Acetyl hexamethyl indanCAS No 15323-35-01,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone

(a) Leave-on products (b) Rinse-off products

(a) 2 %

135

Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate

Level of free allyl alcohol in the ester should be less than 0,1 %

136

Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate

Level of free allyl alcohol in the ester should be less than 0,1 %

137

Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate

Level of free allyl alcohol in the ester should be less than 0,1 %

138

Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate

Level of free allyl alcohol in the ester should be less than 0,1 %

139

Allyl heptanoate CAS No 142-19-82-Propenyl heptanoate

Level of free allyl alcohol in the ester should be less than 0,1 %

140

Allyl caproateCAS No 123-68-2Allyl hexanoate

Level of free allyl alcohol in the ester should be less than 0,1 %

141

Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methylbutanoate

Level of free allyl alcohol in the ester should be less than 0,1 %

142

Allyl octanoateCAS No 4230-97-12-Allyl caprylate

Level of free allyl alcohol in the ester should be less than 0,1 %

143

Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate

Level of free allyl alcohol in the ester should be less than 0,1 %

144

Allyl phenylacetateCAS No 1797-74-62-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

AllylcyclohexyloxyacetateCAS No 68901-15-5

Level of free allyl alcohol in the ester should be less than 0,1 %

147

Allyl isoamyloxyacetateCAS No 67634-00-8

Level of free allyl alcohol in the ester should be less than 0,1 %

148

Allyl 2-methylbutoxyacetateCAS No 67634-01-9

Level of free allyl alcohol in the ester should be less than 0,1 %

149

Allyl nonanoateCAS No 7493-72-3

Level of free allyl alcohol in the ester should be less than 0,1 %

150

Allyl propionateCAS No 2408-20-0

Level of free allyl alcohol in the ester should be less than 0,1 %

151

Allyl trimethylhexanoateCAS No 68132-80-9

Level of free allyl alcohol in the ester should be less than 0,1 %

152

Allyl 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)

153

AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one

0,1 %

154

Myroxylon balsamum var pereirae. extracts and distillatesCAS No 8007-00-9Balsam Peru oil, absolute and Anhydrol(Balsam Oil Peru)

0,4 %

155

4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propionaldehyde

0,6 %

156

Cuminum cyminum fruit oil and extractCAS No 84775-51-9

(a) Leave-on products(b) Rinse-off products

(a) 0,4 % of Cumin oil

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--Damascone)

(a) Oral products(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--Damascone)

(a) Oral products(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 23696-85-71-(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-3 (**)CAS 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 %

162

cis-Rose ketone-2 (**)CAS No 23726-92-31-(2,6,6-Trimethyl-lcyclohexen-1-yl)-2-buten-l-one(cis--Damascone)

(a) Oral products(b) Other products

(b) 0,02 %

163

trans-Rose ketone-1 (**)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans--Damascone)

(a) Oral products(b) Other products

(b) 0,02 %

164

Rose ketone-5 (**)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one

0,02 %

165

trans-Rose ketone-3 (**)CAS 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 %

166

trans-2-hexenalCAS No 6728-26-3

(a) Oral products(b) Other products

(b) 0,002 %

167

l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene

Peroxide value less than 20 mmoles/L (*)

168

dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene;p-Mentha-1,8-diene(Dipentene)

Peroxide value less than 20 mmoles/L (*)

169

PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al

(a) Oral products(b) Other products

(b) 0,1 %

170

IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate

0,1 %

171

Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde

0,5 %

172

3-methylnon-2-enenitrileCAS No 53153-66-5

0,2 %

173

Methyl octine carbonateCAS No 111-80-8Methyl 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 acetateCAS No 2442-10-61-Octen-3-yl acetate

(a) Oral products(b) Other products

(b) 0,3 %

175

PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide

(a) Oral products(b) Other products

(b) 0,01 %

176

IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol

0,5 %

177

2-Hexylidene cyclopentanoneCAS No 17373-89-6

(a) Oral products(b) Other products

(b) 0,06%

178

Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one

(a) Oral products(b) Other products

(b) 0,002 %

179

p-methylhydro-cinnamic aldehyde CAS No 5406-12-2 Cresylpropionaldehydep-Methyldihydrocinnamaldehyde

0,2 %

180

Liquidambar orientalis Balsam oil and extract CAS No 94891-27-7(Styrax)

0,6 %

181

Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(Styrax)

0,6 %

182

Acetyl 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 oforal 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 oilCAS No 93686-00-1

0,6%

184

Opopanax chironium resinCAS 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.’

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GIVEN under my Official Seal

18 September 2008

MARY HARNEY

Minister for Health and Children.

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation).

These Regulations further amend the European Communities (Cosmetic Products) Regulations 2004, as amended.

The purpose of these Regulations is to update the law in relation to the manufacture, marketing and sale of cosmetic products by the implementation of Commission Directive 2008/14/EC 3 and Commission Directive 2008/42/EC 4 with a view to improving the safety of those products.

3 OJ L 42, 16.2.2008, p. 43.

4 OJ L 93, 4.4.2008, p. 13.

These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment) (No. 2) Regulations 2008.

1 OJ L 42, 16.2.2008, p. 43.

2 OJ L 93, 4.4.2008, p. 13.

3 OJ L 42, 16.2.2008, p. 43.

4 OJ L 93, 4.4.2008, p. 13.