Perfumes (fragrances) and colophony
Perfumes (fragrances) and colophony
Perfumes (fragrances) and colophony
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2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 1 (76)<br />
<strong>Perfumes</strong> (<strong>fragrances</strong>) <strong>and</strong> <strong>colophony</strong><br />
Project group<br />
Participants <strong>and</strong> project leader<br />
PG4 – <strong>Perfumes</strong> <strong>and</strong> Colophony<br />
Ann-Therese Karlberg (project leader), Richard Brown, Stephen Carter, Alain Chaintreau, Rol<strong>and</strong><br />
Efraimson, An Goossens, Elisabet Jansson, Jean-Pierre Lepoittevin, Carola Lidén, Marie Norell, Suresh<br />
Rastogi, Maria Sköld <strong>and</strong> Louisane Vervaet<br />
allergen<br />
Amyl cinnamal 2<br />
Amylcinnamyl alcohol 5<br />
Benzyl alcohol 8<br />
Benzyl salicylate 11<br />
Cinnamyl alcohol 13<br />
Cinnamal 16<br />
Citral 19<br />
Coumarine 22<br />
Eugenol 25<br />
Geraniol 28<br />
Hydroxycitronellal 31<br />
Hydroxymethyl-pentylcyclo-hexenecarboxaldehyde (Lyral) 34<br />
Isoeugenol 37<br />
Anisyl alcohol 40<br />
Benzyl benzoate 43<br />
Benzyl cinnamate 46<br />
Citronellol 49<br />
Farnesol 52<br />
Hexyl cinnamaldehyde 55<br />
2-(4-tert-Butylbenzyl)propionaldehyde (Lilial) 58<br />
d-Limonene 61<br />
Linalool 64<br />
Methyl heptine carbonate 67<br />
3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one 70<br />
<strong>colophony</strong> 73<br />
page
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 2 (76)<br />
1. Allergen Amyl cinnamal<br />
CHO<br />
Synonyms, CAS, INCI 2-benzylideneheptanal, α-amyl cinnamic aldehyde. Cas. No. 122-40-7.<br />
Type of material or product Fragrance<br />
Type of exposure/exposed<br />
groups<br />
General exposure mainly from cosmetics, hygiene <strong>and</strong> household products; occupational exposure from<br />
fragrance materials used to mask malodours in products such as cutting fluids or to give a certain smell to a<br />
Prevalence of allergy <strong>and</strong><br />
disease (describe type 1 allergy<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms<br />
Other significant health effects<br />
product. Exposed groups: general population (1, 2)<br />
Amyl cinnamal is a well-known allergen as part of the diagnostic test, the fragrance mix. It accounts for<br />
2-3% of the reactions to the fragrance mix <strong>and</strong> has been identified as a cause of allergic reactions in<br />
persons with eczema from cosmetic hygiene <strong>and</strong> household products (1, 2).<br />
Dermatitis<br />
Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 3 (76)<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 4 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 5 (76)<br />
1. Allergen Amylcinnamyl alcohol<br />
CH 2 OH<br />
Synonyms, CAS, INCI 2-Pentyl-3-phenylprop-2-en-1-ol, α-amyl cinnamic alcohol, Cas. No. 101-85-9.<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong><br />
disease (describe type 1 allergy<br />
Five single cases reported of contact allergy to amyl cinnamyl alcohol <strong>and</strong> allergic reactions by patch<br />
testing were found in 7/179-2/20 (4-10%) of patients with contact eczema from cosmetics.<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Amyl cinnamyl alcohol probably cross reacts with amyl cinnamal<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 6 (76)<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficienty covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 7 (76)<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 8 (76)<br />
1. Allergen Benzyl alcohol<br />
CH 2 OH<br />
Synonyms, CAS, INCI Benzyl alcohol (INCI). Cas. No. 100-51-6.<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Benzyl alcohol is found in several studies as a cause of allergic reactions in 1.2-15% (2-4 cases in each<br />
disease (describe type 1 allergy study) of patients with eczema from cosmetic products.<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 9 (76)<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Cosmetic Directive 76/768<br />
EC Annex VI<br />
Cosmetic Directive 76/768<br />
EC Annex III<br />
Allows the use of benzyl<br />
alcohol < or =1% as a<br />
preservative<br />
Allows the use of benzyl<br />
alcohol as solvent for<br />
perfumes <strong>and</strong> similar products<br />
– no limits<br />
Analytical methods<br />
CEN/ISO/national st<strong>and</strong>ards<br />
Other methods<br />
Cosmet Lex, Vol 2,<br />
European Commission, p<br />
141-145<br />
Rastogi SC. DEPA Survey<br />
no.8-2002 (3)<br />
Ellendt et al. SÖFW-Journal<br />
127 2001:12:29-33 (4)<br />
Method for analysis of benzyl<br />
alcohol in cosmetic products<br />
GC-MS methods for<br />
identification of the 24<br />
fragrance chemicals at the<br />
same time<br />
Main methods available from which the<br />
validated method will be developed.
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 10 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 11 (76)<br />
1. Allergen Benzyl salicylate<br />
OH<br />
O<br />
O<br />
Synonyms, CAS, INCI Benzyl salicylate (INCI), Benzyl-o-hydroxybenzoate. Cas. No. 118-58-1<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Benzyl salicylate is a cause of allergic reactions in 0.2-10% of patients with eczema from cosmetic<br />
disease (describe type 1 allergy products <strong>and</strong> in one study accounted for 75% of reactions to commercial perfumes.<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 12 (76)<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 13 (76)<br />
1. Allergen Cinnamyl alcohol<br />
CH 2 OH<br />
Synonyms, CAS, INCI Cinnamyl alcohol [INCI], Cinnamic alcohol. Cas. No. 104-54-1<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Cinnamyl alcohol is a well-known allergen as part of the diagnostic test, the fragrance mix. It accounts for<br />
disease (describe type 1 allergy 5-14% of the reactions to the fragrance mix. In addition, it has been shown to be a cause of allergic<br />
<strong>and</strong> type 4 allergy respectively, reactions by patch test in 1.7%-75% of patients with eczema from cosmetic products.<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 14 (76)<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
IFRA limit: 0.8% in the<br />
final product<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 15 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 16 (76)<br />
1. Allergen Cinnamal<br />
CHO<br />
Synonyms, CAS, INCI Cinnamal [INCI], Cinnamaldehyde, 3-phenyl-2-propenal, Cinnamic aldehyde. Cas. No. 104-55-2<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Cinnamal is a well-proven allergen as part of the diagnostic test, the fragrance mix. It accounts for 5-36%<br />
disease (describe type 1 allergy of the reactions to the fragrance mix. It gives reactions in 2-3% of consecutively patch tested patients, most<br />
<strong>and</strong> type 4 allergy respectively, of which are of relevance. In addition, it has been shown to be a cause of allergic reactions by patch test in<br />
when relevant)<br />
1-30% of patients with eczema from cosmetic products in several studies.<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 17 (76)<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
Analytical methods<br />
CEN/ISO/national st<strong>and</strong>ards<br />
Other methods<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
IFRA requires “quenching<br />
agents”<br />
Rastogi SC. DEPA Survey<br />
no.8-2002 (3)<br />
Ellendt et al. SÖFW-<br />
Journal 127 2001:12:29-33<br />
(4)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 18 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 19 (76)<br />
1. Allergen Citral<br />
CHO<br />
CHO<br />
Synonyms, CAS, INCI 3,7-dimethyl-2,6-octadien-1-al, mix of cis <strong>and</strong> trans isomers. Cas. No. 5392-40-5<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Citral is a cause of allergic reactions in about 1% of consecutively patch-tested patients. It was the most<br />
disease (describe type 1 allergy frequent cause of reactions to a new diagnostic test for fragrance contact allergy <strong>and</strong> proved to cause<br />
<strong>and</strong> type 4 allergy respectively, contact allergic reactions in 2.6% of patients with eczema from cosmetic products.<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 20 (76)<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
EU Directive 67/548/EEC,<br />
Annex I (Dangerous<br />
substances in chemical<br />
products)<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
IFRA requires “quenching<br />
agents”<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 21 (76)<br />
Analytical methods<br />
CEN/ISO/national st<strong>and</strong>ards<br />
Other methods<br />
Rastogi SC. DEPA Survey<br />
no.8-2002 (3)<br />
Ellendt et al. SÖFW-<br />
Journal 127 2001:12:29-33<br />
(4)<br />
GC-MS methods for<br />
identification of the 24<br />
fragrance chemicals at the<br />
same time<br />
Main methods available from which the<br />
validated method will be developed.<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 22 (76)<br />
1. Allergen Coumarine<br />
O<br />
O<br />
Synonyms, CAS, INCI<br />
Type of material or product<br />
Type of exposure/exposed<br />
groups<br />
Prevalence of allergy <strong>and</strong><br />
disease (describe type 1 allergy<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms<br />
Other significant health effects<br />
Coumarine (INCI), 1-benzopyran-2-one, cis-o-coumarinic acid lactone. Occurs naturally in tonka beans<br />
<strong>and</strong> other plants. Cas. No. 91-64-5<br />
Fragrance<br />
General population<br />
Coumarine is a cause of allergic reactions in about 0.4-0.8% of consecutively patch tested patients. 1/3 of<br />
these cases is not detected by the fragrance mix. Coumarin has caused contact allergic reactions in 0.8-10%<br />
of patients with eczema from cosmetic products.<br />
Dermatitis<br />
Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 23 (76)<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 24 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 25 (76)<br />
1. Allergen Eugenol<br />
OH<br />
OCH 3<br />
Synonyms, CAS, INCI Eugenol (INCI). Cas. No. 97-53-0<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Eugenol is a well-known contact allergen. Many investigations have been performed. It is the cause of<br />
disease (describe type 1 allergy sensitization in 1.2% of consecutive eczema patients <strong>and</strong> accounts for 4-16% of reactions to the fragrance<br />
<strong>and</strong> type 4 allergy respectively, mix. Eugenol has caused contact allergic reactions in 0.7-20% of patients with eczema from cosmetic<br />
when relevant)<br />
products.<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 26 (76)<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 27 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 28 (76)<br />
1. Allergen Geraniol<br />
CH 2 OH<br />
Synonyms, CAS, INCI Geraniol (INCI). Cas. No. 106-24-1<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Geraniol is a well-known contact allergen as an ingredient in the diagnostic test, the fragrance mix. It is a<br />
disease (describe type 1 allergy cause of sensitization in 0.4% of consecutive eczema patients <strong>and</strong> accounts for 3-7% of reactions to the<br />
<strong>and</strong> type 4 allergy respectively, fragrance mix.<br />
when relevant)<br />
Geraniol has caused contact allergic reactions in 1.2-30% of patients with eczema from cosmetic products.<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 29 (76)<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 30 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 31 (76)<br />
1. Allergen Hydroxycitronellal<br />
CHO<br />
OH<br />
Synonyms, CAS, INCI 7-Hydroxycitronellal, Laurine. Cas. No. 107-75-5<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Hydroxycitronellal is a well-known contact allergen as ingredient in the diagnostic test, the fragrance mix.<br />
disease (describe type 1 allergy It is a cause of sensitization in 0.75% of consecutive eczema patients <strong>and</strong> accounts for 6-16% of reactions<br />
<strong>and</strong> type 4 allergy respectively, to the fragrance mix. Hydroxycitronellal has caused contact allergic reactions in 10-45% of patients with<br />
when relevant)<br />
eczema from cosmetic products.<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 32 (76)<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
Analytical methods<br />
CEN/ISO/national st<strong>and</strong>ards<br />
Other methods<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
IFRA limit: 1.0% in the<br />
final product<br />
Rastogi SC. DEPA Survey<br />
no.8-2002 (3)<br />
Ellendt et al. SÖFW-<br />
Journal 127 2001:12:29-33<br />
(4)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 33 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 34 (76)<br />
1. Allergen Hydroxymethyl-pentylcyclo-hexenecarboxaldehyde, (Lyral)<br />
HO<br />
CHO<br />
HO<br />
CHO<br />
Synonyms, CAS, INCI 4-(4-Hydroxy-4-methylpentyl)cyclohex-3-ene-carbaldehyde, Lyral. Cas. No. 31906-04-4<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Lyral was a cause of allergic reactions in about 2.8% of consecutively patch-tested patients. 2/3 of the<br />
disease (describe type 1 allergy cases were relevant. In addition, three relevant cases of contact allergy to lyral from cosmetic products are<br />
<strong>and</strong> type 4 allergy respectively, established.<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 35 (76)<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 36 (76)<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 37 (76)<br />
1. Allergen Isoeugenol.<br />
OH<br />
OCH 3<br />
OH<br />
OCH 3<br />
Synonyms, CAS, INCI Cas. No. 97-54-1<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Isoeugenol is a well-known contact allergen as ingredient in the diagnostic test, the fragrance mix. It is a<br />
disease (describe type 1 allergy cause of sensitization in 1.9% of consecutive eczema patients <strong>and</strong> accounts for 6-22% of reactions to the<br />
<strong>and</strong> type 4 allergy respectively, fragrance mix. Isoeugenol has caused contact allergic reactions in 2-25% of patients with eczema from<br />
when relevant)<br />
cosmetic products.<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 38 (76)<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
Analytical methods<br />
CEN/ISO/national st<strong>and</strong>ards<br />
Other methods<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
IFRA limit: 0.02% in the<br />
final product<br />
Rastogi SC. DEPA Survey<br />
no.8-2002 (3)<br />
Ellendt et al. SÖFW-Journal<br />
127 2001:12:29-33 (4)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 39 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 40 (76)<br />
1. Allergen Anisyl alcohol, 4-methoxybenzyl alcohol<br />
CH 3 O<br />
CH 2 OH<br />
Synonyms, CAS, INCI Cas. No. 105-13-5<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Two studies reported with contact allergy to anisyl alcohol among patients with cosmetic eczema. 3 <strong>and</strong> 4<br />
disease (describe type 1 allergy cases were documented (1.6-20%).<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 41 (76)<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 42 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 43 (76)<br />
1. Allergen Benzyl benzoate<br />
O<br />
O<br />
Synonyms, CAS, INCI Benzyl benzoate (INCI), Cas. No. 120-51-4<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Benzyl benzoate is positive in several studies, but only a single case is reported in each experiment for<br />
disease (describe type 1 allergy patients sensitive to Peru balsam.<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 44 (76)<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 45 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 46 (76)<br />
1. Allergen Benzyl cinnamate<br />
O<br />
O<br />
Synonyms, CAS, INCI Benzyl cinnamate (INCI), Benzyl 3-phenyl-2-propenoate, Cinnamein, Cas. No. 103-41-3<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Benzyl cinnamate is positive in one study of patients with contact allergy to cosmetic products <strong>and</strong> in a<br />
disease (describe type 1 allergy high proportion of patients with contact allergy to Peru balsam.<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 47 (76)<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 48 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 49 (76)<br />
1. Allergen Citronellol<br />
CH 2 OH<br />
Synonyms, CAS, INCI Citronellol (INCI), 3,7-Dimethyl-6-octenol, Cas. No. 106-22-9<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> One case of contact allergy to citronellol of uncertain relevance found by testing consecutive patients.<br />
disease (describe type 1 allergy Two studies of eczema patients with cosmetic eczema show more than one case each of patch test reactions<br />
<strong>and</strong> type 4 allergy respectively, to citronellol.<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 50 (76)<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 51 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 52 (76)<br />
1. Allergen Farnesol<br />
CH 2 OH<br />
Synonyms, CAS, INCI<br />
Type of material or product<br />
Type of exposure/exposed<br />
groups<br />
Prevalence of allergy <strong>and</strong><br />
disease (describe type 1 allergy<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms<br />
Other significant health effects<br />
Farnesol (INCI), 3,7,11-trimethyldodeca-2,6,10-trienol, Cas. No. 4602-84-0. 4 possible isomers<br />
Fragrance<br />
General population<br />
One study of eczema patients with cosmetic eczema shows two cases of contact allergy to farnesol.<br />
Additional cases in Peru balsam positive patients are found.<br />
Dermatitis<br />
Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 53 (76)<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 54 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 55 (76)<br />
1. Allergen Hexyl cinnamaldehyde<br />
CHO<br />
Synonyms, CAS, INCI α-Hexyl cinnamaldehyde, Cas. No. 101-86-0.<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> One case of contact allergy to hexyl cinnamic aldehyde in each of two studies <strong>and</strong> 7 cases in one study,<br />
disease (describe type 1 allergy were found among patients with eczema from cosmetic products.<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 56 (76)<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 57 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 58 (76)<br />
1. Allergen 2-(4-tert-Butylbenzyl)propionaldehyde (lilial)<br />
CHO<br />
Synonyms, CAS, INCI<br />
Type of material or product<br />
Type of exposure/exposed<br />
groups<br />
Prevalence of allergy <strong>and</strong><br />
disease (describe type 1 allergy<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms<br />
Other significant health effects<br />
2-(4-tert-butylbenzyl)propionaldehyde, 4-(1,1-dimethyl-ethyl)-a-methylbenzenepropanal;p-tert-butyl-amethylhydrocinnamaldehyde,<br />
lilial, lilestral, Cas. No. 80-54-6<br />
Fragrance<br />
General population<br />
Two cases of contact allergy to lilial were found in a study of 176 eczema patients with cosmetic eczema<br />
<strong>and</strong> one case with contact allergy to lilial from a deodorant. More cases found, but these may have been<br />
falsely positive.<br />
Dermatitis<br />
Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 59 (76)<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 60 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 61 (76)<br />
1. Allergen d-Limonene<br />
Synonyms, CAS, INCI R-Limonene, (R)-p-Mentha-1,8-diene. Cas. No. 5989-27-5<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Oxidation products of limonene are strong allergens. The frequency of contact allergy to oxidized limonene<br />
disease (describe type 1 allergy is about 2% in consecutive eczema patients. Contact allergy upon occupational exposure has been reported<br />
<strong>and</strong> type 4 allergy respectively, in several cases. However, the majority (33/63) of patients allergic to oxidized limonene reacted to<br />
when relevant)<br />
<strong>fragrances</strong> or markers of fragrance allergy.<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 62 (76)<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
EU Directive 67/548/EEC,<br />
Annex I (Dangerous<br />
substances in chemical<br />
products)<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
IFRA requires less than 20<br />
mmol of peroxide per liter<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 63 (76)<br />
CEN/ISO/national st<strong>and</strong>ards<br />
Other methods<br />
no.8-2002 (3)<br />
Ellendt et al. SÖFW-<br />
Journal 127 2001:12:29-33<br />
(4)<br />
identification of the 24<br />
fragrance chemicals at the<br />
same time<br />
validated method will be developed.<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 64 (76)<br />
1. Allergen Linalool<br />
OH<br />
Synonyms, CAS, INCI Linalool (INCI), Cas. No. 78-70-6<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> One case of contact allergy to linalool in one study <strong>and</strong> 3 cases in another study, were found among<br />
disease (describe type 1 allergy patients with eczema from cosmetic products. Linalool itself is not an allergen, but oxidized linalool<br />
<strong>and</strong> type 4 allergy respectively, contains allergens. The purity of the linalool used in reported patch test studies is not mentioned or<br />
when relevant)<br />
discussed <strong>and</strong> the results are therefore not informative.<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 65 (76)<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 66 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 67 (76)<br />
1. Allergen Methyl heptine carbonate<br />
O<br />
O<br />
CH 3<br />
Synonyms, CAS, INCI Methyl oct-2-ynoate, Cas. No. 111-12-6.<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Single cases were reported. It is a strong sensitizer according to IFRA.<br />
disease (describe type 1 allergy<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 68 (76)<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/EG<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 69 (76)<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 70 (76)<br />
1. Allergen 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one<br />
O<br />
Synonyms, CAS, INCI γ-isomethylionone, Cas. No. 127-51-5.<br />
The names <strong>and</strong> the CAS number do not fit together. Some mistake in the SCCNFP report<br />
Type of material or product Fragrance<br />
Type of exposure/exposed General population<br />
groups<br />
Prevalence of allergy <strong>and</strong> Two cases of contact allergy to γ-methylionone in one study <strong>and</strong> one case in each of two studies, were<br />
disease (describe type 1 allergy found among patients with eczema from cosmetic products.<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
Type of allergy symptoms Dermatitis<br />
Other significant health effects Besides irritancy to the respiratory tract no other significant health effects to the best of our knowledge.<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Potential for development of<br />
clinically relevant st<strong>and</strong>ard<br />
1. Almost ready<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
Comment<br />
A validated method using GC-MS with all analytical parameters clearly<br />
defined i.e. column, elution conditions, MS, etc for simultaneous<br />
quantification of the 24 fragrance chemicals in fragrance concentrates<br />
(mixtures of fragrance chemicals used as raw material) is possible to develop.<br />
The quantification will be performed in SIM (Selective Ion Monitoring) mode<br />
of MS using several ions. In case of interfering substances, since the<br />
fragrance mixtures are very complex, the quantification ion for a fragrance<br />
should be selected after looking at the full mass spectra of the target<br />
substance <strong>and</strong> the interfering substances. Depending upon the concentration
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 71 (76)<br />
of target substances <strong>and</strong> interfering substances a perfume/product perfume<br />
has to be analysed at several dilutions. If technically possible, the method will<br />
be validated for the limit of detection as required by the EU Directive(s).<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
The methods for sample preparation for various cosmetics <strong>and</strong> household<br />
products should be developed when the method for the perfumes <strong>and</strong> similar<br />
products has been validated. A period of 3-5 years is necessary for this work.<br />
We suggest one method for simultaneous quantification of all 24 fragrance<br />
chemicals listed by SCCNFP (1).<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
EU Directive 94/93/<br />
SANCO, SCCNFP/0017/98<br />
final, 18 th December 1999<br />
(1)<br />
EU Commission, DG,<br />
SANCO, SCCNFP/588/02<br />
final, 4 th June 2002 (2)<br />
Protection dem<strong>and</strong>ed for nonadults<br />
(
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 72 (76)<br />
References<br />
1.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Fragrance Allergy in Consumers. A review of the problem.<br />
Brussels, EU Commission, DG, SANCO, SCCNFP/0017/98 final, 18 th December 1999<br />
2.EU Scientific Committee on Cosmetic <strong>and</strong> Non-Food Products intended for consumers. Position statement concerning fragrance chemicals in<br />
detergents <strong>and</strong> other household products. Brussels, EU Commission, DG, SANCO, SCCNFP/588/02 final, 4 th June 2002<br />
3.Rastogi SC. Survey of chemical compounds in consumer products. Contents of selected fragrance materials in cleaning products <strong>and</strong> other consumer<br />
products. Danish Environmental Protection Agency, Copenhagen, Denmark. DEPA Survey no. 8, 2002<br />
4.Ellendt K, Hempel G, Köbler H. Analysis of sensitizing <strong>fragrances</strong> by gas chromatography – mass spectrometry. SÖFW-Journal 127 2001:12:29-33
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 73 (76)<br />
1. Allergen Colophony<br />
Synonyms, CAS, INCI Colophonium (INCI), rosin, gum rosin, tall oil rosin, wood rosin<br />
Type of material or product Natural material that can be used modified or unmodfied using different chemicals. See below.<br />
Type of exposure/exposed Normal population <strong>and</strong> occupational exposure.<br />
groups<br />
Areas of use: Unmodified <strong>colophony</strong>: soldering fluxes, paper, depilatory waxes, cosmetics, dancers’ <strong>and</strong><br />
string players rosin, wood <strong>and</strong> gum from pine trees. Modified <strong>colophony</strong> (modification types):<br />
Esterfication with polyalcohols: adhesieve tackifiers, printing inks, bubble gum; Diels-Alder addition of<br />
maleic acid, maleic anhydride or fumaric acid: paper size, printing inks, shoe glues; Hydrogenation:<br />
printing inks, soldering fluxes, emulsifiers in the production of synthetic rubber, adhesive tackifiers;<br />
Polymerization/dimerization: adhesives, printing inks varnishes; disproportionation/dehydrogenation:<br />
polymerization emulsifiers in the production of synthetic rubber, paper size, adhesive tackifiers, printing<br />
inks, insulating material in electronics industry; formaldehyde modification: paper size, printing inks; salt<br />
formation: soap, detergents, paper size, drier formulations, printing inks.<br />
Note! In principal all modified <strong>colophony</strong> products contain components from unmodified <strong>colophony</strong>, since<br />
modifications are performed just until the desired technical quality is obtained. The residue of unmodified<br />
<strong>colophony</strong> is often not declared. Also after two modifications oxidation products of unmodified<br />
components i.e. abietic acid, can be present in amounts high enough to cause dermatitis in allergic<br />
Prevalence of allergy <strong>and</strong><br />
disease (describe type 1 allergy<br />
<strong>and</strong> type 4 allergy respectively,<br />
when relevant)<br />
individuals.<br />
Colophony is one of the most common causes of contact allergy in dermatitis patients (3.4% of consecutive<br />
patients reacted at patch testing 1 ) <strong>and</strong> in the general population (0.7% 2 ). Numerous case reports of contact<br />
dermatitis from both occupational as well as non-occupational exposure to <strong>colophony</strong> can be found in the<br />
literature. Colophony also causes occupational asthma due to exposure to <strong>colophony</strong>-based solder flux<br />
fumes 3 .<br />
Type of allergy symptoms Dermatitis; the immunologic status of asthma caused by exposure to solder flux fumes is not yet settled<br />
Other significant health effects Asthma due to <strong>colophony</strong>-based solder flux fumes 3<br />
2. Evaluation Classification of priority or<br />
need<br />
Potential for prevention of 1. high<br />
sensitisation/elicitation by 2. possible<br />
limitation<br />
3. low<br />
Comment<br />
A common cause of allergic contact dermatitis <strong>and</strong> of occupational asthma.<br />
See above.<br />
Potential for development of 1. Almost ready Methodologies exist for the evaluation of the resin acids in the solder flux
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 74 (76)<br />
clinically relevant st<strong>and</strong>ard<br />
Priority for development of<br />
st<strong>and</strong>ard<br />
2. Testing<br />
3. Development<br />
4. Research<br />
5. Not realistic<br />
1. high<br />
2. medium<br />
3. low<br />
4. sufficiently covered by<br />
others<br />
fume based on GC technique (See below). However, the active/allergenic<br />
ingredients are not identified <strong>and</strong> the “total resin acids” is taken to be a<br />
surrogate. Instead, we recommend development <strong>and</strong> verification of an HPLC<br />
method to detect selected representative oxidation products that are the main<br />
allergens in unmodified <strong>colophony</strong>.<br />
In principle a method for resin acids <strong>and</strong> oxidation products can be used to<br />
determine any unmodified material in modified materials <strong>and</strong> different<br />
products but research is needed to be able to find methods to h<strong>and</strong>le various<br />
matrixes before the HPLC analysis.<br />
Colophony is present in a large number of products under various names <strong>and</strong><br />
is difficult to detect without analysis.<br />
3. Summary - background Reference (name, number) Brief description Comment<br />
Regulation/limitation/st<strong>and</strong>ard<br />
EU/national/other<br />
Existing/planned<br />
Classified with R43 as a<br />
skin sensitizer within EU.<br />
Products containing >1%<br />
<strong>colophony</strong> should be labelled<br />
with warning “Can cause skin<br />
sensitization”<br />
Very difficult to define 1% of <strong>colophony</strong><br />
since it has a complex composition <strong>and</strong> not<br />
all components are allergenic. Research has<br />
shown that oxidation products of the major<br />
resin acid, abietic acid, cause sensistization 4-7<br />
The UK (HSE, EH40) has a<br />
“maximum exposure limit”<br />
(MEL) i.e. a requirement to<br />
reduce exposure to as low<br />
as is reasonably practicable<br />
(for solder flux fume)<br />
The UK limit is 0.05 mg/m3<br />
TWA <strong>and</strong> 0.15mg/m3 STEL<br />
as a MEL. (for solder flux<br />
fume)<br />
Evidence is present in Criteria Document EH<br />
65/31 from January 1997. (for solder flux<br />
fume)<br />
Analytical methods<br />
CEN/ISO/national st<strong>and</strong>ards<br />
Other methods<br />
GC analysis of fatty <strong>and</strong><br />
resin acid mixtures 8 .<br />
MDHS 83 9<br />
HSE Methods for<br />
None of the methods detect the true allergens<br />
in <strong>colophony</strong> i.e. the oxidation products of<br />
the abietan type resin acids, mainly abietic<br />
acid.
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 75 (76)<br />
ISO 9454-1 Soft soldering<br />
fluxes. Classification <strong>and</strong><br />
requirements. Part 1:<br />
Classification, labelling <strong>and</strong><br />
packaging<br />
Determination of hazardous<br />
Substances: Resin acids in<br />
rosin (<strong>colophony</strong>) solder flux<br />
fume<br />
Flux classification on the basis<br />
of 16 crude tests specified in<br />
ISO 9455-1 to –16, including<br />
an “acid value” with no<br />
specified range corresponding<br />
to a solder containing resin<br />
acids<br />
The abietic acid hydroperoxide which is<br />
described as the major allergen 10 will be<br />
decomposed due to heating when using the<br />
GC method.<br />
Requires major revision<br />
HPLC method for<br />
detection of abietic <strong>and</strong><br />
dehydro-abietic acid in<br />
products 11<br />
The HPLC method is not developed for<br />
detection of abietic <strong>and</strong> dehydroabietic acid<br />
but could be further developed to detect also<br />
the hydroperoxide <strong>and</strong> one secondary<br />
oxidation product such as 7-<br />
oxodehydroabietic acid.<br />
References<br />
1. Schnuch A, Geier J, Uter W et al. National rates <strong>and</strong> regional differences in sensitization to allergens of the st<strong>and</strong>ard series. Population-adjusted<br />
frequencies of sensitization (PAFS) in 40,000 patients from a multicenter study (IVDK). Contact Dermatitis 1997:37:200-209.<br />
2. Nielsen NH, Menné T. Allergic contact sensitization in an unselected Danish population. The Glostrup Allergy Study, Denmark. Acta Derm<br />
Venereol (Stockh) 1992:72:456-460.<br />
3. HSE Asthmagen? Critical assessments of the evidence for agents implocated in occupational asthma. HSE Books (2001).<br />
4. Karlberg A-T. Contact allergy to <strong>colophony</strong>. Chemical identification of allergens, sensitization experiments <strong>and</strong> clinical experiences. Acta Derm<br />
Venereol (Stockh) 1988:Suppl.139, 1-43.<br />
5. Hausen BM, Kreruger A, Mohnert J et al. Contact allergy due to <strong>colophony</strong> (III). Sensitizing potency of resin acids <strong>and</strong> some related<br />
products. Contact Dermatitis 1989:20:41-50.<br />
6. Hausen BM, Börries M, Budianto E, Krohn K. Contact allergy due to <strong>colophony</strong> (IX). Sensitization studies with further products isolated after<br />
oxidative degradation of resin acids <strong>and</strong> <strong>colophony</strong>. Contact Dermatitis 1993:29:234-240.<br />
7. Karlberg A-T, Gäfvert E. Isolated <strong>colophony</strong> allergens as screening substances for contact allergy. Contact Dermatitis 1996:35:201-207.
2003-01-29 CEN/BT/WG 132 N 29 Annex 4d - <strong>Perfumes</strong> <strong>and</strong> <strong>colophony</strong> 76 (76)<br />
8. Holmbom B. Improved GC analysis of fatty <strong>and</strong> resin acid mixtures with special reference to tall oil. J Am Oil Chem Soc 1977:54:289-293.<br />
9. HSE Methods for the determination of hazardous substances: Resin acids in rosin (<strong>colophony</strong>) solder flux fume. In HSE Books ISBN 0-7176-<br />
1363-1 (1997).<br />
10. Karlberg A-T, Bohlinder K, Boman A, Hacksell U, Hermanson J, Jacobsson S, Nilsson JLG. Identification of 15-hydroperoxyabietic acid as a<br />
contact allergen in Portuguese <strong>colophony</strong>. J Pharm Pharmacol 1988:40:42-47.<br />
11. Ehrin E, Karlberg A-T. Detection of rosin (<strong>colophony</strong>) components in technical products using an HPLC technique. Contact Dermatitis<br />
1990:23:359-366.