QRA Impact on the IFRA Certificate
QRA Impact on the IFRA Certificate
QRA Impact on the IFRA Certificate
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<str<strong>on</strong>g>QRA</str<strong>on</strong>g> <str<strong>on</strong>g>Impact</str<strong>on</strong>g> <strong>on</strong> <strong>the</strong> <strong>IFRA</strong> <strong>Certificate</strong><br />
Dr. Matthias Vey<br />
Scientific Director<br />
Internati<strong>on</strong>al Fragrance<br />
Associati<strong>on</strong> (<strong>IFRA</strong>)<br />
RIFM / <strong>IFRA</strong> <str<strong>on</strong>g>QRA</str<strong>on</strong>g><br />
Implementati<strong>on</strong> Workshop<br />
Brussels / Woodcliff Lake<br />
January 23, 2007<br />
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<str<strong>on</strong>g>QRA</str<strong>on</strong>g> DERMAL SENSITIZATION<br />
PROPOSED PRODUCT CATEGORIES<br />
From <strong>the</strong> 40 th Amendment <strong>on</strong>, <strong>IFRA</strong> Standards for<br />
sensitizing fragrance ingredients are based <strong>on</strong> <strong>the</strong><br />
<str<strong>on</strong>g>QRA</str<strong>on</strong>g> (Quantitative Risk Assessment) c<strong>on</strong>cept<br />
In practice this means an increased number of<br />
product categories with individual limitati<strong>on</strong>s<br />
(restricti<strong>on</strong>s).<br />
Grouping product types according to similar SAFs<br />
(Safety Assessment Factors) and exposure,<br />
which lead to similar acceptable use levels of a<br />
fragrance ingredient, resulted in 11 product<br />
categories in <strong>the</strong> <strong>IFRA</strong> Standards based <strong>on</strong> <strong>the</strong><br />
<str<strong>on</strong>g>QRA</str<strong>on</strong>g>.<br />
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NEW <str<strong>on</strong>g>QRA</str<strong>on</strong>g> based <strong>IFRA</strong> STANDARD<br />
Limits for 11 different<br />
product categories<br />
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<str<strong>on</strong>g>QRA</str<strong>on</strong>g> impact <strong>on</strong> <strong>the</strong> <strong>IFRA</strong> <strong>Certificate</strong><br />
• In order for <strong>the</strong> users of fragrance compounds to<br />
be adequately informed about <strong>the</strong> compliance of<br />
<strong>the</strong> fragrance compound with <strong>the</strong> requirements of<br />
<strong>the</strong> Code of Practice and <strong>the</strong> most recent<br />
Amendment for <strong>the</strong> intended applicati<strong>on</strong>(s),<br />
industry provides <strong>the</strong> customers with an<br />
‘<strong>IFRA</strong> <strong>Certificate</strong>’<br />
• The format of <strong>the</strong> <strong>Certificate</strong> gained additi<strong>on</strong>al<br />
complexity with <strong>the</strong> introducti<strong>on</strong> of <strong>the</strong> <str<strong>on</strong>g>QRA</str<strong>on</strong>g><br />
Standards and <strong>the</strong> 11 product categories.<br />
• Guidance was developed to ensure broadest<br />
harm<strong>on</strong>isati<strong>on</strong> of c<strong>on</strong>tent while allowing some<br />
freedom for <strong>the</strong> format<br />
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<str<strong>on</strong>g>QRA</str<strong>on</strong>g> impact <strong>on</strong> <strong>the</strong> <strong>IFRA</strong> <strong>Certificate</strong><br />
In general <strong>the</strong> certificate should include<br />
informati<strong>on</strong> <strong>on</strong><br />
• C<strong>on</strong>formity to <strong>the</strong> <strong>IFRA</strong> Standards <strong>on</strong> ingredients<br />
(ban, specificati<strong>on</strong>s and restricti<strong>on</strong>s) and<br />
c<strong>on</strong>firmati<strong>on</strong> of <strong>the</strong> foreseen or current use level<br />
in <strong>the</strong> intended applicati<strong>on</strong>(s) or a maximal safe<br />
use level for <strong>the</strong> intended applicati<strong>on</strong>(s)<br />
• C<strong>on</strong>formity to <strong>the</strong> o<strong>the</strong>r requirements of <strong>the</strong> <strong>IFRA</strong><br />
Code of Practice<br />
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<str<strong>on</strong>g>QRA</str<strong>on</strong>g> impact <strong>on</strong> <strong>the</strong> <strong>IFRA</strong> <strong>Certificate</strong><br />
• Before <strong>the</strong> introducti<strong>on</strong> of <strong>the</strong> <str<strong>on</strong>g>QRA</str<strong>on</strong>g> Standards,<br />
<strong>the</strong> certificates generally ‘<strong>on</strong>ly’ c<strong>on</strong>firmed <strong>the</strong><br />
(foreseen) use level <strong>on</strong> skin (or for n<strong>on</strong>-skin<br />
products) or provided informati<strong>on</strong> <strong>on</strong> <strong>the</strong><br />
maximum use level of a fragrance compound.<br />
More specific product use informati<strong>on</strong> could have<br />
been required in case of <strong>the</strong> presence of<br />
phototoxic ingredients or <strong>the</strong> presence of<br />
methyleugenol (restricted for systemic toxicity).<br />
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<str<strong>on</strong>g>QRA</str<strong>on</strong>g> impact <strong>on</strong> <strong>the</strong> <strong>IFRA</strong> <strong>Certificate</strong><br />
• Methyleugenol restricti<strong>on</strong>s:<br />
- Fine fragrance: 0.02% (200 ppm)<br />
- Eau de Toilette: 0.008% (80 ppm)<br />
- Fragrancing cream: 0.004% (40 ppm)<br />
- O<strong>the</strong>r leave-<strong>on</strong>: 0.0004% (4 ppm)<br />
- Rinse-off: 0.001% (10 ppm)<br />
- N<strong>on</strong>-skin (as defined in Code of Practice):<br />
0.02% (200 ppm) in fragrance compound<br />
- O<strong>the</strong>r n<strong>on</strong>-cosmetic products not covered<br />
above: 0.001% (10 ppm)<br />
The categories are basically following those<br />
established by <strong>the</strong> SCCP<br />
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<str<strong>on</strong>g>QRA</str<strong>on</strong>g> impact <strong>on</strong> <strong>the</strong> <strong>IFRA</strong> <strong>Certificate</strong><br />
• For fragrance compounds c<strong>on</strong>taining <strong>on</strong>e (or<br />
more) ingredients restricted via a <str<strong>on</strong>g>QRA</str<strong>on</strong>g> Standard<br />
<strong>the</strong> new <str<strong>on</strong>g>QRA</str<strong>on</strong>g> rules superimpose different<br />
categories than those already existing.<br />
• For <strong>the</strong> certificate and <strong>the</strong> determinati<strong>on</strong> of <strong>the</strong><br />
safe (maximum or current) use level of a<br />
compound in a given applicati<strong>on</strong> <strong>on</strong>e must take<br />
into account restricti<strong>on</strong>s from Standards <strong>on</strong> all<br />
ingredients present in <strong>the</strong> formula, whatever <strong>the</strong><br />
driving critical effect is:<br />
sensitizati<strong>on</strong>, systemic toxicity, phototoxicity,…<br />
• In additi<strong>on</strong>, for fragrances used in children’s toys,<br />
<strong>IFRA</strong> asks that <strong>on</strong>ly materials assessed and<br />
approved for use in flavor be used.<br />
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<str<strong>on</strong>g>QRA</str<strong>on</strong>g> impact <strong>on</strong> <strong>the</strong> <strong>IFRA</strong> <strong>Certificate</strong><br />
Categories of applicati<strong>on</strong>s can be different:<br />
• Phototoxicity: Leave-<strong>on</strong>, rinse-off and n<strong>on</strong>-skin<br />
• Systemic toxicity: Fine Fragrance, EdT,<br />
Fragrancing cream, o<strong>the</strong>r leave-<strong>on</strong>, rinse-off,<br />
n<strong>on</strong>-skin, o<strong>the</strong>r n<strong>on</strong>-cosmetic products not<br />
covered above (those categories were not<br />
developed by <strong>IFRA</strong> but required by European<br />
regulati<strong>on</strong>s addressing methyl eugenol <strong>on</strong>ly)<br />
• Sensitizati<strong>on</strong> up to <strong>IFRA</strong> 39 – skin c<strong>on</strong>tact and<br />
n<strong>on</strong>-skin c<strong>on</strong>tact<br />
• Sensitizati<strong>on</strong> via <str<strong>on</strong>g>QRA</str<strong>on</strong>g> - 11 categories<br />
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Definiti<strong>on</strong> of Classes<br />
• Categories of applicati<strong>on</strong>s as c<strong>on</strong>tained in<br />
different types of <strong>IFRA</strong> Standards for each type<br />
of critical endpoint are different – some overlap,<br />
o<strong>the</strong>r’s do not.<br />
• When c<strong>on</strong>sidering restricti<strong>on</strong>s based <strong>on</strong> <strong>the</strong> <str<strong>on</strong>g>QRA</str<strong>on</strong>g><br />
Standard, to avoid c<strong>on</strong>fusi<strong>on</strong> with <strong>the</strong> 11 <str<strong>on</strong>g>QRA</str<strong>on</strong>g><br />
categories <strong>IFRA</strong> decided to talk about ‘classes’<br />
for reporting in <strong>the</strong> certificate.<br />
• Informati<strong>on</strong> about <strong>the</strong> <strong>IFRA</strong> <strong>Certificate</strong> and <strong>the</strong><br />
system of classes was distributed to <strong>the</strong><br />
membership, customers and interested parties<br />
via <strong>IFRA</strong> IL 768 of January, 15, 2007.<br />
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Definiti<strong>on</strong> of Classes<br />
<str<strong>on</strong>g>QRA</str<strong>on</strong>g><br />
Product<br />
Type<br />
‘Old’ <strong>IFRA</strong><br />
category<br />
Systemic<br />
toxicity (Methyleugenol<br />
level<br />
Phototoxicity<br />
‘Food<br />
use<br />
approval’<br />
<strong>IFRA</strong><br />
<strong>Certificate</strong><br />
Class<br />
Category 1<br />
Lip<br />
products of<br />
all types<br />
Leave-<strong>on</strong><br />
O<strong>the</strong>r Leave-<strong>on</strong><br />
(4 ppm)<br />
Yes No* Class 1.B*<br />
Insect<br />
repellent<br />
Leave-<strong>on</strong> O<strong>the</strong>r Leave-<strong>on</strong> Yes No Class 1.B<br />
Toys Leave-<strong>on</strong> O<strong>the</strong>r Leave-<strong>on</strong> Yes Yes* Class 1.A<br />
*With IL 764 <strong>IFRA</strong> recommended to its membership to<br />
follow <strong>the</strong> same rules as for toys that enable access to<br />
<strong>the</strong> fragrance for ingesti<strong>on</strong><br />
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Definiti<strong>on</strong> of Classes<br />
<str<strong>on</strong>g>QRA</str<strong>on</strong>g> Product<br />
Type<br />
‘Old’ <strong>IFRA</strong><br />
category<br />
Systemic toxicity<br />
(Methyl-eugenol<br />
level<br />
Phototoxicity<br />
<strong>IFRA</strong><br />
<strong>Certificate</strong><br />
Class<br />
Category 3<br />
Hydroalc.<br />
Products,<br />
shaved skin<br />
Leave-<strong>on</strong><br />
EdT<br />
(80 ppm)<br />
Yes Class 3.A<br />
Hydroalc.<br />
Products,<br />
shaved skin<br />
Leave-<strong>on</strong><br />
Fine Fragrance<br />
(200 ppm)<br />
Yes Class 3.B<br />
Eye products<br />
of all types<br />
Leave-<strong>on</strong><br />
O<strong>the</strong>r leave-<strong>on</strong><br />
(4 ppm)<br />
Yes Class 3.C<br />
Men’s facial<br />
creams/balms<br />
Leave-<strong>on</strong><br />
O<strong>the</strong>r leave-<strong>on</strong><br />
(4 ppm)<br />
Yes Class 3.C<br />
Tamp<strong>on</strong>s Leave-<strong>on</strong> O<strong>the</strong>r leave-<strong>on</strong><br />
(4 ppm)<br />
No Class 3.D<br />
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Definiti<strong>on</strong> of Classes<br />
<str<strong>on</strong>g>QRA</str<strong>on</strong>g> Product<br />
Type<br />
‘Old’<br />
<strong>IFRA</strong><br />
category<br />
Systemic toxicity<br />
(Methyl-eugenol level<br />
Phototoxicity<br />
<strong>IFRA</strong><br />
<strong>Certificate</strong><br />
Class<br />
Category 10<br />
Hand wash<br />
Laundry<br />
detergents<br />
Rinse-off<br />
O<strong>the</strong>r n<strong>on</strong>-cosmetic<br />
(10 ppm)<br />
No Class 10.A<br />
Fabric softener Leave-<strong>on</strong> O<strong>the</strong>r n<strong>on</strong>-cosmetic<br />
(10 ppm)<br />
No Class 10.A<br />
O<strong>the</strong>r household<br />
cleaning<br />
products,<br />
machine wash<br />
laundry<br />
detergent etc.<br />
Leave-<strong>on</strong><br />
O<strong>the</strong>r n<strong>on</strong>-cosmetic<br />
(10 ppm)<br />
No Class 10.A<br />
Diapers Leave-<strong>on</strong> Leave-<strong>on</strong> No Class 10.B<br />
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Definiti<strong>on</strong> of Classes<br />
Enclosure 1 to <strong>the</strong> Guidance Document<br />
14
C<strong>on</strong>tent of a <strong>Certificate</strong><br />
• Identificati<strong>on</strong> of <strong>the</strong> supplier<br />
• Identificati<strong>on</strong> of <strong>the</strong> fragrance compound<br />
• Date<br />
• Statement that compound complies with<br />
requirements of <strong>the</strong> <strong>IFRA</strong> Code including <strong>the</strong><br />
Standards for <strong>the</strong> specified applicati<strong>on</strong>(s) or<br />
classes with <strong>the</strong> corresp<strong>on</strong>ding actual use level<br />
or maximum use level<br />
• The intended applicati<strong>on</strong>(s) or class(es)<br />
• The supported use level (actual or maximum)<br />
• Specific reference to versi<strong>on</strong> of Code and<br />
Standard (number of <strong>the</strong> Amendment)<br />
• Statement that use at higher c<strong>on</strong>centrati<strong>on</strong> or in<br />
a different applicati<strong>on</strong> requires ano<strong>the</strong>r evaluati<strong>on</strong><br />
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C<strong>on</strong>tent of a <strong>Certificate</strong><br />
Example for a<br />
certificate for a<br />
compound<br />
c<strong>on</strong>taining <str<strong>on</strong>g>QRA</str<strong>on</strong>g><br />
limited materials<br />
(enclosure 2b to<br />
<strong>IFRA</strong> Guidance<br />
document)<br />
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<strong>IFRA</strong> <strong>Certificate</strong>s – General<br />
Suggesti<strong>on</strong>s to keep workload of customers<br />
and suppliers manageable (1/3):<br />
The notificati<strong>on</strong> of new Standards asks fragrance<br />
suppliers to inform <strong>the</strong>ir clients about <strong>the</strong> c<strong>on</strong>formity<br />
of existing compounds within 60 days. Suggesti<strong>on</strong>s:<br />
• Provide <strong>the</strong> informati<strong>on</strong> with priority for active<br />
formulas<br />
• Customers to share informati<strong>on</strong> about <strong>the</strong> actual<br />
use of <strong>the</strong> compound<br />
and<br />
<strong>on</strong>ly ask <strong>the</strong> c<strong>on</strong>firmati<strong>on</strong> of <strong>the</strong> actual use(s), not<br />
across all potential uses (classes)<br />
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<strong>IFRA</strong> <strong>Certificate</strong>s – General<br />
Suggesti<strong>on</strong>s to keep workload of customers<br />
and suppliers manageable (2/3):<br />
• Abstain from asking for calculati<strong>on</strong> of a <strong>the</strong>oretical<br />
maximum use level wherever possible<br />
and<br />
instead focus <strong>on</strong> <strong>the</strong> c<strong>on</strong>firmati<strong>on</strong> of <strong>the</strong> current or<br />
foreseen use level<br />
Practical reas<strong>on</strong> – often, due to <strong>the</strong> nature of <strong>the</strong><br />
base in which <strong>the</strong> compound will be used, oils can<br />
<strong>on</strong>ly be used in a limited number of finished<br />
products.<br />
Fur<strong>the</strong>r, for modificati<strong>on</strong>s of existing products due<br />
to new Standards, it is best for <strong>the</strong> perfumers to<br />
have <strong>the</strong> actual use level so <strong>the</strong>y can create <strong>the</strong><br />
best modificati<strong>on</strong> possible.<br />
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<strong>IFRA</strong> <strong>Certificate</strong>s – General<br />
Suggesti<strong>on</strong>s to keep workload of customers<br />
and suppliers manageable (3/3):<br />
With <strong>the</strong> ever increasing complexity of <strong>the</strong> regulatory<br />
systems a resp<strong>on</strong>sible handling of <strong>the</strong> tools and<br />
requests for informati<strong>on</strong> seems advised.<br />
Investing some time in determining which<br />
informati<strong>on</strong> is essential to have can safe a lot of time<br />
by avoiding time to ga<strong>the</strong>r informati<strong>on</strong> for limited or<br />
no actual use.<br />
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Thank you very much for your<br />
attenti<strong>on</strong><br />
Avenue des Arts 6, B 1210 Bruxelles,<br />
Ph<strong>on</strong>e: +32 2 214 2062, Email: mvey@ifraorg.org<br />
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