QRA Impact on the IFRA Certificate

<strong>QRA</strong> <strong>Impact</strong> on the IFRA Certificate
Dr. Matthias Vey
Scientific Director
International Fragrance
Association (IFRA)
RIFM / IFRA <strong>QRA</strong>
Implementation Workshop
Brussels / Woodcliff Lake
January 23, 2007
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<strong>QRA</strong> DERMAL SENSITIZATION
PROPOSED PRODUCT CATEGORIES
From the 40 th Amendment on, IFRA Standards for
sensitizing fragrance ingredients are based on the
<strong>QRA</strong> (Quantitative Risk Assessment) concept
In practice this means an increased number of
product categories with individual limitations
(restrictions).
Grouping product types according to similar SAFs
(Safety Assessment Factors) and exposure,
which lead to similar acceptable use levels of a
fragrance ingredient, resulted in 11 product
categories in the IFRA Standards based on the
<strong>QRA</strong>.
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NEW <strong>QRA</strong> based IFRA STANDARD
Limits for 11 different
product categories
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<strong>QRA</strong> impact on the IFRA Certificate
• In order for the users of fragrance compounds to
be adequately informed about the compliance of
the fragrance compound with the requirements of
the Code of Practice and the most recent
Amendment for the intended application(s),
industry provides the customers with an
‘IFRA Certificate’
• The format of the Certificate gained additional
complexity with the introduction of the <strong>QRA</strong>
Standards and the 11 product categories.
• Guidance was developed to ensure broadest
harmonisation of content while allowing some
freedom for the format
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<strong>QRA</strong> impact on the IFRA Certificate
In general the certificate should include
information on
• Conformity to the IFRA Standards on ingredients
(ban, specifications and restrictions) and
confirmation of the foreseen or current use level
in the intended application(s) or a maximal safe
use level for the intended application(s)
• Conformity to the other requirements of the IFRA
Code of Practice
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<strong>QRA</strong> impact on the IFRA Certificate
• Before the introduction of the <strong>QRA</strong> Standards,
the certificates generally ‘only’ confirmed the
(foreseen) use level on skin (or for non-skin
products) or provided information on the
maximum use level of a fragrance compound.
More specific product use information could have
been required in case of the presence of
phototoxic ingredients or the presence of
methyleugenol (restricted for systemic toxicity).
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<strong>QRA</strong> impact on the IFRA Certificate
• Methyleugenol restrictions:
- Fine fragrance: 0.02% (200 ppm)
- Eau de Toilette: 0.008% (80 ppm)
- Fragrancing cream: 0.004% (40 ppm)
- Other leave-on: 0.0004% (4 ppm)
- Rinse-off: 0.001% (10 ppm)
- Non-skin (as defined in Code of Practice):
0.02% (200 ppm) in fragrance compound
- Other non-cosmetic products not covered
above: 0.001% (10 ppm)
The categories are basically following those
established by the SCCP
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<strong>QRA</strong> impact on the IFRA Certificate
• For fragrance compounds containing one (or
more) ingredients restricted via a <strong>QRA</strong> Standard
the new <strong>QRA</strong> rules superimpose different
categories than those already existing.
• For the certificate and the determination of the
safe (maximum or current) use level of a
compound in a given application one must take
into account restrictions from Standards on all
ingredients present in the formula, whatever the
driving critical effect is:
sensitization, systemic toxicity, phototoxicity,…
• In addition, for fragrances used in children’s toys,
IFRA asks that only materials assessed and
approved for use in flavor be used.
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<strong>QRA</strong> impact on the IFRA Certificate
Categories of applications can be different:
• Phototoxicity: Leave-on, rinse-off and non-skin
• Systemic toxicity: Fine Fragrance, EdT,
Fragrancing cream, other leave-on, rinse-off,
non-skin, other non-cosmetic products not
covered above (those categories were not
developed by IFRA but required by European
regulations addressing methyl eugenol only)
• Sensitization up to IFRA 39 – skin contact and
non-skin contact
• Sensitization via <strong>QRA</strong> - 11 categories
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Definition of Classes
• Categories of applications as contained in
different types of IFRA Standards for each type
of critical endpoint are different – some overlap,
other’s do not.
• When considering restrictions based on the <strong>QRA</strong>
Standard, to avoid confusion with the 11 <strong>QRA</strong>
categories IFRA decided to talk about ‘classes’
for reporting in the certificate.
• Information about the IFRA Certificate and the
system of classes was distributed to the
membership, customers and interested parties
via IFRA IL 768 of January, 15, 2007.
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Definition of Classes
<strong>QRA</strong>
Product
Type
‘Old’ IFRA
category
Systemic
toxicity (Methyleugenol
level
Phototoxicity
‘Food
use
approval’
IFRA
Certificate
Class
Category 1
Lip
products of
all types
Leave-on
Other Leave-on
(4 ppm)
Yes No* Class 1.B*
Insect
repellent
Leave-on Other Leave-on Yes No Class 1.B
Toys Leave-on Other Leave-on Yes Yes* Class 1.A
*With IL 764 IFRA recommended to its membership to
follow the same rules as for toys that enable access to
the fragrance for ingestion
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Definition of Classes
<strong>QRA</strong> Product
Type
‘Old’ IFRA
category
Systemic toxicity
(Methyl-eugenol
level
Phototoxicity
IFRA
Certificate
Class
Category 3
Hydroalc.
Products,
shaved skin
Leave-on
EdT
(80 ppm)
Yes Class 3.A
Hydroalc.
Products,
shaved skin
Leave-on
Fine Fragrance
(200 ppm)
Yes Class 3.B
Eye products
of all types
Leave-on
Other leave-on
(4 ppm)
Yes Class 3.C
Men’s facial
creams/balms
Leave-on
Other leave-on
(4 ppm)
Yes Class 3.C
Tampons Leave-on Other leave-on
(4 ppm)
No Class 3.D
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Definition of Classes
<strong>QRA</strong> Product
Type
‘Old’
IFRA
category
Systemic toxicity
(Methyl-eugenol level
Phototoxicity
IFRA
Certificate
Class
Category 10
Hand wash
Laundry
detergents
Rinse-off
Other non-cosmetic
(10 ppm)
No Class 10.A
Fabric softener Leave-on Other non-cosmetic
(10 ppm)
No Class 10.A
Other household
cleaning
products,
machine wash
laundry
detergent etc.
Leave-on
Other non-cosmetic
(10 ppm)
No Class 10.A
Diapers Leave-on Leave-on No Class 10.B
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Definition of Classes
Enclosure 1 to the Guidance Document
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Content of a Certificate
• Identification of the supplier
• Identification of the fragrance compound
• Date
• Statement that compound complies with
requirements of the IFRA Code including the
Standards for the specified application(s) or
classes with the corresponding actual use level
or maximum use level
• The intended application(s) or class(es)
• The supported use level (actual or maximum)
• Specific reference to version of Code and
Standard (number of the Amendment)
• Statement that use at higher concentration or in
a different application requires another evaluation
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Content of a Certificate
Example for a
certificate for a
compound
containing <strong>QRA</strong>
limited materials
(enclosure 2b to
IFRA Guidance
document)
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IFRA Certificates – General
Suggestions to keep workload of customers
and suppliers manageable (1/3):
The notification of new Standards asks fragrance
suppliers to inform their clients about the conformity
of existing compounds within 60 days. Suggestions:
• Provide the information with priority for active
formulas
• Customers to share information about the actual
use of the compound
and
only ask the confirmation of the actual use(s), not
across all potential uses (classes)
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IFRA Certificates – General
Suggestions to keep workload of customers
and suppliers manageable (2/3):
• Abstain from asking for calculation of a theoretical
maximum use level wherever possible
and
instead focus on the confirmation of the current or
foreseen use level
Practical reason – often, due to the nature of the
base in which the compound will be used, oils can
only be used in a limited number of finished
products.
Further, for modifications of existing products due
to new Standards, it is best for the perfumers to
have the actual use level so they can create the
best modification possible.
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IFRA Certificates – General
Suggestions to keep workload of customers
and suppliers manageable (3/3):
With the ever increasing complexity of the regulatory
systems a responsible handling of the tools and
requests for information seems advised.
Investing some time in determining which
information is essential to have can safe a lot of time
by avoiding time to gather information for limited or
no actual use.
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Thank you very much for your
attention
Avenue des Arts 6, B 1210 Bruxelles,
Phone: +32 2 214 2062, Email: mvey@ifraorg.org
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