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QRA Implementation

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Timetable for 40 th Amendment and Beyond<br />

<strong>QRA</strong> <strong>Implementation</strong> Workshop<br />

January 23, 2007<br />

William Troy, Ph.D.<br />

Chairman<br />

IFRA Scientific Com.


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Pre-40th<br />

• Historically, IFRA established an<br />

effective date for new Amendments that<br />

was<br />

Immediate, for new creations<br />

12 months for existing fragrances<br />

• Based on the date of issuance of the<br />

Amendment<br />

2


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• As various elements of the process<br />

were changed (e.g., customer<br />

consultation, publication on website),<br />

the effective dates became one month<br />

and 13 months, following the<br />

announcement, for new and existing<br />

fragrances<br />

• With the advent of the 40 th Amendment<br />

it was clear that this timing would not be<br />

practical<br />

3


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Timing for 40th<br />

• Product categories expanded from 2 to<br />

more than 20 (with sub-categories)<br />

• Company computer systems must be<br />

modified<br />

• Reporting formats must be modified<br />

• Personnel training needs<br />

4


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• Scientific Committee decided that an<br />

exceptional period of<br />

- 13 months for new creations, and<br />

- 25 months for existing fragrances<br />

would be adopted for this Amendment<br />

• Therefore, the 4 materials with new<br />

IFRA restrictions could continue to be<br />

used in new creations for 13 months,<br />

and in existing fragrances for 25 mo.<br />

5


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42 nd Amendment<br />

• Now that <strong>QRA</strong> has been implemented,<br />

what about currently restricted<br />

materials?<br />

Currently, 50+ materials restricted<br />

because of skin allergy<br />

Additional materials, not currently<br />

IFRA restricted<br />

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• About half of 50+ have sufficient data to<br />

perform the <strong>QRA</strong> assessment<br />

• Taken together with the non-restricted<br />

materials that have been assessed via<br />

<strong>QRA</strong>, there is a total of 40-45 45 materials<br />

awaiting IFRA action<br />

• The approach to be taken has been<br />

discussed, in depth, at the SC and at<br />

the IFRA Joint Advisory Group (JAG)<br />

7


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• The opinion is unanimous to include<br />

these materials in the 42 nd Amendment,<br />

to avoid dragging out product<br />

reformulations over several years<br />

• Because of the very large number of<br />

materials, another exception will be<br />

made for implementation timing<br />

13 months new creations<br />

25 months existing fragrances<br />

8


I<br />

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The Future<br />

• The increased complexity of the IFRA<br />

process, resulting from the <strong>QRA</strong>, and<br />

the sharply increased numbers of<br />

materials being restricted, have<br />

prompted the question:<br />

Shouldn’t t we make a permanent<br />

change in the implementation time for<br />

new Amendments?<br />

9


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• A task force of the IFRA JAG studied<br />

this question, and the IFRA Board was<br />

also consulted<br />

• It was recognized that, until all currently<br />

restricted materials are subjected to the<br />

<strong>QRA</strong>, Amendments will contain more<br />

materials than usual<br />

• Once these are dealt with, however, the<br />

situation should return to normal<br />

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I<br />

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• From a public credibility point of view,<br />

the Board felt strongly that we cannot<br />

afford to permanently lengthen the<br />

amount of time allotted for product<br />

reformulations, following the publication<br />

of a new Amendment<br />

• They did approve, however, the<br />

extraordinary use of an extended time<br />

period, when necessary<br />

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I<br />

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• Therefore, the use of the 13/25 month<br />

implementation periods will be retained<br />

for most IFRA Amendments, with<br />

exceptions being allowed on a case by<br />

case basis<br />

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