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Smells Good—But is it Safe?
By: Steve Herman
Posted: February 6, 2013, from the March 2013 issue of GCI Magazine.
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As an experiment, on the IFRA homepage, click “Standards”, then the “Standards Restricted” tab, and then search for “citral.” This will help illustrate the following example, as it is what it’s based on. For the categories and the details of the quality risk assessment, download the PDF from the RIFM website.2
Table 1, IFRA Fragrance Categories, has a simplified list of the categories, and Table 2, Eau de GCI, a simple perfume formula (not made to smell good but to show a regulatory lesson) with one regulated material—citral. Citral was added directly, and is also a small component in grapefruit oil.
The IFRA limits in finished products for citral show that how much of the fragrance can be used depends on the application. For a hand cream, Category 5, the safe level is 0.3%. With 5.99% directly added to the formula and 0.01% contributed by the grapefruit, the total for citral is 6.00%.
Calculating the acceptable level: 0.30% x 100% /6.00% = 5%
Of course using a fragrance in a hand cream at 5% is extreme, and there is also a “pragmatic limit” for using fragrance. Even if the IFRA calculations result in an allowed fragrance level of 85% in a baby wipe, that is far beyond the pragmatic level and common sense is expected. Pragmatic levels are specifically indicated for Category 8 (2.00%), Category 9 (5%) and Category 10 (2.50%).
A similar procedure is used to calculate allergens, but that is only necessary if a product is going to be sold in the European Union (EU) and only for labeling purposes, not restricting use levels.
Currently there are 26 allergens listed by the EU,3 but these materials don’t always have to appear on the label. If they are in the finished product at less than 0.001% for a leave-on product or less than 0.01% in a rinse-off product, they are exempt from labeling.
Responsible Product Development
If you use a fragrance in your product, you should have an IFRA compliance letter from your supplier, and it should be updated every two years when new amendments are issued. If you ship to the EU, you must have an allergen statement as well. Also, if you do business in California, check to see if any material it contains is regulated by the Safe Cosmetics Act. And if you don’t have these documents, contact your supplier now.
There is a new proposal that may greatly increase the number of allergens and impose restrictions, and even bans, on some materials, but it is uncertain if this more extreme rule will be enacted. Anyone interested in learning more on this can find a formidable 334-page PDF about it, titled Opinion on Fragrance Allergens in Cosmetic Products, online.4
This proposal would adversely affect the vast majority of fine fragrances. For example, Chanel No 5 would have to be changed beyond recognition. The hope is that such a radical regulation will not be imposed on the industry now or in the future. And the work of RIFM and IFRA is a major line of defense against unreasonable regulations.