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ALLERGEN LIMIT QUESTION?
Hi,
I’ve come accross a doubt regarding allergen substances in the EU market. I’m familiar with the IFRA amendment and declaration of allergen substances when they come in a parfum mixture. But, for the first time I’ve seen an allergen intentionally added as a pure substance in a cosmetic formula, as an ingredient itself: limonene (at 5% as a solvent in a soap). And i was wondering whether this would be compliant with the EU legislation…? Can this substances be added onto the formula intentionally? I don’t really understand that if the Annex III is for substances that cannot be included in a cosmetic except for the defined exception and this particular case doesn’t relate to that defined exception, could it be added?
I really can’t seem to find a clear answer. Or maybe it’s fully dependant on the MoS calculation of the Safety Assessment…? I’ve done my calculation and from the available data (if I’m not mistaken) i got a MoS>100.
Some help would be appreciated.
Thanks!
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2 Replies
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IFRA Conformity Certificate should be issued by your supplier when buying essential oils & fragrances: it contains the %s allowed for each category of products, from baby care to household products.
Regarding the use of limonene, as you’ve noticed, they’ve used it for cleansing purposes (I use 10-15% in a dishwashing paste).
The comment “… I’ve seen an allergen intentionally added as a pure substance in a cosmetic formula, as an ingredient itself” is a bit too much: they used a chemical they considered fit for the product, they didn’t purposefully looked for an allergen and decided to try their luck.
To clear your confussion, here’s an extract from the IFRA Certificate of sweet orange essential oil, which contains 70-90% limonene.
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Annex 3 addresses labeling for presence, whatever the source in the formula.
Benzyl alcohol is commonly and intentionally used as a preservative and is labeled in that regard.
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