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March 27, 2010

Santolina Oil: banned IFRA, for no particular reason?

by Tony Burfield March 2010.

Matthias Vey had the decency to admit, at the BSP Safety Symposium on March 11th at Cambridge UK, that IFRA’s banning of melissa oil in its 44th Amendment was a mistake, albeit one made by his predecessor. Cropwatch considers that the fact that the mistaken ban was queried by humble perfumery technicians throughout the trade, but had apparently escaped the attention of RIFM’s Expert Panel, is an internal matter for IFRA to reflect about. Apologies from Vey too over the dithering with regard to the restriction, or should we say the suspended restriction, of vanillin in IFRA’s 44th Amendment (previously queried by Cropwatch in Cropwatch Newsletter 15), and Vey explained part of the story behind the restriction of oakmoss qualities (first published by Cropwatch in 2008). If, from all this, you get the impression that perfume ingredient regulation is more a matter of politics than of robust scientific evidence, then you would be entirely correct

IFRA have also previously made clear their intentions to ban other essential oils. Santolina oil CAS 84961-58-0 (the botanical species not identified in the IFRA Standard), was banned on undisclosed grounds following an initial review under IFRA’s 40th Amendment 2006. A survey of the IFRA membership had indicated non-support for its continued use. As you will all be aware, IFRA are very fond of saying they represent the industry, when they only represent a part of it, especially that part represented by the large aroma corporates. The fact that santolina oil has a moderate level of use in the trade (300 t/y in 1996) and finds applications in cosmetics because of its beneficial properties, appear to have been escaped the IFRA high-command.

Cropwatch has established a detailed monograph on santolina essential oil from Santolina chamaecyparissus L. (Cotton lavender) at http://www.cropwatch.org/Santolina chamaecyparissus L.pdf which contains references to as much published material as we can currently find. It appears that the composition of Spanish santolina oils from Santolina chamaecyparissus L. vary considerably according to the area in which they are grown, and which subspecies is used to prepare the essential oil (Pérez-Alonso & Velasco-Negueruela 1992). Published pharmacological investigations of S. chamaecyparissus extracts, and Information on Santolina oil so far declared in the IFRA-IOFI labelling manual 2009 (botanical information not indicated) do not indicate any grounds whatsoever for a complete ban of the ingredient for perfumery use.

This makes the reasons behind the IFRA ban of santolina oil all the more obscure. Information displayed on the IFRA site indicates that the RIFM Expert Panel gave three possible reasons, but, in true Kafka-esque fashion, we are not allowed to know which of them applies:

1. The presence of structural alerts as defined in the Human Health Criteria Document (Ford et al., 2000), and/or
2) Adverse data on the material itself and/or
3) Adverse data for a structurally related material

So are we in another melissa oil situation, where the reason for the IFRA ban suddenly evaporates when the evidence is revealed by a third party? We need to know because materials contained in santolina oil may occur in other natural aromatic products. And we need to know because banning an ingredient for undisclosed reasons smacks of toxicological imperialism.

References.:

Ford et al. (2000) “Human Health Criteria Document.” Reg. Tox & Pharm. 31, 166-181, 2000.

Pérez-Alonso & Velasco-Negueruela (1992) « "Essential oil components of Santolina chamaecyparissus L." Flav. & Frag. J. 7, 37-42.

Posted by Tony Burfield on March 27, 2010 in Perfumery, Regulatory Issues, Safety/Toxicity | Permalink

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Comments

While editing this post for publication I noted that Tony was focusing on the Perfumery uses, and I wondered what the situation was for aromatherapy use. A quick Google search and some checks of standard references reveal that the situation for aromatherapy is as obscure as for perfumery.
I only found one retailer for Santolina oil, and they listed it as unsuitable for Aromatherapy use (if it is also banned by IFRA for Perfumery use, it makes one wonder why they are selling it--and they have a Hydrolat too).
I found a number of Internet references listing it as toxic and not suitable for aromatherapy use, but without references.
Tisserand and Balacs, Essential Oil Safety 1995 in their Profile on p. 145 list it as Orally toxic, and suggest "use with caution generally, due to uncertain toxicity: use with caution in epilepsy and pregnancy". Under Toxicity data & recommendations, they state that "no toxicity data for this compound could be found."
Tony in his referenced monograph on Cropwatch has done an extensive search for primary sources on the oil. It would seem that a similar search should be made for aromatherapy uses, but since there don't seem to be any, perhaps that is moot.
But the 300 T supposedly produced in 1996 must have been used somewhere.
And what are those "beneficial properties" that promote its use in cosmetics? The EWG Skin Deep Database gives it a 3 hazard rating with a 76% Data Gap, apparently based on its IFRA banning, but doesn't reveal any firm data; and lists 0 products containing it.

Posted by: Rob Stitt | Mar 29, 2010 7:28:03 PM

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