jeudi 14 mai 2009

IFRA's Stephen Weller Answers Grain de Musc (Part I)

Speaking to the “enemy”, are we?

Well, yes and no.

First of all, IFRA’s been getting a thorough thrashing lately in the perfume blogosphere, so it’s only fair that their Director of Communications, Stephen Weller, should be allowed to respond. This is why I wrote to him three weeks ago. He responded immediately and has kindly authorized me to publish his answer. Apart from his comment on Now Smell This, this is a first.

Secondly, it is worth asking whether IFRA is the real boogeyman here. Stephen Weller’s answer indicates that the pressure for “safer” products is both internal to the industry (self-regulatory mechanisms preceded legislation) and due to external, political pressures.

The show I was invited to along with Octavian Coifan and Bertrand Duchaufour on the French public radio on May 11th confirmed that there are indeed major concerns in the general public about the safety of fragrances: several calls and emails touched on the matter. So did many questions directed to Christophe Laudamiel during his Boston conference the same day (as reported by Jarvis, a frequent commenter on this blog, who attended it).

Emotion-fuelled and misdirected by bad science as those concerns may be (NGO campaigns and sensationalist press articles clearly feed the paranoia directed towards synthetic materials), they do have an impact that public bodies cannot ignore; they have certainly played a role in the increasingly strict regulatory environment.

In this context, IFRA clearly has a more pro-active role to play, to disprove bad science and reassure both the public and public policy-makers. It’s a steep uphill trek: the perfume industry itself has never done much to inform the public, and outright lies (“our products are 100% natural!”) have helped fuel the mistrust of synthetic materials.

An information campaign is called for, but whether it’ll do any good to perfume, perfume-lovers and perfumers is quite another matter: more materials are coming up for restrictions, and pretty soon, I wonder what perfumers will have left to work with, and which perfumes will survive at all...


As Mr. Weller’s letter is quite long, I’ll be dividing it into two separate posts for your reading comfort. My own letter restates several points I made in the one that was published on Perfumer & Flavorist’s website and in my previous posts (click here and here), so I won’t reproduce it here.

Mr. Weller has quoted my questions in his letter (they are underlined; I have emphasized certain phrases in bold; the phrases in italics are mine and refer to my letter).

Dear Denyse,

Many thanks for your email, and you are correct, this is the first time IFRA has entered into a dialogue with the blogosphere. The reason is that IFRA has traditionally focused on the IFRA Code of Practice, IFRA Standards and the industry’s Compliance Program and therefore the main audiences have been the international regulatory authorities, IFRA’s customers, the finished product manufacturers and the fragrance industry itself. In 2008 the industry collectively decided to put equal emphasis on communication and advocacy, pro-actively taking our messages to policy makers and the wider public.

I will try to answer your questions in their order and then add some comments.

Why has the fragrance industry not considered a more explicit and complete allergy warning label? After all, a rash isn’t anaphylactic shock, and food manufacturers label for peanuts which can be deadly for a portion of the population.

There are 26 fragrance materials defined by the EU Cosmetics Directive to be allergens. In Europe, these materials must be labeled on any product containing them at a concentration greater than 0.01% for rinse off and 0.001 for leave on products in order to enable people allergic to these materials to avoid the product. This should serve as adequate warning for the consumer and in most cases does. Where the problem lies is that the list of 26 allergens was drafted by the EU's Scientific Committee for Consumer Safety (originally known as the SCCNFP, then the SCCP and now known as the SCCS – click here for details online) over ten years ago. Almost half the materials on the list of 26 are not deemed to be potential allergens by dermatologists. Unfortunately regulations can take years to change and they do not always keep up with the science.

IFRA and RIFM (Research Institute for Fragrance Materials) have a great deal of expertise and data. When we detect a material has an issue via feedback from a network of dermatologists, or our own research or from manufacturers of products, we carry out a risk assessment. This is evaluated by an entirely independent panel of experts, REXPAN. These people have no connection to the fragrance industry and look purely at the science. They then make a recommendation to IFRA and RIFM for either more data, to draft a Standard or to take no action. If a Standard is required what form it takes very much depends on both the potency of the fragrance material to induce sensitization and the olfactory potency. If a threshold can be determined, below which the material in a statistically significant amount of cases does not induce sensitization and the perfumer concludes that this level is still of olfactory significance, then a limiting Standard is set. If the potency for allergic reactions is very high and would only allow insignificant or useless levels, then the material will be banned. Raw materials are also banned if there is insufficient data that allow a safety assessment (this ban can be lifted, if the missing data are established).

Through this system many materials have been saved because a use restriction has been issued, meaning that the scent can remain. If the amount used in the given product exceeds the restriction outlined in the Standard, then there is a high possibility of the material eliciting contact dermatitis. Since this approach has been active the levels of contact dermatitis have been falling with regard to fragrance materials. It is true that allergic reactions have been rising in general but not to fragrance materials (ref: Schnuch et al Contact Dermatitis, 50: 65-76 (2004)).

The reality is that most manufacturers of finished products follow the EU regulations worldwide and voluntarily label the 26 allergens if any are present in the product above the threshold. So, the labeling is there. Although the skin compatibility of cosmetics, toiletries and fragrances to the vast majority of the population is thoroughly tested, it is unavoidable that a small proportion of consumers may show a skin reaction when using products containing a natural or synthetic ingredient to which they are allergic. There is no substance that can be said to be a non-sensitizer in all circumstances and to all people. At the other end of the scale there are materials to which a significant proportion of people will respond even at very low levels of exposure. Within these extremes there are materials that will only affect a very small proportion of the population, provided exposure is kept below a level peculiar to the specific substance. These are known as weak sensitizers and the fragrance industry uses a number of them as important ingredients.

A lot of the materials we are exposed to in our every day life could be regarded as weak sensitizers. Their benefit is generally much higher than the risk of adverse reaction. In fragrances, they are used due to their unique smell, which cannot be achieved by using other materials with a better risk/benefit ratio.

Allergy to fragrance ingredients does exist and the industry is dedicated to reducing its incidence to the lowest level possible. The current labeling practices may help to reduce an already low incidence by providing greater information to consumers that experience sensitivity.

(To be continued)

Image: Eugenol. This molecule, which gives cloves their scent, is an essential material of perfumery. Its use is now strictly regulated.

16 commentaires:

  1. Thanks for sharing this letter, I am eagerly waiting for the second part.

  2. Hi, Denyse: Thanks for opening up this communication with IFRA, and for sharing this letter with us. I'm glad to see that Mr. Weller's letter clarifies the various roles of SCCP, IFRA, RIFM, and REXPAN (and confirms some of what we had previously discussed about this). I'll be eager to read the next installment...

  3. Jarvis, I think what's interesting is to find out about the role played by the EU sanitary authorities. It makes more sense to see things in this light, though I still think the industry could have defended its interests better if the decision-makers had cared about more than their quarterly reports.

  4. Great and congrats, but personally I am getting seriously tired of all this -worthless?- fight...While we're talking, the 44th is being proposed (merde?) and the fragrance companies are already busy reformulating at an extensive, alarming and devious way which is not that easy to pinpoint (enter my latest Dior observations...very devious).
    Don't know, it might be that I am becoming jaded.

  5. Helg, I agree that there are no grounds to fight on: it's a done deal, and it's getting worse by the minute.
    But journalistic habits die hard, and I still feel it's worthwhile investigating the ins and outs, as well as understanding the mechanisms of the decision process. This may not be Watergate, but I'm not the "cross my arms and let it wash over me" type.

    Getting information out may attract the attention of investigative journalists who are actually paid to do this stuff, which I'm not.

    The main point now is to inform the mainstream public of the sneaky reformulation process: Octavian and I did, repeatedly and insistently, make that point on the radio show to which we were invited.

    It won't lead brands to re-establish the original formulas, and may not even incite them to more transparency, but at least they'll know they're not pulling the wool over the public's eyes. Because blogs like ours aren't necessarily regularly read by non-aficionados, but mainstream readers do reach them when they research a fragrance on Google. It's a small step, but it's worth taking it.

  6. Oof. It's going to take me a bit to digest all this, especially since I'm a little late to the party. Thanks so much for posting.

  7. Amy, yes, I know, there's a lot in there and none of it is particularly sexy.

  8. Hi, D. I have to say that even if much of the restrictions and reformulations are a "done deal," there is definitely value in tracing the convoluted history of how we've come to this situation. Not just for the sake of our enjoyment of perfume, but also, frankly, for understanding the exercise of power/knowledge, and how this regulatory framework has emerged from the micro-relations between all the various parties (government, industry, scientists, physicians, consumers, etc.).

    It's interesting to me that the original 26 fragrance components mentioned by Mr. Weller appear to have been the target of attention because those happened to be the particular components included in the "fragrance mix" used for skin patch testing by dermatologists, dating back to the 60's and 70's. They were probably included in the mix because dermatologists had a sense that they were seeing a lot of cases of patients with sensitization who used products containing these ingredients. Of course, since these were many of the most common fragrance ingredients (e.g. cinnamic alcohol, cinnamic aldehyde, eugenol, iso-eugenol, geraniol, hydrocitronellal, oakmoss absolute), and had been used for many years, the ubiquity of the exposure and the size of the population exposed would have given rise to a lot of cases. (Noting that ubiquity of exposure and size of population are factors independent of the sensitization potential of the ingredient itself).

    So dermatologists flag certain ingredients as potentially of concern (based on the absolute number of cases that they see in their practice, and not necessarily based on actual prevalence of sensitization in the general population). Then the scientists do their various assays (e.g. local lymph node assays and human repeated insult patch tests) in order to try to establish a threshold below which there is little chance of sensitization. (We could have a whole discussion about how THAT gets assessed, but I won't get into that right now).

    Then an industry body like IFRA adopts those threshold standards, and goes about reformulating to meet those standards.

    Then, after some time, a government body like SCCP/SCCS might adopt the IFRA standard so that it becomes reflected in law. It is interesting to note here that, before becoming law, the IFRA standards are only binding on IFRA members, but there would be room for independent perfumers who are not IFRA members to do whatever they want. But if the IFRA standard is enshrined in law, then those perfumers would become outlaw perfumers...

  9. Jarvis, as far as I know, the fragrance mix you mention is still in use (it usually includes not 26 but 8 know allergens, if I've understood well). I'm not clear as to how the list of 26 was compiled and I don't know which of the 26 were withdrawn. More questions to ask Mr. Weller.

    The whole mechanism of how industry standards become law needs to be explored (I mean by me: clearly, lots of people know!). It's a complex, not very sexy subject but as you say, it is worthy of investigation. Because if you understands the mechanisms, you might, at some point, be able to throw a wrench into them. Though I'm not seeing a grassroots movement to defend perfumery...

    Call me a masochist, but when I'm screwed, I want to know how and who by.

  10. Hi, D. Yes, you're right, the original fragrance mix focused on 8 components. Balsam of Peru was also often tested separately. I'm still trying to track down the rest...

    One of the things I'm interested in is how industry and government regulators make use of science to establish guidelines. Mr. Weller writes: "If a threshold can be determined, below which the material in a statistically significant amount of cases does not induce sensitization and the perfumer concludes that this level is still of olfactory significance, then a limiting Standard is set." But these determinations are not based one single study. Rather, it is based on compiling information across multiple studies, and trying to infer something about the dose-response relationship. These studies can be quite variable in how they were conducted (for example, RIFM recently stated that HRIPT studies should ideally have 100 test subjects, but it is clear that many studies are based on a smaller pool of subjects). It is unclear to me still whether a formal statistical framework exists for combining data over studies, or whether it is based on the opinion of "subject-matter experts" who review the data.

    I should note that I'm not trying to speak either for or against the current process -- I'm just trying to understand it at the moment, and bringing what I hope is a healthy skepticism to the whole thing.

  11. Jarvis, my question of course as a non-scientist is: WHO is that perfumer who decides "this is too small an amount to be significant"? How is THAT established?
    See, when we parse the answer (which, being written, was exempt of verbal ping-pong), we find many more questions.
    It would be worthwhile compiling them. And asking them, of course.

  12. Perfumeshrine is right: "merde enfin!"
    Sensitization in the general population? My ass! I've been wearing perfume everyday for 20 years, never had a skin rash and even if I did, so what? Yea Big deal!
    These "safe" allergens-free reformulations made with synthetic molecules might turn out to be more health hazardous (cancers etc), nobody knows that but what we know is that exposure of oakmoss or jasmine never caused anyone to die.

  13. Si j'avais, I can safely say that you (and I, for that matter) are not the general population. Of which less than 2% are allergic to fragrance.

    But if you're not allergic to fragrances, that means you're not allergic to a whole passel of synthetics either, because even the best ones contain, and have contained for decades, tons of them (from aldehydes to eugenol, ionones, coumarin, et j'en passe).

    It's because of the alarmist discourse on synthetics that people are freaked out about fragrance in the first place.

  14. carmencanada, perfume goes against the whole PC mentality, that's the real problem. Perfume is an easy target, always considered luxury but not art. Who's going after wine in France? The french they're all alcoholics!

  15. Si j'avais, the French are actually drinking less wine than ever (but of a better quality). The country who's having very serious drinking issues is the UK.
    But yes, you're right, fragrance (a futile luxury reeking of self-indulgence and, worst of all, French) is an easy target for sanctimonious whining killjoys.