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

I know: it's long, it's not particularly sexy reading and I promise I'll get back to more distracting perfume topics next week. Meanwhile,this is the 2^nd part of Stephen Weller’s answer to my letter. To read Part I, click here.

Why isn’t the industry involved in a more pro-active public campaign to disprove the bad science which supports the claims of anti-fragrance lobbies?

We are just getting started. Watch this space. It takes a while for an organization and an industry to gear itself up to communicate on a broad scale when it has not had to in the past. In future you will see much more openness and pro-active communication from IFRA in order to clarify the facts and refute false claims made on the basis of poor science.

Aren’t the EU regulations of REACH, which compel “all manufacturers and importers of chemicals [to] identify and manage risks linked to the substances they manufacture and market”, the real problem?

I think it is important to clarify the regulatory issue here. It is not REACH. The fragrance industry is quite able to deal with the demands of REACH, albeit at a cost. The real issue lies with the Directorate General for Consumer Protection (DG Sanco) and the Scientific Committee for Consumer Safety (SCCS), which I mentioned earlier. It has a stated policy aim to reduce the risks any product poses to EU consumers, including contact dermatitis. Studies have shown that allergies to fragrances affect less than 2% of the population. However, the European Union is committed to ensuring that citizen’s health and safety are properly protected and any risk, it seems is too high. This is the political reality faced by all manufacturers of all products, not just the fragrance industry. Many of the materials we have to address at IFRA are due to a direct request for data from the SCCS. They tell us that there could be a problem with a material and we then have to provide data to support the continued use of that material. This is how it works in the EU. We at IFRA spend our time defending molecules for perfumers.

Several of the natural materials listed in Amendment 43 (or concerned because they contain listed molecules in high proportions) have been used for centuries without, apparently, decimating entire populations. Couldn’t there have been a communications campaign, directed towards political authorities and the general public, on this point? After all, one of the main causes of allergy is hay fever, and no one is campaigning to pull out trees from cities. Contact dermatitis is easier to avoid than breathing in pollen-laden air…

I can assure you that it does not matter to a regulator if a material has been used for centuries, quite happily, without harming anyone. They will regulate based on the current data on a material and the results of a Risk Assessment. Where the data is wrong or incomplete, we at IFRA along with RIFM endeavor to correct it and usually do. We cannot get away from the fact that some fragrance materials, be they natural or synthetic, elicit contact dermatitis in some people. This has to be addressed in order for fragrance to survive at all in the modern regulatory environment.

Some general comments:

You mention that you are not aware of any anti-fragrance campaigns [in my letter, I was referring to the situation in France, and stating that these campaigns seemed to me to be predominantly Anglo-Saxon and Scandinavian], but I can assure you there are many. I do not wish to give oxygen to their campaigns here but I encounter them daily and we do our best to respond. It is not an Anglo-Saxon issue, it is a global issue. A trend beginning in Canada or Norway will soon be seen in France and Australia. Regulations are global now. So is business and so are NGOs. The current debate with the NGO community is based on the argument that Risk-based decisions are not adequate, that we must now regulate using Hazard-based decisions[1]. This approach would mean that water and oxygen would have to be banned since everything is hazardous depending on it use. It seems absurd and in many cases it is, but the concept has political traction.

I would be happy to enter into a dialogue on these subjects. I realize that there are many, many people interested in this subject and I feel that they should have the facts. As you rightly say the problem is the wish for a 'risk-free' society. This is the political reality we face globally. The fragrance industry is doing its best to navigate this regulatory environment and keep as many materials available as possible for the creation of fragrances. The conspiracy theory you mention simply does not make commercial sense. All fragrance houses use synthetic and natural materials. Some are captive and under patent but most are not. The system of patents ensures continued innovation and R&D for new molecules. Without a patented period there would be very little return on investment and thus no incentive to innovate. This is true for most industries not just fragrance.

I hope this has answered your questions.

Regards,

Stephen Weller

Director of Communications

International Fragrance Association (IFRA)

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[1] What’s the difference between “hazard” and “risk”? According to the Aromatics Online website, “The hazard associated with a chemical is its intrinsic ability to cause an adverse effect. Risk is the chance that such effects will occur. For example, whilst a chemical may have hazardous properties, provided it is handled safely under contained conditions, then any risk to human health or the environment will be extremely low.”

Image: Moskene. When you Google it you get nothing but "contact allergy" articles. It is strictly verböten.

Stephen Weller de l’IFRA répond à Grain de Musc (2ème partie)

Je sais : c’est long, c’est aride, et je vous promets de revenir à la question bien plus distrayante des parfums la semaine prochaine… Mais, en attendant, voici la 2^ème partie de la réponse de Stephen Weller, directeur de la communication de l’IFRA. Pour consulter la première, cliquez ici…

Pourquoi l’industrie ne fait-elle pas activement campagne pour réfuter le discours pseudo-scientifique que diffusent les lobbies anti-parfum ?

Nous nous y sommes attelés récemment. Il faut du temps pour qu’une organisation et une industrie se préparent à communiquer à grande échelle lorsqu’elles n’ont pas eu la nécessité de le faire auparavant. À l’avenir, l’IFRA manifestera une plus grande ouverture et communiquera de façon proactive afin de tirer les faits au clair et de réfuter des affirmations erronées fondées sur des erreurs scientifiques.

Qu’en est-il des problèmes posés par la réglementation européenne sur les substances chimiques, REACH qui, je cite « fait porter à l’industrie la responsabilité d’évaluer et de gérer les risques posés par les produits chimiques et de fournir des informations de sécurité adéquates à leurs utilisateurs » ? N’est-ce pas là la principale menace que redoute l’industrie du parfum ?

Il faut faire une mise au point sur les problèmes réglementaires. Il ne s’agit pas de REACH. L’industrie du parfum est tout à fait capable de gérer les exigences de REACH, même si c’est onéreux. Le vrai problème est posé par la Direction Générale "Santé et protection des consommateurs" (DG Sanco) et le Comité Scientifique sur la Sécurité des Consommateurs (CSSC) dont j’ai déjà parlé. Le but de leur politique est de réduire les risques posés par tout produit pour les consommateurs européens, y compris la dermatite de contact. Des études ont démontré que l’allergie aux parfums affecte moins de 2% de la population. Toutefois, l’Union Européenne s’engage à garantir la protection de la santé et de la sécurité de ses citoyens et tout risque reste, semble-t-il, trop élevé. Voilà la réalité politique que doivent affronter tous les fabricants de tous les produits, et pas uniquement l’industrie du parfum. C’est souvent le CSSC qui demande directement à l’IFRA des données sur les matériaux. On nous dit qu’il peut y avoir un problème avec tel matériau : nous devons alors fournir des données permettant de justifier le maintien de son utilisation. Voilà comment ça marche dans l’UE. À l’IFRA, nous passons notre temps à défendre les molécules pour les parfumeurs.

Plusieurs des matériaux naturels figurant dans l’amendement 43 (ou concernés parce qu’ils contiennent de fortes proportions des molécules figurant sur la liste) ont été utilisés depuis des siècles sans, apparemment, décimer des populations entières. N’y aurait-il pas pu avoir une campagne de communication sur ce point, s’adressant aux autorités politiques et au grand public ? Après tout, l’une des manifestations allergiques les plus répandues est le rhume des foins, et personne ne fait campagne pour qu’on abatte les arbres dans les villes. La dermatite de contact est plus facile à éviter que d’inspirer un air chargé de pollen…

Je peux vous assurer qu’il importe peu aux autorités de réglementation qu’un matériau ait été allègrement utilisé pendant des siècles sans faire de mal à personne. Leurs réglementations se fondent sur les données actuelles disponibles sur un matériau et sur les résultats d’une évaluation des risques. Lorsque les données sont erronées ou incomplètes, nous, à l’IFRA, en collaboration avec le RIFM, tentons de rectifier le tir et nous y parvenons en général. Nous ne pouvons pas passer outre le fait que certains matériaux odorants, qu’ils soient naturels ou synthétiques, provoquent des dermatites de contact chez certaines personnes. Il faut aborder ce problème pour que le parfum puisse survivre, sous quelque forme que ce soit, dans l’environnement réglementaire actuel.

Quelques commentaires généraux :

Vous dites que vous n’avez pas eu connaissance de campagnes anti-parfums [S.W. fait référence à un passage de ma lettre où je suppose que ces campagnes sont essentiellement un phénomène anglo-saxon et scandinave], mais je peux vous assurer qu’elles sont nombreuses. Je ne tiens pas à reproduire leurs propos ici mais je m’y affronte tous les jours et nous faisons de notre mieux pour réagir. Il ne s’agit pas d’un problème anglo-saxon, mais mondial. Une tendance née au Canada ou en Norvège se manifestera bientôt en France et en Australie. Aujourd’hui, les réglementations sont mondiales. Tout comme le commerce et les ONG. Pour les ONG, les décisions fondées sur le risque sont insuffisantes : selon elles, nous devons désormais réglementer en fonction du danger[1]. Selon cette logique, il faudrait interdire l’eau et l’oxygène, puisque tout est dangereux, selon la façon dont on l’utilise. Cela peut sembler absurde et ce l’est dans plusieurs cas, mais le concept est porteur sur le plan politique.

Je serais ravi d’entamer un dialogue sur ces sujets. Je sais qu’énormément de personnes s’y intéressent et je pense qu’elles ont droit aux faits. Comme vous le dites très justement, le problème, c’est le désir d’une société « sans risques ». Voilà la réalité politique à laquelle nous nous affrontons quotidiennement. L’industrie du parfum fait de son mieux pour négocier cet environnement réglementaire en maintenant le plus possible de matériaux pour la création des parfums. La théorie de la conspiration que vous citez n’a aucun sens du point de vue commercial. Toutes les maisons de parfum utilisent des matériaux synthétiques et naturels. Certains sont captifs et brevetés, mais la plupart ne le sont pas. Le système des brevets garantit l’innovation et la poursuite de la recherche et du développement de nouvelles molécules. Sans une période au cours de laquelle une molécule est brevetée, il y aurait très peu de retour sur investissement et donc, aucune incitation à l’innovation. Ceci est vrai dans la plupart des industries, et pas seulement de celle du parfum.

J’espère avoir répondu à vos questions.

Cordialement,

Stephen Weller

Directeur de la Communication

International Fragrance Association (IFRA)

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[1] La notion de danger renvoie au potentiel nocif d’une substance ; celle de risque renvoie à la manière dont le danger est géré ou maîtrisé.

Image: l'aldéhyde cinnamique (odeur de cannelle) fait partie des matériaux d'usage restreint par l'IFRA.

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 11^th 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...

STEPHEN WELLER’S ANSWER TO GRAIN DE MUSC

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.