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Background facts

As a follow-up to the article NUNII published mid-May of this year, and entitled “NUNII takes proactive measures to avoid endocrine disruptors (or EDCs : endocrine-disrupting chemicals) in its products”, we felt that it would be worth while to address this subject in more depth with an industry specialist.

With this aim in mind NUNII LABORATOIRE conducted an interview with the respected French expert Mr Franck CHUZEL, Toxicologist and who holds a Ph.D. in endocrinology. Mr CHUZEL has managed research projects as well as toxicology risk evaluation department for numerous leading multinationals, in Life Science industries. Building on his experience Franck CHUZEL founded LifeScientis in 2015, a biotech company, with the aim of addressing two major issues of these industries: ensuring the effectiveness of products placed on the market and the safety of users.

His company offers a strategic and operational support in the identification of the hazard and the evaluation of the toxicological risk, in particular on Endocrine Disruptors (EDC’s). On the other hand, its R & D team, based on soft chemistry methods, develops solutions for encapsulating compounds (active agents, ingredients, etc.) to propose alternatives in these fields. The Safety aspect is thus included throughout the entire value chain of the company.

On the research side, LifeScientis has developed partnerships with the CNRS (French National Center for Scientific Research), the University of Nice Sophia-Antipolis and the French “Maison de la Chimie”, a Parisian institution studying chemicals.

He has been studying EDCs for the past 20 years, and as direct result of his extensive experience, he has been mandated to provide professional opinions for the OECD and the European Commission and as lecturer on the matter of EDCs during several years.

Danger versus Risk : 2 drastically different notions

Mr CHUZEL, you have extensively debated on the difference there is between hazard and risk in your numerous releases or lectures : Would you mind explaining this difference ?

Well, people – and often the media, and translators – confuse the notions of Hazard with that of Risk in global health issues. Perhaps these notions have not been very well explained. Hazard is the ability to create harmful effects, whereas risk is the combination of hazard and exposure to that hazard.

Let me take a very simple example to explain the difference. We understand that danger is everywhere ; when for example at time tiles can be heard falling down from the roof causing skull fracture, this is the hazard. Risk, however, isn’t the same : depending on whether there is no wind, or the day is extremely windy, the hazard is the same, but the risk is going to vary. Thus, even in the presence of a great hazard, the risk can be low. In our example, how to deal with this risk ? It is recommended to not go out when there is a very strong wind.

As far as endocrine disruptors are concerned, and perhaps even more so, it is this difference between hazard and risk which is very important and one of the keys to the debate. This is most certainly related to the complexity of the regulatory mechanisms involved in the endocrine area that makes their study and risk assessment trickier.

The key to the mastery of EDCs is risk management, and ultimately, risk mastering. Our job is to point out what hazards there may be, in terms of product safety in relationship to the use of EDCs, and what risk is there too ; this then allows consumers to make an informed decision.

Besides, every individual has a different notion of what risk actually is. Again, a revealing example of this approach is the publicized case of Angelina Jolie who decided a few years ago to have a global mastectomy when she discovered that she had a genetically gene deficiency which could have led her to POTENTIALLY develop breast cancer in her later years. This is neither a good nor a bad decision, we do not have to judge, it is her decision which concerns only her. However, you understand that we are dealing with issues that are largely and intimately related to ourselves as an individual, our personality, our history and our fears whether they are conscious or unconscious elsewhere. What is required today from industrialists, regulatory authorities and toxicologists by all consumers and patients is to extrapolate this risk for the greatest number, whereas this notion remains profoundly individual. It is therefore essential to explain and communicate on these aspects.

EDCs today : efficient communication to educate

So you are saying that today’s debate on EDCs is first and foremost a matter of communication ?

Yes, it is also a communication issue, because not only the perception of risk has greatly evolved in recent years, but also the acceptance of this risk. Especially because there is an important and very varied communication on these aspects. One of the big reasons – whether we agree or disagree with that – has been the questioning of a bipolar functioning between those in the know how – the white coat for the researcher and the doctor or industrialist, regulatory authorities – and on the other side those not in the know how – patients, consumers, users. Nowadays, there is communication difficulty on the part of manufacturers and product makers. And the root of the problem is that the professionals with the expertise on EDCs do not know how to communicate it to the general public. This bipolar mode of functioning creates unease among the citizens who have the impression of not being in control of their choices as consumers, the impression of not been given the full facts, that information is hidden (voluntarily or involuntarily), a lack of understanding and also the sentiment of not having all the information on hand to make an informed decision, and as a consequence there is a growing level of distrust amongst consumers. The digital revolution and the new mode of information communications tools have completely shaken up this system and created a multipolar world with a myriad of actors, each with very different stand points. Thus, today, people ask even more questions because the information is on the one hand more easily available but also superabundant. People are therefore disoriented and yet feel neither protected nor reassured, not knowing who to refer to. They are worried about the perceived power of lobbying, and in the end, consumers do not know who to believe anymore. We must therefore help to distinguish the true from the false, fact or fiction.

In my opinion, the problem to be solved is : “How to restore the trust contract between manufacturers and consumers ? ” We must be able to abandon complex and obscure information that can be decrypted only by professionals and create the means to meet the expectations of consumers through open communication and education. But be careful, simplifying does not mean caricaturing the information. This is the challenge in general, but especially when it comes to EDCs. Citizens therefore need to be helped to distinguish fact from fiction.

Manufacturers now need to take a stand

This means that a true revolution in mentalities needs to take place among manufacturers today ?

Well, in a way, that is true, but not only. Manufacturers are faced with 2 options : either they stick their heads in the sand and take shelter behind current EDC regulation, or they decide to take this issue proactively and alter their corporate behaviour accordingly, in order to reduce and ultimately control risk caused by EDCs. In my view, manufacturers have no other alternative but to position themselves with risk reduction and control : NUNII Laboratoire, for example, has taken the conscious decision to act on this issue from its foundations in its use of EDCs.

In my opinion, this is the way of the future, the industry has no other choice for the future. Manufacturers must position themselves and personally, I am convinced that whoever chooses not to question these aspects will suffer and will not survive long term. On the other hand, those who understand the issue of EDC’s and who seek solutions to these issues, will differentiate themselves in the long term and come out ahead of their competitors. For example, some luxury companies have already made the change and their suppliers are adapting. In addition, large industrial groups will soon make their toxicology records open to the public, to avoid the unspoken and possible extrapolations. These large groups are now moving the lines and hence are sending a strong signal to the market in general that the time for change is now. But like all industries, resistance to change is strong and it will take time for all players to follow suit.

The issue of EDCs makes us realize that toxicological information plays a fundamental role in the identification, characterization of hazard and risk management. Thus, from a toxicological point of view, it is also true that even if there are standardized processes for assessing the risk of a new technology, a new treatment or a new product, assumptions will ALWAYS be necessary in the face of UNCERTAINTY inherent to the asked questions. This is often because the information needed for the risk assessment is required BEFORE adequate information is available. This is particularly true for EDCs with, for example, legitimate questions about long-term effects or possible “cocktail” effects. However, stopping everything in the absence of definitive information is not necessarily desirable, since lack of action can also have major consequences, particularly in the health field. This is the issue of current debates, which should not be overlooked or underestimated.

One certainty today is that we will be confronted with these questions as citizens regardless of our status (industrial or not). Because the decision to use or not compounds with enormous potential in well-being and health, remains and will remain based on uncertainty. It is up to us, in all interdisciplinarity, to continue to put in place the initiatives allowing us to always better identify the hazards, to evaluate them, and to master the risks. It’s also up to us to continue inventing and putting in place the alternatives of tomorrow.

Yes, undoubtfully, the manufacturers have a major role to play, but they cannot be isolated. It is also all the players who will have to position themselves so that all initiatives are supported and valued to face these issues collaboratively. The challenge lies here.

Hope is around the corner

Yes, because questions posed by EDCs challenge our thoughts and force us to reconsider our models. The hope is that this pushes us to think even more across multi disciplines to integrate these technological approaches with their ethical, legal and societal impacts. This transdisciplinary approach exists but it must be encouraged and developed more.  EDCs, provide a unique opportunity to rethink the use of our scientific, industrial and regulatory knowledge by integrating more societal involvement, communication and exchanges.

Will we succeed ? I think so, because the flood gates have already been opened, but as the legend of the Native American Indian Hummingbird teaches, us each actor must play their part no matter how small.