Discussions between authorities and producers on the market take on a new dimension
A constructive exchange between authorities, experts and marketers, fuelled by the latest scientific advances, marked this 4ème edition of the Aromadays congress.
During 2 days, 150 congressmen, actors of the essential oils sector, attended the presentation of the results of the last scientific studies which came to "shake up" the project of the European Commission to introduce, in the revision of the CLP regulation, the principle of Mocs (More than One Constituent Substances) for the classification and the labeling of the substances of more than one constituent, considering that complex substances have the same "behavior" as mixtures.
The central question of the exchanges was whether the main component has the same toxicological profile as the whole oil?
In this context, the new h-Placentox test, invented by the CNRS team of Professor and researcher Patrice Rat, to assess the endocrine disrupting effects of substances, is robust, innovative and predictive.
First of all, he rehabilitates lavender essential oil, which has been the subject of much media controversy in recent years, by attributing hormone modulating effects to it, but without observing any deleterious effects on the placenta, unlike all the proven endocrine disruptors (bisphenol A, phthalates, etc.) that have been tested in parallel and that induce placental alterations. In addition, the work shows that " some constituents quantified at more than 80% in some essential oils do not have the same toxicological profile when evaluated alone or when studied in the overall essential oil at the same concentration"..
This test was ranked 1er on 256 international tests by the European Pepper platform for the assessment of endocrine disruptors and is undergoing international OECD validation.
The 3 years of research by Dr. Sophie Fouyet, Yslab and Mathilde Hagege, Léa Nature, with Pr RAT's team demonstrating the TOTUM effect of Essential Oils, confirm the results of hormonal modulation but without deleterious placental effects for all the essential oils tested (Tea Tree, Lavender, Ylang Ylang, Wintergreen, Niaouli, Orange).
This work also demonstrates that drom a toxicological point of view, a constituent, even a majority one, is not representative of the essential oil as a whole. For example, the oil
Orange essential oil containing 95% of limonene does not have the same hormonal modulating effects as limonene alone tested at the same concentrations.
The European Commission, represented at the congress by Dr. Sylvain Bintein of the DG Environment, suggested an opportunity: derogations, applicable to complex substances, could be submitted by the industry to the European Commission, with a scientific and robust technical file, demonstrating the safety of the essential oil as a whole. This dossier would be forwarded to Echa's Risk Assessment Committee. On the basis of a positive opinion, a specific provision introduced in Annex 1 of the CLP Regulation through a delegated act would allow to obtain this derogation.
Given the investment that the production of relevant scientific evidence could represent for SMEs, Cosmed, in the context of this exchange, has requested that the criteria for analyzing exemption files be communicated in advance.
