Document Type
Oral Presentation
Location
Oxford Conference Center
Event Website
https://oxfordicsb.org/
Start Date
22-4-2026 1:40 PM
End Date
22-4-2026 2:00 PM
Description
The ongoing revision of the EU Classification, Labelling and Packaging (CLP) Regulation represents a critical development for the essential oil industry. A provisional derogation has been introduced for plant-derived, non-chemically modified Multi-Constituent Substances (MOCS), including essential oils, following sustained advocacy efforts. However, the European Commission is required to deliver, by the end of 2029, a scientific report reassessing the validity of this derogation based on scientifically and regulatorily accepted safety evaluation approaches. In the absence of such a derogation, essential oils could be classified solely on the basis of individual constituents exceeding regulatory thresholds, irrespective of the whole oil safety and real-world use and exposure. The outcome of this assessment will therefore play a decisive role in shaping the future regulatory framework for essential oils in the EU.
In parallel, there is a growing trend toward hazard-based classification of whole substances as CMR category 1B. Current discussions concerning tea tree essential oil, which is facing a proposed classification as a category 1B reproductive toxicant, exemplify this regulatory pressure. Application of a whole-substance, hazard-driven approach could result in severe restrictions or bans on essential oils in cosmetic applications, with significant consequences for the natural cosmetics sector and other industries that rely on natural ingredients.
Industry and scientific organizations stress the importance of distinguishing hazard-based from risk-based safety and regulatory evaluations. Hazard classifications derived from high-dose rodent studies using oral gavage or dietary administration are not representative of typical human exposure to essential oils, which predominantly occurs via dermal application at low concentrations. Moreover, decades of widespread use of tea tree essential oil have not yielded epidemiological evidence of reproductive toxicity in humans. Key scientific challenges include interspecies differences in metabolism, the relevance of exposure routes in combination with high doses, and the interpretation of toxicological endpoints for natural complex substances.
Continued, coordinated engagement between industry and scientific organizations is therefore essential to generate robust, relevant data and to support proportionate regulatory decisions grounded in sound science. The ongoing revision of the EU Classification, Labelling and Packaging (CLP) Regulation represents a critical development for the essential oil industry. A provisional derogation has been introduced for plant-derived, non-chemically modified Multi-Constituent Substances (MOCS), including essential oils, following sustained advocacy efforts. However, the European Commission is required to deliver, by the end of 2029, a scientific report reassessing the validity of this derogation based on scientifically and regulatorily accepted safety evaluation approaches. In the absence of such a derogation, essential oils could be classified solely on the basis of individual constituents exceeding regulatory thresholds, irrespective of the whole oil safety and real-world use and exposure. The outcome of this assessment will therefore play a decisive role in shaping the future regulatory framework for essential oils in the EU.
In parallel, there is a growing trend toward hazard-based classification of whole substances as CMR category 1B. Current discussions concerning tea tree essential oil, which is facing a proposed classification as a category 1B reproductive toxicant, exemplify this regulatory pressure. Application of a whole-substance, hazard-driven approach could result in severe restrictions or bans on essential oils in cosmetic applications, with significant consequences for the natural cosmetics sector and other industries that rely on natural ingredients.
Industry and scientific organizations stress the importance of distinguishing hazard-based from risk-based safety and regulatory evaluations. Hazard classifications derived from high-dose rodent studies using oral gavage or dietary administration are not representative of typical human exposure to essential oils, which predominantly occurs via dermal application at low concentrations. Moreover, decades of widespread use of tea tree essential oil have not yielded epidemiological evidence of reproductive toxicity in humans. Key scientific challenges include interspecies differences in metabolism, the relevance of exposure routes in combination with high doses, and the interpretation of toxicological endpoints for natural complex substances.
Continued, coordinated engagement between industry and scientific organizations is therefore essential to generate robust, relevant data and to support proportionate regulatory decisions grounded in sound science.
Recommended Citation
Bascoul, Cecile; Carter, Dakota; Dawson, Joseph; Valentiner, Tim; and Osguthorpe, Russell J., "Hazard vs Risk: Scientific Considerations on the EU CLP Approach to MOCS and Whole Essential Oil Classification with Tea Tree Essential Oil as an Illustrative Example" (2026). Oxford ICSB. 27.
https://egrove.olemiss.edu/icsb/2026_ICSB/Schedule/27
Publication Date
April 2026
Accessibility Status
Screen reader accessible, Searchable text
Included in
Hazard vs Risk: Scientific Considerations on the EU CLP Approach to MOCS and Whole Essential Oil Classification with Tea Tree Essential Oil as an Illustrative Example
Oxford Conference Center
The ongoing revision of the EU Classification, Labelling and Packaging (CLP) Regulation represents a critical development for the essential oil industry. A provisional derogation has been introduced for plant-derived, non-chemically modified Multi-Constituent Substances (MOCS), including essential oils, following sustained advocacy efforts. However, the European Commission is required to deliver, by the end of 2029, a scientific report reassessing the validity of this derogation based on scientifically and regulatorily accepted safety evaluation approaches. In the absence of such a derogation, essential oils could be classified solely on the basis of individual constituents exceeding regulatory thresholds, irrespective of the whole oil safety and real-world use and exposure. The outcome of this assessment will therefore play a decisive role in shaping the future regulatory framework for essential oils in the EU.
In parallel, there is a growing trend toward hazard-based classification of whole substances as CMR category 1B. Current discussions concerning tea tree essential oil, which is facing a proposed classification as a category 1B reproductive toxicant, exemplify this regulatory pressure. Application of a whole-substance, hazard-driven approach could result in severe restrictions or bans on essential oils in cosmetic applications, with significant consequences for the natural cosmetics sector and other industries that rely on natural ingredients.
Industry and scientific organizations stress the importance of distinguishing hazard-based from risk-based safety and regulatory evaluations. Hazard classifications derived from high-dose rodent studies using oral gavage or dietary administration are not representative of typical human exposure to essential oils, which predominantly occurs via dermal application at low concentrations. Moreover, decades of widespread use of tea tree essential oil have not yielded epidemiological evidence of reproductive toxicity in humans. Key scientific challenges include interspecies differences in metabolism, the relevance of exposure routes in combination with high doses, and the interpretation of toxicological endpoints for natural complex substances.
Continued, coordinated engagement between industry and scientific organizations is therefore essential to generate robust, relevant data and to support proportionate regulatory decisions grounded in sound science. The ongoing revision of the EU Classification, Labelling and Packaging (CLP) Regulation represents a critical development for the essential oil industry. A provisional derogation has been introduced for plant-derived, non-chemically modified Multi-Constituent Substances (MOCS), including essential oils, following sustained advocacy efforts. However, the European Commission is required to deliver, by the end of 2029, a scientific report reassessing the validity of this derogation based on scientifically and regulatorily accepted safety evaluation approaches. In the absence of such a derogation, essential oils could be classified solely on the basis of individual constituents exceeding regulatory thresholds, irrespective of the whole oil safety and real-world use and exposure. The outcome of this assessment will therefore play a decisive role in shaping the future regulatory framework for essential oils in the EU.
In parallel, there is a growing trend toward hazard-based classification of whole substances as CMR category 1B. Current discussions concerning tea tree essential oil, which is facing a proposed classification as a category 1B reproductive toxicant, exemplify this regulatory pressure. Application of a whole-substance, hazard-driven approach could result in severe restrictions or bans on essential oils in cosmetic applications, with significant consequences for the natural cosmetics sector and other industries that rely on natural ingredients.
Industry and scientific organizations stress the importance of distinguishing hazard-based from risk-based safety and regulatory evaluations. Hazard classifications derived from high-dose rodent studies using oral gavage or dietary administration are not representative of typical human exposure to essential oils, which predominantly occurs via dermal application at low concentrations. Moreover, decades of widespread use of tea tree essential oil have not yielded epidemiological evidence of reproductive toxicity in humans. Key scientific challenges include interspecies differences in metabolism, the relevance of exposure routes in combination with high doses, and the interpretation of toxicological endpoints for natural complex substances.
Continued, coordinated engagement between industry and scientific organizations is therefore essential to generate robust, relevant data and to support proportionate regulatory decisions grounded in sound science.
https://egrove.olemiss.edu/icsb/2026_ICSB/Schedule/27
Comments
Cécile Bascoul, Ph.D., is Director of Product Safety at dōTERRA, where she leads the company's safety strategies for essential oil-based dietary supplements and cosmetic products. With nearly 20 years of experience across academia and the pharmaceutical, cosmetic, and nutraceutical industries, she specializes in the safety evaluation of natural complex substances. Dr. Bascoul actively contributes to advancing botanical safety science through her engagement with international scientific, industry, and regulatory initiatives, collaborating across sectors to strengthen safety assessment approaches. Her work focuses on integrating toxicological principles with real-world evidence to enable responsible innovation and improve safety frameworks for botanicals and essential oils.