News Details
ECHA RAC Classifies Essential Oil Fragrances as Reproductive Toxicants: Burgeonal and Cyclamal Under Scrutiny
On 5 December 2024, ECHA's Risk Assessment Committee (RAC) published its meeting highlights and adopted changes to the list of chemicals. The discussion decided that two groups of essential oil fragrances should be classified as category 1B reproductive toxicants under the EU’s Classification, Labelling, and Packaging (CLP) Regulation.
Burgeonal and Cyclamal Groups Classified as Reprotoxic 1B Under CLP Regulation
The RAC opinions are based on two proposals for fragrance substances: one for Burgeonal compounds and the other for Cyclamal compounds. Both are widely used as fragrances in personal care, cleaning, and consumer products. The classification reflects concerns about their potential to impair fertility or harm the unborn child.
Industry Concerns over RAC’s Classification of Essential Oil Compounds
The European Federation of Essential Oils warned that the classification could potentially lead to some essential oils being classified as Reprotoxic 1B, potentially stopping their use in cosmetics and consumer products. The industry also argued that reproductive toxicity observed in laboratory animals does not apply to humans, as seen in a similar classification proposed for tea tree oil.
Details of RAC's Decisions on Burgeonal and Cyclamal Groups
ECHA’s Risk Assessment Committee has accepted the proposed changes to the essential oil classification that specify the potential reproductive toxicity under the CLP Regulation. The list of accepted changes is listed below:
|
Substance |
Uses |
Proposal by Dossier Submission |
RAC Opinion |
|
Burgeonal group |
All substances included in this proposal are used as fragrances/perfumes or for masking. |
To keep the entry for 2-(4-tert-butylbenzyl) propionaldehyde. To add Repr. 2; H361d (suspected of damaging the unborn child) for 4- tert-butylbenzoic acid. To classify the remaining group of substances as Repr. 1B; H360Fd (may damage fertility, suspected of damaging the unborn child). To add Note on additivity. |
RAC agreed to the proposal by Sweden. |
|
Cycalmal Group |
3-p-cumenyl-2-methylpropioaldehyde is used as a fragrance in a wide range of products. The uses include cosmetics, cleaning and washing agents, polishes and wax blends, rinsing agents for textiles, personal care products (deodorants), air care products, etc |
To add Repr. 1B; H360FD (may damage fertility, may damage the unborn child) for substance a. To classify b as Repr. 1B; H360FD (may damage fertility, may damage the unborn child). To add a Note on additivity. |
RAC agreed to Sweden's proposal for cyclamal. However, RAC agreed on Repr. 1B; H360Fd for the other substances from the group |
For further details, refer to the RAC Meeting highlights in the Annex
We acknowledge that the above information has been compiled from European Chemical Agency.
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