ANSES carries out expert assessments on the dangerousness and risks of chemical substances under the REACH regulation and, in this context, proposes appropriate management measures. This regulation provides that substances with manifest endocrine disrupting properties can be identified as being of very high concern (Substance of Very High Concern – SVHC). As part of the National Strategy on Endocrine Disruptors (SNPE) deployed by France, the Agency assesses substances that potentially have harmful effects on endocrine systems. The effect of resorcinol on thyroid hormone synthesis was examined in this setting.
Serious and worrying effects on human health
On the basis of the experimental and clinical data available, the ANSES experts have established that this substance meets all the hazard criteria necessary to be defined as an endocrine disruptor according to the WHO criteria and the 2013 recommendations of the European Commissionto know :
- an endocrine mode of action: strong evidence for an effect of resorcinol on the regulation of thyroid hormone concentration via the inhibition of an enzyme essential to their biosynthesis;
- adverse health effects: identification of severe hypothyroidism during clinical observations following significant drug exposure to this substance by the cutaneous route in humans (goiter, loss of energy, generalized edema, weight gain, depression in some cases) ; Induction of thyroid effects in experimental tests by different routes of exposure;
- a biologically plausible link between the mode of action and the adverse effects: consistency between the inhibiting action of resorcinol and the severe hypothyroidism observed.
Thus, the evidence having been established in humans, ANSES concludes that resorcinol is a proven endocrine disruptor.
Due to this property, resorcinol raises concerns as exposure to this substance can lead to severe health effects. Indeed, this substance might, depending on the exposure conditions, trigger or aggravate hypothyroidism. Furthermore, even mild hypothyroidism in pregnant women can cause irreversible neurodevelopmental disorders in the unborn child. In addition, it is difficult to establish a safe exposure dose, particularly in sensitive populations such as those with latent hypothyroidism or during critical periods of fetal development, for example.
For these reasons, ANSES considers that the endocrine disrupting properties of resorcinol present a sufficient level of concern to meet the criteria for identification as a substance of very high concern (SVHC) according to the provisions of the European REACH regulation.
The identification dossier, proposed by ANSES, is in public consultation on the website of the European Chemicals Agency (ECHA) until April 17. Link to file: echa.europa.eu/documents/10162/53d2eb0e-b0e8-fabb-b4b0-a56c246cb0a3
The consequences of being identified as a Substance of Very High Concern
If identified as an SVHC, resorcinol will be included in the candidate list for authorization under REACH. This procedure implies the obligation for industry to notify ECHA of the presence of the substance in manufactured or imported articles containing resorcinol at more than 0.1%. SVHC identification also opens up the possibility of inclusion of resorcinol in Annex XIV of the REACH regulation, which subjects certain uses to temporary and renewable authorisation, leading to strict control of its use in Europe and encouraging the substitution of the substance.
Additional investigations underway for the environment
The endocrine disrupting properties of resorcinol might also have environmental consequences. Thus, ANSES is also carrying out an assessment of the potential harmful effects for species in the environment.