In a guest column published on March 19, 2019 by regulatory news provider Chemical Watch, Paul Ashford, managing director of consulting firm Caleb Management Services, discussed the latest developments in the regulation of resorcinol (CAS 108-46-3). This chemical is used in rubber and plastics industries and is also authorized for use in food contact plastics. It has been listed in the Community Rolling Action Plan (CoRAP) for 2019-2021 to be evaluated by France as a “potential endocrine disruptor” with “high aggregated tonnage,” as adopted on March 19, 2019 (FPF reported).

Ashford criticized this development, pointing out that resorcinol has already been evaluated by Finland, with evaluation officially concluded in 2017 and a Risk Management Optional Analysis (RMOA) published in 2018. However, this assessment was then “challenged at recent Member State Committee meetings,” eventually resulting in France “intervening” to take over the re-evaluation task. Ashford ascribed this to the lack of “a formal consensus process on the content of substance evaluation reports” in the REACH procedures.

Ashford explained that resorcinol “has been known as a thyroid-active substance” since its use in topical ointment formulations, in concentrations “greater than 25%.” Some patients applying these ointments to open wounds were observed to develop a goiter (a swelling of the thyroid gland), which was, however, reversible. Later, it has been demonstrated that “resorcinol acts as a thyroid-active substance through a thyroid peroxidase (TPO) mode of action.” However, no other human exposure situations have been observed to result in an effect comparable to the induction of goiters following application to injured skin, because direct exposure through bloodstream appears to be absolutely critical to development of any thyroid effects.

Summarizing research carried out by the industry-managed Resorcinol Task Force, Ashford concluded that there are no real data gaps remaining in the resorcinol dossier, apart from the need “to consider any potential effect on amphibians.” Although “adverse environmental impacts were not expected to be an issue of any significance” due to the ready biodegradability and low environmental release of the substance, the Task Force would have been willing to fund a study of this endpoint once “an agreement amongst regulators about the selection of appropriate test methods” emerges. Ashford commented, however, that “it is not clear whether the intent of the French intervention is to trigger the filling of this particular data gap.” He further said that “member states should not have the ability to re-open substance evaluations on grounds which are self-evidently unclear and seemingly subjective” and requested that France provides “further publicly-scrutinized arguments to support its case.”

Read more

Paul Ashford (March 19, 2019). “Guest Column: Resorcinol faces the latest in a long line of regulatory challenges.Chemical Watch

Emma Davies (February 14, 2019). “ECHA considers reopening concluded REACH evaluation in ‘exceptional’ move.Chemical Watch