The publication followed the previous identification of cholecalciferol an ED during its assessment by the European Chemicals Agency under the Biocides Regulation (EU) No 528/2012.
The decision forms part of a new objective to inform consumers of the presence of disruptors in their purchased products, based on the French AGEC Act on waste reduction and the circular economy.
However, concerns have been raised over the impact of the new labelling requirement and the possible deterring effect it may have on consumer trust and consumption of vitamin D products and supplements amid significant widespread deficiencies.
Vitamin D and endocrine disruption
Unlike other vitamins, vitamin D is a hormone and as such, it acts on the endocrine system. If our intake is too high, the endocrine balance can be disturbed, which can have harmful effects on health. The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) points out that serious effects have already been observed in humans following vitamin D overdose.
Publishing a public opinion against the new regulation, ANSES note that the doses of cholecalciferol used in biocidal products to eradicate rodents are far higher than the doses of vitamin D provided by a normal diet, including foods fortified with vitamin D.
The decree will confirm the presence of vitamin D3 at levels of above 0.1% by product weight, which will be displayed through a specific app named 'Scan4Chem'. The app was developed as part of the EU LIFE AskREACH project to enable consumers to track the presence of harmful substances in their purchased products.
In addition, the statement "Contains the substance Cholecalciferol. This substance has health benefits when used according to the precautions and dosage specified on the package leaflet or product labelling. If in doubt, seek the advice of a health professional." will be displayed on such products above the threshold value of vitamin D.
Potential risk
The IASDA report stresses: “There is concern that this decision may cause consumers to mistrust vitamin D supplementation, which will be particularly problematic given the high prevalence of vitamin D deficiency among the population."
Luca Bucchini, managing director of Hylobates Consulting and vice chair of ESSNA, explains the decision: “Indeed, cholecalciferol, while endogenous and beneficial, does interact with the endocrine system like other important micronutrients such as iodine. And in high doses, it has adverse effects.
“Even after ANSES publicly stated that while formally correct, the listing would be counterproductive, this legal mechanism proved impossible to stop,” he adds.
He emphasises the current prevalence of vitamin D deficiencies in France, with 70% of adults noted to have inadequate intakes in 2019.
Yet, regarding any associated public health concerns following publication, he says that the damage has mostly been mitigated and a negative effect may not be seen, thanks to the ANSES' intervention spurred by nutritionists. This included an array of published reports stressing the importance of vitamin D consumption whilst spreading awareness of the prevalence and associated dangers of deficiencies.
“Though it has created some confusion and conflict with EU law, the effect on consumers is probably likely to be low,” he predicts.