An opinion from the Scientific Committee on Consumer Safety (SCCS) has led the European Commission to consider introducing a ban of nanoforms of Synthetic Amorphous Silica (SAS) for use in cosmetics. However, since SAS is also a key component for most toothpastes using sodium fluoride and toothpaste is governed under the policies for the manufacture and use of cosmetics in Europe – it directly impacts the most commonly used anti-caries ingredient. The ramifications of this potential ban is immense as it could impact the affordability and availability of fluoride toothpastes resulting in an increase in caries and significant decline in oral health throughout Europe.
IADR engaged with The Platform for Better Oral Health in Europe to submit a dual-faceted report that addresses the need for further research into the health effects from oral exposure to SAS and the adverse public health effects of a potential ban on SAS. IADR emphasized that based on published physio-chemical, ecotoxicological, toxicology, safety, and epidemiology data, SAS is essentially non-toxic in humans via the oral route of exposure if produced and used under current hygiene standards and use recommendations. Although very little data exists concerning systemic effects in humans, animal studies and experience (use of untreated SAS as a direct food additive) indicates that no oral toxicity is expected. IADR supported further research that differentiated amongst a). oral exposure to SAS due to ingestion in food formulations, b). oral exposure during brief periods (≤2 minutes) where a marked portion of SAS is expectorated e.g. toothpaste and c). dermal exposure e.g. cosmetics on skin. To provide further definition, IADR noted the importance of that studies that discern the risk of oral exposure to SAS during brushing, also consider that a small fraction of SAS will be ingested, especially in children, and some toothpaste remains in the oral cavity for a longer period after expectoration.