Hungary aims to classify oral care additive sodium chlorite as hazardous

24 Oct 2023 --- The European Chemicals Agency has released Hungary’s proposal to classify sodium chlorite as a potential health and aquatic hazard, a move that could jeopardize the use of this chemical in various products, including oral care items.

Sodium chlorite is currently not subject to regulation under the Cosmetics Regulation or the CLP (Classification, Labelling, and Packaging) Regulation. It is typically used in oral care products like toothpaste and mouthwash.

“Sodium chlorite — an inorganic sodium salt — is often used in whitening products for oral hygiene because it dissolves the colored organic pigmentation that has penetrated the tooth. Currently, the EU Cosmetic Regulation does not foresee any limitation on its use,” shares Obelis Group.

Sodium chlorite’s toxicity and regulatory implications
In a recent evaluation, Hungary determined that sodium chlorite raises concerns regarding acute toxicity, skin corrosion and irritation, eye damage and irritation and repeated dose toxicity. Notably, mutagenicity had already previously been confirmed. Sodium chlorite is harmful to tooth enamel when in the presence of citric acid in a product.

These findings led Hungary to propose that regulatory action at the EU level is necessary, calling for a harmonized classification and labeling of the substance.

Moreover, a study conducted by the Ministry of Environment of Denmark revealed that even a 1% concentration of sodium chlorite can result in mucosal and gum irritation.

The chemical’s effects extend to the liver and nervous system and prove harmful to tooth enamel when in the presence of citric acid in a product, finds the study. However, it is essential to note that neither the agent nor citric acid is currently subject to upper limits under the Cosmetics Regulation.

Proposed harmonized classification
Hungary is spearheading the classification of sodium chlorite based on several factors, including its oxidizing properties, potential to corrode metals and acute toxicity. The proposed classification encompasses:

Ox. Sol. 1 (Hazardous to the Aquatic Environment)

• Met. Corr. 1 (Metals Corrosion)
• Acute Tox. 3 (Acute Toxicity)
• Acute Tox. 2 (Highly Acute Toxicity)
• Skin Corr. 1 (Skin Corrosion)
• Eye Dam. 1 (Eye Damage)
• Muta. 2 (Mutagenicity)
• STOT RE 2 (Specific Target Organ Toxicity)
• Hazardous to the Aquatic Environment

Hungary will be providing information pertaining to the chemical’s physical and human health aspects, while Ireland will address environmental considerations, in this collaborative effort.

In conclusion, Hungary’s initiative to classify sodium chlorite as a potential hazard within the oral care industry could signify a shift in the regulatory landscape. This development underscores the ongoing importance of chemical safety and its impact on various sectors, including personal care and oral hygiene products.

By Venya Patel