MIL-OSI Europe: Written question – Potential harmonised classification of sodium fluoride and its impact on oral health in the EU – E-002751/2025

Source: European Parliament

Question for written answer  E-002751/2025
to the Commission
Rule 144
Dimitris Tsiodras (PPE)

The World Health Organization (WHO) recognises that ensuring access to affordable fluoride toothpaste is a key public health measure for reducing tooth decay across the population.

The French health and safety agency has recently proposed a harmonised classification of sodium fluoride as a category 1 material for its reproductive toxicity and endocrine-disrupting properties.

If confirmed, this classification would automatically prohibit the use of sodium fluoride in cosmetic products such as toothpastes and mouthwashes, unless an exemption is granted under Article 15 of the Cosmetic Products Regulation[1].

This would significantly restrict EU consumers’ access to essential oral-care products that are widely recognised by scientists, healthcare professionals and public health authorities worldwide as both safe and effective.

  • 1.In the event that fluoride toothpastes cease to be available in the EU, what public health measures is the Commission considering to prevent the potential increase in dental caries among the EU population?
  • 2.How does the Commission assess the potential loss of competitiveness and jobs in the EU’s oral care industry, especially among small and medium-sized enterprises, in comparison to global competitors, and what support measures are being planned for companies and workers affected by this proposed classification?

Submitted: 7.7.2025

  • [1] Regulation (EC) No 1223/2009 of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj).
Last updated: 14 July 2025

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