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. 2022 Mar-Apr;33(2):52-60.
doi: 10.1590/0103-6440202204522.

Fluoride concentration in toothpaste marketed to children in Brazil and Mexico, and discussion on current regulations

[Article in Portuguese]
Ademir Melo Leite Filho  1 , Astrid Carolina Valdivia-Tapia  1 , Ritta de Cássia Nascimento Pinto Costa  2 , Emilia Valenzuela Espinoza  3 , Antônio Pedro Ricomini Filho  1 , Jaime Aparecido Cury  1
Affiliations

Fluoride concentration in toothpaste marketed to children in Brazil and Mexico, and discussion on current regulations

[Article in Portuguese]
Ademir Melo Leite Filho et al. Braz Dent J. 2022 Mar-Apr.

Abstract
in English, Portuguese

Fluoride toothpastes market to children should contain a minimum concentration of 1000 ppm of fluoride (F), which must be chemically soluble to provide anti-caries effect. Therefore, we determined the concentrations of total fluoride (TF) and total soluble fluoride (TSF) in toothpastes marketed to children in Brazil and Mexico and analyzed the current regulations in force in both countries. Twenty-four brands were found and purchased in Brazil (19 formulated with NaF/SiO2, three with Na2FPO3/CaCO3 and two with Na2FPO3/SiO2) and six in Mexico (all with NaF/SiO2). TF and TSF concentrations were determined after the purchase (fresh samples) but fluoride stability in Na2FPO3/CaCO3-formulations was checked after 18 months. The analyses were performed with an ion-specific electrode and the results expressed in ppm F (mg F/kg). The TF concentrations found ranged from 476.0 to 1385.3 ppm F and they were close the declared by the manufactures (500 to 1450 ppm F). The TF concentrations found were not greater than 1500 ppm F, in accordance with the current regulations of both countries. However, toothpastes presenting TSF concentrations lower than 1000 ppm F were found either in low fluoride toothpaste (500 ppm F) formulated with NaF/SiO2 as in fresh and aged Na2FPO3/CaCO3-toothpastes, originally fabricated with 1000-1100 ppm of TF. In conclusion, although most toothpastes analyzed showed TSF concentration higher than 1000 ppm F, the regulations in force in both countries allow that products not in agreement with the best available evidence are available in the market.

Os dentifrícios fluoretados comercializados para crianças devem conter concentração mínima de 1000 ppm de fluoreto (F), que deve ser quimicamente solúvel para ter efeito anticárie. Portanto, determinamos as concentrações de fluoreto total (FT) e fluoreto solúvel total (FST) em dentifrícios comercializados para crianças no Brasil e no México e analisamos as regulamentações vigentes em ambos os países. Vinte e quatro marcas foram encontradas e adquiridas no Brasil (19 formuladas com NaF/SiO2, três com Na2FPO3/CaCO3 e duas com Na2FPO3/SiO2) e seis no México (todas com NaF/SiO2). As concentrações de FT e FST foram determinadas após a compra (amostras frescas), e a estabilidade do fluoreto nas formulações de Na2FPO3/CaCO3 foi verificada após 18 meses. As análises foram realizadas com eletrodo íon-específico e os resultados expressos em ppm F (mg F/kg). As concentrações de FT encontradas variaram de 476,0 a 1.385,3 ppm F e foram próximas às declaradas pelos fabricantes (500 a 1.450 ppm F). As concentrações de FT encontradas não ultrapassaram 1.500 ppm F, de acordo com as regulamentações vigentes de ambos os países. No entanto, dentifrícios com concentrações de FST inferiores a 1.000 ppm F foram encontrados tanto em dentifrício com baixa concentração (500 ppm F) formulado com NaF/SiO2 como em dentifrícios com Na2FPO3/CaCO3 frescos e envelhecidos, originalmente fabricados com 1.000-1.100 ppm de FT. Em conclusão, embora a maioria dos dentifrícios analisados apresentasse concentração de FST superior a 1.000 ppm F, as regulamentações vigentes em ambos os países permitem que produtos que não estejam de acordo com a melhor evidência disponível estejam presentes no mercado.

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Figures

Figure 1
Figure 1. Concentrations of total fluoride (TF) expected (declared by the manufacturer), total fluoride (TF) and total soluble fluoride (TSF) in toothpastes purchased in Brazil and in Mexico (ppm F). Analyses were performed in Sept-Oct 2019 with fresh samples.
Figure 2
Figure 2. Concentrations of total fluoride (TF) expected (declared by the manufacturer), total fluoride (TF), total soluble fluoride (TSF), FPO3 2- ion, fluoride ion (FI) and percentage of insoluble fluoride (% ins-F) found in Na2FPO3/CaCO3-based toothpastes fresh (2019) and after 18-month storage at room temperature (2021).
See this image and copyright information in PMC

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