Evaluation of erosive potential

Products suspected of having an erosive potential on dental hard tissue by virtue of their acidic components must be tested as follows. An aqueous solution of the product is made (1 g/15 ml distilled water) and its pH is measured. If the pH-value is below 5.7 or if it is impossible to make an aqueous solution of the product, the following in vivo test must be performed.

Parallel or in addition to the measurement of interdental plaque pH, the pH of oral fluid is recorded during and for at least 15 minutes after consumption of the product using a clean (i.e., plaque-free) electrode. This electrode must either be placed on the buccal surface of either the maxillary canine or first premolar, or it is facing an interproxinal space (i.e., is identical with the electrode used for plaque-pH measurement).

For the in vivo test, each product must be tested in at least two volunteers. The results of the measurements must be adequately documented.

A product is regarded as not presenting a significant erosive potential if

the interdental plaque pH does not fall below 5.7, and the acid exposure of the plaque-free electrode does not exceed 40mmol H+ x min, established by calculating the area under the curve [acid concentration (in micromols H+) x time (in minutes)]. (This value is equivalent to the exposure to a solution of pH 5 for 4 minutes).