The Food and Drug Administration (FDA) yesterday said it would place limits on the use of the preservatives methylisothiazolinone (MI) and a mixture of methylchloroisothiazolinone and methylisothiazolinone (MCI/MI), following a media report questioning athe absence of a standard in the country compared with long-established restrictions in the EU, the US and Japan.
The report cited a study released at the British Association of Dermatologists’ Annual Conference in July, which pointed out that an epidemic of contact allergy to MI and MCI/MI may be on the horizon.
According to the study, the sensitization rate to MCI/MI remains at a high prevalence of about 2 percent. This is even after “the maximum concentrations of 7.5 and 15 ppm for leave-on and rinse-off products, respectively, were recommended” in the wake of “a European ‘epidemic’ of contact dermatitis caused by MCI/MI” when sensitization rates rose to 5 percent.
FDA official Yeh Meng-yi (葉孟宜) said that maximum concentrations of MI and MCI/MI are scheduled to be announced. The preliminary conclusion of the expert meeting on the matter is that the limits should be set at 0.01 percent (100ppm) for MI and 0.0015 percent (15ppm) for MCI/MI.
“MI will not be allowed at all in products that come into contact with mucous membranes, and the maximum concentration of MCI/MI for rinse-off products will be set at 0.1 percent [1,000ppm],” Yeh said, adding that the regulations have been discussed and proposed in accordance with those of the EU.
When it was pointed out that the European Commission is now planning to restrict the use of MCI/MI to rinse-off products, which have been restricted to a maximum MCI/MI concentration of 0.0015 percent, Yeh acknowledged that the EU’s standard is stricter, but added that the limits made public in response to the media report have not yet been finalized as further discussions will be carried out and experts’ opinions solicited.