EC Restricts Use of Propylparaben, Butylparaben and MCI/MI

The European Commision has adopted two measures restricting the use of butylparaben, propylparaben and methylchloroisothiazolinone (and) methylisothiazolinone in cosmetic products. This decision follows an assessment by the independent Scientific Committee on Consumer Safety (SCCS), and both amendments alter Article V of EU Regulation 1223/2009 (Cosmetics Regulation).

As part of Commission Regulation (EU) No. 1004/2014, an amendment published on Sept. 18, 2014, propylparaben and butylparaben are now capped at a 0.14% maximum when used individually or together. Previously, the allowed limit was 0.4% for these two preservatives when used individually and 0.8% when mixed with other esters. They are being banned from leave-on products designed for the diaper area of young children below the age of thre,e since existing skin irritation and occlusion may allow increased penetration than intact skin. The new standards for propylparaben and butylparaben will be enforced for products starting Apr. 16, 2015.

Also, as part of Commission Regulation (EU) No. 1003/2014, an amendment published on Sept. 18, 2014, the mixture of methylchloroisothiazolinone (and) methylisothiazolinone (MCI/MI) will be banned from leave-on products. The measure is aimed at reducing the risk from and the incidence of skin allergies. The preservative can still be used in rinse-off products at a maximum concentration of 0.0015 % of a mixture in the ratio 3:1 of MCI/MI. The measure will apply for products on July 16, 2015.

The EC noted that many parabens are safe, effective preservatives. The EC previously banned the use of  isopropylparaben, isobutylparaben, phenylparaben, benzylparaben and pentylparaben due to the lack of data necessary for reassessment.