SCCS published a clarification opinion on October 10, 2011 where they concluded as follows:
For general cosmetic products containing parabens, excluding specific products for the nappy area, the SCCS considers that there is no safety concern in children (any age group) as the MOS was based on very conservative assumptions, both with regards to toxicity and exposure. The risk assessment in opinion SCCS/1348/10 was carried out for the most lipophilic compound, butylparaben, using the very low NOEL value of 2 mg/kg bw/day in juvenile rats, a high dermal absorption value of 3.7% and a cumulative human exposure value of 17.4 g/day to cosmetic products containing lipophilic parabens. This approach is confirmed to be very conservative by recent human biomonitoring data from Europe and the United States ( for adults and children above 6 years) suggesting that systemic exposure doses are considerably lower than estimated in the paraben opinion.
In the case of children below the age of 6 months, and with respect to parabens present in leave-on cosmetic products designed for application on the nappy area, a risk cannot be excluded in the light of both the immature metabolism and the possibly damaged skin in this area. Based on a worst case assumption of exposure, safety concerns might be raised. Given the presently available data, it is not possible to perform a realistic quantitative risk assessment for children in the pertinent age group as information on internal exposure in children is lacking.
Scientifically sound data on the pivotal link between dermal absorption in rats and humans, in particular with regard to the metabolism of the parent parabens in the skin and specific exposure information for cosmetic products used for children would allow a refinement of the above assessment.
With regard to pregnant women, the unborn foetus will be better protected than the neonate/newborn or early infant exposed dermally to parabens by the more efficient systemic parabens inactivation by the mother.