SCCS takes another look at propyl- and butylparaben and rules them safe again
Parabens are currently permitted as preservatives in the EU's Cosmetics Directive at a maximum concentration of 0.4 per cent when used individually or 0.8 per cent when used as a mixture of esters.
Since 2005, the substances have been assessed by the Commitee on a number of occasions. In March 2011, the SCCS considered that methylparaben and ethylparaben were safe, when used at the maximum authorised concentrations.
Despite numerous reviews, ongoing concerns have been expressed as to the potential endocrine-related toxicity of propyl and butylparaben while several member States also highlighted their unease with sunscreens, in that the Commission recommends children below three years old to avoid exposure the sun, yet young children are in fact exposed and thus may not be protected with current paraben concentrations.
Then in March 2011, Denmark notified the Commission that it had banned propyl- and butylparaben, the isoforms and salts in cosmetic products for children up to three years of age.
Seven months later, the SCCS adopted a clarification to its previous opinion in light of the Danish clause of safeguard and concluded that for general cosmetic products containing parabens, excluding specific products for the nappy area, there was no safety concern in children.
In its newest opinion, published on 3 May, the SCCS looked at whether these particular parabens needed to be updated while also taking into account in its assessment the information available about exposure to sunscreens.
The Committee carried out a quantitative risk assessment incorporating 'several layers of conservatism' including a high dermal absorption value of 3.7 per cent and a cumulative human exposure value of 17.4 g/day to cosmetic products containing parabens.
"This conclusion was drawn in a conservative way due to the lack of scientifically sound data on the pivotal link between dermal absorption in rats and humans, in particular in relation to the metabolism of the parent compound in the skin," the opinion read.
In this instance, the concerns of the SCCP/SCCS expressed previously and reiterated in recent opinions “remain unchanged and reinforced after the evaluation of both the reproductive toxicity and the toxicokinetics studies on propyl and butylparaben.”
With regards to the issue of sunscreens for infants, other groups of children up to the age of 10 years as well as adults, the SCCS ruled the use of 18g sunscreen per day/person during the limited periods per year of intended sun exposure as representing a realistic and protective amount.
"We emphasise the need that children up to 6 months of age should not be exposed to direct sunlight but should be protected by appropriate means such as adequate clothing, shade etc. If these measures are followed, sunscreens are then applied only in skin areas which are not protected by the clothes."