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Opinion on Parabens - Updated request for a scientific opinion on propyl- and butylparaben - Colipa P82 (Preservatives)

Final Opinion

Details

Publication date
3 May 2013
Author
Scientific Committee on Consumer Safety (SCCS)

Description

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, G. Degen, W. Lilienblum (rapporteur), E. Nielsen, V. Rogiers, T. Sanner, S. Ch. Rastogi (chairman), J. van Engelen, R. Waring, I.R. White, Th. Platzek, Ch. Rousselle, J. van Benthem, A. Luch, P.-J. Coenraads, D. Gawkrodger
Contact:SANTE-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1514/13
Doi: 10.2772/66369
Adopted on: 3 May 2013

Conclusion of the opinion:

1.Taking into consideration recent data, does the SCCS consider that its opinions of 2010 (SCCS/1348) and 2011 (SCCS/1446) on propylparaben when it is used as preservative in cosmetics products, both intended for adults and young children, need to be updated?

2. Taking into consideration recent data, does the SCCS consider that its opinions of 2010 (SCCS/1348) and 2011 (SCCS/1446) on butylparaben when it is used as preservative in cosmetics products, both intended for adults and young children, need to be updated?

Recent data confirms that the toxicokinetics of parabens in rats and humans differ considerably. 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 toxicokinetic studies on propylparaben recently submitted to the SCCS. The same data were extrapolated for the evaluation of the risk by butylparaben exposure.

The additional submitted data does not remove the concern expressed in the previous opinions on the relevance of the rat model for the risk assessment of parabens. Although much toxicological data on parabens in rodents exists, adequate evidence has not been provided for the safe use of propyl- or butylparaben in cosmetics. For these reasons, the SCCS reiterates its previous conclusions and requests regarding an improvement of the data, in particular (i) on the exposure of humans including children to propyl- and butylparaben in cosmetic products and (ii) the toxicokinetics of propyl- and butylparaben in humans.

3. Several Member States have highlighted that, despite the Commission's recommendation to avoid exposure to the sun of children below three years old, young children are exposed and they are protected from the harmful effects of the sunlight through the use of sunscreens. The SCCS is therefore asked to take into account in its assessment the information available about exposure to sunscreens, especially as far as children below three years old are concerned.

The SCCS has reviewed the available data on human exposure to sunscreens for: infants 3 month old, other groups of children up to the age of 10 years as well as adults. The SCCS is of the opinion that the use of 18 g sunscreen per day/person during the limited periods per year of intended sun exposure represents a realistic amount which is protective as well for babies, children and adults. The SCCS emphazises the need that children up to 6 months of age should not be exposed to direct sunlight but should be protected from sunlight by use of 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 .

Keywords:

SCCS, scientific opinion, preservative, P82, parabens, directive 76/768/ECC

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on parabens, 3 May 2013.

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