10 Oct 2014
EU Prohibits the Use of 5 Parabens and Restricts the Use of Triclosan in Cosmetic Products
In order to ensure the safety of cosmetic products for human health, the European Commission has adopted REGULATION (EU) No 358/2014 that prohibits the use of 5 parabens and limits the maximum concentrations of Triclosan in cosmetic products. This was published in the Official Journal on 9 April 2014 and amends Annexes II and V of existing Regulation (EC) No 1223/2009.
The Scientific Committee on Consumer Safety (SCCS) has called for toxicological data and a complete dossier of toxicity of long-chain parabens for evaluation. However, since there is limited information submitted for safety evaluation of isopropyl-, isobutyl-, phenyl-, benzyl-, and pentylparaben, human risk cannot be evaluated. In addition, SCCS confirmed the Scientific Committee on Consumer Products (SCCP) position to consider that the continued use of triclosan as a preservative at the current maximum concentration limit of 0,3 % in all cosmetic products would raise a potential risk to human health.
The European Commission has taken and adopted the opinions from SCCS, which are now incorporated into the EU Cosmetic Regulation EC 1223/2009 as an amendment, as follows:
INCI Name/Chemical Name
Isopropylparaben and its salts
Isobutylparaben and its salts
Annex II (Prohibited List) is amended by including the following parabens in Entries 1374-1378.
Annex V (List of preservatives allowed) is amended and Entry 25 is replaced by the following table:
Name of Common Ingredients Glossary
Product type. Body parts
Max. concentration in ready for use preparation
Wording of condition of use and warnings
5-Chloro-2- (2,4- dichlorophenoxy) phenol
(a) 0,3 %
(b) 0,2 %
This regulation has entered into force in all Member States since the twentieth day following that of the publication in the Official Journal of the European Union. From 30 October 2014 onwards: New cosmetic products to be placed on the Union market have to comply with this regulation. From 30 July 2015 onwards: Any products not complying with this regulation must be removed from the market by this date.
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