Restriction had been on the agenda for several months following the converging opinions of the SCCS, the European Scientific Committee in charge of assessing the safety of cosmetic ingredients. It has now been given the force of law with the publication of regulation 358/2014, which modifies the Cosmetics Regulation. Several parabens are thus banned, and the use of triclosan is restricted.
Regulation 358/2014 is dated April 9, 2014 and has been published in the Official Journal of the European Union on April, 10. It amends Annex II (substances prohibited in cosmetic products) and Annex V (list of preservatives allowed) of the Cosmetics Regulation 1223/2009.
It is binding and directly applicable in all Member States of the European Union.
Triclosan is currently allowed at a maximum concentration of 0.3% as a preservative in cosmetic products.
The experts' scientific opinion
The European experts have published several opinions on triclosan. Their conclusions:
• the use of triclosan as a preservative at the current maximum concentration limit of 0.3% in all cosmetic products is not safe for the consumer because of the magnitude of the aggregate exposure,
• its use at a maximum concentration of 0.3% in toothpastes, hand soaps, body soaps/shower gels and deodorants, face powders and blemish concealers is safe.,
• other uses of triclosan in nail products where the intended use is to clean the fingernails and toenails before the application of artificial nail systems at a maximum concentration of 0.3% and in mouthwashes at a maximum concentration of 0.2% are safe for the consumer.
The new regulation
Annex V, entry 25, of the Cosmetics Regulation 1223/2009, is amended.
Triclosan is now allowed:
• with a maximum concentration of 0.3%:
> in toothpastes, hand soaps, body soaps/shower gels, deodorants (non-spray), face powders and blemish concealers, nail products for cleaning the fingernails and toenails before the application of artificial nail systems ;
• with a maximum concentration of 0.2%:
> in mouthwashes.
Parabens are currently allowed as preservatives in cosmetic products at a maximum concentration of 0.4% when used alone, and at a maximum concentration of 0.8% when used in mixtures of several parabens.
The experts' scientific opinion
In December 2010 and October 2011, the SCCS' experts have published their latest opinions on parabens. Their conclusions:
• the experts confirmed that Methylparaben and Ethylparaben are safe at the maximum authorized concentrations,
• as limited or no information was submitted by industry for the safety evaluation of Isopropylparaben, Isobutylparaben, Phenylparaben, Benzylparaben and Pentylparaben, the human risk cannot be evaluated for these compounds; therefore, those substances should no longer be listed in Annex V (preservatives allowed) and, given that they might be used as antimicrobial agents, they should be listed in Annex II (substances prohibited) to make clear that they are prohibited in cosmetic products.
• No concerns were raised on the safety of 4-Hydroxybenzoic acid and its salts (Calcium paraben, Sodium paraben, Potassium paraben).
Propylparaben and Butylparaben
The conclusions the SCCS drew on Propylparaben and Butylparaben were challenged by a study carried out by the French authorities; therefore a further risk assessment of those two substances was adopted by the SCCS in May 2013.
Measures on Propylparaben and Butylparaben are under preparation, as a second step in the risk management of parabens.
The new regulation
Five parabens (and their salts) are added Annex II (substances prohibited) of the Cosmetics Regulation 1223/2009 :
> Isopropylparaben, Isobutylparaben, Phenylparaben, Benzylparaben, Pentylparaben.
These five substances are also removed of the entry 12 of Annex V (preservatives allowed). The rest of this entry (maximum concentrations) remained unchanged for the others parabens.
Propylparaben and Butylparaben are still appear in the list of allowed preservatives with the maximum concentration pf 0.4% (when used alone) and 0,8% (when used in mixtures of parabens)… until their case is settled by the experts.
The application of these new restrictions
The application of these new dispositions will be deferred to allow the industry to make the necessary adjustments to product formulations.
In particular, undertakings will be granted six months to place on the market compliant products, and 15 months to stop making available on the market non-compliant products after the entry into force of this new regulation, in order to allow existing stocks to be exhausted.
• for new products: from 30 October 2014 only cosmetic products which comply with these new restrictions shall be placed on the Union market.
• for products that are already marketed: from 30 July 2015 only cosmetic products which comply with these new restrictions shall be made available on the Union market.
For further information
• See the full text or regulation 358/2014