EC Scientific Committee To Reconsider Preservative MI Use In Cosmetics
This article was originally published in The Rose Sheet
Executive Summary
New data from trade association Cosmetics Europe has prompted the EC’s Scientific Committee on Consumer Safety to take another look at the safety of methylisothiazolinone when used in rinse-off products and leave-on hair products. Previously, the committee’s assessment of the preservative found that there was no safe concentration when used in leave-on cosmetic products.
The EC’s Scientific Committee on Consumer Safety will consider use of preservative methylisothiazolinone in rinse-off products at a higher concentration threshold than previously recommended, as well as the ingredient’s use in leave-on hair products, based on new data supplied by trade group Cosmetics Europe.
In December 2013, the committee adopted the opinion that there is no safe concentration of MI in leave-on products, but the ingredient is safe when used in rinse-off products at concentrations less than or equal to 15 ppm (Also see "Attn. Europe: CIR Identifies Safe Limit For Preservative MI In Leave-Ons" - HBW Insight, 16 Jun, 2014.).
Those recommended standards differed significantly from a 2004 opinion issued by SCCS’s predecessor the Scientific Committee on Cosmetic Products and Non-Food Products, which identified MI as safe in finished cosmetic products at a maximum concentration of 100 ppm.
Cosmetic use of MI in combination with methylchloroisothiazolinone has been restricted since 1989 in Europe to a maximum level of 15 ppm of a mixture in the ratio of 3:1 (MCI/MI).
To date, EU regulations have permitted cosmetic manufacturers to use higher levels of standalone MI to preserve products due to previous evidence suggesting that its sensitizing potential was markedly less pronounced than that of MCI.
However, in recent years concerns have arisen about MI owing to reports of allergic contact dermatitis from MI exposure, as well as an observed rise in contact allergy to the MCI/MI combination.
The latter contributed to the EC’s decision in September 2014 to ban use of the MCI/MI combination in leave-on products beginning July 15, 2016.
Increased sensitization to MCI/MI also has drawn attention to standalone MI.
In its most recent opinion on MI, SCCS notes: “The rise in contact allergy to MCI/MI cannot be explained by a change in exposure to MCI/MI in cosmetics,” which has been limited to concentrations of 15 ppm or less for more than two decades. Rather, it “is due to the increasing exposure to MI, present in concentrations very near 100 ppm both in leave-on and rinse-off cosmetics.”
“Further, there is some indication of the levelling-off of the frequency of reactions to MCI/MI whilst MI continues to increase,” the committee adds.
Such reasoning informed SCCS’ recommendation to restrict standalone MI preservative use more stringently in cosmetic products by prohibiting its use in leave-on products and lowering the ceiling for MI concentration levels in rinse-off products.
In its Jan. 5 request for an updated scientific opinion, the EC says it received new data from Cosmetics Europe in June 2014 concerning the safety of MI in rinse-off and hair leave-on products and indicates that new cosmetovigilance data related to the ingredient were slated for delivery by the end of 2014.
Further, “considering that the concentration limit of MI to 15ppm suggested by SCCS is based on the data related to the mixture MCI/MI and, according to Cosmetic Europe, 15 ppm would be insufficient for effective preservation in the majority of commercially available products, the commission finds it appropriate to request the safety evaluation of MI in rinse-off and leave-on hair cosmetic products.”
Nano-Form UV Filter Also Up For Review
The EC also has issued a request for a scientific opinion on UV filter methylene bis-benzotriazolyl tetramethylbutylphenol.
The ingredient’s safety was assessed in 1998 by SCCS’ predecessor, which determined it safe in cosmetic products at a maximum 10% concentration.
SCCS was asked to take another look in 2013 to assess MBBT in its nano form, but the committee did not reach a conclusion, as “no appropriate data on genotoxicity of nano form of MBBT were provided.” However, the commission did note that there did not appear to be a concern regarding systemic effects of dermally applied nano-sized MBBT.
In August 2014, BASF submitted a safety dossier on MBBT with genotoxicity data for nano-sized MBBT, which SCCS will consider as it reassesses the ingredient’s safety.
Additionally, SCCS will take a look at dichloromethane, currently used as a solvent in cosmetic products. The commission found in 2012 that the ingredient is not safe in concentrations up to 35% in hair sprays, based on data regarding the neurobehavioral and neurodevelopmental effects of exposure.
The group will now examine new data on those concerns provided by the European Federation for Cosmetic Ingredients.
Three ingredient opinions adopted by SCCS at its Dec. 16 plenary meeting are currently open for comments: preservative ethyl lauroyl arginate HCl; hair dye basic blue 124; and preservative polyaminopropyl biguanide. Comments are due Jan. 30.