Opinion on PHMB
The Scientific Committee on Consumer Safety (SCCS) has concluded that PHMB is safe to use up to a concentration of 0,1%.
The decision is based in the light of this 4 questions:
“1- In light of the new data provided, does the SCCS consider Polyaminopropyl Biguanide (PHMB) safe when used as preservative in all cosmetic products up to a maximum concentration of 0.1%?
In the previous opinion, the SCCS stated that the Polyaminopropyl Biguanide (PHMB) is not safe up to maximal concentration of 0.3%. The safe use could be based on a lower use concentration and/or restrictions with regard to cosmetic products' categories. In order to ensure the safe use of PHMB at a lower concentration than 0.3%, the applicant presented new dermal absorption studies on additional representative cosmetic formulations. Based on the data provided, the SCCS is of the opinion that the use of Polyaminopropyl Biguanide (PHMB) as a preservative in all cosmetic products up to 0.1% is safe.
2- Alternatively, taking into account the EU market data available, does the SCCS consider Polyaminopropyl Biguanide (PHMB) safe when used as preservative up to a maximum concentration of 0.1% in all cosmetic products with the exclusion of those products categories (body lotion, hand cream and oral care) in which this ingredient is seldom used?
Not applicable.
3- According to the new data provided, does the SCCS consider Polyaminopropyl Biguanide (PHMB) safe for use in sprayable formulations up to a maximum concentration of 0.1%?
As no new safety data on inhalation is available on PHMB, its use in sprayable formulations is not advised.
4- Does the SCCS have any further scientific concerns with regard to the use of Polyaminopropyl Biguanide (PHMB) in cosmetic products?
Not answered”
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Opinion on HEPB
“ 1- In light of the data provided, does the SCCS consider safe the use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products with a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics?
Based on the information provided by the applicant, the use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products with a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics is not considered safe. It is of note that a maximum concentration of 2.0 % under an aggregate exposure scenario for cosmetics could be considered safe if more reliable and supporting data on in vitro dermal penetration was provided.
2- Alternatively, what is, according to the SCCS, the maximum target concentration considered safe for use of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products under an aggregate exposure scenario for cosmetics?
Based on the information provided by the applicant, a maximum concentration of 0.7 % of Hydroxyethoxyphenyl Butanone (HEPB) as a cosmetic preservative in rinse-off, oral care and leave-on cosmetic products can be considered safe.
3- Does the SCCS have any further scientific concerns regarding the use of Hydroxyethoxyphenyl Butanone (HEPB) in cosmetic products?
The SCCS is aware that Hydroxyethoxyphenyl Butanone (HEPB) is also used as skin conditioning agent. According to the Cosmetics Regulation 1223/2009 a substance authorised as preservative at specific conditions of use (e.g. maximum concentration) can only be used for other purposes at the same conditions of use set up for the preservative function. In the specific case of Ethylzingerone, this substance cannot be used as conditioning agent at concentrations higher than that one authorised for the preservative function. More evidence would be needed to exclude eye irritation.”
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