REGULATIONS 45
Cosmetic Ingredient Review and EU update
Dr Martin Perry – Advanced Development and Safety Laboratories Limited, UK
This article looks at the final safety assessments issued by the Cosmetic Ingredient Review expert panel during 2018. The Cosmetic Ingredient Review expert panel meets four times a year. The safety assessments in this article are from the 146th, 147th, 148th and 149th meetings of the panel. The article also looks at the amendments that have been made to the European Cosmetic Regulation (EC) No 1223/2009 in 2018.
Alkane diols The Cosmetic Ingredient Review expert panel assessed the safety of 10 alkane diols and found that seven of them: Propanediol, 1,5-Pentanediol, Hexanediol, 1,10- Decanediol, Methylpropanediol, Butyl Ethyl Propanediol and Isopentyldiol are safe in cosmetic products in the present practices of use and concentrations as described in their safety assessment.1
For three alkane
diols (1,4-Butanediol, 2,3-Butanediol, and Octanediol) there was insufficient information to determine their safety in cosmetic products.
Malic acid
The Cosmetic Ingredient Review expert panel last reviewed the safety of Malic Acid and sodium malate in 2001. In 2001 they concluded that malic acid and sodium malate were safe to use as pH adjusters in cosmetic products. The panel decided to
May 2019
re-open the safety assessment as the number of uses and concentrations of Malic Acid and Sodium Malate had increased. The panel concluded that Malic Acid and Sodium Malate are safe in the present practices of use and concentrations as described in their amended safety assessment.2
For Malic Acid the panel
considered its use at concentrations of up to 2.1% in leave-on products and 50% in products diluted for baths. For sodium malate the panel considered its use at 0.02% in skin care products.
Peppermint derived ingredients In 1998 the Cosmetic Ingredient Review expert panel issued a report that concluded Mentha Piperita (Peppermint) Oil, Mentha Piperita (Peppermint) Leaf Extract, Mentha Piperita (Peppermint) Leaf and Mentha Piperita (Peppermint) water are safe in cosmetic products. After 15 years the Cosmetic Ingredient Review expert panel re-evaluated the conclusions to this report and decided to review the safety of peppermint derived ingredients. In their 2018 report they concluded that Mentha Piperita (Peppermint) Oil, Mentha Piperita (Peppermint) Extract, Mentha Piperita (Peppermint) Leaf, Mentha Piperita (Peppermint) Leaf Cell Extract, Mentha Piperita (Peppermint) Leaf Extract, Mentha Piperita (Peppermint) Leaf Juice and Mentha Piperita (Peppermint) Leaf Water
are safe in cosmetic products in the present practices of use and concentrations as described in their safety assessment when formulated to be non-sensitising.3
The
panel concluded that there was insufficient data to determine the safety of Mentha Piperita (Peppermint) Flower/Leaf/Stem Extract, Mentha Piperita (Peppermint) Flower/Leaf/Stem Water and Mentha Piperita (Peppermint) Meristem Cell Culture in cosmetic products.
Sultaines
The Cosmetic Ingredient Review expert panel reviewed the safety of 13 alkyl sultaines and concluded that they are safe in the present practices of use and concentration.4
Sultaines are structurally
related to betaines and are predominantly used as antistatic agents, surfactants, skin conditioning and hair conditioning agents. Cocamidopropyl Hydroxysultaine has the highest reported maximum concentration of the alkyl sultaines and is used at up to 11.5% in rinse–off products and 2.5% in leave–on face and neck products. Alkyl sultaines may contain amine impurities such as 3,3-Dimethylaminopropylamine which may cause sensitisation but these are reported to be at very low levels that sensitisation is considered to be unlikely.
Witch hazel The Cosmetic Ingredient Review expert
PERSONAL CARE NORTH AMERICA
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