EU Cosmetic Regulation Updates

Restriction on the use of silicones Octamethylcyclotetrasiloxane / Cyclomethicone (D4) and Decamethylcyclopentasiloxane / Cyclopentasiloxane (D5)

The dangers to the environment of these substances were raised in April 2015 by the United Kingdom, which had submitted a dossier to the European Chemicals Agency (ECHA) proposing the restriction of both D4 and D5 in cosmetic products that are washed off in normal conditions of use.

Consequently the European Commission acted to restrict the use of silicones octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in wash-off personal care products this past January.

Per Regulation (EU) 2018/35, wash-off cosmetic products must not contain a concentration of D4 or D5 higher than 0.1%. According to the document, this limit “effectively ensures that all intentional use of D4 and D5 will cease since those substances must be present in wash-off cosmetic products in a much higher concentration to perform their intended function.”

The European Commission classifies D4 and D5 as persistent, bioaccumulative and toxic (PBT) very persistent and very bioaccumulative (VPvB) substances, respectively.

Notably, the new restriction applies only to wash-off products—D4 and D5 eventually evaporate from products intended for prolonged contact with the skin or hair and thus pose a lesser environmental risk, whereas the ingredients enter the water supply before evaporating from wash-off products.

Applicable products containing either ingredient in a concentration higher than 0.1% will not be allowed on the European market after Jan. 31, 2020.

The restriction will only apply to wash-off cosmetic products that, under normal conditions of use, are removed with water shortly after application because in these circumstances D4 and D5 are emitted to the aquatic environment before evaporation. Moreover, it is pointed out that economic operators should be allowed sufficient time to take appropriate measures to comply with the restriction. The new restriction will therefore only apply as from 31 January 2020.

The restriction is incorporated into the REACH Regulation’s Annex XVII. This Annex contains the list of restricted hazardous substances, mixtures and articles on the EU market. The relevant provisions state that D4 and D5 shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0.1% by weight of either substance, after 31 January 2020.

COMMISSION REGULATION (EU) 2015/1190 of 20 July 2015

amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

The European Commission has published a new Regulation, Commission Regulation 2015/1190, which amends the Cosmetic Products Regulation 2009.

Regulation 2015/1190 states that the use of hair-waving or straightening products and eyelash-waving products containing thioglycolic acid, or its salts, at concentrations up to 11 % can only be used by professionals. The Regulation also lists a number of dyes, and their maximum concentrations, for use in hair-care products. These are (maximum concentration in parentheses):

  • 3-[(4-amino-3-methyl-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]-N,N,N -trimethylpropan-1-aminium, methylsulfate salt, HC Blue No 17 (2.0 %)
  • Phosphoric acid compound with 4-[(2,6-dichlorophenyl) (4-imino-3,5-dimethyl-2,5-cyclohexadien-1-ylidene) methyl]-2,6-dimethylaniline (1:1), HC Blue No 15 (0.2 %)
  • Disodium 2,2′-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate), Acid Green 25 (0.3 %)
  • Sodium, 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate, Acid Violet 43 (0.5 %)
  • 1,4-Benzenediamine, 2-(methoxymethyl) &1,4-Benzenediamine, 2-(methoxymethyl)-, sulfate (1.8%)
  • 1-N-Methylmorpholiniumpropylamino-4-hydroxyanthraquinone, methyl sulfate (0.5 %)
  • Ethanol, 2,2′-[[3-methyl-4-[(E)-(4-nitrophenyl)azo]phenyl]imino]bis-, Disperse Red 17 (0.2 %) • 4-Amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium salt, Acid Black 1 (0.5 %)
  • Disodium 3-hydroxy-4-[(E)-(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate, Pigment Red 57 (0.4 %)

A further Regulation was published subsequently which removes 3-Benzylidene Camphor, a UV filter and absorber, from Annex VI of the Cosmetic Products Regulation 2009. Laboratories testing these products on behalf of manufacturers and regulators will need to have validated procedures in place to measure these substances at the appropriate concentrations with an acceptable measurement uncertainty.