Substances Known As D4 And D5 Become Subject to EU-wide Restriction in “Wash-off” Cosmetic Products
09 February 2018
On 11 January 2018, Regulation 2018/35 restricting the substances octamethylcyclotetrasiloxane (‘D4’) and decamethylcyclopentasiloxane (‘D5’) was published in the Official Journal. The substances are used in, among others, cosmetic products. 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. The dossier demonstrated that action on a Union-wide basis was necessary in order to address the risks to the environment posed by the use of D4 and D5 when discharged into waste water.
Pursuant to their investigations, the relevant ECHA committees opined that the substances do indeed pose concerns for the environment when present in cosmetic products that are used or disposed of with water, concluding that the proposed restrictions would be a targeted and appropriate Union-wide measure to minimise emissions caused by washed-off products. The opinions were duly submitted to the European Commission. The Commission, in turn, considered that those risks should be addressed on an EU-wide basis. The concentration limit of 0.1% would effectively ensure 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 proposed restriction concerns cosmetic products as defined by EU Regulation 1223/2009 on the safety of cosmetic products. In cosmetics that are intended to stay in prolonged contact with the skin, the hair or the mucous membranes, D4 and D5 evaporate over time after application and any residue is washed off in the course of normal ablutions. The UK’s dossier to introduce EU restrictions did not cover those products, considering that they did not represent the major source of risk to the environment from D4 and D5, and, consequently, the risk which they may present to the environment has not yet been assessed by the relevant ECHA committee.
According to the UK’s 2015 report, leave-on products include leave-on moisturisers, lipsticks and other make-up products for the face and eyes, as well as deodorants. On the other hand, wash-off products include oils for use in the bath or shower, make-up removing products (e.g. facial cleansers, scrub and mud masks), hair care products (e.g. shampoo and wash-off hair conditioner), and shower gels.
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.
- For the purposes of this entry [in Annex XVII], “wash-off cosmetic products” means cosmetic products that, under normal conditions of use, are washed off with water after application.
The new Regulation entered into force on the twentieth day following that of its publication in the Official Journal. As noted above, a transition period of two years from then will allow producers to adjust their production methods to ensure compliance with the new restriction.
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