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1. D4 And D5 Restricted In Wash-Off Personal Care
Products.Are There Any New Alternatives?
Earlier this year, both Octamethylcyclotetrasiloxane (D4) and
Decamethylcyclopentasiloxane (D5) were added to ECHA’s restricted
substances list, contained in Annex XVII of REACH. Under Commission
Regulation (EU) 2018/35– which was published on January 10th 2018 – D4
and D5 can no longer 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 January 31st 2020.
What are D4 and D5?
D4 and D5 are cyclosiloxanes (which are basic members of the broad family
of silicone materials) mainly used as monomers for silicone polymer
production. D4 and D5 – along with Dodecamethylcyclohexasiloxane
(D6) – are the three cyclosiloxanes in commercial production, and are
odourless, colourless liquids, commonly used as intermediates or basic raw
materials in the production of silicone rubbers, gels and resins.
In addition to this, they also have a direct use in a number of personal care
products, including body lotions, hair styling aerosols, pressurized sprays
and sun care spray products.
What is the restriction procedure?
A Member State, or ECHA (at the request of the European Commission) can
begin the restriction procedure if they are concerned that a substance poses
an unacceptable risk to human health or the environment.
This intention to prepare a restriction proposal is published in the registry of
intentions, and a dossier proposing the restriction must be prepared in
accordance with Annex XV of REACH and submitted to ECHA within 12
months of the intention being made. The dossier contains background
information such as the identity of the substance and justifications for the
proposed restrictions.
The dossier is then made publicly available for consultation, where
stakeholders can provide comments on the restriction on the ECHA website.
After this, ECHA’s Committee for Risk Assessment (RAC) and Committee
for Socio-Economic Analysis (SEAC) will give their respective opinions,
before the European Commission makes its final decision.
Once the restriction has been adopted, manufacturers, importers, distributors,
downstream users and retailers must comply.
2. Why are D4 and D5 restricted?
In April 2015, the UK submitted a dossier to ECHA, proposing to restrict
D4 and D5 in wash-off cosmetic products. This was assessed by the RAC in
March 2016, who concluded in its opinion that D4 meets the criteria in
Annex XIII of REACH to be identified as a PBT (persistent,
bioaccumulative and toxic) substance and as a vPvB (very persistent and
very bioaccumulative) substance, and that D5 fulfils the criteria to be
identified as a vPvBsubstance.
Due to concerns that D4 and D5 may have the potential to accumulate in the
environment and cause unpredictable and irreversible long-term effects, in
June 2016 the RAC and SEAC agreed with the UK’s proposal to restrict D4
and D5 in wash-off personal care products. In addition to this, the SEAC
recommended to defer the application of the restriction for 24 months to
allow stakeholders to take necessary compliance measures.
This restriction comes into force on January 31st 2020, applies
to ‘cosmetic products’ as defined in Article 2(1)(a) of EC Regulation
1223/2009 on cosmetics that – under normal conditions of use – are washed
off with water after application.
Potential further restrictions
At present, D4 and D5 are not restricted in other products. However, ECHA
is currently working on a further proposal to restrict D4, D5 and D6 in leave
on personal care products and other consumer/professional products,
such as dry cleaning products, waxes and polishes, and other washing and
cleaning products. In addition to this, a proposal has been made to also
restrict D6 in wash-off cosmetic products.
An intention to prepare a restriction proposal has been published in
the registry of restriction intentions, and the proposal is expected to be
submitted in January 2019.
If these proposals are adopted, D6 will join D4 and D5 and will no longer be
placed on the market in wash-off cosmetic products in a concentration
equal to or greater than 0.1%, and leave on personal care products and
other consumer/professional products containing D4, D5 and D6 in
concentrations equal to or greater than 0.1% shall not be placed on the
market.
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cosmetic silicone series products. Welcome to communicate
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Super low viscosity dimethicone fluids 1cst,1.5cst,5cst
Octamethyltrisiloxane(CAS:107-51-7)
