On June 22, 2023, a draft amendment to the REACH regulation (Registration, Evaluation, Authorization and Restriction of Chemicals) was published amending Annex XVII. The change is aimed at introducing restrictions on the use of D4, D5 and D6 silicones. Specifically, it is about extending the restrictions already applicable to substances D4 and D5 to silicone D6 in rinse-off cosmetics and to add analogous restrictions in leave-on cosmetics for these silicones.
Ingredients
D4, D5 and D6 are ingredients from the group of silicones, specifically siloxanes, with skin and hair conditioning properties, acting as solvents and emollients. Silicones are also added to cosmetics to ensure appropriate sensory and application properties: they give smoothness, slip and silky effect, improve their consistency and stability.
The silicones listed above are:
- D4 – octamethylcyclotetrasiloxane,
- D5 – decamethylcyclopentasiloxane,
- D6 – dodecamethylcyclohexasiloxane.
Silicones D4 and D5 are already restricted under REACH (entry 70, Annex XVII). This means that they are not placed on the market and made available on the market in rinse-off products at a concentration of ≥0.1% after January 31, 2020.
In addition, in accordance with the Cosmetic Regulation 1223/2009, D4 is included in Annex II, item 1388 – i.e. in the list of substances prohibited in cosmetic products.
Background
The upcoming changes in the law take into account the environmental risks associated with the use of these silicones. The European Chemicals Agency (ECHA) has identified D4, D5 and D6 as Substances of Very High Concern (SVHC) with persistent, bioaccumulative and toxic properties.
The Risk Assessment Committee (RAC) has assessed the potential risks of D4 and D5 in cosmetic products and concluded that there is need for their restriction.The proposed limitation is aimed at minimizing the emission of these substances into the environment and ensuring their proper management throughout their life cycle.
What will change
According to the new changes in REACH, silicones D4, D5 and D6 cannot be placed on the market and made available on the market as:
• substances on their own,
• components of other substances,
• in mixtures
in a concentration equal to or greater than 0.1% by weight of the respective substance.
How does this relate to cosmetic products?
- D6 will not be placed on the market and made available on the market in rinse-off cosmetic products at a concentration of ≥ 0.1% after 2 years from the entry into force of the regulation.
- Additionally, D4, D5 and D6 will not be placed on the market and made available on the market in leave-on cosmetic products at a concentration of ≥ 0.1% after 3 years from the entry into force of the Regulation.
The use restrictions will therefore extend to D6 silicone for rinse-off products and to leave-on products for all three silicones.
Change dates
Proposed date of adoption of the regulation: 4th quarter of 2023.
The restriction of the use of D6 in rinse-off cosmetic products will apply 2 years after the entry into force of this regulation.
The restrictions on the use of D4, D5 and D6 in leave-on products will apply 3 years after the entry into force of the regulation.
The coming amendment is an example of the impact of horizontal legislation and environmental issues on the cosmetics regulation.
The draft amendment to REACH can be found at the following links:
https://news.wko.at/news/oesterreich/0068-Su—Anhang-Beschraenkung-Siloxane-(D4-D5-D6)-REACH-Anh.pdf
