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  • Writer's pictureDaniel Jiménez

REACH Amendment: Restrictions for D4, D5 and D6 in cosmetic products

The recently published Regulation (EU) 2024/1328 introduces significant modifications to Annex XVII of the REACH Regulation. Specifically, entry 70 of Annex XVII has been amended to include usage restrictions for three specific compounds: Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) in various mixtures, including cosmetic products.




Background and Context


The REACH Regulation (Registration, Evaluation, Authorisation, and Restriction of Chemicals) is a European Union regulation aimed at ensuring a high level of protection for human health and the environment from the risks posed by chemicals. This regulation requires companies to register chemicals that they manufacture or import in quantities exceeding one tonne per year.


Specific Modifications


The new amendment extends the previously established restrictions for D4 and D5 in rinse-off cosmetic products. Now, these restrictions also apply to:


  • Octamethylcyclotetrasiloxane (D4)

  • Decamethylcyclopentasiloxane (D5)

  • Dodecamethylcyclohexasiloxane (D6)


These substances have raised concerns due to their bioaccumulative properties and persistence in the environment.


Impact on the Cosmetic Industry


The cosmetic industry will be particularly affected by these restrictions, as D4, D5, and D6 are commonly used in products such as deodorants, hair care products, and other cosmetics. The inclusion of these substances in the list of restrictions in Annex XVII means that cosmetic products containing these substances will need to be reformulated or withdrawn from the market.


Specific Dates and Concentrations


REACH Amendments Effective Date: The amendments to the REACH regulations will come into force on the specified effective date.


  • Rinse off: D4 and D5: 31 January 2020 D6: June 6, 2027

  • Leave On : D4 D5 and D6: 6 June 2027

  • Maximum Allowed Concentration: For cosmetic products, the concentration of D4, D5, and D6 must not exceed 0.1% by weight individually or in combination.


These restrictions are designed to minimize the release of these substances into the environment and reduce their potential negative impact.


Justification for the Amendment


The justification for this amendment is based on studies that have shown that D4, D5, and D6 are persistent in the environment and can accumulate in aquatic organisms. According to the European Chemicals Agency (ECHA), these substances pose significant environmental risks due to their potential for bioaccumulation and toxicity.


Official Sources


To support this information, here are some official sources:


  1. European Chemicals Agency (ECHA): Publications and studies on the properties and risks associated with D4, D5, and D6. ECHA - D4, D5 and D6

  2. REACH Regulation: Full text and amendments of the REACH Regulation. REACH Regulation - Annex XVII

  3. Official Journal of the European Union: Official publication of Regulation (EU) 2024/1328. OJ EU - Regulation (EU) 2024/1328


Conclusion


The amendment of the REACH Regulation through Regulation (EU) 2024/1328 underscores the European Union's commitment to protecting the environment and human health. The new restrictions on D4, D5, and D6 require the cosmetic industry to take measures to ensure compliance with these regulations, thereby promoting safer and more sustainable products.


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