2023년 06월 22일, EU REACH 규정의 Annex XVII에서 D4, D5, D6을 제한하는 내용으로 TBT 통보문을 발표하였습니다.

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출처 : Chemlinked

On June 22, 2023, EU introduced new amendments to the Annex XVII to Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) through a draft regulation notified to WTO. This draft proposes to further restrict the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) in cosmetics as well as other consumer and professional products. It is currently open for comment until August 21, 2023.¹

Reason for Amendments

D4, D5, and D6 are listed as substances of very high concern (SVHC) under REACH due to their very persistent and very bioaccumulative (vPvB) properties. On January 10, 2018, the European Commission adopted the Commission Regulation 2018/35 to restrict rinse-off cosmetics containing D4 and/or D5 to be placed on the market. This restriction has come into effect since January 31, 2020.

When the Committee for Risk Assessment (RAC) assessed the proposal that was ultimately adopted in Commission Regulation 2018/35, it did not exclude a potential risk of using D4 and D5 in leave-on cosmetics. For this reason, the Commission mandated the European Chemicals Agency (ECHA) to prepare a dossier to assess the risks associated with D4 and D5 in leave-on cosmetics, as well as in other consumer and professional products. Later in February 2018, the Commission requested ECHA to also include D6 in the dossier, given its similarities to D4 and D5 in terms of properties and potential risks. Based on ECHA's submitted dossier, together with the supporting opinions from RAC and the Committee for Socio-economic Analysis (SEAC), the Commission drafted the new amendments.

Amendments Related to Cosmetics

The draft proposes a stricter restriction on D4, D5, and D6 that are in a concentration equal to or greater than 0.1% by weight of the respective substance, with a two-year transitional period. According to the draft, these substances shall not be placed on the market as a substance on its own, as a constituent of other substances, or in mixtures. Moreover, as the Commission is aware that reformulating the leave-on cosmetics would incur significant costs for the cosmetic industry, the draft grants a three-year transitional period for these products.

Exceptionally, the proposed transitional period does not apply to rinse-off cosmetics containing D4 and D5, as the corresponding restriction has already taken effect from January 31, 2020, in accordance with the Commission Regulation 2018/35.

Further Reading

• EU to Adopt 11 Changes to the Use Requirements for Cosmetic Ingredients
• EU to Amend the Use Requirements for 13 Nanomaterials in Cosmetics
• EU to Implement a Union-wide Ban on PFHxA in Cosmetics

Reference Links

[1] G/TBT/N/EU/989 Draft Commission Regulation Amending Annex XVII to Regulation (EC) No 1907/2006 as Regards Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6)