Amendment to Annex XVII of Regulation (EC) No 1907/2006: Restrictions on D4, D5, and D6 in Consumer and Professional Products

“Commission Regulation (EU) 2024/1328 Amending Annex XVII to REACH (Regulation (EC) No 1907/2006) on D4, D5, and D6 Substances

Commission Regulation (EU) 2024/1328, published on 17 May 2024, amends Annex XVII to the REACH Regulation concerning Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6). These substances are identified as Persistent, Bioaccumulative, and Toxic (PBT), with additional very persistent and very bioaccumulative properties.

Key Updates:

• Derogations for Industrial Uses: Allowed in silicone polymer production, polymerization, repackaging, and lab research under controlled conditions.
• Medical Devices: D5 and D6 are permitted for use in wound care and stoma treatment under Regulation (EU) 2017/745.
• Silicone Polymers: D4, D5, and D6 can be used in certain silicone polymer mixtures under specific derogations.
• Rinse-off Cosmetic Products: Restrictions clarified for D4 and D5.
• Mixtures Containing Residues: Allowed if D4, D5, or D6 concentrations are ≤0.2% by weight.
• Deferral Periods: Two-year general deferral, with three-year and seven-year deferrals for cosmetic and medical products, respectively.

The regulation aims to minimize environmental emissions and aligns with previous restrictions on these substances. It is binding in all EU Member States.”

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AL_202401328##~https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401328##~https://www.boe.es/buscar/doc.php?id=DOUE-L-2024-80711##~https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1328R%2801%29&qid=1724141086239

Region: EU Harmonized (27 Markets), Spain