silicone, translucent, phthalates free, tested in compliance with 1907/2006/CE (REACH). Meets FDA CFR 21 PART 177.2600, USP XXXII class VI requirements, European Pharmacopoeia 3.1.9 Ed. VII 2011, ISO 10993 Sections 5,10,11:2009, BfR Recommendation XV & XXI Cat. 2, European Reglement 1935/2004/CE, DM 21/03/1973 e seguenti, Japan Ministry of Health and Welfare Notice No.370,1959.