Regulatory Compliance

About CYROLITE® Compounds

Evonik products comply with USP Class VI, ISO 10993 (Tripartite), and FDA food contact regulations as shown below (only "clear" products tested except CYREX® which was tested in a white medical). The products comply with RoHS and REACH requirements, are free of heavy metals, plasticizers, natural latex, REACH SVHC substances and are BPA free.
Regulatory requirements
 
Food contact (1)
USP Class VI (2)
ISO 10993-1 (Tripartite) (3)(4)
CYROLITE® MD L40
 •
 •
 •
CYROLITE® G-20
 •
 •
 •
CYROLITE® G-20 HIFLO®
 •
 •
 •
CYROLITE® GS-90
 •
 •
 •
CYROLITE® CG-97
 •
 •
 •
CYROLITE® Med 2
 •
 •
 •
CYROLITE® Protect (5)
 •
 •
  Not tested
XT® polymer 
 •
 •
 • (8RG grade not tested)
CYREX® 200-8005 (6) 
 •
 •
 •
The following PDF contains a more detailed description of the regulatory status of many grades of CYROLITE® acrylic -based compounds:
Product Compliance Data Sheet for CYROLITE®
Notes:
(1) Products meet FDA food contact requirements of 21 CFR 177.1010 (ACRYLITE® and CYROLITE®) or 21 CFR 177.1580 (CYREX®) under Condition C (no Alcohol) and Condition D @ 8% alcohol.
(2) Class VI United States Pharmacopoeia tests for determining the suitability of a plastic material intended for use in fabricating containers or accessories thereto, for parenteral preparations.
(3) Indicated products have been found to be non-hemolytic, non-cytotoxic, non-pyrogenic, non-sensitizing, and non-mutagenic when tested following the Tripartite and ISO 10993-1 protocols.
(4) In clear and 000, 001, 301 and 3128 tints only. Other colors not tested. In CYREX® 200 8005 color only.
(5) Not REACH complaint.
(6) Not BPA free.