Regulatory Compliance

Evonik products comply with USP Class VI, ISO 10993 (Tripartite), and FDA food contact regulations as shown below. 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
	ACRYLITE® MD™ L40	CYROLITE® G-20	CYROLITE® G-20 HIFLO®	CYROLITE® GS-90	CYROLITE® CG-97	CYROLITE® Med 2	XT® polymer
Food contact (1)	•	•	•	•	•	•	•
USP Class VI (2)	•	•	•	•	•	•	•
ISO 10993-1 (Tripartite) (3)(4)	•	•	•	•	•	•	• (8RG grade not tested)

Notes:
(1) Products meet FDA food contact requirements of 21 CFR 177.1010 or 21 CFR 180.22 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.