Regulatory Compliance

About CYROLITE® Compounds

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
 
Food contact (1)
USP Class VI (2)
ISO 10993-1 (Tripartite)(3) (4)
ACRYLITE® MD L40 
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CYROLITE® G-20 
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CYROLITE® G-20 HIFLO® 
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CYROLITE® GS-90 
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CYROLITE® CG-97 
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CYROLITE® Med 2 
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Notes:
(1) Products meet FDA food contact requirements of 21 CFR 177.1010 (ACRYLITE® and CYROLITE®) 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.  
(5) Not BPA free.
Evonik Industries is a worldwide manufacturer of PMMA products sold under the PLEXIGLAS® trademark on the European, Asian, African and Australian continents and under the ACRYLITE® trademark in the Americas.