AB 2300: Medical devices: Di-(2-ethylhexyl) phthalate (DEHP).

Existing law prohibits a person or entity from manufacturing, selling, or distributing in commerce any toy or childcare article that contains, among other things, Di-(2-ethylhexyl) phthalate (DEHP) in concentrations exceeding 0.1%.

This bill would, commencing January 1, 2030, prohibit a person or entity from manufacturing, selling, or distributing into commerce in the State of California certain intravenous solution containers made with intentionally added DEHP, as defined. The bill would extend the deadline to January 1, 2032, for a person or entity who has a pending United States Food and Drug Administration approval or who does not have adequate equipment to manufacture the DEHP-free intravenous solution container and who meets other specified requirements, including providing prescribed notices to consumers. The bill would also, commencing January 1, 2035, prohibit a person or entity from manufacturing, selling, or distributing into commerce in the State of California certain intravenous tubing made with intentionally added DEHP. The bill would prohibit a person or entity from manufacturing, selling, or distributing in commerce intravenous tubing or intravenous solution containers containing unintentionally added DEHP, as defined. The bill would prohibit a person or entity from replacing DEHP for revised or new products with other specified ortho-phthalates.