REACH EC 1907/2006

Registration, Evaluation, Authorization and Restriction of Chemicals Regulation EC 1907/2006

The Registration, Evaluation, Authorization and Restriction of Chemicals Regulation EC 1907/2006, commonly referred to as REACH, is a European regulation on chemicals and their safe use. With the publication of candidate lists for authorization, the European Chemicals Agency identifies sets of substances of very high concern (SVHC) that manufacturers must disclose to customers if used in their products above 0.1% by weight.

Based on the current version of the candidate list for authorization, selected Baxter products may contain the following SVHCs above the disclosure threshold:

CHEMICAL	MANUFACTURING PROCESS USAGE	BAXTER PRODUCTS CONTAINING REFERENCED CHEMICAL
Lead	Trace in glass & lead solder	Infusor & electronic infusion pumps & PD/HD Devices
Cadmium	Plastics & Electrical Components	Electromechanical Devices & Electrical Component
Diisobutyl phthalate	Plasticizer	Apheresis Kits for use with CS3000 Blood Cell Separator/CS3000 Plus Blood Cell Separator, Autopheresis-C System, and Amicus™ IV administration sets IV drug containers IV accessories such as catheters, stopcocks IV admixture, compounding and transfer devices Blood administration, warming, transfer and collection devices Respiratory therapy and anesthesia devices, suction devices Irrigation containers and accessories Feeding containers and accessories Legacy Hillrom Products
Benzyl butyl phthalate (BBP)	Plasticizer	IV administration sets IV drug containers IV accessories such as catheters, stopcocks IV admixture, compounding and transfer devices Blood administration, warming, transfer and collection devices Respiratory therapy and anesthesia devices, suction devices Irrigation containers and accessories Feeding containers and accessories Additional Baxter products
Bis (2-ethylhexyl)phthalate (DEHP)	Plasticizer	Apheresis Kits for use with CS3000 Blood Cell Separator/CS3000 Plus Blood Cell Separator, Autopheresis-C System, and Amicus™ IV administration sets IV drug containers IV accessories such as catheters, stopcocks IV admixture, compounding and transfer devices Blood administration, warming, transfer and collection devices Respiratory therapy and anesthesia devices, suction devices Irrigation containers and accessories Feeding containers and accessories Legacy Hillrom Products
Dibutyl phthalate (DBP)	Plasticizer	Apheresis Kits for use with CS3000 Blood Cell Separator/CS3000 Plus Blood Cell Separator, Autopheresis-C System, and Amicus™ IV administration sets IV drug containers IV accessories such as catheters, stopcocks IV admixture, compounding and transfer devices Blood administration, warming, transfer and collection devices Respiratory therapy and anesthesia devices, suction devices Irrigation containers and accessories Feeding containers and accessories Legacy Hillrom Products
Polybrominated biphenyls	Plastics & Electrical Components	Electromechanical Devices & Electrical Components Apheresis Kits for use with CS3000 Blood Cell Separator/CS3000 Plus Blood Cell Separator, Autopheresis-C System, and Amicus™ IV administration sets IV drug containers IV accessories such as catheters, stopcocks IV admixture, compounding and transfer devices Blood administration, warming, transfer and collection devices Respiratory therapy and anesthesia devices, suction devices Irrigation containers and accessories Feeding containers and accessories Legacy Hillrom Products Legacy Hillrom (Qstress and Eli) Products Electromechanical Devices & Electromechanical Components
Diisononyl phthalate (DINP)	Plastics, Electrical Components, Plasticizer, Adhesives and Sealants	IV administration sets IV drug containers IV accessories such as catheters, stopcocks, Luers, Valves Irrigation containers and accessories Feeding containers and accessories Additional Baxter products Legacy Hillrom (Qstress and Eli) Products Electromechanical Devices & Electrical Components
Di-isodecyl phthalate (DIDP)	Plastics, Electrical Components, Plasticizer, Adhesives and Sealants	IV administration sets IV drug containers IV accessories such as catheters, stopcocks. Luers, Valves Irrigation containers and accessories Feeding containers and accessories Additional Baxter products Electromechanical Devices & Electrical Components
4-tert-butylphenol	Resins, Adhesives, Sealants, Rubber	IV administration sets IV drug containers IV accessories such as catheters, stopcocks, Luers, Valves Irrigation containers and accessories Feeding containers and accessories Additional Baxter products
Tetrabromobisphenol A (TBBA or TBBPA)	Resins, Adhesives, Sealants, Rubber	Electromechanical Devices & Electrical Components IV administration sets IV drug containers IV accessories such as as catheters, stopcocks, Luers, Valves Irrigation containers and accessories Feeding containers and accessories Legacy Hillrom Products Additional Baxter products

For further inquiries on the information provided please contact [email protected]

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REACH EC 1907/2006