Product: Medical devicesService: Hospital services

Order establishing the concentration levels of di-(2-ethylhexyl) phthalate above which the use of tubing containing said substance is prohibited under Article L5214-1 of the French Public Health Code

Article L5214-1, as amended by Law No 2016-41, prohibits use of tubing containing di-(2-ethylhexyl) phthalate (DEHP) in paediatric, neonatal and maternity services. The aim of the draft order is to establish the levels of di-(2-ethylhexyl) phthalate (DEHP) above which the use of tubing containing said substance is prohibited.The draft national regulation sets the maximum concentration of DEHP at 0.1 % weight by weight (w/w) of plasticised material, above which the use of said tubing is prohibited.This limit is not necessarily applicable to all types of tubing used. It is thus laid down that, if alternatives for certain categories of medical devices designated on a restrictive basis are not currently available, the maximum permitted level of DEHP should be increased to 40 % w/w of plasticised material. This limit corresponds to that set out in monograph 3.1.1.2 of the European Pharmacopoeia (8th edition) (Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components).The notified draft order references the provisions applicable to DEHP present in electrical and electronic equipment, set out in Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment, as amended by Commission Directive (EU) 2015/1787.