DEHP Regulated in Certain Medical Devices in North Carolina, USA
GENEVA, SWITZERLAND / AGILITYPR.NEWS / August 21, 2025 / SGS, the world’s leading testing, inspection and certification company, has published SafeGuardS 119.25, summarizing North Carolina’s ban on di(2-ethylhexyl) phthalate (DEHP) in intravenous (IV) bags and tubing.
SB 600 (session law 2025-60) was signed on July 3, 2025, regulating DEHP in IV solution containers and tubing. This amendment adds Article 19C, DEHP Hazard Management, to Chapter 130A of North Carolina’s General Statutes on public health. Stakeholders should be aware, California has also regulated DEHP in IV bags and tubing.
DEHP is commonly used in medical devices as a plasticizer to increase flexibility.
The new law includes the following definitions:
- ‘IV solution container’ means a container used to house medicine, fluid or nutrition therapy that is intravenously delivered to a patient in a hospital, outpatient facility or other healthcare facility
- ‘IV tubing’ means tubing used to intravenously administer fluids, medication or nutrients directly to an adult, child or infant
- ‘Ortho-phthalate’ means a class of chemicals that are esters of ortho-phthalic acid, including all the chemicals listed in SafeGuardS 119.25
SGS experts publish SafeGuardS to inform stakeholders about regulatory changes that could impact their business. SafeGuardS 119.25 includes useful tables summarizing key highlights of SB 600, including effective dates, as well as abbreviations for ortho-phthalates.
Stakeholders are encouraged to refer to the original SafeGuardS 119.25 for more details.
SGS chemical testing services
SGS offers a comprehensive range of testing services to help manufacturers and suppliers ensure their products are safe and comply with national and international regulations concerning harmful chemicals. In the end, it’s only trusted because it’s tested. Learn more about SGS’s chemical testing services.
SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full North Carolina, USA, Regulates DEHP in Certain Medical Devices SafeGuardS.
Subscribe today and receive SGS SafeGuardS direct to your inbox.
For further information, contact:
Dr. HingWo Tsang
Global Information and Innovation Manager
Tel: +852 2774 7420
Website: www.sgs.com/hardlines
LinkedIn: SGS Connectivity & Products
About Us
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
Contacts
Ben Christie
ben@sugarloafmarketing.comSugarloaf Marketing, Broad Oak, UK
Phone: 07933563883
www.sugarloafmarketing.com