EU Regulates the Use of Phthalates in Medical Devices
The proposed amendment requires the ban of substances that are classified or recognized as
1. Carcinogenic, Mutagenic or toxic to Reproduction 1A or 1B (CMR, in accordance with Regulation (EC) No 1272/2008), or
2. Endocrine Disruptors (EDCs)
In concentrations above 0.1% by mass of homogeneous material, contained within medical devices that come into contact with the human body. The regulation states that such substances would be phased out within 8 years, should safer alternatives become available.
Extended Safety Requirements for Pregnant or Nursing Women
If specific medical devices are meant for the treatment of children, pregnant or nursing women, phthalates, which are classified as CMR, should be banned as of 1 January 2020. The only exceptions are the cases when the manufacturer has the ability to prove that no other safer substances are available, in which case the device’s labeling and (or) packaging needs to clearly indicate the presence of substances that are classified CMRs 1A or 1B or as EDCs.
The proposed Regulation also covers devices that contain or consist of nanomaterials that can be released in the human body. In accordance with the amendments, manufacturers are required to incorporate evidence as part of the device’s technical documentation or instructions, which demonstrates that the use of nanomaterials is in compliance with safety and performance requirements and standards.
(1) Report on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 – C7-0318/2012 – 2012/0266(COD))
About SGS Electrical and Electronics Services
SGS is committed to keeping readers up to date on the latest regulations and policies concerning the use of hazardous substances in medical devices (http://www.sgs.com/
Feel free to contact an SGS expert should you require more information.
SGS Consumer Testing Services
Product Line Manager - Medical Devices
SGS Fimko Ltd
FI-00211 Helsinki, Finland
t: 358 40 560 9500
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.