For a better user experience please update your browser or use Chrome or Firefox browser.
Utilities
Publication detail
HomeUpdate of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties
Latest edition.
Publication metadata
The SCHEER was requested to provide an update of the guidelines on the benefit-risk assessment (BRA) of the presence, in the medical devices specified in the regulation, of phthalates, which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED), according to the criteria outlined in the mandate. Only minor changes were included in this update regarding terminology for selection of alternatives for the CMR/ED phthalates. The main text describing the selection and evaluation procedure remains essentially the same as presented in the guidelines as published in 2019. The update mainly concerns the progress made in the last five years regarding the application, exposure and toxicology of alternatives for the phthalate plasticisers in medical devices which is presented in additional Annexes. Phthalates are widely used in industry as plasticisers of polymers, in a variety of applications such as coated fabrics and roofing membranes, as well as in medical devices, adhesives, paints, inks and enteric-coated tablets. Di-(2-(ethylhexyl) phthalate (DEHP) is the most widely used phthalate in medical devices. Dimethyl phthalate (DMP) and diethyl phthalate (DEP) are not used as plasticisers but for other purposes e.g. as additives in cosmetics, medical devices, and household products.
- Published:
- Corporate author(s): Directorate-General for Health and Food Safety (European Commission)
- Themes: Consumers' health , Scientific and technical research
- Subject: adjuvant , carcinogenic substance , endocrine disruptor , health risk , medical device , public health , regulation (EU) , reproductive health , toxic substance
|
PDF
|
|||
| ISSN 2467-4559 | ISBN 978-92-68-28232-8 | DOI 10.2875/3841716 | Catalogue number EW-01-25-070-EN-N |
- Released on EU publications website:
Document viewer
Note:
The publication cannot be displayed in the document viewer. Open web version
You may access it from: Download and languages