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

Edited on 06/27/2023
Author: 
Commission Européenne
Year of publication: 
2019
Source type: 
Institutionnel
Description: 

This document provides guidelines for assessing the risks/benefits of phthalates (classified as CMR or PE) and their alternatives in medical devices, in order to compare them and potentially avoid a regrettable substitution.

1 Carcinogenic Mutagenic Reprotoxic

2 Endocrine disruptor