The SCHEER was requested to provide 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 legal obligation section from the mandate. 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 e.g. as additives in cosmetics, medical devices, and household products. The interaction of phthalates with the polymers they are embedded in is weak, so they may be released from the plastic product into the environment and into the human body if the product is in contact with it.
The Medical Device Regulation, Regulation (EU) 2017/745 allows the use of CMR 1A/1B and/or ED substances in medical devices above a concentration of 0.1% w/w. when a proper justification can be provided (Annex I, Chapter II Section 10.4). For such a justification several steps need to be considered including the availability of alternative substances, materials, designs, and medical treatments. In addition, the risk associated with such alternatives should be weighed against the risk of the use of CMR 1A/1B and/or ED identified phthalates covered under MDR Annex I Chapter II Section 10.4.1. However, the risk by itself is not the only parameter to consider: also the impact of the possible alternatives on the functionality, performance and the overall benefit-risk ratio of the medical device shall be evaluated.
These Guidelines describe the methodology on how to perform a BRA for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices and/or or parts or materials used therein at percentages above 0.1% by weight (w/w). They also describe the evaluation of possible alternatives for these phthalates used in medical devices, including alternative materials, designs or medical treatments. They are intended to be used by the relevant stakeholders e.g. manufacturers, notified bodies and regulatory bodies. The approach of these Guidelines may also be used for a BRA of other CMR/ED substances present in medical devices.
During the preparation of these Guidelines for BRA of the use of CMR/ED phthalates in medical devices, SCHEER noticed that a number of BRA methodologies are theoretically available. However, there is a considerable lack of data needed for the BRA for potential relevant alternatives to be used in medical devices. Therefore, SCHEER encourages manufacturers to generate data of high quality on such alternatives for CMR/ED phthalates in medical devices. Pending on new scientific evidence, it is recommended to evaluate the use and usefulness of these Guidelines after an application period of three years.
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.
SCHEER (Scientific Committee on Health, Environmental and Emerging Risks),
SCHEER: Wim H. de Jong (Chair and Rapporteur ), Teresa Borges, Rodica Mariana Ion , Demosthenes Panagiotakos, Emanuela Testai, Theo Vermeire.
SCCS members: Ulrike Bernauer, Christophe Rousselle.
External experts: Stéphane Bégué (Etablissement Français du Sang, EFS, Paris, France), Hilde B. M. Kopperud (Nordic Institute of Dental Materials, Oslo, Norway), Maria Rosaria (Istituto Superiore di Sanità, Dip. Ambiente e Salute, Roma, Italy), Tanja Schmidt (Ansbach University of Applied Science, Ansbach, Germany).
Experts from EU Agencies: Francesco Ignatius (European Medicines Agency), Evgenia (European Chemicals Agency), Katarina Volk (European Food & Safety Authority)
18 June 2019. Link