SCHEER - UPDATE 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

SCHEER WG on phthalates
SCHEER members: Teresa Borges, Rodica Mariana Ion, Wim de Jong (Chair and Rapporteur), Renate Krätke, Demosthenes Panagiotakos, Emanuela Testai
SCCS members: Ulrike Bernauer
External experts: Pascal Amireault, Maria Rosaria Milana, Tanja Schmidt
Experts from EU Agencies: Francesco Pignatti, Evgenia Stoyanova, Katharina Volk
Observer (JRC): Hubert Chassaigne
Contact: SANTE-SCHEERec [dot] europa [dot] eu (SANTE-SCHEER[at]ec[dot]europa[dot]eu)
On request from: European Commission
Adopted on: 14 June 2024

Main changes in the first UPDATE of the guidelines

The 2019 “SCHEER guidelines on the benefit-risk assessment of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties” have been revised for the first time after five years. The update was based on experiences with the guidelines and a literature search over the last five years. Changes were included in the following sections:

• Scope: referring to information on the use of the guidelines.
• Introduction: regarding chemical description of substances of the group of phthalates as esters of phthalic acid, and recent regulatory developments.
• Methods: a section was included with the sources of evidence used and the use of the Weight of Evidence (WoE) approach of the SCHEER, and in view of the literature search performed.
• Framework: in the framework for the evaluation of alternatives in the non-phthalate scenario, the terminology of “potential relevant” candidates for assessment as alternatives for CMR/ED phthalates, has been changed into “most relevant” candidates (starting in Step 5 of the framework). While a number of alternatives might be available, the focus should be limited to the likely most relevant alternatives based on a preliminary evaluation of the suitability of the available alternatives. This is to avoid unnecessary extensive evaluation of many alternatives. For the evaluation of alternatives, a minimum number to be evaluated is suggested to be 3, while evaluation of less than 3 alternatives needs to be justified by additional information.
• Framework: Step 1 Description and characterisation of the composition of the medical device. Additional information with reference to (EN) ISO 10993-18 was included.
• New information on regulation regarding ED hazard classification was included (Category 1: known or presumed endocrine disruptors, and Category 2 suspected endocrine disruptors, both for human health and for the environment).
• Annexes: the number of Annexes was extended with Annex 8 that describes the exposure to currently used CMR/ED phthalate alternatives, Annex 9 that describes the health hazards of currently used CMR/ED phthalate alternatives, and Annex 10 that describes progress in the development of CMR/ED phthalate alternatives for use in blood bags.

Keywords:

Update, guidelines, benefit-risk assessment, CMR/ED phthalates, medical devices, SCHEER

Opinion to be cited as:

SCHEER (Scientific Committee on Health, Environmental and Emerging Risks), Update 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, preliminary version adopted on 12 March 2024, final version adopted on 14 June 2024.