Phthalates SCHEER guidelines update proposal published

The European Commission has launched a public consultation on an update to its guidelines on benefit-risk assessments for medical devices containing phthalates. This is the first time the Commission has proposed updating the guidelines since they were released in 2019.

The proposed update was published on 21 March 2024 by the Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). The guidelines must be updated every five years under the EU Medical Devices Regulation (MDR, 2017/745).

The Commission explained: “Following a request from the European Commission, SCHEER provided the first update of the guidelines on the benefit-risk assessment of phthalates in medical devices specified in the mandate, which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED).”

The guidelines detail the methodology medical device manufacturers should use to perform risk-benefit analysis to justify keeping certain CMR/ED phthalates over the 0.1% threshold in their products or parts that make up their products.

Among the major updates proposed in the guidelines, the committee has updated the description of chemical substances categorized as phthalates as esters of phthalic acid, while also updating the methods and framework sections, and including new information on classifying endocrine-disrupting hazards based on regulations.

Three new annexes are also included, these being:

• Annex 8, on currently used CMR/ED phthalate alternatives
• Annex 9, on the toxicology of currently used CMR/ED phthalate alternative
• Annex 10, on progress in the development of CMR/ED phthalate alternatives for use in blood bags

Stakeholders can comment on the proposed updates to the guidelines on the Commission’s website until 28 April 2024. A publice hearing was initially scheduled for 11 April 2024, but has since been cancelled.