EU’s Revised Phthalates Guideline Features New Annexes Focused On Alternatives

The effects of phthalates, plasticizers used in many medical devices, on the human endocrine system, have long been debated. But how safe are the alternatives? Updated guidelines give more insight.

Phthalates Hazard
• Source: Shutterstock: Gustavo Frazao

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) adopted its revised guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices during its plenary meeting on 12 March 2024. This was three months ahead of its deadline.

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