EU Phthalates in Devices Guidelines Updated

The Scientific Committee on Health, Environmental and Emerging Risks is refining its existing guidelines for the benefit-risk assessment of medical devices containing phthalates known to be carcinogenic, mutagenic, toxic to reproduction or have endocrine-disrupting (ED) properties.

Some of the changes include:

• New information regarding ED hazard classification as Category 1 (known or presumed endocrine disruptors) and Category 2 (suspected endocrine disruptors, both for human health and for the environment)
• New annexes that describe the exposure to currently used phthalate alternatives; the health hazards of currently used phthalate alternatives; and progress in the development of phthalate alternatives for use in blood bags

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