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SCHEER draft guidelines on phthalates in medical devices to be published shortly

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is due to publish its preliminary report on phthalates in medical devices on this webpage on 18 March 2019, following the committee’s September 2017 acceptance of the benefit-risk assessment request from the European Commission’s Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs.

In addition, the Commission and SCHEER are holding a joint public hearing in Brussels on the Preliminary Guidelines on 4 April 2019. Interested parties will be invited to submit comments on the scientific evidence online before 29 April 2019, via an electronic template.

The full title of the consultation is ‘Public consultation on the Preliminary 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.’

Potential attendees at the consultation must register in advance and will be asked to provide full professional details, to specify the subject they wish to address in the hearing and to submit a 1-2 page technical justification for their request. Persons attending the hearing should be scientists with appropriate expertise in the field who can present and understand the scientific arguments.

Persons attending the hearing who wish to make presentations are requested to limit these to scientific matters related to the subject (for example, to provide additional scientific evidence, discuss interpretation of data or clarify data). Invitees shall under no circumstances engage in public relations or lobbing activities.

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