The aim of this opinion is to assess whether the use of bisphenol A in medical devices could give reasons for concern from the health point of view and, if possible, to provide indications on limit values for BPA release from medical devices.
In line with the Stakeholder Dialogue Procedures (Annex IV to the Rules of Procedures of the Scientific Committees), SCENIHR is now seeking feedback from the scientific community and stakeholders on the risk assessment related to the safety of the use of bisphenol A in medical devices.
All interested parties are invited to submit written comments on the preliminary opinion by 26 March 2014 in view of gathering specific comments, suggestions, explanations or contributions on the scientific basis of the opinion, as well as any other scientific information regarding the questions addressed, to enable Scientific Committees to focus on issues which need to be further investigated.
The electronic template provided with the documents should be used exclusively for the submission of comments, with reference made to the line and page numbers. Please note that comments submitted by email or post cannot be taken into account.
As stated in the Rules of Procedures (Annex IV), a submission will not be considered if it is:
- submitted after the deadline set out in the call;
- presented in any form other than what is provided for in the instructions and template;
- not related to the contents of the document;
- contains complaints against institutions, personal accusations, irrelevant or offensive statements or material;
- is related to policy or risk management aspects, which is outside the scope of SCENIHR's activities.
The SCENIHR will assess all comments from interested parties which are submitted in line with the criteria above and taken into consideration, if found relevant.
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