Public consultation on phthalates in medical devices
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
The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) today publish 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.
Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided Guidelines on the benefit-risk assessment of the presence, in the medical devices specified in the mandate, of phthalates which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction or endocrine-disrupting.
These Guidelines describe the methodology on how to perform a benefit-risk assessment (BRA) for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices and/or or parts or materials used therein at percentages above 0.1% by weight (w/w).
They also consider the evaluation of possible alternatives for these phthalates used in medical devices.
They are intended to be used by the relevant stakeholders e.g. manufacturers, notified bodies and regulatory bodies.
The approach of these Guidelines may also be used for a BRA of other CMR/ED substances present in medical devices.
During the preparation of these Guidelines for BRA of the use of CMR/ED phthalates in medical devices, SCHEER noticed that a number of BRA methodologies are theoretically available. In addition, there is a considerable lack of data for potential alternatives to be used in medical devices. Therefore, manufacturers are encouraged to produce (semi)quantitative data on the use of alternatives for CMR/ED phthalates in medical devices.
Pending on new scientific evidence, it is recommended to evaluate the use and usefulness of these Guidelines after an experience period of three years.
In line with the Stakeholder Dialogue Procedures (Annex V to the Rules of Procedures of the Scientific Committees), the Scientific Committees are now seeking feedback from the scientific community and stakeholders on this Preliminary Guidelines.
All interested parties are invited to submit written comments on the Preliminary Guidelines by 29 April 2019 in view of gathering specific comments, suggestions, explanations or contributions on the scientific basis of the Guidelines, as well as any other scientific information regarding the questions addressed, to enable the Scientific Committees to focus on issues that 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 V), a submission will not be considered if:
- it is submitted after the deadline set out in the call,
- it is presented in any other form than the template provided,
- it exceeds the maximum length indicated for each section, or contains comments which do not correspond to the indicated title of that particular section,
- it contains information on individual cases or any other material not included in published reports,
- it contains complaints against institutions, personal accusations or irrelevant or offensive statements or material. Complaints should be made according to the existing procedures,
- it is related to policy or risk management aspects.
The Scientific Committee will assess all comments from interested parties which are submitted in line with the criteria above and will take them into consideration if they are found relevant.
The European Commission reserves the right to publish all comments received on the Scientific Committees' website. Please read the Privacy statement before submitting comments.
(deadline: 29 April 2019, 23:59 (CET))