EFSA's Scientific Committee has launched an open consultation on a draft Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals. This document describes harmonised risk assessment methodologies for combined exposure to multiple chemicals for all relevant areas within EFSA’s remit, i.e. human health, animal health and ecological areas. First, a short review of the key terms, scientific basis for mixtures risk assessment and approaches to assessing (eco)toxicology of chemical mixtures is given, including existing frameworks for these risk assessments. This background was evaluated, resulting in a harmonised framework for risk assessment of mixtures of chemicals. The framework is based on the risk assessment steps with tiered and stepwise approaches for both whole mixture approaches and component-based approaches. Specific considerations are given to component-based approaches including the grouping of chemicals into common assessment groups, the use of dose addition as a default assumption, approaches to integrate evidence of interactions and the refinement of assessment groups.
Interested parties are invited to submit written comments by 15th September 2018 at midnight (CET time). Please use the electronic template provided to submit comments and refer to the line and page numbers. Kindly note that after 2 hours of non-activity your working session will expire and comments submitted after that time will not be recorded and transmitted. Therefore, if the page is left inactive for more than 2 hours, please re-open it from the link before restarting to comment. If you would like to submit additional data to support your comments or file send an email to: SCER.PublicConsult.EUS.003 [at] efsa.europa.eu. Please note that comments will not be considered if they:
- are submitted after the closing date of the consultation
- are presented in any form other than what is provided for in the instructions and template
- are not related to the contents of the document
- contain complaints against institutions, personal accusations, irrelevant or offensive statements or material
- are related to policy or risk management aspects, which is out of the scope of EFSA's activity.
EFSA will assess all comments from interested parties which are submitted in line with the criteria above. The comments will be further considered by the EFSA Scientific Committee and taken into consideration if found to be relevant.
Persons or organisations participating in a Public Consultation of EFSA, are responsible for ensuring that they hold all the rights necessary for their submissions and consequent publication by EFSA. Comments should inter alia be copyright cleared taking into account EFSA’s transparency policy and practice to publish all submissions. In case the submission reproduces third-party content in the form of charts, graphs or images, the required prior permissions of the right holder(s) should have been obtained by the PC respondent.
Publication of contributions
Contributions will be published and may be re-used by EFSA in a different context. It should be noted that contributions submitted by individuals in a personal capacity will be published as such, indicating the author’s first and family name, unless a substantial justification for protection is provided by the respondent. Contributions submitted on behalf of an organisation are also made publicly available and attributed to the organisation in question.