Public consultation on Guidance for the identification of biological relevance of adverse/ positive health effects from experimental animal and human studies

EFSA’s Scientific Committee has developed a draft guidance document providing generic issues and criteria to consider biological relevance, particularly when deciding on whether an observed effect is of biological relevance, i.e. is adverse (or shows a positive health effect) or not. The opinion clarifies a number of definitions and concepts, such as, responses of a biological system to exposure, mode of action and adverse outcome pathways, thresholds, critical effect, modelling approaches, biomarkers, which are central to biological relevance and in order to achieve that these concepts are used in a consistent way across EFSA areas of activity. Several case studies covering the various EFSA areas are referred to in the guidance and annexed to the opinion to illustrate the proposed approach. Following this public consultation, the scientific committee will review the contributions and consider them in developing the final version of the guidance document.

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders, EFSA has launched public consultations on this draft document. Interested parties are invited to submit written comments by 1 May 2017.

Please use the electronic template provided to submit comments and refer to the line and page numbers of the respective document. A generic comments field is also available in this online tool. Please note that after 2 hours 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 a while, before restart commenting, we advise you to refresh or re-open the page from the link.

If you would like to submit data-sets to support your comments or submit files send an email to: SCER.PublicConsult.85 [at] efsa.europa.eu (SCER[dot]PublicConsult[dot]85[at]efsa[dot]europa[dot]eu)

Please note that comments will not be considered if they:

• are submitted after the closing date of the public consultation;
• 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 are 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 EFSA’s Scientific Committee and taken into consideration if found to be relevant.

All comments submitted will be published. Comments submitted by individuals in a personal capacity will be presented anonymously. Comments submitted formally on behalf of an organisation will appear with the name of the organisation.