Latest EFSA Guidance on the assessment of the safety of feed additivesfor the environment replaces the 2008 version: Find out what is new!

Posted 23 April, 2019

The EFSA Guidance on the assessment of the safety of feed additives for the environment, adopted by the FEEDAP Panel on 27 February 2019, has recently been published and has replaced the 2008 version of the document. This new EFSA guidance addresses much more detailed & up-to-date strategies for conducting and reporting environmental risk assessments (ERAs) to be included as part of application dossiers for the EU registration of feed additives.

Moving ahead with the times, modern techniques and constantly evolving tools for data collection, EFSA has launched this guidance considering the increasing complexity of accurate safety assessments and specific protection goals, post marketing monitoring needs, data requirements and calculations of quantitative structure-activity relationships, among other features not covered by the previous version. As an example, screening & assessment of persistent bioaccumulative & toxic substances (PBTs) are now explicitly described. On the other hand, while Phases I & II of the environmental safety assessment are the same as in the 2008 version, the original three-step decision tree consists now of a more elaborated set of exclusion criteria for deciding the need of a second phase assessment. Similarly, Phase IIC has been added on top of Phase IIA & IIB, considering more refined calculations for PEC (predicted environmental concentration) & PNEC (predicted no effect concentration). In addition, there is a separate section describing a literature review procedure to support feed additives’ environmental safety and, last but not least, an extensive appendix section which will help applicants find relevant applications & examples of the ERA methodologies proposed by EFSA in this guidance.

Along with the guidance, the Outcome of the Public Consultation, held between October & November 2018, has been made available on the EFSA webpage (see link). Pen & Tec has participated in this public consultation, along with another 10 stakeholders and members of the scientific community throughout Europe, who provide input and comments strongly emphasising the need of clarity & consistency within not only the discussed document, but also with other current EFSA guidance & EU regulations related to feed additives. These comments have been assessed and taken into account by EFSA to produce the final guidance document, available in the EFSA Journal from 5 April 2019 (see link).