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Guidance on the assessment of the safety of feed additives for the environment

EFSA Panel on Additives and Products or Substances used in Animal Feed (EFSA FEEDAP Panel) et al. EFSA J. .

Abstract

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives used in animal nutrition. It specifically covers the assessment of the safety for the environment. [Table: see text].

Keywords: environment; feed additives; guidance; risk assessment.

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Figures

Figure 1
Figure 1
Quick‐check – Environmental Risk Assessment: Phase I
  1. *PEC in ground water is set equal to PEC in pore water (see Section 2.6.2).

Figure 2
Figure 2
Decision scheme for assessing PBT or vPvB properties of the feed additive
Figure 3
Figure 3
Phase II decision tree for the environmental risk assessment of soil and aquatic compartment for terrestrial animals (PECA and PECB concern PECs for soil, groundwater, surface water and sediment recalculated using procedures described in Sections 3.3.1–3.3.5 and Section 3.4, respectively; PNECI and PNECR are initial and refined PNECs calculated using procedures described in Sections 3.3.6 and 3.5, respectively)
Figure A.1
Figure A.1
Tiers in an effect assessment scheme, showing the refinement of the process through the acquisition of additional data (redrafted after EFSA PPR Panel, 2013)

References

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