Animal dietary exposure: overview of current approaches used at EFSA

Abstract

At EFSA, animal dietary exposure estimates are undertaken by several Panels/Units to assess the risk of feed contaminants, pesticide residues, genetically modified feed and feed additives. Guidance documents describing methodologies for animal dietary exposure assessment are available both at EFSA and international levels. Although appropriate within pertinent regulatory frameworks, the methodologies used to assess animal dietary exposure vary across risk assessment areas. There are different approaches ranging from quick worst-case estimations to more refined methods assessing actual exposure, resulting from the use of a heterogeneous selection of animal populations and default values to estimate feed intake. Furthermore, current feed classification systems in place at international and national levels contain a large and heterogeneous number of feed materials, which may benefit from further harmonisation efforts. This technical report presents an overview of the current approaches in place at EFSA to assess the exposure to chemicals in feed. The possibility for a greater harmonisation of feed classification and terminology is also addressed by comparing the structure of the EU catalogue of feed materials and the Harmonised OECD tables of feedstuffs derived from field crops with the EFSA FoodEx2 system.

Animal dietary exposure in the risk assessment of feed derived from genetically modified plants

“…The EFSA GMO Panel aims to provide advice for applicants, and also for the risk analysis community, 6 on how to report information and to improve consistency on estimates of expected ADE in applications for authorisation of GMPs under Regulation (EC) No 1829/2003. This expands on information available in Regulation (EU) 503/2013, in the guidance document on risk assessment of food and feed from GM plants (EFSA GMO Panel, 2011 ), in the EFSA scientific report on animal dietary exposure (EFSA, 2019b ), and EFSA (e.g. EFSA FEEDAP Panel, 2017 ) or other international (OECD, 2009a , 2013 ) guidelines for animal dietary exposure in other risk assessment contexts (e.g.…”

“…The lack of a harmonised feed classification system and of a comprehensive database of EU feed consumption (EFSA, 2019b ) has resulted in expected ADE estimates to NEPs based on different and customised approaches, characterised by: (i) heterogeneous selection of animal species and categories, (ii) heterogeneous selection of feed materials entering the final diet or ration used to estimate overall exposure to the target substance and (iii) the use of a variety of predefined default values publicly available for the total daily amount of feed consumed, feed inclusion rate in standard diets, animal body weight and the type of productivity (e.g. milk production) and the physiological status, to predict feed intake in animals.…”

“…The main sources used are the OECD guidance documents (OECD, 2009a , 2013 ) and the recommendations given in the FEEDAP Guidance (e.g. EFSA FEEDAP Panel, 2017 ), as recently described (EFSA, 2019b ). In a limited number of cases, applicants have used ad hoc references from the literature, which were considered on a case‐by‐case basis by the EFSA GMO Panel (see Table 3 ).…”

“…The absence of a harmonised feed classification system and of a comprehensive database of EU feed consumption results in different and customised approaches for expected ADE estimates to NEPs, based on publicly available sources of default values for the animal body weight, the total amount of feed consumed daily and the inclusion rate of feed materials in standard diets and rations (EFSA, 2019b ).…”

“…An EFSA procurement 11 is ongoing to explore the feasibility of implementing a harmonised feed classification system and developing an EU feed consumption database, to support a more accurate estimation of expected ADE, by approaching the standards in place for human dietary exposure (EFSA, 2019b ). Until this procurement is completed, the EFSA GMO panel is not in the position to propose specific feed consumption data and therefore suggest to continue using an approach based on predefined default values publicly available for body weights, total daily intakes and inclusion rate of feed materials in standard diets or rations, to predict feed consumption in animals.…”