This document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 17.3 of Regulation (EC) No 1332/2008, for the authorisation of food enzymes. It specifically covers the characterisation of ...
The EFSA Scientific Committee addressed in this document the peculiarities related to the genotoxicity assessment of chemical mixtures. The EFSA Scientific Committee suggests that first a mixture should be chemically characterised as far as possible. Alth ...
The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically ...
This statement describes the approach followed by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for performing refined exposure assessment in the framework of the re-evaluation of already permitted food additives. Estimation of ...
In preparation of receiving dossiers on food enzymes, in 2009, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids published guidance on data requirements and methodologies foreseen in the risk assessment of food enzymes. Ba ...
This statement addresses a request to EFSA from the Dutch Ministry of Health, Welfare and Sport to assess the impact of recent evidence underlying the conclusions of the 2016 RIVM report on the t-TDI for BPA of 4 μg/kg bw per day set by EFSA in 2015. The ...
The pre-market environmental risk assessment (ERA) of regulated products such as genetically modified organisms, plant protection products and feed additives is an important process to safeguard the desired level of protection of the environment and biodi ...
Since its foundation, EFSA and the Member States have made significant progress in the area of data collection for risk assessment and monitoring. In partnership with competent authorities and research organisations in the Member States, EFSA has become a ...
Microbiological risk assessment is defined by the CODEX Alimentarius Commission as ‘a scientifically based process consisting of the following steps: (i) hazard identification; (ii) hazard characterisation; (iii) exposure assessment; and (iv) risk charact ...
Methodologies for integrating (weighing) evidence and assessing uncertainties are of utmost importance to ensure that scientific assessments are transparent, robust and fit for purpose to support decision-makers. One of the key challenges remains the deve ...