The EFSA is being very clear about how important is to indicate which parts of the dossier were already submitted in a previous application, which ones are updated or modified, and which are new.
In the summary, it will be enough to detail the scope of the current application and the inclusion of new information, regarding the identity, safety, and efficacy of the product (as well as important changes in factors such as the manufacturing process or activity of use in comparison with which it has been out on the market).
The second section focuses mainly on the identity, characterization, and conditions of use of the additives. Not only the changes in the product (as well as in any of the production phases) will be described, but also the statistical methodologies used. The guide facilitates the understanding of this through the following example: for those modifications that have an impact on the physicochemical properties of the additive, complementary data on the physical properties, stability and / or homogeneity of the product will be included. The same for when the safety of the product may be susceptible to change (it will need to be complemented with studies that refer to these aspects).
When referring the groups of microorganisms used as additives or as production strains, the guide emphasizes the importance of filling in the necessary information to evaluate and grant the ‘’ QPS status’’, the Qualified Presumption of Safety.
In addition, the results obtained from the post-marketing monitoring plans that have been carried out after the last authorization must be specified.