Opinion of the Scientific Committee on a request from EFSA related to A generic approach to the safety assessment by EFSA of microorganisms used in food/feed and the production of food/feed additives (Request No EFSA-Q-2004-021) (adopted on 15 April 2005)

In 2003 a working document On a generic approach to the safety assessment of microorganisms used in feed/food and feed/food production prepared by a working group consisting of members of the former Scientific Committee on Animal Nutrition, the Scientific Committee on Food and the Scientific Committee on Plants of the European Commission was made available for public consultation. This proposed the introduction of the concept of Qualified Presumption of Safety (QPS), which could be applied to selected groups of microorganisms. Future applications involving a strain of microorganism falling within a QPS group would be freed from the need for further safety assessment other than any specific requirements introduced as a qualification. Establishing QPS status, as proposed in the document, rested on four pillars: the taxonomic grouping for which QPS is sought; whether sufficient is known about the proposed group of organisms (familiarity) to conclude on their safety; whether the grouping proposed contains known pathogens and, finally, the intended end use. Microorganisms not considered suitable for QPS would remain subject to a full safety assessment. When responsibility for safety assessments formally passed to the European Food Safety Authority (EFSA), EFSA Management asked its Scientific Committee to consider whether the QPS approach could be applied to the safety assessment of microorganisms across the various EFSA scientific panels. In doing so, the Committee was required to take into account the response of the stakeholders to the QPS approach. The Scientific Committee concluded that QPS could provide a generic assessment system that could be applied without compromising on safety to all requests received by EFSA for the safety assessments of microorganisms deliberately introduced into the food chain. Its introduction would make more transparent and aid the consistency of approach across the EFSA panels and make better use of assessment resources by focussing on those organisms that present the greatest risks or uncertainties. QPS could also have a role in the safety assessment of microbial products used as food and feed additives since the QPS status of production strains could inform and aid this part of product assessments. However, the Committee recognised that the concept of QPS as initially proposed did not encompass those safety issues that are product-specific. Consequently, consideration would need to be given to product-specific data and how these could be accommodated within a generic assessment system. Finally the Committee concluded that, to become established as a tool for safety assessment within EFSA, QPS status would have to be determined in advance of and independent of applications of Notifiers. It was further concluded that this would best be done under the aegis of EFSA. The Committee recommended that the more commonly notified organisms should be identified and their suitability for QPS status determined.