Panel members at the time of adoption
This new Guidance will become mandatory as of 21 April 2022.
During the six-month transition period to the new guidance, EFSA is still using the previous version, available at https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2009.1305, the Statement on microbial characterisation (available at https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2019.5741) and the Statement on dietary exposure (available at https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2016.4581). Starting from 21 April 2022, the new Guidance supersedes these three aforementioned guidance documents.
In view of the new scientific requirements becoming mandatory as of 21 April 2022, applicants are encouraged to start using already the new guidance when preparing data.
Following a request from the European Commission, EFSA developed an updated scientific guidance to assist applicants in the preparation of applications for food enzymes. This guidance describes the scientific data to be included in applications for the authorisation of food enzymes, as well as for the extension of use for existing authorisations, in accordance with Regulation (EC) No 1331/2008 and its implementing rules. Information to be provided in applications relates to source, production and characteristics of the food enzyme, toxicological data, allergenicity and dietary exposure estimation. Source, production and characteristics of the food enzyme are first considered only for enzymes of microbial origin and subsequently for those enzymes derived from plants and for enzymes from animal sources. Finally, the data requested for toxicology, allergenicity and dietary exposure applies to all food enzymes independent of the source. On the basis of the submitted data, EFSA will assess the safety of food enzymes and conclude whether or not they present a risk to human health under the proposed conditions of use.
This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6850/full