Safety Assessment RP1591 Fumonisin Esterase

In accordance with Retained EU Regulation 1831/2003 on feed additives, the application RP1591 for the authorisation of fumonisin esterase (FUMzyme) as a feed additive for use in all species, from DSM Nutritional Products has been submitted for authorisation in GB. Whilst it was a Member State of the EU, UK accepted the assessments of EFSA in respect of authorisations for regulated food and feed products. Since the end of the transition period, FSA/FSS has adopted equivalent technical guidance and quality assurance processes to be able to undertake GB risk assessments for regulated product applications. Where EFSA, prior to the end of the transition period, evaluated an application for the product for which an application is now made to GB, FSA/FSS has decided to make use of the EFSA risk assessment, where this is appropriate, in forming its opinion. Therefore, FSA/FSS risk assessors have reviewed the EFSA opinion 2 for the application below in the context of intended GB use and have concluded that the intended uses are safe. In reviewing the output of the EFSA risk assessments the reviewers have verified that the standard approach as outlined in the relevant guidance3 has been followed and the arguments made are consistent with the data summarised in the opinion. Consideration has been given to the processes undertaken to ensure the opinions are robust and whether there are any aspects that would require further review such as specific issues for the countries of GB. The result of the assessment is that the EFSA scientific opinion is adequate also for GB risk analysis. Therefore, a full risk assessment has not been performed by FSA/FSS.