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Risk assessment

Assessment of two novel foods, and miscellaneous regulated products applications under the relevant EU retained law

England and Wales specific

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have undertaken an assessment to quality assure risk assessments conducted by the European Food Safety Authority (EFSA), of two novel foods, one food additive and one flavouring application as outlined in the linked assessments.

Background

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have undertaken an assessment to quality assure risk assessments conducted by the European Food Safety Authority (EFSA), of two novel foods, one food additive and one flavouring application as outlined in the linked assessments. FSA/FSS risk assessors have reviewed the EFSA opinions for the applications listed in the context of intended GB use and have concluded that the intended uses are safe.  

Summary

Four applications have been submitted for authorisation in each nation of Great Britain (GB), where the decision on authorisation is made by the respective Ministers in England, Scotland and Wales. 

In respect to Northern Ireland, EU Food Law on NFs continues to apply under the current terms of the Protocol on Ireland/Northern Ireland (NIP). This means the four applications require authorisation under the EU’s authorisation procedures, before being placed on the market in Northern Ireland.  

Whilst it was a Member State of the EU, the UK accepted the assessments of EFSA in support 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 make independent GB risk assessments. Where EFSA, prior to the end of the transition period, evaluated an application for a product for which an application is now made to GB, FSA and FSS has decided to make use of the EFSA risk assessment, where this is appropriate, in forming the GB safety assessment.  

The EFSA risk assessment has been reviewed to ensure it is appropriate for GB risk analysis. The result of the assessment is that the EFSA scientific opinion is adequate also for GB considerations. FSA and FSS risk assessors have reviewed the EFSA opinions for the applications below in the context of intended GB use and have concluded that the intended uses are safe.  

The FSA/FSS safety assessment for each application is published within a separate report at the links below. These represent the opinions of the FSA and FSS in relation to these dossiers. 

Key uncertainties

The uncertainties for each of the opinions is explored in the individual assessments.  

Next steps

The opinions have informed the risk proposal for risk management that is subject to public consultation. Following this process they will be supporting evidence to be considered by Ministers to inform decision making on whether to authorise the individual applications for use in England, Scotland and Wales.  

Risk assessments

RP1292 Assessment of the safety of the extended uses of UV-treated Baker’s yeast (S. cerevisiae) as a novel food

RP1158 Assessment of the safety of Vitamin D2 Mushroom (Agaricus bisporus) powder as a novel food ingredient

RP1382 Assessment of new Flavouring Substance 3-(1-((3,5-dimethylisoxazol-4-yl)methyl)-1H-pyrazol-4-yl)-1-(3-hydroxybenzyl)imidazolidine-2,4-dione

RP1194 Assessment for the Application for a change in the Steviol Glycoside Specification in Great Britain to Include a New Manufacturing Method for Steviol Glycosides Including Rebaudioside M.