Safety assessments of twelve feed additive applications
This is a collection of all the safety assessments for the twelve applications for feed additives for use in animal feed.
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), for eleven of the feed additives, outlined in the linked safety assessments. FSA/FSS risk assessors have reviewed the EFSA opinions for these applications, listed in the context of intended GB use. For the twelfth application, RP1059 3-nitrooxypropanol (3-NOP) (Bovaer® 10), this has undergone a full FSA/FSS safety assessment. The FSA/FSS conclusion is that all the additives are safe, at the intended concentrations of use.
Twelve 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.
Under current operating arrangements for Northern Ireland, businesses seeking a new authorisation for a regulated feed product to be placed on the Northern Ireland market will continue to follow EU rules. From Autumn 2023, the Windsor agrifood Framework will allow UK public health standards to apply for retail goods moved via the green lane and placed on the NI market. Therefore, goods moving via this route containing GB authorised products will be able to be placed on the NI market.
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 assessments have been reviewed to ensure they are appropriate for GB risk analysis. The result of the assessment is that the EFSA scientific opinions are adequate also for GB considerations. FSA and FSS risk assessors have reviewed the EFSA opinions for eleven of the applications below in the context of intended GB use and have concluded that the intended uses are safe. For the twelfth application, RP1059 3-nitrooxypropanol (3-NOP) (Bovaer® 10), this has undergone a full FSA/FSS safety assessment, including full review of the applicant dossier for ruminants (animals that chew the cud) for milk production and for reproduction. The views of the Animal Feed and Feed Additives Joint Expert Group (AFFAJEG) and the Advisory Committee on Animal Feedingstuffs (ACAF) have been taken into account in the FSA/FSS safety assessment for this application.
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.
The uncertainties for each of the opinions is explored in the individual assessments.
The opinions have informed the risk proposal for risk management that is subject to public consultation. Following this process, there 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.
RP1052 Assessment of the application for L-lysine monohydrochloride and concentrated liquid L-lysine (base) produced by fermentation with Corynebacterium glutamicum KCCM 80216 or KCTC 12307BP as a feed additive for all animal species