The guidance will be published in the next few weeks and will be implemented on March 27, 2021.
Montserrat Cerrato Sánchez, senior regulatory affairs manager, Pen & Tec Consultancy, attended the open session of the 150th Plenary meeting of the FEEDAP Panel meeting of the European Food Safety Authority (EFSA), held on November 19, at which the renewal guidance was adopted, and which observers could attend and ask questions.
The meeting served to highlight some of the key amendments to the existing draft renewal guidance following the comments received during the public consultation.
These included the addition of the requirement for data provision on antimicrobial production data, she said.
“Data on antimicrobial production should be provided in cases where this was not already assessed in the original application. There might be cases in which data should be provided even if, in the first dataset, those were not required, for example, owing to an update on microorganism identification such as the reallocation of a strain to the newly recognized species, Bacillus velezensis, a species known to produce antimicrobial substances,” said EFSA in response to a question put by Cerrato Sánchez.
With regard to genotoxicity, new studies will be required (in compliance with the most recent guidance(s)) if no clear conclusion on genotoxicity could be reached in the previous assessment of the additive, reported the Pen & Tec regulatory affairs specialist. “Additionally, the text now also will refer to the requirement to demonstrate exposure of the target tissue to the active substance in the case of negative results in an in vivo genotoxicity study.”
Coccidiostats data provision
Moreover, the studies required to provide evidence of the maintained susceptibility of coccidiostats need to be completed within two years prior to the date of the submission of the applicant’s dossier, she said. The strains used for susceptibility testing of coccidiostat should not be older than three months.
Another change to the draft worth mentioning, she told us, is that quantitative data on the production and use of the feed additive per target species/categories and geographical distribution are not compulsory anymore, but encouraged:
“EFSA mentioned that these data, if provided, will be taken into account in the assessment of the safety for the target animal species. The guidance will specify that data should cover until up to one year before submission.”
When applicants are providing an extensive literature search as part of the safety update, it should cover at least the period since the last assessment until up to one year before the date of submission of the renewal application. At least two bibliographic databases should be used. For the documentation of the literature search, EFSA encourages applicants to use relevant parts of the PRISMA flow diagram. Additionally, there will be the requirement to do a critical synthesis and comprehensive analysis as part of that safety-orientated literature review, said Cerrato Sánchez.
Brexit and zootechnical feed additive approvals
Beyond questions related to the renewal guidance, observers at the FEEDAP Panel meeting heard about Brexit implications when it comes to the efficacy studies needed for zootechnical feed additive approvals. Typically, for such authorizations, three efficacy studies need to be conducted, in two different locations, at least one of which should be in the EU.
The FEEDAP Panel said studies in this respect that were finalized before the withdrawal of the UK from the EU would be considered as being conducted in the EU. However, any studies finalized after the UK exit from Europe, from January next, would not be considered as having been undertaken in the EU. This does not necessarily invalidate such a study, said the FEEDAP Panel, but another trial would have to be performed, beyond the UK, in a market within the EU-27 when applying for an EU zootechnical feed additive authorization.
EFSA is also drafting guidance on efficacy in relation to the new functional group of technological feed additives - hygiene condition enhancers - which should be made available to the panel for discussion in Q1 2021, said Cerrato Sánchez.
The Authority’s guidance concerning the safety of use of additives for users/workers still needs to be updated, but, due to EFSA’s workload and the COVID-19 situation, that update won’t take place before summer 2021, noted the consultant.