New efficacy guidance for feed additives
The European Food Safety Authority (EFSA) has introduced updated guidance on the efficacy assessment of feed additives, report the Argenta experts.
Key changes include:
- Animal welfare compliance: In vivo trials now require certification from a competent authority or an independent ethical committee to ensure alignment with animal welfare directives.
- Reduced efficacy trials: The number of required efficacy trials has been decreased.
- Zootechnical additives: For enzyme additives, in vitro data can partially replace the need for in vivo trials.
Argenta is running a free-to-access webinar on the topic on October 3.
Antimicrobial resistance in Bacillus species
EFSA has also published a report cataloguing antimicrobial resistance genes in Bacillus species used for producing food enzymes and feed additives, say the regulatory specialists.
"This report is part of EFSA's efforts to standardise and enhance the quality of data used in scientific assessments. It provides an overview and inventory of current practices within EFSA and across national food safety authorities in Europe for assessing the quality of existing and new scientific evidence and explores the methodologies and criteria used to evaluate the reliability, relevance, and adequacy of data that inform risk assessments and regulatory decisions."
The reeport is aimed at those working in the areas of food safety, risk assessment, and regulatory affairs.
Advancements in biotechnology: Microorganisms and genomic techniques
In addition, the risk assessor has released an opinion on the emerging use of microorganisms developed through new genomic techniques (NGTs).
The opinion identifies a variety of products containing microorganisms obtained with new genomic techniques (NGTs), falling within the remit of EFSA, that are expected to be placed on the market in the EU in the next 10 years, reads Argenta's summary.
The review finds no novel risks associated with NGT microorganisms compared to those produced by those obtained by established genomic techniques (EGTs) or by conventional mutagenesis. Notably, the higher efficiency and specificity of NGTs may reduce genome-related hazards.
EFSA concluded that current guidance is "partially applicable" for NGT microorganisms, meaning fewer regulatory requirements may be needed for specific cases.
Updated QPS microorganisms list
The latest update to EFSA's qualified presumption of safety (QPS) list for microorganisms has been announced as well, notes the Argenta team.
The list contains microorganisms, intentionally added to food and feed, which have received QPS status; the data is relevant to professionals in animal nutrition, regulatory affairs, and related fields.
EFSA assesses the safety of microorganisms in the applications it receives for market authorisation of feed additives, food additives, food enzymes, food flavourings, novel food, and plant protection products.
A QPS status is the result of a pre-assessment that covers safety concerns for humans, animals and the environment. During this process, experts assess the taxonomic identity of the microorganism, the related body of knowledge and potential safety concerns .
Microorganisms that are not well defined, for which some safety concerns are identified or for which it is not possible to conclude whether they pose a safety concern to humans, animals or the environment are not considered suitable for QPS status and must undergo a full safety assessment.
The QPS status allows for a harmonized safety assessment approach, simplifying the regulatory process for products that meet the criteria.
