The Registration of Animal Feed Additives in the EU – Improving Time to Market London, UK
Posted 15 June 2016
Pen & Tec Consulting held a 2-day practical course with interactive workshops to provide training on the entire procedure for obtaining a marketing authorisation for a feed additive in the European Union, under Regulation (EC) No 1831/2003 and Regulation (EC) No 429/2008. The course was designed to help applicants avoid unnecessary delays in the registration process and speed up time to market.
An important part of the course was devoted to working on case studies in the workshop sessions, showing participants all the data requirements needed to obtain a feed additive marketing authorisation. This included an assessment of strategic options, planning timelines and the construction of a complete EU regulatory plan. Some of the other topics covered are summarised below:
GMMs and their products intended for feed use
Due to the diversity of genetically modified microorganisms (GMMs) and their products intended for animal consumption, four categories are distinguished depending on the nature of the product and on the information required for the risk assessment. These can range from single compounds such as purified amino acids or vitamins, to pure cultures of viable GMMs such as probiotics.
The course covered the scientific information that should be provided in applications, including a comprehensive characterisation of the recipient/parental organism, the donor of the genetic material, the genetic modification and the final genetically modified microorganism. Depending on the specific case, data on composition, toxicity, allergenicity, nutritional value and environmental impact should be submitted. Failure to provide this information can result in EFSA asking additional questions and extending the evaluation period, increasing the time it takes to bring your product to market.
If you are interested in registering a feed additive derived from a GMM, Pen & Tec can help identify the correct category, data requirements and advise on the most suitable and quickest market entry options.
Design and reporting of animal studies
The aim of tolerance tests is to provide an evaluation of the potential toxicity of the additive to the target animals and to establish a margin of safety, whereas efficacy studies must prove the positive effect of the additive at the recommended dose.
Pen & Tec Consulting can show applicants how to conduct and report studies concerning safety for the target animal, as well as efficacy trials according to the additive use, animal species and category. This includes advice on the adequate statistical power (include at least six replicates!), relevant end-points, appropriate statistical analysis (Tukey, Scheffé, Dunnet) or the possibility of conducting a meta-analysis.
If you follow the right steps on designing, checking and analyzing the raw data of animal studies, you can avoid questions from EFSA during the evaluation period and prevent unnecessary delays!
Please note that EFSA plans to revise all guidance documents used in the feed additive area during 2016. This task will likely be finalised by the end of 2017. Pen & Tec will keep up to date with the latest changes in animal feed legislation and guidelines in Europe, and can help applicants with existing or future challenges encountered when registering feed additives.