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Registration of Animal Feed Additives in the EU (European Union) Training Course
This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
Details
Course overview
The EU has transformed its food legislation in the last two decades, creating the European Food Safety Authority (EFSA) and adopting a harmonised approach to food safety ‘from farm to fork’. The Feed Additives Regulation (Regulation (EC) No 1831/2003), which applies to all feed additives and pre-mixtures, establishes a common procedure across the EU for authorising animal feed additives and lays down rules for their placing on the market, labelling and use. Since the 2021, the new EU Transparency Regulation (EU) 2019/1381 has applied to all regulated products in the food chain, including feed additives. This means big changes to the way that food business operators/applicants write & submit their feed additive dossiers.
Obtaining marketing approval for a feed additive in the EU is complex and this practical and interactive two-day course will provide a comprehensive introduction to the entire regulatory dossier submission, taking participants through all the necessary steps to obtain marketing authorisation in line with the new EU regulation on transparency.
Presentations will cover the regulatory framework and data required to establish the characterisation, quality, safety and efficacy of the different types of feed additives. An important part of the programme will be devoted to working on case studies in the workshop sessions, which have been designed to help consolidate learning, and there will be ample time for discussion with our expert faculty. We will also focus on the Transparency Regulation and explain the new procedure for feed additive approvals.
Benefits of attending:
- Gain a comprehensive overview of the EU regulatory framework and relevant legislation
- Understand the roles of the EU Commission, the EURL, EFSA and Member States, and learn about how the new EU Regulation on Transparency will affect the feed additive approval process
- Discuss types of feed additives and acceptable claims
- Clarify the data required – product characterisation safety, quality and efficacy
- Get to grips with EC, EURL and EFSA guidelines and guidance documents
- Learn how to conduct a strategic data audit and gap analysis
- Better manage EU registration projects
- Master the art of writing successful feed additive dossiers
- Discuss post-submission hurdles – dossier validation and EFSA clock-stops
- Know how to interact with the EU Commission, Member States and EFSA
Who should attend?
- Managers working in:
- Regulatory affairs
- Marketing
- R&D
- Product development
- Scientists in CROs where clients demand EFSA-compliant studies
- Those seeking to review special problems in the registration of feed additives in the EU
Programme
EU Regulatory Framework - the Basic Legislation and Procedures
EU Transparency Regulation – main changes and outline of new procedures
EURL and EFSA Guidance Documents, EFSA Open Portal
Workshop: Strategic Planning - Matching Commercial and Regulatory Objectives
Notification of studies on the EFSA Open Portal
Section II - Characterisation and Quality Requirements
Workshop: Building Section II
Workshop on microorganism safety & whole genome sequence requirements
Section III - Safety for Target Animals, Consumers, Users and the Environment
Workshop: Building Section III
Section IV - Efficacy
Good Study Design - Ticking the EFSA Boxes
Workshop: Building Section IV
Writing and Managing the Dossier, e-submission food chain platform
Final Discussion, Questions and Answers
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We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.