Registration of Animal Feed Additives in the EU
19-20 June 2023 – ONLINE
This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.
The registration is OPEN NOW.
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
- Managers working in:
- Regulatory affairs
- 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
Rocío Duchén Bocángel
Rocío Duchén (MSc) is a chemist, with experience in research, technical translation and consulting. Rocío has worked in research fields including biochemistry, natural products and food additives, as well as in the development and validation of analytical methods. She is currently a Senior Regulatory Affairs Manager at Pen & Tec Consulting and, since her incorporation in 2017, she has broadened her experience on dossier preparation and study monitoring for the registration of food and feed EU regulated products, including technological and zootechnical feed additives, renewals, food additive applications and novel food consultations. Her day-to-day experience in the EU regulatory context gives her the chance to keep up to date on the latest updates to the food law, authorities’ procedures, guidance documents and newest online tools available for applicants willing to register their products in the EU.
Caroline Idowu (MChem) is a chemist by background and has been working at Pen & Tec Consulting since 2019. During her time at Pen & Tec and her current role as Regulatory Manager, she has been involved in a wide range of projects along each stage of the EU authorisation process for both animal feed and food including food improvement agents and novel foods.
She has experience in assessing the regulatory feasibility of new products, data auditing, dossier compilation/submission and report reviewing. She is focussed on working closely with clients at every stage of their regulatory journey to help bring their products to market.
Day 1. Start at 9:30h CET / 8:30h UK time
09:30 – 09:45h CET: Introduction & Objectives
09:45 – 10:15h CET: EU Regulatory Framework – the Basic Legislation and Procedures
10:15 – 10:45h CET: EU Transparency Regulation – main changes and outline of new procedures
10:45 – 11:00h CET: Break
11:00 – 12:00h CET: EURL and EFSA Guidance Documents, EFSA Open Portal
12:00 – 13:00h CET: Workshop: Strategic Planning – Matching Commercial and Regulatory Objectives
13:00 – 14:00h CET: Lunch
14:00 – 14:15h CET: Notification of studies on the EFSA Open Portal
14:15 – 14:45h CET: Section II – Characterisation and Quality Requirements
14:45 – 15:15h CET: Workshop: Building Section II
15:15 – 15:30h CET – Break
15:30 – 16:15h CET: Workshop on microorganism safety & whole genome sequence requirements
16:15 – 17:00h CET: Section III – Safety for Target Animals, Consumers, Users and the Environment
17:00 CET – Close of day
Day 2. Start at 9:30h CET / 8:30h UK time
09:30 – 10:00h CET: Review of Day 1 – Discussion, Questions and Answers
10:00 – 11:00h CET: Workshop: Building Section III
11:00 – 11:15h CET: Break
11:15 – 12:15h CET: Section IV – Efficacy
12 :15 – 13:15h CET : Good Study Design – Ticking the EFSA Boxes
13:15 – 14:15h CET: Lunch
14:15 – 15:15h CET: Workshop: Building Section IV
15:15 – 15:30h CET: Break
15:30 – 16:30h CET: Writing and Managing the Dossier, e-submission food chain platform
16:30 – 17:00h CET: Final Quiz
17:00 – 17:30h CET: Final Discussion, Questions and Answers
17:30h CET – Close of course
To book the course please follow the link.
“The course was well researched, up to date and very useful. The speakers were knowledgeable and helpful.”
Simone Midori Costa
“Very dense in information, as expected. The experience of the speakers makes a lot of difference because many different examples were presented.”
Probiotics International Ltd
“A very good, informative course that was well delivered.”
“Definitely worthwhile coming.”
“Excellent presentation. Good interaction, very clear explanation.”