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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

Book now

Book now

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.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • ALL4FEED
  • Alltech
  • Aveve Biochem
  • Bayer Animal Health GmbH
  • Clariant Produkte (Deutschland) GmbH
  • Danisco UK Ltd
  • DuPont Nutrition&Biosciences
  • Elanco Animal Health
  • Ferro Metal & Chem Corp, LTD (Phibro Animal Health)
  • Huvepharma
  • IMERYS INDUSTRIAL MINERALS S.A
  • Jefo Nutrition Inc.
  • Kaesler Nutrition
  • Lohmann Animal Health GmbH
  • LUCTA, S.A. (ESA08074908)
  • Metex NoovistaGo
  • Ministry of Agrarian Policy and Food of Ukraine
  • Nutreco Nederland- TN Marketing
  • Nutreco Netherlands BV
  • Nutrition Sciences NV
  • Orffa Additives B.V.
  • Orion Corporation
  • Orion Pharma
  • Phibro Animal Health Corporation
  • Probiotics International Ltd
  • Teknofarma S.r.l.
  • United Animal Health. - Sheridan
  • Vetagro S.p.A.
  • ViloFoss
  • Zoetis Belgium S.A.

Very clear talks. I liked especially the incorporation of the polls. That really help me translate the new info to case studies

Eline Klaassens, Product Manager Human Health, Baseclear, Jun 21

Excellent speakers, different styles but all very good.

Dora Rodriguez, Regulatory Affairs Director, Jefo Nutrition Inc., Jun 21

The content was very useful and all speakers were at adequate level. Workshops helped me a lot to digest the content of presentations.

Athanasios Karalis, Product Stewardship Manager, IMERYS INDUSTRIAL MINERALS S.A, Jun 21

Very useful, gave me the needed information, excellent speakers.

Elina Koskinen, Orion Corporation, Jun 21

Overall talks were very good and I learned a lot (as I'm kind of new to this area). I liked that so many questions could be answered from the participants. online tools was also very good.

Eline Klaassens, Product Manager Human Health, Baseclear, Jun 21

This webinar was really helpful for me, although I'm a bit new in this registration process I think that now I will be able to do it. The content and the presentations were complete and detailed and the speakers were experts in this matter and answered all of our questions, they were also really friendly which is always nice. It was a same that we couldn't meet in person.

Mònica Longares, Regulatory services specialist, Lucta, S.A., Jun 21

All the webinar was very interesting and useful, but I liked particularly the workshops sessions with concrete examples.

Tifenn PERROT, Responsable réglementaire, ALL4FEED, Jun 21

I thought the webinar was very informative, doing it virtually allowed more info to be given and me you did not need to travel. The speakers had great knowledge, spoke clearly and answered all questions.

Lauren Park, Principal Investigator, Roslin Nutrition, Jun 21

Overall talks were very good and I learned a lot (as I'm kind of new to this area). I liked that so many questions could be answered from the participants. online tools was also very good.

Eline Klaassens, Product Manager Human Health, Baseclear, Jun 21

Very knowledgeable. Excellent.

Kehinde Aigberua, Consultant, Quality Auditor, Elanco Animal Health, Jun 19

It was a friendly atmosphere and the content , pace and the subjects were expertly chosen. I would gladly attend another course from Elinor and Ana. Both of them had a lovely attitude and clearly experts in their areas.

Cana Eisenhauer, Regulatory Manager, Kaesler Nutrition, Jun 19

[The course had] clear structure, very lively presentation. Definitely worthwhile coming.

Günther Becker, Director, OXEA GmbH, May 18

Very dense in information, as expected. The experience of the speakers makes a lot of different because many different examples were presented.

Simone Midori Costa, Registration Specialist, Trouw Nutrition, May 18

Excellent presentation. Good interaction, very clear explanation.

Kalinka Grozeva, Quality Control Director, Vetagro S.p.A., May 18

The speakers were very knowledgeable and well prepared and equipped to answer questions. The exercises were very helpful. The course was well researched, up to date and very useful.

Jason Keegan, Regulatory Research Specialist, Alltech, May 18