Registration of Animal Feed Additives in the EU

This course will take participants through all of the necessary steps to obtain marketing authorisation for a feed additive in the European Union.

Course overview

This course will provide a comprehensive introduction to the entire regulatory dossier submission for approval of a feed additive in the EU, taking participants through all the necessary steps to obtain marketing authorisation. 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.

Key areas covered and course objectives:

  • Understand the EU regulatory framework and relevant legislation
  • Roles of the EU Commission, the EURL, EFSA and Member States
  • Types of feed additives and acceptable claims
  • Data required – product characterisation safety, quality and efficacy
  • EC, EURL and EFSA guidelines and guidance documents
  • How to conduct a strategic data audit and gap analysis
  • Managing EU registration projects
  • Writing successful feed additive dossiers
  • Post-submission hurdles – dossier validation and EFSA clock-stops
  • Interacting with the EU Commission, Member States and EFSA

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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 Day One

Introduction and objectives of the course

EU regulatory framework – the basic legislation and procedures

EURL and EFSA guidance documents

Workshop: Strategic planning – matching commercial and regulatory objectives

Section II – Identity

Section II – Requirements for microorganisms intended for use as additives or production strains

*Workshop: Building Section I*I

Section III – Safety for target animals, consumers, users and the environment

Programme Day Two

Review of day one -– discussion, questions and answers

Workshop: Building Section III

Section IV – Efficacy

Good study design – ticking EFSA boxes

Workshop: Building Section IV

Workshop presentations

  • Presentation by each team
  • Review and discussion

Writing and managing the dossier

  • Writing the dossier
  • Post-marketing monitoring plan
  • EFSA completeness check
  • Quality control, submission and follow-up
  • Handling EFSA clock-stops

Final discussion, questions and answers

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.

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Previous customers include...

  • Alzchem AG
  • Aveve Biochem
  • Bayer Animal Health GmbH
  • Chr. Hansen A/S
  • Clariant Produkte (Deutschland) GmbH
  • Danisco UK Ltd
  • Devenish Nutrition Limited
  • DuPont Industrial Biosciences
  • Elanco Animal Health
  • Elanco Tiergesundheit AG Zweigniederlassung Österreich
  • Ferro Metal & Chem Corp, LTD (Phibro Animal Health)
  • Herbonis Animal Health GmbH
  • Kaesler Nutrition
  • Kemin Europa SA/NV
  • LUCTA, S.A.
  • METABOLIC EXPLORER
  • Ministry of Agrarian Policy and Food of Ukraine
  • Nutreco Nederland BV
  • Nutreco Nederland- TN Marketing
  • Nutreco Netherlands BV
  • Nutrition Sciences NV
  • Orion Corporation Orion Pharma
  • Orion Pharma
  • OXEA GmbH
  • Phibro Animal Health Corporation
  • Trouw Nutrition
  • University College Cork
  • Vetagro S.p.A.
  • Zinpro
  • Zoetis Belgium S.A.

Nice package, but I think there were a bit too much information in two days.

Jouni Heikkinen, Laboratory Director, Biosafe - Biological Safety Solutions Ltd/Oy

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

Excellent presentation. Good interaction, very clear explanation.

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

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

Günther Becker, Director, OXEA GmbH

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

[The speakers] were both very good and engaging. A very good, informative course that was well delivered.

Harry Ancill, Regulatory Affairs Assistant, Probiotics International Ltd

Interesting and relevant course.

Sophie Nixon, Veterinary Research Manager, Probiotics International Ltd

Excellent content, excellent speakers.

Pauliina Halimaa, Product Manager, Bioinformatics, Biosafe - Biological Safety Solutions Ltd/Oy

Extremely satisfied. I have learnt a lot about the feed additives and the regulatory frame work. Truly appreciated the speakers and their clear presentations.

Mohammed Boularas, Senior Associate Regulatory Affairs, Zoetis Belgium S.A.

My expectations were met and course was very well organised

Elisa Salvetti, Marie S. Curie Research Fellow, University College Cork

Excellent content, some information on the slides was a bit small to read, but overall excellent content

Stephanie Allen, Regulatory Affairs Associate, Danisco UK Ltd