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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.

17-18 Jun 2020

GBP 1,399 1,199 *
EUR 1,959 1,679 *
USD 2,182 1,870 *
* When you book before 10 Apr

Book now

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.

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.

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.

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
  • 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

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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

Course 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 II

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

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

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

Presenters

Elinor McCartney

Elinor established Pen & Tec Consulting in 2000, coinciding with publication of the EU white paper on food safety, and dedicated to providing specialist services in new product development and registration of feed additives in Europe. She has managed the growth of services to include all categories of feed additives. Elinor is a graduate of the Royal Veterinary College, where she obtained her PhD in enteric diseases of piglets. She also holds an MBA (with distinction) from the Open University, and has tutored in Finance and Marketing for the Open University Business School in several European countries.
Elinor has worked in general veterinary practice, in the veterinary pharmaceutical industry and in various technical and commercial roles concerning the supply of additives and speciality ingredients to the feed industry. Elinor helps clients understand EU/EFSA legislation, guidelines and guidance and has assisted many applicants to achieve or maintain EU approval of a wide range of products, including, technological, sensory, nutritional, zootechnical and coccidiostat feed additives.

Joan Castelló

Joan Castelló is as a regulatory consultant for the food and animal health industry since 2018. He holds a bachelor’s degree in chemistry (Lindenwood University, USA), specialising in biochemistry. Joan gained experience in food chain safety while working as an analyst at a food microbiology testing laboratory in London, UK. Since joining Pen & Tec in 2018, Joan has been involved on the registration of feed additives in the EU as well as on the design of EFSA-compliant registration studies, and has also developed expertise in US FDA regulatory requirements.

Book now

17-18 Jun 2020
17-18 Jun 2020 Cavendish Hotel, London GBP 1,399.00
EUR 1,959.00
USD 2,182.00
+ VAT @ 20.00%
GBP 1,199.00
EUR 1,679.00
USD 1,870.00
Until 10 Apr*
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Alltech
  • Alzchem AG
  • Aveve Biochem
  • Bayer Animal Health GmbH
  • Biosafe - Biological Safety Solutions Ltd/Oy
  • Clariant Produkte (Deutschland) GmbH
  • Devenish Nutrition Limited
  • DuPont Nutrition&Biosciences
  • Elanco Animal Health
  • Elanco Tiergesundheit AG Zweigniederlassung Österreich
  • Ferro Metal & Chem Corp, LTD (Phibro Animal Health)
  • Huvepharma
  • In Vivo NSA
  • Kaesler Nutrition
  • Kemin
  • Kemin Europa SA/NV
  • LUCTA, S.A.
  • METABOLIC EXPLORER
  • Ministry of Agrarian Policy and Food of Ukraine
  • Novus Spain SA
  • Nutreco Nederland BV
  • Nutreco Nederland- TN Marketing
  • Nutreco Netherlands BV
  • Orion Corporation Orion Pharma
  • OXEA GmbH
  • Probiotics International Ltd
  • Trouw Nutrition
  • University College Cork
  • Vetagro S.p.A.
  • Zoetis Belgium S.A.

Very knowledgeable. Excellent.

Kehinde Aigberua, Consultant, Quality Auditor, Elanco Animal Health

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

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

Günther Becker, Director, OXEA GmbH

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

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

Excellent presentation. Good interaction, very clear explanation.

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

[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

My expectations were met and course was very well organised

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

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.

Interesting and relevant course.

Sophie Nixon, Veterinary Research Manager, Probiotics International Ltd

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