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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.

20-21 Jun 2022

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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 27th of March this year, 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

This online seminar is brought to you by Pen & Tec´s regulatory experts. The format will be as interactive as possible and will be composed of a series of lectures, workshops, questionnaires, and online polls.


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

Presenter

Elinor McCartney (More...)

Dr Elinor McCartney 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.

Book now

Book now

20-21 Jun 2022
Live webinar
20-21 Jun 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 16 May 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

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

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.

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Previous customers include...

  • Alltech
  • Alzchem AG
  • Aveve Biochem
  • Chr. Hansen A/S
  • DuPont Nutrition&Biosciences
  • Elanco Austria GmbH
  • Ferro Metal & Chem Corp, LTD (Phibro Animal Health)
  • Huvepharma
  • IMERYS INDUSTRIAL MINERALS S.A
  • In Vivo NSA
  • Kaesler Nutrition
  • Lohmann Animal Health GmbH
  • Metex NoovistaGo
  • MicroSynergies
  • Ministry of Agrarian Policy and Food of Ukraine
  • Nestle Purina PetCare
  • Nutreco Nederland- TN Marketing
  • Nutreco Netherlands BV
  • Orion Corporation Orion Pharma
  • Orion Pharma
  • OXEA GmbH
  • Probiotics International Ltd
  • Roslin Nutrition Ltd
  • Teknofarma S.r.l.
  • Trouw Nutrition
  • United Animal Health. - Sheridan
  • University College Cork
  • ViloFoss
  • Zoetis
  • Zoetis Belgium S.A.

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.

Monica Longares, 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

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

Very knowledgeable. Excellent.

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

[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, May 18