Presented by
Management Forum
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.
★★★★★ "Very clear talks. I liked especially the incorporation of the polls. That really help me translate t... more"
- Format: Bespoke training
- CPD: 12 hours for your records (depending on your requirements)
- Certificate of completion
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
The Registration of Animal Feed Additives in the EU course will cover:
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
Joan Castelló Latorre
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.
Elinor McCartney
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.
Laura Payo Lewis
Laura Payo Lewis is a regulatory consultant for the food and animal health industry. She has a masters in biotechnology from the University of Salamanca, and interned in the cell culture quality control department of Intervet/Schering-Plough Animal Health in 2010. She specialises in EU food and feed enzyme and probiotic registrations, and has developed expertise in US FDA regulatory requirements. Since 2011, she has been working at Pen & Tec Consulting, a regulatory affairs consultancy focused on helping companies to understand and comply with European food and feed laws in order to successfully sell their products and minimize their time to market. She currently runs the regulatory affairs department at Pen & Tec’s head office in Spain where she has managed multiple registration processes, gaining approval of food and feed products.
Reviews of IPI's Registration of Animal Feed Additives in the EU training course
Very clear talks. I liked especially the incorporation of the polls. That really help me translate the new info to case studies
Jun 16 2021
Eline Klaassens 
Product Manager Human Health, Baseclear
Jun 16 2021
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 16 2021
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 16 2021
All the webinar was very interesting and useful, but I liked particularly the workshops sessions with concrete examples.
Tifenn PERROT 
Responsable réglementaire, ALL4FEED
Jun 16 2021
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 16 2021
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 16 2021
Excellent speakers, different styles but all very good.
Dora Rodriguez 
Regulatory Affairs Director, Jefo Nutrition Inc.
Jun 16 2021
Very useful, gave me the needed information, excellent speakers.
Elina Koskinen 
Orion Corporation
Jun 16 2021
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 5 2019
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 5 2019
Very knowledgeable. Excellent.
Kehinde Aigberua
Consultant, Quality Auditor, Elanco Animal Health
May 23 2018
[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 23 2018
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 23 2018
Excellent presentation. Good interaction, very clear explanation.
Kalinka Grozeva 
Quality Control Director, Vetagro S.p.A.
May 23 2018
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 23 2018
[The course had] clear structure, very lively presentation. Definitely worthwhile coming.
Günther Becker
Director, OXEA GmbH
May 23 2018
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
May 17 2017
My expectations were met and course was very well organised
Elisa Salvetti
Marie S. Curie Research Fellow, University College Cork
May 17 2017
Excellent content, excellent speakers.
Pauliina Halimaa
Product Manager, Bioinformatics, Biosafe - Biological Safety Solutions Ltd/Oy
May 17 2017
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.
May 17 2017
Interesting and relevant course.
Sophie Nixon
Veterinary Research Manager, Probiotics International Ltd
May 19 2016
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
Belgium
- Aveve Biochem
- Huvepharma
- Kemin
- Kemin Europa SA/NV
- Nutrition Sciences NV
- Versele-Laga
- Zoetis
- Zoetis Belgium S.A.
- Zoetis Belgium SA
Netherlands
- BaseClear
- Nutreco
- Nutreco N.V.
- Nutreco Nederland BV
- Nutreco Nederland- TN Marketing
- Nutreco Netherlands BV
- Orffa Additives B.V.
- Trouw Nutrition
United Kingdom
- Danisco UK Ltd
- Devenish Nutrition Limited
- Elanco Animal Health
- Ferro Metal & Chem Corp, LTD (Phibro Animal Health)
- Probiotics International Ltd
- Roslin Nutrition
- Roslin Nutrition Ltd
- Volac International Ltd.
Germany
- Alzchem AG
- Bayer Animal Health GmbH
- Clariant Produkte (Deutschland) GmbH
- Kaesler Nutrition
- Lohmann Animal Health GmbH
- OXEA GmbH
Denmark
- Chr. Hansen A/S
- DLG Group a.m.b.a
- DuPont Nutrition&Biosciences
- IFF,
- ViloFoss
Finland
- Bioproton Europe Oy
- Biosafe - Biological Safety Solutions Ltd/Oy
- Orion Corporation
- Orion Corporation Orion Pharma
- Orion Pharma
United States of America
- MicroSynergies
- Nestle Purina PetCare
- Phibro Animal Health Corporation
- United Animal Health. - Sheridan
- Zinpro
France
- ALL4FEED
- In Vivo NSA
- METabolic EXplorer
- METEX NOOVISTAGO
Ireland
- Alltech
- University College Cork
- Zinpro
Italy
- Teknofarma S.r.l.
- Vetagro S.p.A.
Spain
- Lucta, S.A.
- Novus Spain SA
Austria
- Elanco Austria GmbH
Canada
- Jefo Nutrition Inc.
Greece
- IMERYS INDUSTRIAL MINERALS S.A
Switzerland
- Herbonis Animal Health GmbH
Ukraine
- Ministry of Agrarian Policy and Food of Ukraine
Run Registration of Animal Feed Additives in the EU Bespoke training for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
