Virtual Seminar: A Post-Transparency Guide to Feed Additive Registration in the EU
15-16 November 2021
This interactive course has been designed to give practical advice on building and submitting a feed additive dossier in the EU. You will gain a comprehensive overview of the entire registration process, from notifying studies to structuring and compiling a feed additive/renewal dossier, the submission process and how to comply with the latest changes following the Transparency Regulation.
The registration is open.
To see full agenda please visit: Online Academy.
The Feed Additives Regulation (Regulation (EC) No 1831/2003), establishes a common procedure for authorising animal feed additives in the EU 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 guide will provide a comprehensive outline of the entire regulatory dossier submission process to obtain marketing authorisation.
Presentations and practical exercises will cover the regulatory framework and data required to establish the characterisation, quality, safety and efficacy of the different feed additives.
Managers working in:
- Business development
- Feed business operators
- Strategic marketing managers
- Registration managers
- Product managers
- R&D scientists
- Project managers
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.
Dr Eliana Henriquez Rodriguez is an Agricultural Engineer with applied experience in animal production and research. Eliana holds a MSc in Animal Breeding and Reproduction Biotechnology (Autonomous University of Barcelona and Polytechnic University of Valencia, Spain) as well as a PhD in Agricultural and Food Science and Technology (University of Lleida, Spain). Eliana’s thesis focused on the validation of genetic markers to improve pork quality and generated results published in different peer-reviewed journals. In addition to working as a supervisor on pig farms in Venezuela, Eliana’s experience in industry and academia also includes an internship with Pig Improvement Company (USA) and a laboratory research project at TEAGASC Food Research Centre (Ireland), as part of her PhD training.
Throughout her professional and academic life, Eliana has developed skills in animal production management, molecular genetic techniques, experimental design, statistical analysis and scientific writing. In her role at Pen & Tec Consulting, Eliana is responsible for providing internal & external regulatory & scientific training for EFSA- compliant studies, and manages feed additive registration projects.
Elinor established Pen & Tec Consulting in 2000, coinciding with publication of the EU white paper on food safety, and is 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 specialises in both EU food and feed product registrations. She is an experienced regulatory manager, helping numerous clients take their products to market, such as enzymes used as animal digestibility enhancers or as food processing aids. She holds a Master in Biotechnology from the University of Salamanca, and interned in the cell culture quality control department of Intervet/Schering-Plough Animal Health in 2010.
Laura has delivered seminars on regulations and procedures for registering feed and feed additives in the EU. She also provides training sessions for client regulatory teams on all aspects of the EU registration process, on topics such as understanding data requirements for the risk assessment of food and feed products derived from genetically modified microorganisms. Since joining Pen & Tec in 2011, Laura has acquired a deeper knowledge of the regulatory requirements in other jurisdictions, working on Food Additive Petitions or GRAS determinations (US FDA) or feed additive registrations in Brazil.
- Understand the feed additive registration process
- Learn how to use the EFSA connect portal – pre-submission activities
- Gain a practical insight into using the e-submission food chain platform
- How to deal with confidential data under the new Transparency Regulation
- Manage questions from EFSA during the risk assessment process
- Find out what needs to go on a EU-compliant feed additive label
- Consolidate your knowledge with practical exercises
To book the course please follow the link.