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
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:
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
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
Writing and managing the dossier
Final discussion, questions and answers
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 CastellóJoan 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.