A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
4-5 December 2023 – ONLINE
Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – the registration is OPEN NOW.
Meeting regulatory requirements for feed and feed additives in the EU and other key markets such as China and the USA are major challenges for businesses in the field of animal nutrition. This seminar will review EU legislation, examine procedures and data requirements, and discuss to what extent EFSA-compliant data can be used to achieve approvals in China and the USA (or vice versa).
The EU has transformed its food legislation in the last two decades, creating EFSA (European Food Safety Authority) in 2002 and adopting a harmonised approach to food safety, ‘from farm to fork’. The 2003 Feed Additives Regulation introduced a central (‘one door-one key’) approval system for feed additives, involving the EU Commission, the EURL (European Union Reference Laboratory), EFSA and the Standing Committee on the Food Chain and Animal Health, with delegates from 28 Member States (comitology).
Regulation (EC) No 1831/2003 recategorised feed additives and extended the scope to include amino acids, silage agents and urea. New classes of feed additives were added, e.g. mycotoxin inactivators, feed hygiene condition enhancers. The EU completed its ban on antibiotic growth promoters in January 2006 and although coccidiostats remain as feed additives, maintaining approvals presents considerable challenges for FBOs (feed business operators). Re-evaluation of around 500 feed additives started in 2010 and the EU has prohibited feed additives for which no re-evaluation dossier was submitted, or which fail EFSA’s scrutiny. A new feed regulation, the feed material register and the catalogue of feed materials have all improved transparency in feed labelling, while allowing some physiological and functional claims.
Depending on intended use, the US FDA may regulate a product added to animal feed as either a drug or a feed ingredient. In either case, the Food Drug and Cosmetic Act requires the sponsor to obtain FDA approval or GRAS recognition prior to marketing. In the past, FDA has followed a policy of enforcement discretion to allow marketing of unapproved products if evaluated by the AAFCO feed ingredient definition process and listed in the AAFCO Official Publication. The FDA now encourages sponsors to use the food additive petition procedure for new products.
The Chinese Ministry of Agriculture introduced new guidance and legislation on feed additives, adopting some aspects of EU/EFSA, other aspects of USA FDA, and some uniquely Chinese approaches in the area of animal nutrition.
For these reasons many companies manufacturing or marketing feed additives wish to address, as far as possible, the regulatory requirements of EU, Chinese and US authorities in a single project. This event will provide an excellent forum to discuss with key experts the regulatory requirements and how to comply with them. Furthermore, informal workshops will enable delegates to work together to solve regulatory problems
Managers working in:
- Business development
- Feed business operators
- Strategic marketing managers
- Registration managers
- Product managers
- R&D scientists
- Project managers
- Senior managers seeking a ‘snapshot’ of current regulatory trends and challenges in feeds and feed additives in Europe, China and the USA.
Dr Eliana Henriquez Rodriguez
Dr. Eliana Henriquez Rodriguez, a highly accomplished Agricultural Engineer with a profound specialization in animal production and research. Her unwavering passion for animal science is backed by an impressive academic background, including a Master of Science degree in Animal Breeding and Reproduction Biotechnology, as well as a PhD in Agricultural and Food Science and Technology.
Over the years, Eliana has honed her skills in animal production management, molecular genetic techniques, experimental design, statistical analysis, and scientific writing. At her role as a Senior Regulatory Affairs manager at Pen & Tec Consulting (part of the Argenta Group), she excels in providing both internal and external regulatory and scientific training for EFSA-compliant studies, and it is also an expert on the Transparency Regulation. Furthermore, she manages important feed additive registration projects, showcasing her commitment to advancing agricultural practices and food safety.
Dr Montserrat Cerrato Sánchez
Dr. Montserrat Cerrato Sánchez is a highly experienced Senior Regulatory Affairs Manager specialising in feed product registrations and feed labelling compliance. Her expertise lies in handling coccidiostat and probiotic feed additive applications, where she has played a key role in assisting clients with project management, preparation of registration dossiers, and conducting EFSA-compliant studies. Her dedication to ensuring regulatory compliance extends to providing valuable advice on all aspects of feed labelling development, ensuring that feedstuffs are presented and advertised in accordance with applicable regulations.
Throughout her career, Montse has been recognized for her outstanding abilities in the field of regulatory affairs. She has conducted training sessions for client regulatory teams, imparting her knowledge on the EU feed additive registration process and feed labelling legislation.
Kristi O. Smedley, PhD, has been consulting in the regulation of Food and Drug Administration (FDA) regulated products since 1996. Previous to this she worked at the FDA’s Center for Veterinary Medicine in the animal feed and policy areas for 10 years. She has also authored two publications that compare and contrast the global regulation of feed ingredients. In the past 10-years her consulting has been predominantly with animal feed ingredients. Kristi is an active volunteer with the American Association of Feed Control Officials as an advisor and committee member. She earned her doctorate in ruminant nutrition from Virginia Tech.
Xiaohua He is the Managing Director of knoell Shanghai in China. She studied chemistry and environmental chemistry. After holding PhD in Biogeography in the Environmental Research Centrum at the University Saabruecken in Germany, she worked in research and teaching in ecotoxicology and molecular toxicology in the University Saarbrucken and University Tier.
Xiaohua He joined knoell in 2007, where she is a subject matter senior expert in environmental chemistry and eoctoxicology, as well as in China regulatory affairs. Dr He is appointed as Managing Director of knoell Shanghai since 2017, where she is works with the local and knoell global animal health teams together carrying out consultancy services in China with aspects of regulatory support, complicance strategy, study management and monitoring, dossier preparations and submissions.
- The changing face of EFSA – engaging stakeholders, status of new EFSA guidance
- EU procedures and timelines in relation to feed additive applications
- Update on the UK animal feed legislation
- Permitted claims for feed ingredients
- US FDA approaches to the regulation of nutritional products for animals
- The legal framework for feed additives in China
To see full course program please click: here.
To book the course please follow the link.
“The course was well researched, up to date and very useful. The speakers were knowledgeable and helpful.”
Simone Midori Costa
“Very dense in information, as expected. The experience of the speakers makes a lot of difference because many different examples were presented.”
Probiotics International Ltd
“A very good, informative course that was well delivered.”
“Definitely worthwhile coming.”
“Excellent presentation. Good interaction, very clear explanation.”