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 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. As part of this conference, informal workshops will enable delegates to work together to solve regulatory problems.
*Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
Welcome and introduction
Implementation of Regulation (EC) No 1831/2003 on Additives for Use in Animal Nutrition – An update
- Re-evaluation of existing feed additives: where are we?
- Recent developments / ongoing discussions
The Role of the EU and Comitology
- Scope of EU feed additive legislation – in or out of scope?
- Differences between feeds, feed additives and veterinary products
- Feed and feed additive claims – best practices
- Post-EFSA opinion – Comitology
- Special case of supplementary dossiers
New approaches to the risk assessment of feed additives of botanical origin: How to deal with complex mixures and their variability?
- Whole mixture versus component – based approach: data requirement, applicability and limitations
- New concepts in mixture assessment: grouping of chemicals, dose addition, handling data gaps
- The weight of evidence approach to integrate different sources of evidence
- The margin of exposure as a tool to identify the need for refinement
- How to integrate uncertainty in risk assessment
Workshop one: Strategic options for animal nutrition products in the EU
Workshop feedback and discussion
Networking drinks reception
Review of day one – Focus on EU/EFSA – BREXIT update
BREXIT Blues – Food chain blocked, broken or better?
- Where are we now?
- Possible scenarios: best, most likely & worst case
- Consequences for UK companies in the EU
- Consequences for non-UK companies in the UK
Study design and statistics – What EFSA wants
- Basic EFSA-compliant study designs and key end-points
- Recent changes in statistics
- Frequently asked questions from EFSA
The US FDA approach to the regulation of feed ingredients
- Legal and regulatory framework
- Authorisation pathways for feed ingredients
- Recent changes
- Key differences from EU
The Chinese approach to feed additives
- Regulatory management framework
- Key regulations and changes
- Import & registration procedures
Workshop two: Study design and statistics Led by Dr Eliana Henriquez Rodriguez, Pen & Tec
Workshop feedback and discussion
Workshop three: Managing dossier projects – best practices
Workshop feedback and discussion
Discussion, questions and answers
Close of forum
Managing Director ,
Pen & Tec Consulting Group, Food and Feed Regulatory Affairs, Spain.
Hector Velasquez-Estay, is Managing Director, of Pen & Tec Consulting Group, Food and Feed Regulatory Affairs, Spain.
Héctor was born in Arica, Chile, and educated at Liceo A1 and the Universidad Federico Santa María, Valparaiso, where he studied electronic engineering for 3 years before emigrating to Spain in 1983. He holds a diploma in Sales and Marketing Management from the EAE business school in Barcelona, Spain, and a diploma in Business from the UK Open University.
Héctor has worked in sales management in a variety of SMEs and multinationals, including flexible packaging for the food industry, electronic components, specialised steel and paper for industrial applications. In 2003, he joined Pen & Tec Consulting, an EU regulatory affairs consultancy that specialises in helping companies to take their food and feed products to market, and offers advice on optimising the return on investment from clients’ product portfolios. Since becoming Managing Director in 2009, Héctor has grown the business from a small partnership to a team of 23 members of staff.
Current position: Managing Director, partner and shareholder at Pen & Tec Consulting Group, responsible for all business areas (strategy, finance, administration, human resources, sales/marketing), excluding client technical support.
Languages: Fluent in Spanish, English, Catalan. Good spoken Italian. Elementary French.
Nationality: Dual Spanish/Chilean.
Food and Drug Administration (FDA)
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.
Regulatory & Market Access Consultant ,
Mr. Raymond Ng (Msc, BA) is a Regulatory & Market Access Consultant at Precise Global with Master’s degree from University of Nottingham and has extensive knowledge on Chinese food & feed additives (incl. pet food) import & export regulations. His research specialises in China’s governmental policies including the changes in Chinese food & feed safety laws and its impact on international businesses. Mr Ng will share with you the registration & importation procedure and highlight important areas to be particularly concerned about. He has vast insight and practical experience in dealing with Chinese regulatory obligations and looks forward to sharing his knowledge.
Dr Elinor McCartney,
Regulatory Consultant ,
Pen & Tec Consulting
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 (Dick) 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.
Francisco Javier Piquer,
Technical and Regulatory Support ,
Ministry of Agriculture, Fisheries, Food and Environment of Spain
Javier Piquer studied Veterinary Medicine at University of Zaragoza and obtained a PhD degree in Poultry Nutrition at Iowa State University (USA). He has been working in the field of animal nutrition at the university and also at different companies of the feed sector, where he was involved in providing technical support to the sales force and in regulatory issues. Since 2005 he has been working at the Animal Feed Unit of the Ministry of Agriculture, Fisheries, Food and Environment of Spain where he has been involved in the development of European Legislation on Animal Nutrition and its implementation at national level.
Principal Administrator/ Administrative Coordination Officer ,
Since 2002 Marta Ponghellini has covered the position of Principal Administrator/ Administrative Coordination Officer in the legislative area of the Directorate-General for Health and Consumers (DG SANCO) of the European Commission in Brussels, dealing with developments in Community policies and strategic objectives in the field of animal nutrition. Prior to this position she worked as the veterinarian inspector of the Public Veterinary Service in Parma on animal health and hygiene of the livestock production. Before this experience she has exercised its liberal profession mainly in the field of food producing animals and she was responsible for quality control in a food factory. In more than fifteen years, she co-operates with the Faculty of Veterinary Medicine, University of Parma as Lecture in schools of training for veterinarians and as a teacher in courses aimed at veterinarians in master campus to different professionalism at other universities. She holds degrees in veterinary medicine with honours, and she has achieved the following post degrees: Veterinary public health; Law and Veterinary Legislation; Avian Technology Poultry and Pathology; Ecology.
Eliana Henriquez Rodriguez,
Agricultural Engineer ,
Pig Improvement Company
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. As well as 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.”
- 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.
The Rembrandt Hotel
11 Thurloe Place
Opposite V&A Museum.
Nearest underground station: South Kensington.