Two day meeting on Regulation Update on Animal Feed and Feed Additives in the EU, USA and China, annual conference now in its 6th successful year.
6-7 Dec 2018
& 5-6 Dec 2019
This conference 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). Re-evaluation by the EU of around 500 feed additives started in 2010 and the EU is systematically prohibiting feed additives for which no re-evaluation dossier was submitted, or which fail the European Food Safety Authority’s (EFSA) scrutiny. A new feed regulation, the feed material register and the catalogue of feed materials have 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 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.
Welcome and introduction
Implementation of Regulation (EC) No 1831/2003 on Additives for Use in Animal Nutrition – An update
The Role of the EU and Comitology
New approaches to the risk assessment of feed additives of botanical origin: How to deal with complex mixures and their variability?
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?
Study design and statistics – What EFSA wants
The US FDA approach to the regulation of feed ingredients
The Chinese approach to feed additives
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
Elinor McCartney (6-7 Dec 2018)
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.
Kristi Smedley (6-7 Dec 2018)
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.
Marta Ponghellini (6-7 Dec 2018)
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.
Ruud Bremmers (6-7 Dec 2018)
Bremmers Rudd studied at the University of Wageningen (Netherlands), and graduated in Animal Nutrition and Physiology and Business Management. His previous employment includes Trouw Nutrition Netherlands (Nutreco), Head of the Agricultural Department; R&D Manager at Loders Croklaan (Unilever) (feed additives & feed materials); Sales & Marketing Manager of feed additives at Hoechst (former Chemical/Pharmaceutical company). His is the founder of Regal BV in 2000, (Managing Director). He specialised in regulatory affairs related to feed and feed additives, responsible for numerous registration projects, and start-ups of companies.
Raymond Ng (6-7 Dec 2018)
Mr. Raymond Ng (Msc, BA) is a Regulatory & Market Access Consultant at Accestra 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.
Laura Payo Lewis (6-7 Dec 2018)
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.
Francisco Javier Piquer (6-7 Dec 2018)
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.
Eliana Henriquez Rodriguez (6-7 Dec 2018)
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.”
Hector Velasquez-Estay (6-7 Dec 2018)
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.
Paola Manini (6-7 Dec 2018)
Paola Manini is a senior Scientific Officer at the European Food Safety Authority (EFSA) since 2009. In the FEED Unit, which supports the EFSA Panel on Additives and Products or Substances used in animal feed (FEEDAP Panel), she coordinates the working group on feed flavourings and has coordinated the working group on vitamins (until 2016). She has been involved in several EFSA horizontal projects aimed at harmonising methodologies in risk assessment, like the PROMETHEUS project (Principles and process for dealing with data and evidence in scientific risk assessment), the guidance on Uncertainty and the Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals (currently under public consultation).
Paola graduated in Chemistry at the University of Parma in 1992 (summa cum laude) and received her PhD in Analytical Chemistry in 1997, with a dissertation on liquid chromatography-mass spectrometry (LC-MS) applied to food and water analysis. She has a master’s degree in Occupational and Environmental Toxicology (1998).
From 1997-2009, she worked as contract researcher at the Laboratory of Occupational and Environmental Toxicology of the University of Parma, in a multidisciplinary research group headed by Professor Antonio Mutti, where she brought her experience with MS-hyphenated techniques. Her main research activity was aimed at investigating the metabolism of industrial chemicals and environmental pollutants, the mechanisms of oxidative stress induced by these chemicals, and at developing of new biomarkers of exposure, early effect and susceptibility.
Paola Manini is author of 92 peer-reviewed publications and 4 book chapters.