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 additive 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.
UK animal feed legislation
The role of the EU and comitology
EFSA’s risk assessment of feed additives, what is new?
Workshop one: Strategic options for animal nutrition products in the EU
Workshop feedback and discussion session
Networking drinks reception
Review of day one – focus on EU/EFSA/ Brexit
An update on the ‘Brexit blues’ – where are we now?
Study design and statistics – what EFSA wants
The US FDA approach to the regulation of feed ingredients
China market access and regulatory requirements for feed additives
Workshop two: Study design and statistics
Workshop feedback and discussion session
Workshop three: Managing dossier projects – best practices
Workshop feedback and discussion session
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.
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.
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.
Montserrat Anguita works as a scientific officer of the FEED Unit at the European Food Safety Authority (EFSA) since 2008. Montserrat got the degree in veterinary science in 2001 at the Universitat Autònoma de Barcelona. In 2006 she completed her PhD studies. Afterwards she worked for two more years at the same University as a researcher in the area of animal nutrition before joining EFSA.
Eliana Henriquez Rodriguez
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 training for EFSA- compliant studies, and manages feed additive registration projects.
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.
Elizabeth Lewis, is Scientific & Regulatory Adviser for NutraSteward. She joined NutraSteward as Director in 2016. Elizabeth has an established track record of providing consultancy services to clients wishing to navigate the regulatory approval processes for novel food and animal feed ingredients. Over the past 10 years, she has collaborated closely with numerous international clients to develop robust regulatory strategies to market. She has extensive experience of the preparation, submission and stewardship of successful scientific applications for novel food and feed ingredients in Europe, the U.S. and Canada. In this role, she has advised clients on the design and placement of studies to support the safety and efficacy of a wide range of ingredients including additives, functional food ingredients and new sources of vitamins and minerals. Additionally, she has developed a strong network of contacts within European, U.S. and Canadian regulatory bodies and academic institutions.