- Home
- A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China Training Course
Annual two-day regulatory update on animal feed and feed additives in the EU, USA and China – now in its tenth successful year.
Details
Course overview
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).
Programme highlights:
- Update on the UK animal feed legislation
- The changing face of EFSA – engaging stakeholders, status of new EFSA guidance
- Re-evaluation of EU feed additives – challenges remaining
- EU ten-year renewals – a smaller hurdle for approved feed additives?
- EU procedures and timelines in relation to feed additive applications
- New approaches to the risk assessment of feed additives of botanical origin
- Permitted claims and borderlines between feeds, veterinary medicines and feed additives – differences between the EU, USA and China
- US FDA approaches to the regulation of nutritional products for animals
- The legal framework for feed additives in China
Where the industry is today
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.
Who should attend?
- Regulatory
- 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.
Programme – day one
UK animal feed legislation
- Where are we now?
- Recent developments
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
EFSA’s risk assessment of feed additives, what is new?
- Work developed by the FEED unit and FEEDAP panel on guidance documents in the last years – current and future work
- General aspects related to EFSA’s developments
Workshop one: Strategic options for animal nutrition products in the EU
Workshop feedback and discussion session
Networking drinks reception
Programme - day two
Review of day one – focus on EU/EFSA/ Brexit
An update on the ‘Brexit blues’ – where are we now?
- Recapitulation – a short history of Brexit
- What are the latest developments?
- 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
China market access and regulatory requirements for feed additives
- Regulatory management framework
- Key regulations and changes
- Market access requirements and registration procedures
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
Presenters
Elinor McCartney (More...) (3-4 Dec 2020, 2-3 Dec 2021)
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.
Ruud Bremmers (More...) (3-4 Dec 2020)
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.
Eliana Henriquez Rodriguez (More...) (3-4 Dec 2020)
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 (More...) (3-4 Dec 2020)
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 (More...) (3-4 Dec 2020)
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.
Book now
Book now
|
3-4 Dec 2020 Live webinar |
|||
|
3-4 Dec 2020 Live webinar |
GBP 999.00 EUR 1,439.00 USD 1,630.00 Until 22 Oct* |
Enrol now
to attend Live webinar |
|
|
2-3 Dec 2021 Live webinar |
|||
|
2-3 Dec 2021 Live webinar |
GBP 999.00 EUR 1,439.00 USD 1,630.00 Until 21 Oct 21* |
Enrol now
to attend Live webinar |
|
Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code
Customised in-house training
We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.
You may also be interested in
- How to Write Effective SOPs
- Practical Implementation of GCP in Veterinary Field Studies
- Veterinary Pharmaceutical Submissions in the EU
- Improving Processes and CAPA (Corrective and Preventative Action)
- A Practical Approach to Veterinary Vaccine Development and Registration in the EU
- Registration of Animal Feed Additives in the EU
- Introduction to Veterinary Pharmacovigilance
- Registration of Veterinary Vaccines in the USA and Canada
- Advanced Veterinary Pharmacovigilance
Previous customers include...
- Anitox Corp
- Anitox Ltd
- Biomin Holding GmbH
- CHR Hansen A/S
- Christian Hansen A/S
- Elanco Animal Health
- Impextraco N.V.
- InSci Associates Ltd
- INVIVO NSA
- Lohmann Animal Nutrition
- Lucta S.A.
- LUCTA, S.A.
- Merial
- MERIAL- GROUPE BOEHRINGER INGELHEIM
- Novus International Inc
- Novus Spain SA
- Nutreco Nederland
- Pathway Intermediates
- Pathway Intermediates Limited
- Pen & Tec Consulting SL
- Pen & Tec GmbH
- Probotics International Ltd (Protexin)
- SFH Consult
- Tonisity International
- Treibacher Industrie AG
- Triveritas Limited
- TRM
- Trouw Nutrition
- Vetcare Ltd
- Vitablend
“All good and informative.”
Helena Oliveira, Regulatory Affairs Manager, Nutreco, Dec 19
“Hector's presentation was the clearest analysis I have seen on the effects of Brexit on UK industry and the economy. ”
David Pickard, Regulatory Manager, Inroads International Ltd, Dec 19
“All speakers delivered their presentations in a clear and concise manner, supported by informative slides.”
Beccy Christmas, Regulatory Affairs Officer, Micron Bio-Systems Ltd, Dec 19
“My goal was to gain an overall understanding of registrations in China and USA and I succeeded in that, thanks to the speakers who were excellent.
”
Rosa Vainio, Product Registration Specialist, Hankkija Oy, Dec 19
“As with previous years the course was very informative and gave a rounded set of opinions from various perspectives (industry, EFSA, consultants etc).”
Joshua Forster, Regulatory Executive, CYTON BIOSCIENCES LTD, Dec 19
“Well-organised course with the relevant content I needed to stay on top of the field and a good opportunity to meet other professionals. I very much appreciated having the printed presentations as it makes taking notes much more efficient. ”
Adalberto Costessi, Product Manager, BaseClear, Dec 19
“Very well presented, very informative content and a friendly atmosphere. ”
Maria Brogan, Formulation Technologist Manager, Mervue Laboratory , Dec 19
“Excellent course content with very useful and topical discussions. The speakers were competent and captivating with a good presentation pace.”
Kalinka Grozeva, Quality Control Director, Vetagro S.p.A., Dec 19
“I think that the speakers were really very good and made an interesting meeting out of potentially dry material. Level of discussion was good. Excellent course.”
Colin Capner, Project Coordinator, Ridgeway Research Ltd, Dec 18
“Very good quality, I would recommend to new comers in this area together with also more experienced people.”
Anne Cadoux, Head of Regulatory Affairs , Boehringer Ingelheim, Dec 18
“A really nice atmosphere, very good speaker and interesting workshops. ”
Cornelia Hüttinger, Regulatory Affairs Manager, Klifovet AG, Dec 18
“Very good content and organisation, very qualified and experienced speakers.”
Juliane Dohms, International Manager Regulatory Affairs, Phytobiotics Futterzusatzstoffe GmbH, Dec 18
“Good speakers, good program, quite general overview.”
Kalinka Grozeva, Quality Control Director, Vetagro S.p.A., Dec 18
“All presentations were of high quality and explained the topics covered very well. ”
Angelo Lauwaerts, Business Development Manager , Proviron Industries NV, Dec 18
“I think it was excellent.”
David Adimpong, Scientist & Laboratory Manager, Envirosystems.co.uk, Dec 17