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A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
Two day meeting on Regulation Update on Animal Feed and Feed Additives in the EU, USA and China, annual seminar now in its tenth successful year.
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 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.
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
Book now
| 3-4 Dec 2020 | |||
| 3-4 Dec 2020 | Rembrandt Hotel, London | GBP 1,399.00 EUR 1,959.00 USD 2,182.00 + VAT @ 20.00% |
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register. |
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Previous customers include...
- Akzo Nobel
- Anitox Corp
- BENEO GmbH
- CALYSTA, Inc
- Christian Hansen A/S
- Danisco (UK) Limited
- Danisco Animal Nutrition
- Drayton Animal Health Ltd
- DuPont Nutrition&Biosciences
- Format International Ltd
- Hankkija Oy
- INVIVO NSA
- IRTA
- Kaesler Nutrition
- Klifovet AG
- Lohmann Animal Nutrition
- MERIAL- GROUPE BOEHRINGER INGELHEIM
- Micron Bio-Systems Ltd
- Norkem Ltd
- OXEA GmbH
- Pen & Tec GmbH
- PROBIOTICS INT LTD
- Proviron Industries NV
- Royal Canin
- SANOFI CHIMIE
- TRM
- Vetagro S.p.A.
- Veterinary Medicines Directorate
- Vitablend
- Zoetis Belgium S.A.
“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
“A really nice atmosphere, very good speaker and interesting workshops. ”
Cornelia Hüttinger, Regulatory Affairs Manager, Klifovet AG
“Good speakers, good program, quite general overview.”
Kalinka Grozeva, Quality Control Director, Vetagro S.p.A.
“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
“All presentations were of high quality and very well explaining the topic covered...The presentation were mostly of high quality and to the point. I’m personally not such a fan of the exercises, bringing to me less added value than the discussions after the presentations, and the presentations themselves.”
Angelo Lauwaerts, Business Development Manager , Proviron Industries NV
“Very good content and organisation, very qualified and experienced speakers.”
Juliane Dohms, International Manager Regulatory Affairs, Phytobiotics Futterzusatzstoffe GmbH
“Content was really great, not too heavy. All speakers were very clear and happy to take questions ”
Sarah Harrison, Research Coordinator, Ridgeway Research Ltd
“A very informative course, good content without being overwhelming. Clear and engaging speakers. Very comfortable surroundings. ”
Sarah Norton, Senior Scientific Officer, Veterinary Medicines Directorate
“It was great, very global, so not only EU resctricted, covered the main relevant areas in my opinion and was very well organized and carried out.”
Odile Bideau, Project Manager, Chef du Monde S.L.
“I really enjoyed it, the venue was good, the organizers were helpful, even the hotel staff was helpful. ”
Nisha Kaushik, Regulatory Affairs , Vitalus Nutrition Inc.
“A comprehensive course with clear and engaging speakers, and useful workshops.”
Sarah Norton, Senior Scientific Officer, Veterinary Medicines Directorate
“I think it was excellent”
David Adimpong, Scientist & Laboratory Manager, Envirosystems.co.uk
“Very interesting to see the updates and the speakers' opinions.”
Luisa Paches Samblas, Regulatory Procedures Team Leader, Cyton Biosciences Ltd.
“Presentations, speakers and content were very comprehensive”
Dhiraj Lakhichand Jain, Proprietor, BioBota Consulting
“Everything was very good”
Irene Margüenda, Regulatory Affairs Manager, Norel S.A.
“Practical and pertinent”
Dora Rodriguez, Jefo Nutrition Inc