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A Regulatory Update on Animal Feed and Feed Additives in the EU (European Union), 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.

2-3 Dec 2021

& 6-7 Dec 2022

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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

UK animal feed legislation

  • Where are we now?
  • Recent developments

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

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

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 three: Managing dossier projects – best practices

Presenters

Elinor McCartney (More...) (2-3 Dec 2021, 6-7 Dec 2022)

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 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 (More...) (2-3 Dec 2021)

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.

Book now

Book now

2-3 Dec 2021
Live webinar
2-3 Dec 2021
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 28 Oct*
Enrol now
to attend
Live webinar
6-7 Dec 2022
Live webinar
6-7 Dec 2022
Live webinar
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 1 Nov 22*
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

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

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.

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Previous customers include...

  • ADISSEO FRANCE SAS
  • Ajinomoto Eurolysine SAS
  • BaseClear
  • Bayer Animal Health GmbH
  • Bio-Competence Centre of Healthy Dairy Products LLC
  • Chr.Hansen A/S
  • Danisco (UK) Limited
  • Delacon Biotechnik GmbH
  • DHI
  • DP Consulting
  • Elanco
  • Envirosystems.co.uk
  • Evonik Industries AG
  • Format International Ltd
  • INVE
  • INVIVO NSA
  • IRTA
  • knoell
  • Novus International (Beijing) R&D Center
  • Nutreco Nederland
  • OCEAN HARVEST TECHNOLOGY COMPANY LTD
  • OLMIX
  • Omya International AG
  • PROBIOTICS INT LTD
  • Probotics International Ltd (Protexin)
  • Research and Markets
  • Saudi Food and Drug Authority
  • Vetagro S.p.A.
  • Vitalus Nutrition Inc.
  • Zinpro Animal Nutrition (Europe), Inc

All good and informative.

Helena Oliveira, Regulatory Affairs Manager, Nutreco Nederland BV, 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

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., Dec 17