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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.
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
Presenter
Elinor McCartney (More...)
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.
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2-3 Dec 2021 Live webinar |
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2-3 Dec 2021 Live webinar |
GBP 1,199 999 EUR 1,719 1,439 USD 1,942 1,630 Until 21 Oct* |
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9-10 Dec 2021 Face-to-face, (venue not yet confirmed) |
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9-10 Dec 2021 Face-to-face (venue not yet confirmed) |
GBP 1,399 1,199 EUR 1,959 1,679 USD 2,182 1,870 Until 28 Oct* |
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