A Regulatory Update on Animal Feed and Feed Additives in Europe the USA Training Course

Course overview

Meeting regulatory requirements for feed and feed additives key markets in Europe and the USA are major challenges for businesses in the field of animal health and nutrition. This seminar will review current EU legislation and EFSA guidance, examine procedures and data requirements, and discuss to what extent EFSA-compliant data can be used to achieve approvals in the EU, including UK/GB and the USA. 

Programme highlights:

• Update on feed/feed additive legislation in the EU (and UK/GB post-BREXIT)
• The changing face of EFSA – effects of the Transparency Regulation
• EU 10-year renewals – a smaller hurdle for approved feed additives?
• EU/EFSA procedures and timelines in relation to feed additive applications
• Permitted claims on feeds, veterinary medicines and feed additives – Europe vs. USA
• US FDA approaches to the regulation of nutritional products for animals

Where the industry is today in Europe

The EU has transformed its food legislation in the last 2 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 27 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, physiological condition stabilisers. Obtaining and maintaining approvals presents considerable challenges for business operators. The 2009 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.

The EU Transparency Regulation and the EU feed additive REFIT programme herald further major changes in the way that feed additives are classified and evaluated in the EU, whereas BREXIT has introduced additional complexity and possible divergence from EU/EFSA approaches.

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, and is more closely involved than previously in the AAFCO procedure.

Many companies manufacturing or marketing feed additives wish to address, as far as possible, the regulatory requirements of EU, UK/GB 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 and the USA.

Introduction & registration of feed additives: Overview

Feed and feed additive products in the EU: definitions, classification and claims

• Differences between feeds, feed additives and veterinary products
  • Feed additives: Categories/functional groups & Register of Feed Additives
  • Feed Materials: Feed Materials Register & Catalogue
• Claims – best practices

The role of the EU and Comitology

• Scope of EU feed additive legislation – EU Mandate
• Post-EFSA opinion – Comitology
• Special case of supplementary dossiers

EFSA’s risk assessment of feed additives & role of EURL

• EFSA: Administrative check & risk assessment
• EURL: Samples & validation/verification

The transparency regulation – changes to feed additive registration procedure

EFSA Guidance/statements & new platforms – what’s new?

United Kingdom and Great Britain situation

• Registration of feed additives in the UK post Brexit

Workshop 1: Micro-organisms intended for use as feed additives or production strains in the EU – requirements and practical examples

Workshop 2: Design of efficacy studies for EU registrations – what EFSA wants

Workshop 3: Registration process of feed additives in the EU – practical examples

The US FDA approach to the regulation of feed ingredients

• Legal and regulatory framework
• Authorisation pathways for feed ingredients
• Recent changes
• Q&A