Pen & Tec are partners of Feed Additives Global 2018. Dr Elinor McCartney, President of Pen & Tec, explains the opportunities and challenges faced by applicants during the EU feed additive authorisation procedure in her article for the The Organisation for Professionals in Regulatory Affairs (TOPRA).
Focus on European feed additives: Complexity, change and challenges ahead
Feed additives have been legislated in the EU since 1970, originally under Directive 70/524. The first feed additive list was a copy-paste of food additives, many with technical functions such as feed conservation, anti-oxidant actions, or gelling effects, plus antimicrobial growth promotors and coccidiostats. There were many amendments over the following decades, but major changes arrived in the early 1990s, with the advent of feed enzymes and feed probiotics, revolutionary products that enabled radical changes in feed formulations as well as non-antibiotic approaches to gut health and animal performance. The food chain crises of the 1990s, especially mad cow disease (BSE – bovine spongiform encephalopathy), salmonella and dioxins also heralded a radical review of all food chain legislation, with major changes applied first to animal feed additives, then to food ingredient, enzymes and food additives.
A new feed additive regulation, Regulation 1831/2003, was one of the first legislative acts to emerge form Regulation 178/2002, the “General Foo Law” regulation, followed by legislation on genetically modified organisms (GMOs), a feed hygiene regulation and a new feed regulation. All feed additives were subject to notification and re-evaluation by the European Food Safety Authority (EFSA), dossier deadlines in November 2010. In additional, Regulation 1831/2003 completed the EU prohibition of antimicrobial growth promoters. Amino acids, silage inoculants, and urea were reclassified as feed additives. There were around 11,000 notifications, condensed to around 500 dossiers for re-evaluation, a task that EFSA is still completing.
Today, the feed additive regulation covers technological, sensory, nutritional, zootechnical and coccidiostat categories of feed additives. EFSA is completing a detailed update of key guidance documents and the EU Commission is re-assessing the feed additive regulation after 15 years in force. The current changes and complexity of the authorisation procedures offer opportunities and challenges to applicants.
To view the complete version of the article, first published in the journal Regulatory Rapporteur, May 2018, p16–19, click here: Focus on European feed additives.