Our upcoming event in Amsterdam features a stream dedicated to the latest in Global Markets and Regulations, highlights from the stream include:

• The Food and Agriculture Organization of the U.N. explain which markets are best suited to certain products
• Meet and discuss regulation with senior representatives from FEFANA, FAMI-QS, EFSA and leading consultants and advisors
• Recent EU regulatory changes & trends impacting feed formulations in Europe
• Markets of interest around the world

Ahead of the event here is an exclusive insight article, recently published by Feedinfo News Service, discussing the role of feed additives as the regulatory landscape for veterinary medicines in Europe evolves.

New rules expected to be adopted shortly by the European Parliament and the Council of Ministers will see the EU veterinary antibiotics regime tighten even further, part of a series of changes affecting the use of veterinary pharmaceuticals and medicated feed.

While the two trilogue agreements—one on veterinary medicine and the other on medicated feed—have not yet been officially adopted and published in the EU’s Official Journal, various details have been made available, along with a draft text for the veterinary medicine regulation.

Key features include:

• a restriction on prophylactic antibiotic treatment to single animals, banning group prophylaxis via medicated feed (notably, this is said not to affect the use of coccidiostats, which are organized under a different category in the EU’s classification system)
• a call for the Commission to establish reciprocity of EU standards in the use of antibiotics for imported foodstuffs, meaning that antibiotic growth promoters may not be used in animals whose meat will be exported to Europe
• the creation of a list of antimicrobials which are critically important in human medicine and which will not be available for use in the veterinary sector
• the opening up of the central EU licensing procedure to all animal health products, an approach which is aimed at better facilitating the single market and improving the availability of animal health solutions in smaller countries
• a unified system of pharmacovigilance to monitor for adverse effects
• measures to incentivize new innovation in antimicrobial research: “longer periods of protection for technical documentation on new medicines, commercial protection for innovative active substances, and protection for significant investments in data generated to improve an existing antimicrobial product or to keep it on the market”
• a call for the Commission to define maximum levels for cross-contamination of various active medicinal substances, in consultation with EFSA
• a call to extend rules about medicated feed prepared by feed mills or professionals to all animal medicines administered orally, whether via feed or drinking water, including “top dressing” systems in which the farmer prepares the medicated mix (strictly speaking, instructions for the Commission to consult with the European Medicines Agency to establish rules on this matter)

The animal medicines and feed additives industries respond:

Many animal nutrition experts and other stakeholders have weighed in positively on the EU’s stance against prophylactic antibiotics.

AnimalhealthEurope, an association representing manufacturers of animal medicines, vaccines, and animal health products, has stated that they lend “support to clear rules regarding the ban of routine prophylactic use of antibiotics in line with the industry’s responsible use of medicines approach.” As the group told Feedinfo: “For us, clarity is given within the use of the word ‘routine’…Under our responsible use approach we advocate that antibiotics should only be used ‘as little as possible, as much as necessary’. Our view is that responsible use of antibiotics must go hand-in-hand with good hygiene and biosecurity measures, good husbandry and nutrition, supported by vaccination plans and other preventive measures in a comprehensive animal health plan. This includes the use of diagnostics for the early detection of disease. This is an approach that we have been promoting for over a decade…”

Increased focus on non-pharmaceutical health management, including nutritional interventions, is bound to be received positively by the feed additives industry.

Uwe Ranft, Executive Director and Chief Commercial Officer for Europe, the Middle East and Africa for Novus International, observed: “During the last decade, Novus has become a referent leader in Europe in providing science-based alternative solutions to antibiotics in animal production. The European Union’s action undoubtedly will mean an increase of the usage of such feeding concepts and will entail a growth of the market for the solutions supporting gut health, animal performance and welfare, as well as producer profitability…products like proteases, eubiotics based on benzoic acid and phytogenic compounds as well as chelated trace minerals will be key to approach this new European scenario.”

Indeed, the feed additives industry is, overall, proud of its contributions to the EU’s long-sought goal of reducing antimicrobial usage in veterinary medicine as much as possible.

In the words of Biomin’s Vice President for Development and Innovation Franz Waxenecker, “We’ve seen a multi-decade long effort by regulatory authorities to restrict the application of antimicrobials in farm animals to the role of treating sick animals… This development is only possible because of the fact that there have been scientific breakthroughs that enable further successful reduction of antibiotics without impairing the health, performance or welfare of animals. It is a testament to the value of biosecurity, novel veterinary tools and feed additives that promote gut performance. At BIOMIN we have a 30+ year track record of antibiotic-free feeding programs and a full suite of gut performance and mycotoxin risk management tools to support profitable and sustainable farm animals.”

A spokesperson for Dupont concurs:

“In our research we have observed that everything in the gastrointestinal tract (GIT) is connected: the nutrition, the microbiome and the gut and immune function. We have termed this interaction: nutribiosis… Considering how everything fed to the animal combines and interacts in the GIT, rather than taking a siloed approach, provides animal producers with new ways to fight AMR. For example, to mitigate the risk of an outbreak, producers can look for a combination of feed additives, such as enzymes and probiotics, that work together to create a more favorable nutribiotic state. Combined, they improve nutrient digestibility, control which substrates are available for bacteria and help maintain the balance of the microbiome, which helps prevent challenges that would result in lost performance.”

However, while the EU has been consistent in its efforts to reduce antibiotic use, some felt that it could go further in recognizing the utility of feed additives in heading off diseases now that preventative antibiotics may no longer be used for this purpose.

Dr. Leo den Hartog, Director of R&D at Trouw Nutrition, a company determined to be part of the solution to the AMR challenge, observed recently: “The example of the agricultural sector in the Netherlands speaks for itself: between 2009 and 2017, the sales of antibiotics have dropped by 63.4% without negatively affecting performance (SDa, 2018). In fact, the decreased use in antibiotics even led to a reduced prevalence of some AMR bacteria. However,” he continued, “it is necessary to have a new category of feed additives within the legislation, allowing claims about preventive animal health. This will stimulate and help the industry in bringing adequate nutrition to market. Combining feed-farm-health management will ultimately help farmers reduce the need for antibiotics while maintaining animal performance. Innovations in animal production and a cooperative regulatory framework are key to achieve this aim.”