Borderline products difficult to define and deal with

Various new legislations on feed materials and feed additives were implemented lately. With Commission Regulation (EC) 575/2011 on the catalogue of feed materials and especially Regulation (EC) 767/2009 on the placing on the market and use of feed, new opportunities for characterising and labelling of feed have arisen. Companies therefore face the challenge to decide on the appropriate categorisation of their products. In 2011 the European Commission published a recommendation establishing guidelines for the distinction between feed materials, feed additives, biocidal products and veterinary medicinal products. However this still gives a lot of room for discussion and interpretation within the legal defi nitions.

“Innovation in animal health and nutrition often occurs at a faster pace than the regulatory system in place” said Klaus Hellmann, CEO of Klifovet AG in his introduction to the attendees of the company’s conference at the occasion of its 15th anniversary. Delegates came from three continents, representing 13 countries. Based on the day-to-day experience of consultancy at Klifovet, there are a high number of companies trying to identify new opportunities for marketing authorisation of their products in Europe as well as in the US.

Many of these products are novel compounds which can not be easily categorised as drug or feed or feed additive.

Borderline products
Driess Minne, head of the Veterinary Division of the Federal Agency for Medicines and Health Products in Belgium gave an overview on these so called ‘borderline products’. “There is no clear borderline for a number of products such as feed additives, feed intended for particular nutritional purposes, but also cosmetics and biocides” he said. As member of the EU-wide CMDv working group for borderline products he is involved in the harmonisation of this grey zone in Europe. His conclusion was that there is no substitute for a case-by-case approach to new products as rules and guidance cannot cover all possibilities.

The need to differentiate between feed, zootechnical feed additive and drug claims was emphasised by Beate Lohr, head of regulatory affairs at Klifovet. She detailed the current requirements of EU legislation to substantiate a claim for products. Whereas prevention or treatment of a disease is a claim strictly reserved for veterinary drugs, other claims can be made for feed as long as the claim is objective and understandable by the user and there is substantiated scientific evidence to demonstrate the claimed effect. “In the end, for a lot of products this provides the opportunity for companies to select between different options. Companies need to be aware of their overall liability for their products. However there is no general conclusion but always a case-by case decision,“ Lohr said. „Once the decision for a claim has been taken it is crucial to develop the product according to the selected strategy, to provide consistent data and to present the product according to the chosen classifi cation,” was her advice to companies when planning the development and presenting the product. A review of opinions from the Standing Committee on the Food Chain and Animal Health illustrated recent case-by-case decisions for various feed products. For the US Douglass Oeller explained the challenging legal situation. As former FDA assessor he gave an insight on the regulation of feed additives with the possibility of an AAFCO feed ingredient defi nition, resulting in allowance of marketing under a policy of enforcement discretion by the FDA. “This policy may change in the future” Oeller said and described an alternative possibility, which is FDA approval of a feed additive petition.

Registering options
More than one possibility is also given when it comes to the registration of products with immunological effects. They can be presented as zootechnical feed additive, feed with a PARNUT (feed intended for particular nutritional purposes) claim or as drugs. Regina Wolf, head of the product development department at Klifovet, gave an overview on these different options and highlighted the major differences in product development emphasising the essential pre-requisites, resources required and time involved. “Analyse first” was her conclusion for a successful registration, emphasising the importance of SWOT and Gap analyses including market research. A tailor-made development plan including all aspects of the objectives and options helps designing studies that are appropriate for the intended purpose.

Isabel Radeloff, head of Klifovet’s clinical trial unit, emphasised the need for careful planning, conduct, evaluation and reporting of safety and efficacy studies that shall facilitate the substantiation of claims for feed containing products. A well designed protocol, respecting the marketing objectives of a product’s claim, is a pre-requisite for any study, to be established prior to commencement and including a description of all procedures and statistical evaluation planned. Based on her experience at Klifovet, studies may be placed at various locations as long as quality management principles are complied with.