Regulation 1831/2003

Grey area substances is the term used for those substances or products that are perceived not to fall conveniently into either the feed material or feed additive category. Regulation 1831/2003 does allow a decision to be made by the Standing Committee. There have been some moves to re-categorise some products or substances as feed materials, but this should not be considered as a safety net for orphan additives (See Orphan additives).

 

 

 

The industry is a bit worried about the so-called ‘orphan additives’ – the term used for additives that were authorised under Directive 70/524 and entered onto the Register not supported by an application under Article 10 of Regulation 1831/2003. In other words this concerns additives that are generally used and needed, but no company intends to take the initiative for re-registering, for example for generally used anti-oxidants.

 

Planning and building a dossier is a time-consuming and pricy activity. “A typical dossier for registration of a zootechnical additive for broilers takes three to five years and costs about 250,000 euros,” says Elinor McCartney of Pen & Tec Consulting. “For one extra specie you can easily add another 100,000 euros.” McCartney elaborated on the complexity of applying for a registration of a feed additive. She explained a matrix plan for submitting a dossier (Table 2), where eight steps are defined. “Basically re-registration is simpler because one can work with existing information. If you are a pioneer and want to register a new product that is difficult because ‘new’ means ‘potentially dangerous’. In a worst case, pre-registration work on safety and efficacy would cost well in excess of one million euros. Elanco, for example, estimates that registration of a new coccidiostat would cost about 20 million euros.”McCartney also signals a Catch 22 in submitting and conducting efficacy research. With pigs, for example, it is required to use healthy weaned piglets in clean conditions and apply good husbandry. In most of these cases no significant differences will be recorded. “Healthy pigs only exist in laboratory situations, not under regular farm conditions,” she said. “I remember a case where such pigs were exposed to a post-weaning disease and significant improvements with the tested product were obtained…but EFSA rejects such a study.”

 

 

In some cases there might be some relief from legislation already established in the food sector. Already registered food additives, which are also used in animal feed, can profit from this work. Article 7 of 1831/2003 states: ‘The implementation rules shall include provisions which allow for simplified procedures for the authorisation of additives which have been authorised for use in food.’ Elizabeth Lewis of Cantox Consultants said the EU is preparing a list of flavouring substances, which should be ready by 31 December 2010. “That will be a source of up-to-date assessments and database of flavourings,” she said. In the technologial category Lewis refers to the food enzymes, which are added to foods to perform a technological function in the manufacture, treatment, storage and so forth of food, including processing aids. The EU is harmonising the rules for evaluation (Regulation 1332/2008) and intends to establish a community list of enzymes. “There is an initial two year period for data submission, followed by a transition period. This might give some potential feed additives opportunities for the future.”

 

 

For each feed additive applicants have to prepare a dossier including methods of analysis for the submitted additive. Regulation 1831/2003 established an EU Reference Laboratory (better known as CRL) to look at the analytical methods. Its work is supported by a consortium of National Reference Laboratories (currently 35). “The objective of the evaluation is to establish whether the conditions of use can be enforced by analytical methods. We also keep a sample bank of feed additives,” said Guiseppe Simone of CRL. “Applicants have to support the costs of CRL, which in general was 6,000 euros, but nowadays we have a flexible approach.”It often occurs that feed additives, for whatever reason, cannot be identified or not in the expected quantity. Therefore Simone has some tips for applicants when preparing a dossier. “Put yourself into the shoes of another laboratory that intends to apply the method, but never used the method. Modify your method, if it implies the use of matrix matched standards, requiring identical feed samples as blank,” he said. “And when a standard or ring trial validated method exist for the matrix feed but not for premixes or the product, you have two options: (1) contact a second laboratory to verify the method or (2) check, e.g. by doing experiments, whether the scope of the feed method can be extended to cover the other matrices as well. The second option has my preference.” Simone also advises to use as many possible results from former experiments suitable to characterise the method, if that is required. Detailed info on CRL can be obtained from their website: http://irmm.jrc.ec.europa.eu/crl-feed-additives where the new administrative guidance for applicants can be found as well as an on-line declaration system and a refurbished methods database.