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Regulation 1831/2003

These eight digits with the slash are well known, since this regulation is the basis for the re-registration of feed additives in Europe. By early November dossiers of all feed additives have to be submitted to the European Commission for re-evaluation. Health Claims Europe organised a one day interactive workshop directed at Feed & Additives Regulation in Europe during April in Brussels with the focus on how to guarantee that vital additives are still available in the near future, and on how daily feed and feed additives businesses prepare for this.

By Dick Ziggers
Regulation 1831/2003 on additives for use in feed replaced the former Directive 70/524 as the main legal text for feed additives as was explained by Keith Millar, head of the Animal Feed Branch of the UK Food Standards agency. “The main differences are that antibiotic growth promoters are phased out in the EU and that urea, amino acids and salts are transferred from Directive 82/471 to be included in Regulation 1831/2003,” he said. Furthermore, new categories and functional groups are established, silage additives are brought formally within the scope and all feed flavours are to be specifically authorised. And the major issue will be that all currently authorised additives need to be re-assessed.
 
Regulation 1831/2003 divides all additives into categories and then into functional groups. There are four categories – technological, sensory, nutritional and zootechnical. Each of these is divided into functional groups. Coccidiostats and histomonostats form a separate category. A technological additive is any substance added to the feed for a technological purpose. Sensory additives are substances to improve or change the organoleptic properties of feed, or the visual characteristics of the food derived from animals. Zootechnical additives are used to favourably affect the performance of animals in good health or the environment.
 
Together with nutritional additives in these categories there will be borderline cases with feed material definitions. Where a substance is presented or claimed to favourably affect the characteristics of the feed or the animal products, the nutritional needs of animals or environmental consequences of animal production, it needs to be qualified as a feed additive. This is one of the purposes of the Community laws on feed additives: to require evidence in support of these claims through the pre-market approval process. In contrast, feed materials generally do not make such claims, and therefore there is no need to require such rigorous safety evaluation, as foreseen for feed additives. Nutritional and function claims for feed materials are allowed (Art. 13 Regulation 767/2009).
 
Grey area substances
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).
 
“There are also various types of authorisation, but the most pressing one is Article 10, which deals with re-authorisation of existing products under 70/524,” Millar said.
 
Millar further explains that existing products can be kept on the market provided that they were already notified by the Commission by November 2004 and that they were entered onto the Register of feed additives by the Commission by November 2005, and that a valid application is made for authorisation by 7 November 2010 (Table 1). “It is hard for the member states to gauge how many valid applications will be made and this might be a possible bottleneck in the assessment systems,” Millar noted. A prioritisation system was agreed upon and a ‘promise’ (Article 7/10/3) was made that dossiers would be assessed within six months. In practice it means that an application needs to be tabled by the end of September to the Community Reference Laboratory (CRL), which judges the application. When applications come in later the CRL won’t have enough time to judge the application.
 
 
 
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.
“If the application for these products is not handed in, they will be drawn from the market,” said Didier Jans of Fefana, the EU Association of feed additives and premix operators. “Fefana is taking care of the orphan additives that are needed, but nobody is taking care of them.” Fefana has prepared a list of orphans based on information provided by the industry. “However, there is no guarantee over the non-orphans. We also have almost no information on colourants. Our list is updated as often as necessary and any information on applications prepared by producers, or other means is most welcome. We will keep this information confidential, but at least update our list,” Jans said to the delegates.
 
 
Jans also refers to the ‘non-holder-specific’ additives, which are additives that several companies want to put on the market, but no one wants to do the initial job. Within the regulations there is no legal obligation to cooperate. “Fefana tries to help its members and the industry to solve these problems by coordinated actions,” Jans said.
 
Pricy business
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.”
 
 
Some relief from food regulation
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.”
 
Currently the relevant food legislation provides availability of food specifications and assessments. This provides opportunities for avoiding duplication of effort. A simplified procedure for assessment of feed additives already authorised for use in food is already put in place. These additives need additional data for the feed dossier to make the transition from food, but there is potential for exemptions and extrapolations of data.
 
EU Reference Laboratory
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.
 
*Health claims Europe is a cooperation of Ignace Debruyne & Associates VOF (ignace.debruyne@scarlet.be) and Nutrimedes BVBA (info@nutrimedes.com).
 

Source: AllAboutFeed vol 1 no 4, 2010

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  • Table 1 - Re-evaluations of additives timeline

    Table 1 - Re-evaluations of additives timeline

  • Table 2 - Planning and building a dossier matrix

    Table 2 - Planning and building a dossier matrix

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