Information and admission procedure
Feed additives are an indispensable aid in animal nutrition. They can be used to adapt recipes to the performance-oriented nutrient requirements of the animals. In addition, feed additives can contribute to the improvement of animal welfare, sustainability and environmental protection in the field of feed, among many other areas of application. With their help, individual weaknesses of larger recipe components can be compensated for and the excretion of valuable nutrients, such as nitrogen or phosphorus, can be minimised.
According to feed law, additives are included in the definition of feed, but due to the various special features they are presented separately. Historically, the first comprehensive legal summary of common additives was made with Directive 70/524/EEC, which was only replaced more than three decades later by the current Additives Regulation (EC) 1831/2003. The currently valid definition for additives is: "Feed additives" are substances, micro-organisms or preparations, other than feed materials or premixtures, which are intentionally added to feed or water, in particular to fulfil one or more of the functions mentioned in Article 5(3). In comparison, feed is described according to Regulation (EC) 178/2002 as follows: "Feed" means any substance or product, including additives, whether processed, partially processed or unprocessed, intended for oral animal feeding.
Another important definition is that of "oral animal feeding": this is the intake of feed into the animal's digestive tract through the mouth or beak in order to meet the nutritional needs of the animals or to maintain the productivity of normally healthy animals. In addition to a separate regulation in Regulation (EC) 767/2009, this text is the basis for the fact that, apart from other misleading claims, all statements on effects of feed additives in the direction of prevention or therapy of diseases are inadmissible, unless they concern the scope of application of coccidiosis defence substances (coccidiostats) or that of feed for specific nutritional purposes (dietetic feed) according to Regulation (EU) 2020/354.
Additives are the only product group within feed for which authorisation is required. For this purpose, an application must be submitted to the European Commission and accompanied by the required application documents or those prepared in accordance with Regulation (EC) 429/2008. The subsequent procedure follows a specific timetable, but it is difficult to estimate the exact time horizon until an authorisation regulation is available. Experience shows that a procedure is rarely completed before one year has elapsed and can also take several years. Further details and information on authorisation can be found on the website of the European Food Safety Authority (EFSA) and on the website of the Federal Office of Consumer Protection and Food Safety in Germany.
Categories and groups
Feed additives are a very extensive and heterogeneous group, which is divided into five categories, which in turn consist of various functional groups (for a complete breakdown, see Annex I of Regulation (EC) 1831/2003):
- technological additives (preservatives, antioxidants, binders, emulsifiers, stabilisers, gelling agents, silage additives, anti-caking agents, release agents, substances to reduce mycotoxin contamination (mycotoxin reducers), hygienising agents, etc.),
- sensory additives (the most extensive category of colourings and flavourings in products),
- nutritional additives (vitamins, trace elements, amino acids, urea, etc.),
- zootechnical additives (digestibility enhancers, gut stabilisers, substances favourable to the environment, other zootechnical additives and agents to stabilise the physiological condition),
- coccidiostats and histomonostats (currently only coccidiostats are authorised).
The assignment of an additive to a category and functional group is quite easy to recognise on the basis of the identification number: For example, silage additives always start with the string 1k, binders with 1g and vitamins with 3a. However, there are also products with authorisations for several functional groups (e.g. individual amino acids that can also be used as flavourings), but the number only indicates one of the possible groups. The EU Register of Additives contains a clear presentation of all currently authorised additives with the linked original authorisation regulations. It should be noted that the register itself is only informal; only the respective authorisation regulations are legally binding.
The register also lists products that still have the old E-numbers or only numbers. This does not mean, however, that all food additives are also permitted or that groups such as phytogenic flavourings can be used in principle. These "old products" are additives for which an application for authorisation as a feed additive had to be submitted before 8 November 2010 and for which the procedure could not yet be completed in the course of the re-evaluation of all additives. Therefore, only those products for which an application for authorisation and the necessary application documents are available may be used until the re-evaluation is completed.
With regard to the intended use, the following points, among others, must be observed:
- For binders (1g), the definition according to Annex I of the Ordinance on Additives is decisive. According to this, these are technological substances which increase the tendency of the particles of a feed to adhere. This is primarily a matter of feed quality. In connection with binders, it is therefore not permitted to advertise their binding of metabolic products, harmful gases or toxins, as this would be a violation of the permitted use and the authorisation conditions.
- Additives to reduce mycotoxin contamination(1m) may also be called mycotoxin reducers in a compound feed. However, their use is only permitted if the feed law guideline or limit value for the respective mycotoxin is complied with in the compound feed concerned. In addition, it is not permissible to use the term toxin reducer in the context of product labelling.
- In the case of substances that have a favourable effect on the environment, there is only one approved product, 3-NOP (3-Nitro-Oxy-Propanol, 4c1). The application of the binding of harmful gases of different types (ammonia, methane, etc.) in connection with other substances, such as clay minerals or flavouring substances, is therefore not permissible.
- In the case of agents for stabilising the physiological state, there are no approved products yet. However, there are first applications with the aim of using e.g. CBD as an additive to improve resistance to stress factors. In connection with stress, a corresponding special nutritional purpose (dietary feed) for dogs and pigs can be claimed if the legal requirements in this regard are met.
In the case of additives, the demarcation from other products or legal matters plays an important role. In order to clarify this problem systematically, test questions are used (modified after Dr. Sabine Kruse, German Ministry of Agriculture):
- Taking into account the objective purpose of use (results from the scientifically justified assessment of the effects that can be achieved with the substance, irrespective of whether these effects are disclosed claimed or intended), is the substance to be considered as an additive within the meaning of Regulation (EC) No 1831/2003?
Examination on the basis of the Register of Feed Additives or, in the case of non-authorised products, by comparison with the functional groups according to Annex I of the Additives Regulation.
- Is the substance to be considered as a veterinary medicinal product, taking into account the objective use?
Examination based on the definition of veterinary medicinal product according to Article 4 of Regulation (EU) 2019/6 and the conflict standard according to Article 3 of the same EU Regulation.
Both pharmacologically undisputed and claimed effects are to be included. The conflict-of-law rule essentially states that if the classification of feed additive or medicinal product is not clear, medicinal product law takes precedence.
- Is the substance to be considered as feed material or straight feeding stuff?
Test criteria are the straight feeding stuff catalogue in the form of Regulation (EU) 68/2013, the straight feeding stuff register of the European feed industry (Feedmaterialsregister) and especially in Austria and Germany the positive list of the Standards Commission for Straight Feeding stuffs in the Central Committee of German Agriculture. A feed material must meet the relevant definition and thus make a significant contribution to the nutrient supply of an animal or have a favourable effect on the digestive tract or its eubiosis.
Tolerances and marking
In the case of additives and premixtures (mixture of two or more additives or at least one additive with a carrier), the legal tolerances according to Annex IV of Regulation (EC) 767/2009 are not applicable, as these only apply to feed materials and compound feed. This results in less leeway in the marketing of these products. In the event of a control by the feed monitoring authorities, only the analytical measurement uncertainty of the test method used specifies the permissible range of deviation from the declared content. Labelling regulations for additives and premixtures can be found in Article 16 of the Ordinance on Additives.
Note for farmers:
The following legal requirements must be met when using additives:
When buying in compound feed, there are no specifications as to which additives may be contained in it.
- If the farmer is only a primary producer according to Regulation (EC) 183/2005 on feed hygiene requirements, he may only buy in silage additives and use them for ensiling.
- For the own production of compound feed with various additives or premixes, an increased documentation requirement applies in the form of an obligation to keep records on the products purchased and used, the recipe of the mixture produced and the intended use of the compound feed produced. In this case, amino acids, urea, flavourings, emulsifiers, antioxidants without maximum content, preservatives, acidity regulators, binders, and flow and coagulation aids may be used. Under these conditions, the LFBIS number is still sufficient for registration as a feed business operator. The feed control is carried out by the provincial control authority (usually the competent official veterinarians of the district administrative authorities).
- If additives other than those mentioned under points 2 and 3 (e.g. vitamins, trace elements, enzymes, microorganisms) or premixtures containing such additives are used for own compound feed production, registration or even authorisation with the Federal Office for Food Safety (BAES) is required. The farmer concerned is then also subject to the control of this federal authority. There are currently only very few farms that are registered with the BAES (e.g. HBLFA Raumberg-Gumpenstein) and no farm in Austria that has an authorisation.
- Additives may only ever be used under those conditions for which they are authorised according to the authorisation ordinance. This includes, on the one hand, the target animal species for which the product is intended and also the respective feed type for which the additive was applied for. As a rule, the use is only permitted in compound feed, the usability in straight feed or via the drinking water must be explicitly stated. Furthermore, for individual additives it is stipulated in the authorisation conditions that they may only be introduced into the compound feed as a premix. This applies in particular to products that may cause a higher health risk if mixed in inhomogeneously (e.g. trace element compounds).
In practical use, each use of an additive must comply with the authorisation conditions. Some examples with permissible multiple uses are given below:
- Formic acid (1k236) is permitted as an ensiling additive, as a preservative and as a hygiene improver,
- Propionic acid (1k280, E280) as a preservative, flavouring agent and silage additive,
- Bentonite (1m558i) as a binder and mycotoxin reducer,
- clinoptilolite (1g568) as a binder and flow aid,
- Citric acid (1a330) as preservative and acidity regulator,
- Cysteine (3c392), histidine (3c352), isoleucine (3c381) and arginine (3c363) as flavouring agent and amino acid,
- taurine as flavouring (2b16056) and vitamin-like substance (3a370).
In contrast, the following variants are not allowed because certain uses are not permitted:
- Clinoptilolite (1g568) may not be used and advertised for environmental improvement (through reduced harmful gases) or as a mycotoxin reducer. Furthermore, this additive is only permitted for addition to compound feed at up to 1% (10,000 mg/kg) in complete feed, based on 88% dry matter, and must therefore not be mixed into water or milk;
- various microorganism strains authorised as silage additives (functional group 1k) cannot be used as zootechnical additives ("probiotics"),
- Mixtures of synthetic or natural flavouring substances (functional group 1a) constitute premixtures, but may not be used for environmental improvement (pollutant gas reduction, functional group 4c) or as zootechnical additives (functional group 4d) without an authorisation procedure. As an example of an authorised zootechnical additive, product 4d15 can be mentioned, which contains a saponin source in addition to the flavouring substances thyme oil and star anise oil.
Additives are naturally present in various feed materials and can thus have additive-like effects. Well-known examples of this are vegetable oils with vitamin E or animal by-products with vitamin D. Likewise, many macro-components contain different trace element contents or essential amino acids. When using and advertising these products, care must be taken to ensure that the actual function of a feed material as a nutrient supplier or the positive effect on digestion is in the foreground; other advantages or effects for animal nutrition can be cited as a "side effect", so to speak, if this can be proven by scientific data (literature, studies). It becomes problematic with regard to the classification under feed law if straight feeding stuffs are exclusively associated with effects that represent a use subject to authorisation for additives or even medicinal products. For example, alleged positive effects on the environment due to the binding/avoidance of harmful gases by various wood products (e.g. lignocellulose) or promises of healing by herbs, parts of herbs or herbal mixtures.
The Institute for Animal Nutrition and Feed(email@example.com) will be happy to answer any further questions on this topic, especially if there are any uncertainties regarding legal options and the use of additives or feed materials with additive effects.
For matters concerning feed control, please contact the feed control authority centrally responsible in Austria (Federal Office for Food Safety, BAES for short).
Last updated: 31.10.2023