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15.1.2011 Official
Journal
of
the
European
Union L
11/75
COMMISSION RECOMMENDATION
of 14 January 2011
establishing guidelines for the distinction between feed materials, feed additives, biocidal products
and veterinary medicinal products
(Text with EEA relevance)
(2011/25/EU)
THE EUROPEAN COMMISSION,
(3) In
order
to
avoid
inconsistencies
in
the
treatment
of
such
products, to facilitate the work of the national competent
Having regard to the Treaty on the Functioning of the European
authorities and to help the interested economic operators
Union,
to act in a framework providing an appropriate level of
legal certainty, non-binding guidelines for the distinction
Having regard to Regulation (EC) No 767/2009 of the European
between feed materials, feed additives and other kinds of
Parliament and of the Council of 13 July 2009 on the placing
products should be established.
on the market and use of feed, amending European Parliament
and Council Regulation (EC) No 1831/2003 and repealing
(4) The
measures
provided
for
in
this
Recommendation
are
Council Directive 79/373/EEC, Commission Directive
in accordance with the opinion of the Standing
80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC,
Committee on the Food Chain and Animal Health,
93/74/EEC, 93/113/EC and 96/25/EC and Commission
Decision 2004/217/EC ( 1 ), and in particular Article 7(1) thereof,
HAS ADOPTED THIS RECOMMENDATION:
Whereas:
For the distinction between feed materials, feed additives and
other kinds of products the guidelines provided in the Annex to
(1)
The distinction between feed materials, feed additives and
this Recommendation should be taken into account.
other products such as veterinary drugs has implications
for the conditions for their placing on the market,
depending on the relevant applicable legislation,
Done at Brussels, 14 January 2011.
(2) Feed
business
operators
and
national
competent
control
authorities are frequently confronted with questions
For the Commission
regarding the classification of products, which might
jeopardise the marketing of feed throughout the
The President
European Union.
José Manuel BARROSO
( 1 ) OJ L 229, 1.9.2009, p. 1.

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L 11/76
EN
Official Journal of the European Union
15.1.2011
ANNEX
GUIDELINES FOR THE DISTINCTION BETWEEN FEED MATERIALS, FEED ADDITIVES AND OTHER
PRODUCTS
These guidelines are intended to assist the national competent authorities and the feed business operators to enforce and
to apply the relevant legislation.
They are based on the provisions laid down in the legislative framework governing the different kinds of products
concerned, with a particular view to the definitions of these products provided therein, in order to identify indications for
a distinction between the product types.
For any product, the criteria proposed for the distinction between the different kinds of products should not be applied
subsequently but simultaneously in order to create a profile of each specific product, taking into account all its char
acteristics. None of the criteria can be used exclusively or takes precedence over another.
Analogy with other products cannot be used as a discriminatory criterion but may be helpful to review a decision already
made based on the application of the established criteria. However, it can also be used to check for consistency.
1. Feed
legislation
1.1. Legal
texts
The following definitions can be found in the relevant legislation:
Article 3(4) of Regulation (EC) No 178/2002 ( 1 ):
‘feed’: any substance or product, including additives, whether processed, partially processed or unprocessed,
intended to be used for oral feeding to animals.
Following on from this broad definition of feed, recital 3 of Regulation (EC) No 767/2009 states that ‘feed may
take the form of feed materials, compound feed, feed additives, premixtures or medicated feedingstuffs.’
Article 3(2) of Regulation (EC) No 767/2009:
‘feed materials’: products of vegetable or animal origin, whose principal purpose is to meet animals’ nutritional
needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and
organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral
animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as carrier of
premixtures;
‘carrier’: a substance used to dissolve, dilute, disperse or otherwise physically modify a feed additive in order to
facilitate its handling, application or use without altering its technological function and without exerting any
technological effect itself;
‘feed intended for particular nutritional purposes’: feed which can satisfy a particular nutritional purpose by virtue
of its particular composition or method of manufacture, which clearly distinguishes it from ordinary feed. Feed
intended for particular nutritional purposes does not include medicated feedingstuffs within the meaning of
Directive 90/167/EEC;
‘oral feeding of animals’: the introduction of feed into an animal’s gastrointestinal tract through the mouth with the
aim of meeting the animal’s nutritional needs and/or maintaining the productivity of normally healthy animals.
Article 2(2)(a) of Regulation (EC) No 1831/2003 ( 2 ):
‘feed additives’: substances, micro-organisms or preparations, other than feed material and premixtures, which are
intentionally added to feed or water in order to perform, in particular, one or more specific functions that are
enumerated in Article 5(3) of the Regulation:
(a) favourably affect the characteristics of feed;
(b) favourably affect the characteristics of animal products;
( 1 ) OJ L 31, 1.2.2002, p. 1.
( 2 ) OJ L 268, 18.10.2003, p. 29.

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EN
15.1.2011 Official
Journal
of
the
European
Union L
11/77
(c) favourably affect the colour of ornamental fish and birds;
(d) satisfy the nutritional needs of animals;
(e) favourably affect the environmental consequences of animal production;
(f) favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora
or digestibility of feedingstuffs; or
(g) have a coccidiostatic or histomonostatic effect.
Article 2(2)(h) of Regulation (EC) No 1831/2003:
‘processing aids’: any substance not consumed as a feedingstuff by itself, intentionally used in the processing of
feedingstuffs or feed materials to fulfil a technological purpose during treatment or processing which may result in
the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the
final product, provided that these residues do not have an adverse effect on animal health, human health or the
environment and do not have any technological effects on the finished feed.
Moreover, recital 11 of Regulation (EC) No 767/2009 reads as follows: ‘(…). Feed materials are primarily used to
meet animals’ needs, for example for energy, nutrients, minerals or dietary fibres. They are usually not chemically
well-defined except for basic nutritional constituents. Effects which can be justified by scientific assessment and
which are exclusive to feed additives or veterinary drugs should be excluded from the objective uses of feed
materials. (…)’
1.2. Consequences for the distinction between feed materials and feed additives
1.2.1. D e r i v a t i o n f r o m t h e l e g a l t e x t s
— ‘Feed additives are substances (…) other than feed material’: A product cannot be a feed material and a feed
additive at the same time,
— ‘Animals’ nutritional needs’: It is not possible to indicate an exhaustive list of relevant elements but the
following characteristics of feed materials can be considered to be the most important:
(a) to supply energy, nutrients, minerals or dietary fibre; and
(b) to maintain the function of the intestinal tract,
— ‘Principal purpose is to meet animals’ nutritional needs’ and ‘primarily used to meet animals’ needs’: Apart from
the usual primary function of delivering nutrients to the animal, feed materials can have other purposes, for
example if they are used as carriers or if they are not digestible in the animals' intestinal tract. This is in line
with the aims of ‘oral feeding’ (‘meeting the animal’s nutritional needs and/or maintaining the productivity of
normally healthy animals’) which corresponds to the primary intended use according to the ‘feed’ definition.
1.2.2. C r i t e r i a t o b e s i m u l t a n e o u s l y c o n s i d e r e d i n a c a s e - b y - c a s e e v a l u a t i o n
— Production and processing method — chemical definition and level of standardisation or purification: Products
of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the simple
processing thereof, as well as organic or inorganic substances can be considered feed materials (e.g. fatty acids
or calcium carbonate). Chemically well-defined substances that are purified and give a certain level of standard
isation guaranteed by the manufacturer might qualify as feed additives (e.g. aromatic oil specifically extracted
from plant material). Nonetheless, certain feed materials are chemically well-defined substances and stan
dardised (e.g. sucrose). On the other hand, natural products of whole plants and parts of these or products
thereof resulting from a limited physical processing such as crushing, grinding or drying would be feed
materials.
— Safety and mode of use: If for reasons of animal or human health it is necessary to set a maximum content of
the product in the daily ration the products qualify for classification as additive. However, also for certain feed
materials maximum inclusion rates apply. Feed additive status might offer improved scope for effective
management of the product in terms of stability, homogeneity and with respect to over-dosage. Feed
additives are usually used at low incorporation rates. However, many feed materials, such as mineral salts,
are also used at low incorporation rates in the feed ration.
— Functionality: Feed additives are defined by their functions as laid down in Article 5(3) of Regulation (EC) No
1831/2003. However, these functions are not exclusive to feed additives. Thus, a feed material can also exert
an additive function (e.g. as a thickener) but this should not be the only intended use.

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L 11/78
EN
Official Journal of the European Union
15.1.2011
2. Biocidal
products
2.1. Legal
texts
The following definitions can be found in the relevant legislation:
Article 2(1) of Directive 98/8/EC ( 1 ):
‘biocidal products’: active substances and preparations containing one or more active substances, put up in the
form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or
otherwise exert a controlling effect on any harmful organism by chemical or biological means;
‘active substance’: a substance or micro-organism including a virus or a fungus having general or specific action on
or against harmful organisms;
‘harmful organism’: any organism which has an unwanted presence or a detrimental effect for humans, their
activities or the products they use or produce, or for animals or for the environment.
Point 1(a) of Annex I to Regulation (EC) No 1831/2003:
‘preservatives’: substances or, when applicable, micro-organisms which protect feed against deterioration caused by
micro-organisms or their metabolites.
Article 1(2) of Directive 98/8/EC provides for the following:
‘This Directive shall apply to biocidal products as defined in Article 2(1)(a) but shall exclude products that are
defined or within the scope of the following instruments for the purposes of these Directives:
(…)
(o) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs, Council
Directive 82/471/EEC of 30 June 1982 on certain products used in animal nutrition and Council
Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs,
(…)’.
Annex V to Directive 98/8/EC contains an exhaustive list of 23 product types with an indicative set of descriptions
within each type, including the following feed related product types:
Product-type 3: Veterinary hygiene biocidal products: Products in this group are biocidal products used for
veterinary hygiene purposes including products used in areas in which animals are housed, kept or transported.
Product-type 4: Food and feed area disinfectants: Products used for the disinfection of equipment, containers,
consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption
of food, feed or drink (including drinking water) for humans and animals.
Product-type 5: Drinking water disinfectants: Products used for the disinfection of drinking water (for both humans
and animals).
Product-type 20: Preservatives for food or feedstocks: Products used for the preservation of food or feedstocks by
the control of harmful organisms.
2.2. Consequences
for
the
distinction
between
feed
and
biocidal
products
By virtue of Article 1(2) of Directive 98/8/EC, products that are defined or that fall under the scope of the feed
legislation, including processing aids, are no biocidal products but are to be considered as feed (Precedence of the
feed legislation over the legislation on biocidal products).
Products in products types 3 and 4, as set out in Annex V to Directive 98/8/EC, are not considered to be feed.
However, certain products could qualify for product types 5 or 20 and also be considered as feed, usually feed
additives. Due to the above mentioned precedence of feed legislation over biocidal product legislation, such
products are to be considered feed. Products to preserve feed or water for animals are not biocidal products. If
such products are listed in product type 5 or 20, they are not intended to be administered to animals.
( 1 ) OJ L 123, 24.4.1998, p. 1.

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EN
15.1.2011 Official
Journal
of
the
European
Union L
11/79
3. Veterinary
medicinal
products
(VMPs)
3.1. Legal
texts
The following definitions can be found in the relevant legislation:
Article 1 of Directive 2001/82/EC ( 1 ):
‘veterinary medicinal product’:
(a) any substance or combination of substances presented as having properties for treating or preventing disease in
animals; or
(b) any substance or combination of substances which may be used in or administered to animals with a view
either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immuno
logical or metabolic action, or to making a medical diagnosis;
‘medicated feedingstuffs’: any mixture of a veterinary medicinal product or products and feed or feeds which is
ready prepared for marketing and intended to be fed to animals without further processing, because of its curative
or preventive properties or other properties as a medicinal product covered by the definition ‘veterinary medicinal
product’.
Article 2(2) of Directive 2001/82/EC provides for the following:
‘In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of
a ‘veterinary medicinal product’ and within the definition of a product covered by other Community legis
lation, the provisions of this Directive shall apply.’
Article 3(1) of the same Directive provides for the following:
‘This Directive shall not apply to:
(a) medicated feedingstuffs as defined in Council Directive 90/167/EEC of 26 March 1990 laying down the
conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the
Community;
(…)
(d) any additives covered by Council Directive 70/524/EEC of 23 November 1970 concerning additives in
feedingstuffs, where they are incorporated in animal feedingstuffs and supplementary animal feedingstuffs
in accordance with that Directive;
(…)’.
Article 13(3) of Regulation (EC) No 767/2009 reads as follows:
‘The labelling or the presentation of feed materials and compound feed shall not claim that:
(a) it will prevent, treat or cure a disease, except for coccidiostats and histomonostats as authorised under
Regulation (EC) No 1831/2003; this point shall not, however, apply to claims concerning nutritional
imbalances provided that there is no pathological symptom associated therewith;
(…)’.
3.2. Consequences
for
the
distinction
between
feed
and
VMPs
— If, after consideration of all the characteristics of an unclassified product, the conclusion is that it might be a
VMP, it should be considered a VMP (precedence of the VMPs legislation over feed legislation, except for
authorised feed additives).
— Medicated feedingstuffs are not VMPs but, according to recital 3 of Regulation (EC) No 767/2009, a form of
feed containing medicated pre-mixes and being subject to a prescription by a veterinarian.
— Based on the definition of ‘particular nutritional purpose’ (see under point 1.1 above), the borderline between
feed and veterinary medicinal products is set. The particular nutritional purposes such as ‘support of liver
function in the case of chronic liver insufficiency’, ‘reduction of urate stones formation’ or ‘reduction of the risk
of milk fever’ can be achieved by feed.
( 1 ) OJ L 311, 28.11.2001, p. 1.

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