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2013-05-03 Booklet Premixtures
2013-05-03 Booklet Premixtures
Premixtures
Fefana Publication
P remixtures
Contributors:
FEFANA Working Group Premixtures, and in particular:
ISBN 978-2-9601289-0-1
© FEFANA 2013
-03-
Table of Contents
Preamble 7 b. pH 17
c. Moisture 18
Introduction 9 d. Bulk density 18
e. Reactivity 18
I. The various types of f. Contaminants 18
premixtures 10 g. Solubility in water 19
h. Hygroscopicity 19
1. Product forms 11 i. Shelf life 19
2. Product functions 12 j. Flowability 19
3. Different constraints 13 k. Dustiness 19
a. Quantitative requirements 60
b. Instructions for taking,
preparing and packaging
the samples 60
Preamble
FEFANA is the EU Association of With a unique framework, the as-
Specialty Feed Ingredients and sociation is able to draw on the ex-
their Mixtures. With more than 100 ceptional knowledge of our mem-
members from 28 countries, it rep- bers, bringing together expertise
resents feed business operators and science. This is why we are
active in the feed chain, such as able to provide you with such a
specialty feed ingredients produc- valid publication.
ers, premixtures manufacturers,
users, importers and distributors. The feed premixture industry has
developed greatly over the last
Established in 1963, FEFANA has decades. It is regarded as a key
represented and served the inter- partner for the compound feed
ests of its industry ever since and industry, farmers and other feed
it is a recognised partner for na- business operators in handling
tional, European and international complexity. Just to mention a few:
authorities and fellow organiza- in global sourcing of specialty feed
tions in the feed and food chain. ingredients, in managing many
formulations, of safe and smooth
Specialty Feed Ingredients and handling of ingredients with many
their Mixtures are fundamental in different properties. Fefana is a
the livestock chain to ensure bal- provider of tailor made solutions
anced feed, thus contributing to ani- and a partner to work on conveni-
mal health and welfare. Quality and ent and sustainable feed to food
safety are at the heart of our busi- solutions.
ness and we believe that innovation
and sustainability are key concepts In this booklet we would like to
that we will continue to focus on. provide the up-to-date information
about the role of the premixture
industry in the feed to food chain.
Didier Jans
FEFANA Secretary General
-09-
Introduction
This booklet has been designed In particular we start with a de-
and developed by the members of scription of the various types of
the FEFANA Working Group Pre- premixtures and go on to explain
mixtures. The aim of this working the sourcing and procurement
group is to promote, defend and process of premixture ingredients,
represent the common and gen- their formulation, manufacturing,
eral interests of the European pre- packaging and transport. We then
mixture industry. focus on the quality management
and safety, and provide informa-
The different chapters in this tion on their physical and chemical
booklet aim to draw a picture of characteristics.
the European premixture industry
and are based on EU legislation We hope you will find this booklet
at the time of editing. We aim to useful and that it will clarify the land-
update the relevant information as scape in which the EU premixture
appropriate following changes in industry is operating.
legislation.
Peter Fidder
Chairman Working Group
Premixtures
Premixtures -10- -11-
I. The various types However, manufacturing process- 1. Product forms Liquid premixtures: in general
of premixtures es of feed are diverse and new these liquid premixtures are in-
technologies have become avail- Solid premixtures: these premix- cluded after further processing of
In the European Union, premix- able, feeding practices steadily tures in powder form are usually the feed ingredients (e.g. post-pel-
tures are defined as “mixtures of change according to the market mixed with the other feed materi- leting / extrusion). It is particularly
feed additives or mixtures of one trends, scientific progress and als in the early steps of the feed helpful for feed additives which
or more feed additives with feed economic constraints, new feed production, as close as possible may be sensitive to temperature,
materials or water used as carri- additives and functional feed in- to the mixer, but before any other moisture or high pressures (e.g.
ers, not intended for direct feed- gredients are entering the market treatment (such as pelleting, etc). enzymes).
ing to animals”. The terms premix, and the regulatory environment is They represent the vast majority of
base-mixes, blends, etc, are com- evolving. Therefore, the premix- premixtures used on the market. This can also be used to apply fla-
monly used as synonyms and re- ture industry is constantly adapt- vouring/appetizing substances at
flect the large variety of products. ing its offer to the needs of its cus- the surface of the feed and there-
tomers. fore provide higher palatability.
The use of premixtures is mainly
aimed at: Premixtures can take many differ-
ent forms according to their use
▪▪ Reducing the number of ingre- or their specific function(s) in the
dients to be supplied, handled feed.
and incorporated in the feed
mills.
▪▪ Ensuring proper homogenisa- Picture 1:
Manufacturing flowchart of compound
tion of the feed additives in feed. Source: IFF, Braunschweig
the final feed, especially for
those additives that are added
in very small quantities or that
may present specific risks for
the animals if not given in the
right amount.
▪▪ Eventually providing standard-
ised products with sustainable
quality and safety to the feed
industry.
Premixtures -12- -13-
2. Product functions ll Flavour blends: They are also 3. Different constraints II. Sourcing and
feed additives blends, but fla- procurement
Premixtures - in either liquid or vouring blends are specifically Depending on the type of products
solid form - can contain one or affected by Intellectual Proper- manufactured, the need to oper- 1. Legal, Quality system,
more feed additives, with similar ty aspects. The right combina- ate under tight control is increas- Customer requirements
or different functions. Basically, tion and balance of the differ- ing and production is becoming
the following product types can ent flavouring compounds can more complex due to the following a. Registered and approved Feed
be defined according to their func- lead to very different results in factors: business operators
tions in the feed: terms of smell or palatability of
final feed. Flavour blends are ▪▪ Increasing number of ingredients Feed business operators shall
not operate without a registration
▪▪ Pre-dilution: They are premix- based on extensive experi-
or an approval according the Eu-
tures of one feed additive with ence, research and know-how ▪▪ Possible chemical interactions ropean Feed Hygiene regulation.
a carrier or carriers, with the that must be protected. between different types of ad- Feed Business operators can
aim to dilute the feed additive ditives leading to only source from registered and /
and then better incorporate it ▪▪ Complex premixtures: Com- or approved establishments.
in large amounts of feed ma- plex premixtures contain a va- ll Potential stability issues EU Feed Hygiene Regulation re-
terials or potentially in another riety of feed additives, which ll Potential caking issues quires that sourcing of feed addi-
premixture. are aimed to cover the nu- tives as nutritional additives, zoot-
tritional needs and the tech- ▪▪ Possible physical interactions echnical additives, antioxidants
▪▪ Specific blends: These prod- nological, zootechnical and between the different products with a fixed maximum content
in complete feed, colorants as
ucts are designed to fulfil spe- sensory objectives linked to leading to:
carotenoids and xantophylls, is
cific function in feed: the particular feed. They are only allowed from approved feed
usually the only supply of feed ll Potential lack of homogeneity business operators. It is also the
ll Feed additives blends: These additives in the feed mills. case for the use of certain feed
blends are usually premix- Therefore, the operators manu- materials (biomasses or proteins
tures containing additives of facturing premixtures need to im- obtained from micro-organisms).
the same functional groups plement robust quality systems Other feed materials (minerals,
(e.g. vitamins, minerals, ca- in their site (further described in carriers, etc), flavouring sub-
rotenoids, acids, preserva- other chapters). stances, other technological ad-
tives, etc…) and which can ditives and colorants (other than
carotenoids and xanthophylls)
be used for different types of In addition, all premixture manu-
are sourced from operators that
feeds and potentially different facturers have to strictly follow the are properly registered and follow
animal species or categories. general food and feed law and hy- the same strict control regime.
More than one blend is usually giene requirements thereof. For certain feed materials and
incorporated in the feed mill. additives sourced from coun-
Premixtures -14- -15-
tries outside the European Union it sets limit values above which ▪▪ As the occurrence of these unde- d. Customer requirements
(third countries), a representative their presence in animal feeds is sirable substances in premixtures
company established in the EU forbidden or values that should is essentially due to the natural It is quite common that customers
should be identified, declared to trigger further investigation. presence in these raw materials, of the premixture industry have
national authorities and properly These lists are regularly updated sourcing of high quality and reli- the desire for the use of specific
listed. This representative must in the light of technical and scien- able ingredients is of real impor- feed additives, preparations, carri-
ensure that the manufacturer in tific progress. tance; ers or other functional ingredients.
the third country meets at least When these values are exceed- ▪▪ Being in the middle of the feed These requirements are often
the hygiene standards in Europe ed, Member States, in coopera- chain, it is the responsibility of related to the preference for cer-
and that the product is compliant tion with the economic operators premixture manufacturers to en- tain origins or physical properties.
with EU legislation. concerned, must carry out inves- sure that all their products com- Therefore, premixture manufac-
tigations to identify the sources of ply with the legal limits whatever turers need to handle a large vari-
b. Legal requirements the substances in question. the level of additives and carriers ety of different ingredients to fulfil
They must then inform the Com- used, and that the premixture will their customers' preferences and
Maximum levels are set by law to mission of the outcome of these not lead to exceeding maximum specific requirements.
limit as far as possible the pres- investigations and the measures limits once diluted in compound
ence of undesirable substances taken to reduce the level of the feed. e. Sourcing of incoming materials
and products in animal feed put substances or eliminate them.
into circulation within the Euro- The use of raw materials (feed c. Quality system The approval of good quality sup-
pean Union (EU). materials or additives) that do not pliers and the selection of excel-
“Undesirable substance” means comply with these requirements Suppliers to the premixture in- lent ingredients are a key aspect
any substance or product, with is prohibited, even if diluted in a dustry are supposed to have a of any operator's quality and safe-
the exception of pathogenic premixture. quality and feed safety system in ty management system(s). Poor
agents, which is present in and/ For premixtures there are some place, including a HACCP sys- raw materials will result in the
or on the product intended for specific legal limits defined for tem, where risk assessment and production of poor quality finished
animal feed and which presents a undesirable substances as well management of supplied ingredi- product and may also compro-
potential danger to animal or hu- (e.g. heavy metals, dioxins, coc- ents, ensure that these products mise the safety of the operator's
man health or to the environment cidiostats, carryovers …). The comply to the applicable legisla- entire process.
or could adversely affect livestock rationale for fixing such limits in tion and agreed specifications. It Therefore operators will focus on
production. premixture is to reduce the pres- is quite common that these suppli- ensuring that their suppliers and
These requirements apply to ence of these contaminants as ers and manufacturers have qual- ingredients are of the required
all products intended for animal much as possible, whatever the ity systems implemented like FA- quality and standard.
feed, including raw materials for source, at every level of the feed MI-QS, GMP+, OVOCOM, UFAS,
feed (basic feed materials and chain. However, this approach FEMAS, QS, or similar systems.
functional feed ingredients), feed implies additional complexity and Mutual recognition between these
additives and complementary responsibilities for premixture certification systems is of utmost
feedingstuffs. manufacturers: importance for a good functioning
Legislation lays down a list of un- of the internal market.
desirable substances, for which
Premixtures -16- -17-
2. Ingredients specifications In case the material is a feed ad- 3. Specific requirements for a. Particle size
(feed additives, feed ditive imported from outside the premix ingredients
materials used as carriers) European Union, a written confir- Particle size is very relevant for a
and packaging materials mation of its compliance with the According to European leg- good distribution in premixtures,
current EU feed Regulations is- but most important for a good dis-
islation, premixtures of feed
sued by the supplier is needed. tribution in the final feed.
a. Management requirements for additives do not require spe-
Documentation is required that Ingredients with low particle size
premixture ingredients cific product authorization.
these feed additives are produced have in theory more chance to
in compliance with the EU require- They can be manufactured be mixed homogeneously. On the
Information shall describe the and placed on the market,
ments. other hand, such ingredients, also
product to be purchased, includ-
Operators have a list of internally provided they only contain ad- depending on many other factors
ing, where appropriate, require-
ments for approval of purchased
approved suppliers and each sup- ditives duly authorized (includ- (moisture, electrostatic charges,
plier shall be subject to periodical ing specific restrictions of use particle size distribution and shape,
product.
review. when applicable) and carriers etc...), may have more tendency to
Selection and approval of all raw
Premixture operators evaluate that comply with the EU legis- cake and be more difficult to pro-
materials shall include their origin,
and select suppliers based on cess. Finally, such ingredients may
transport, storage, and handling. lation. The operator shall doc-
their ability to supply products in give rise to occupational health
Any potential hazard associated ument that he/she complies
accordance with the operator’s re- concerns, especially when they
with ingredients shall be docu- with these requirements.
quirements. Criteria for selection, have inherent toxicity or sensitizing
mented.
evaluation and re-evaluation are properties, high dusting potential
Each ingredient shall have a writ-
established. and particle size in the thoracic or
ten specification, including qual-
pulmonary fractions (<50 or <10
ity agreement, which is amended
b. Specifications for packaging microns respectively.
when change of documented pa-
materials Coarse ingredients give less ho-
rameters takes place.
mogeneity, are usually less dusty
In addition to the analytical char-
Packaging materials should be and do in general flow better.
acteristics of the ingredient, the
suitable for their intended use Here the industry has to find the
specification should include,
and in particular they should pre- best compromise.
where appropriate, details of any
vent contamination of the prod- In a lot of cases the premixture
undesirable substance with which
uct. A specific chapter of this industry will and has to apply pre-
the ingredient may typically be as- Picture 2:
booklet is dedicated to packaging blending steps, depending on the
sociated, and any other hazards Particle size: Example of an additive
(Chapter V). preparation. Microscopic picture of physical properties of the used in-
or limitations associated with the
Packaging materials shall not Vitamin D3 beadlets. gredients and the desired flowing
ingredient material which have
transfer any undesired substanc- properties, as well as to the applied
been considered in the operator’s
es to the products that are packed amounts to be weighed and dosed.
HACCP system.
into it.
Where appropriate, requirements
b. pH
for analytical monitoring shall be
Ingredients can have a wide
defined.
range of pH values because of
Premixtures -18- -19-
their chemical properties or the e. Reactivity plicable feeds for which the pre- ing or during storage. This will oc-
way they are processed. mixture is intended. cur faster in warmer circumstances
Some additives are more or less Reactivity of ingredients is often Most commonly known contami- with a high relative humidity and de-
sensitive to high or low pH values related to their properties and to nants are heavy metals like lead, pending on the raw materials used.
in a premix, especially if there is their environment. cadmium, arsenic and mercury,
free moisture present. Higher moisture levels in the ingre- as well as dioxins and dioxin-like i. Shelf life
dients used, more or highly water- PCB’s, but also physical impuri-
c. Moisture soluble soluble ingredients, or very ties as well as microbiological Ingredients shall have a suitable
fine particle sizes (more surface contamination shall be avoided. shelf life when received, so that
Moisture levels especially in carri- contact possible) will increase the Unexpected contamination from the levels and quality can be guaran-
ers are very relevant, as they can chance of unwanted reactions. supply chain is limited by sourcing teed up to the end of shelf life of
highly contribute to total moisture These unwanted reactions can of known and certified suppliers and the premixture.
levels in premixtures. also be strengthened by high or low manufacturers, as well as by means
In general free moisture in pre- pH values in moister environments. of selection of reliable transport (to j. Flowability
mixture will affect stability and Sensitivity to high temperatures avoid cross-contamination).
can also lead to microbial con- is also an important parameter Ingredients are selected and as-
tamination, as well as increasing for ingredients intended to be g. Solubility in water sessed on their flowability as
the chance on mold formation. further used in harsh feed manu- well. This important aspect will be
High moisture levels can also facturing processes (pelletizing, For certain applications it is im- further developed in Chapter VIII
have negative effect on flowabil- extrusion, etc). portant to have total solubility of on Physical and chemical charac-
ity and can more easily generate Sensitivity to light and oxygen is ingredients (e.g. milk replacers, teristics.
lumps in a premixture. especially relevant to define stor- liquid feeds, etc). If a product is
age and packaging conditions. water soluble as defined by its k. Dustiness
d. Bulk density chemical properties; concentra-
f. Contaminants tion and temperature of water Dusty products may give rise to
Bulk density of ingredients, in rela- influence the solubility. However, occupational health concerns
tion to the particle size, is a rele- Basically, premixtures should not the formulation of the product is and may give rise to a risk of dust
vant parameter in order to achieve contain levels of contaminants that also important (e.g. granulation/ explosions.
sufficient homogeneity. Carriers impose a risk to feed or food safety particle size); feed additives in dif-
with lower bulk density will achieve or affect the expected quality. ferent preparations forms or with In conclusion, ingredients for pre-
a higher separation between active Inclusion of premixtures in feed added anti-caking can have dif- mixtures are selected based on
particles in premixtures, depending according to the instruction on ferent solubility than the straight different criteria, often in mutual
on the amount of carrier present. In the label or guide documents feed additive as such. agreement between Sourcing and
addition a consistent and constant should not lead to any undesired Procurement, Operations, Formu-
bulk density of ingredients will lead contamination of this feed. h. Hygroscopicity lation and Quality Assurance.
to a more constant performance of Therefore it is appropriate to Hygroscopic ingredients can attract
dosing, weighing and packaging agree, besides legally defined water, and make the premixture
equipment and therefore to a more limits for premix, also on limits subject to lumping, discolouring or
constant final product. that are only defined for the ap- chemical reactions during process-
Premixtures -20- -21-
so as to better exploit synergies then mixed (taking into account components; anti-caking agents 2. Nutritional aspects
between the different acids. Usu- of interactions, linked to e.g. wa- to avoid the chemical interaction
ally, these blends do not contain ter content) usually with a mineral between different components of The amount of nutritional ad-
carriers or only in small amounts. carrier(s). the premixtures, improve flowa- ditives (vitamins, trace ele-
ll Flavouring blends formulation ll Other specific blends are usu- bility or limit compaction in silos
ments, amino acids) and feed
is based on an important level of ally formulated on the basis of the or when stacking bags, etc…) or
knowledge, research and experi- regulatory limitations (minimum / of the final feeds (e.g. binders to
materials (usually minerals) in
ence on the interactions between maximum dose) of the products ensure proper manufacturing of premixtures depends on the
the different molecules, in order (e.g. for enzymes) and are based pellets); requirements of the target ani-
to get the proper smell and taste on the knowledge of the feed ll The particular required func- mal and the intended use and
for the different animal species composition and animal species tions mainly provided by the in- dilution (complete/complemen-
and categories, in the different and categories of destination. clusion of zootechnical additives tary feed, nature of other com-
types of target feed. This is why or coccidiostats. The levels (mini- ponents of the daily ration, etc).
it needs a high level of protection c. Complex Premixtures mum and maximum dosages) The needs for each animal
(Intellectual Property) to ensure and conditions of use of zootech- mainly depend on the species,
constant innovation. The use of These products are formulated nical additives or coccidiostats
age category, physiological
carriers depends on the type of on the basis of the type of animal are usually defined by the au-
flavouring blends; they are usual- species/categories, as well as the thorisation and by scientific tests
condition (gestation, lactation,
ly based on plant feed materials, type of feeds to be produced. The on animals to define the most ef- etc). Allowances for each nutri-
salt or sweeteners. Liquid blends formulation takes into account dif- ficient and safe doses to be used; ent further take into account a
are also available for specific ap- ferent parameters: ll The carrier used for complex pre- safety factor for individual dif-
plications. ll The nutritional requirements mixtures depends on the concen- ferences. These basic animal
ll Vitamin blends are formulated of the target animal (see below). tration of the premixtures in the requirements and allowances
on the basis of nutritional levels Industry recommendations also final feed (inclusion rate, usually are published by different sci-
of vitamins. The nutrient level is usually take into account the from 0.2 to 2.5 % but varying from entific bodies, but not regularly
defined in accordance with the know-how regarding the behav- 0.05-5% depending on markets), updated.
target animal’s allowances and iour and possible losses of the on the composition of the premix-
With constant improvement
potency of the products. The dif- different feed additives during ture and also the possible inter-
ferent vitamin forms are then se- manufacturing, storage and fur- actions between the ingredients.
of growth capacities and pro-
lected and mixed. The carriers ther process into feeds; The number of carriers may vary duction yields of modern live-
are most often inert, usually of ll The technological require- from 1 to 3 different carriers, main- stock, the intake of essential
mineral or plant origin. ments based on production ly from plant and mineral origin. nutrients needs to be adapted
ll Trace elements blends are for- constraints, either for the premix- regularly in order to best utilise
mulated on the basis of nutritional tures itself (e.g. specific particle the genetic potential of these
levels of trace elements. The nu- size required for good mixing in animals.
trient level is defined in accord- the target compound feed, pres- This is why industry recommen-
ance with animal’s allowances ence of antioxidants to increase dations also take into account
and the different trace elements the shelf life of the premixture or
the need to maintain the perfor-
compounds or preparations are to limit the degradation of other
Premixtures -24- -25-
mance and welfare of animals. 3. Characteristics of the be predicted to a certain extent, 4. Choice of carrier(s)
Industry recommendations may ingredients only a solid experience helps
also consider the potential loss- to anticipate and prevent the These ingredients should be
es of feed additives during man- Each ingredient of a premix- above-mentioned issues and ad- chemically inert to avoid any in-
ufacturing, storage and further ture has particular physical just the formulations accordingly. teraction with the additives, and
processing into feeds (steam/ (particle size, shape, density, have a particle size, shape and
heat treatment). flowability, compressibility) density compatible with the oth-
Once the desired concentra- and chemical (potency, purity, er components in order to allow
tions of each component are pH, reactivity, stability) char- proper mixing. Particle size and
defined, formulators should acteristics that influence the shape of carriers are important
also take into account the bio- overall recipe. aspects. Two kinds of carriers
availability of the ingredients, Physical characteristics usu- are commonly used:
the potency (e.g. biological ac- ally play a role on handling
tivity of vitamin E) and purity of and mixing properties, while ▪▪ Inorganic carriers of mineral
the different forms of additives chemical characteristics may origin, such as limestone (cal-
(e.g. concentration of active particularly influence the sta- cium carbonate), dicalcium
substance in the preparation bility of the mixtures. phosphate, etc
or from different salts/esters of Particles of uniform size and ▪▪ Organic carriers of spelling -
the additive, etc) to define the density tend to form homo- vegetable (wheat middlings,
right amount of each additive geneous mixtures, while par- etc) or sometimes animal ori-
or mineral in the premixture. ticles with different sizes and gin (e.g. lactose, whey, etc)
coarse shapes will have great-
er tendency to segregate or Although carriers are inert and
not to mix properly (see Chap- present little or no nutritional val-
ter VIII). ue, they have a crucial role in the
Interactions between ingredi- premixture. The selection and in-
ents when mixed are also an corporation rate of the carrier(s) is
important aspect of the formu- therefore an important aspect of
lation and depend on different the formulation. Carriers can per-
factors (nature of the blend, form different roles:
concentrations, nature of car-
rier, moisture content and wa- ▪▪ Adjusting the formulation to
ter activity, etc). the desired incorporation rate
Although these handling/mixing ▪▪ Diluting the ingredients to
properties and interactions can avoid interactions and improve
stability
Premixtures -26- -27-
can help reducing dusting po- 7. Regulatory requirements 8. Specific customer 10. Conclusions
tential of premixtures and thus requirements
exposure of workers Premixture manufacturers need In conclusion, the formulation
to comply with all legislations in As most premixture formula- of premixtures is not simply
Some ingredients may also force in the European Union. tions are tailor-made, the for- an arithmetic exercise to cal-
present risks for the target Of particular importance for mulator has to meet particular culate the right concentration
animal if not dosed in the right formulation is the need to take specifications of customers: of each ingredient in the tar-
amount. Feed additives may into account all the specific re- get feed. It requires not only
have maximum limits that strictions of use for each feed ▪▪ On the ingredients: absence of expertise in animal nutrition
need to be complied with. For additive, such as maximum (or genetically modified organisms but also fundamental know-
other critical ingredients such minimum) limits, incompatibili- (eg for organic feed), specific how, borne by experience,
as “functional feed ingredi- ties, contraindications, target origin for products, preferred for the selection of the right
ents” or new feed materials, a species, etc… additives, etc ingredients, in close rela-
safety evaluation also needs In addition, specific require- ▪▪ On the final product’s charac- tionship with all departments
to be performed to ensure that ments also apply for organic teristics: inclusion rate, han- (sourcing/purchasing, sales /
the product can be used safely production (positive list of ad- dling properties, particle size commercials, quality, regula-
at the desired dose in feed. ditives, origin of carriers) or or bulk density, resistance to tory affairs, production and
genetically modified substanc- feed processing, shelf life, etc occupational safety).
The quality management sys- es (e.g. carriers of vegetal ori-
tem of the operator should gin). 9. Logistic aspects
therefore include a check of As premixture manufacturers
each formulation before pro- also sell across European bor- The premixture industry is
duction. ders, they need to comply with global and purchases ingredi-
Quality and safety aspects are the requirements from third ents all over the world. Avail-
expanded further in the rel- countries. This may have an ability of quality ingredients
evant chapters. impact on the choice of cer- is therefore an important pa-
tain ingredients and potentially rameter that affect the formu-
imply the use of feed additives lation. The substitution of an
not authorised within the Eu- ingredient/additive by another
ropean Union, which is done in a formulation should always
under very tightly controlled be evaluated carefully with re-
conditions. gards to each of the aspects
developed in this chapter and
in line with quality manage-
ment system.
Premixtures -30- -31-
Picture 5:
Silos
Premixtures -34- -35-
4. Weighing and dosing crease in weight into a weigher A well designed dosing system will ing system may be more accurate
mounted on loadcells. have multiple weighers, which will than this.
This is probably the most critical ▪▪ “Loss in Weight” system – vary in capacity to allow for accu-
part of the process of making pre- where the automated con- rate weighing, for increased dos-
mixtures. If the required raw ma- trol system measures the ing speeds and a shorter batch-
terials are not weighed correctly, decrease in weight from the ing time, as weighments can take
then the resulting premixes may weigher, where the weigher place over each scale if required
not be within the specified toler- is the storage silo and dosing simultaneously. Each weigher will
ances required. screw mounted on loadcells. then have multiple silos above it
The design of a weighing system is ▪▪ Hand dispensing weigher on a which will contain products that
very complex and many factors need high accuracy platform scale are required in similar quantities.
to be taken into account such as: The accuracy of the weighing sys-
Within most premix plants and an- tem also depends upon many fac- Picture 7:
Weigher in a weigher. The combination
▪▪ Number of products in a pre- imal feed plants, the normal meth- tors, for example: of two weighing hoppers of different sizes
mix to be dosed od of weighing is “gain in weight’ allows for accurate dosing over a wide
▪▪ Quantities of each products be and ‘hand weighing’ in a dispen- ▪▪ The type of loadcell being range of weights.
dosed sary. used Source: ALFRA
▪▪ Accuracy of each product to Loss in weight requires an in- ▪▪ The number of loadcells being
be dosed creased cost of equipment, as used on each weigher
▪▪ Throughput of the plant each silo/dosing screw combina- ▪▪ The location of the weigher
▪▪ Batch sizes to be produced tion requires its own set of load- ▪▪ The design of the weigher
cells, amplifier and software. In ▪▪ The design of the equipment
Due to the above factors the addition, at the moment a bin/silo around the weigher
weighing system is usually auto- is being refilled, the use of such
mated and controlled by a comput- system is impossible. Most weighing systems are accu-
ed Process Control System (PCS) Loss in weight systems are how- rate to within 0.1% of the scale ca-
in order to control the complexity. ever faster for production as mul- pacity. Therefore a 1000kg scale
Dependent on these factors, the tiple feeds can take place simulta- will be able to dose to within 1kg
design of the premix plant may in- neously, unlike a ‘Gain in weight’ of the required product target, a
corporate a combination of the fol- system, where each feed has to 50kg weigher should be within
lowing weighing methods: be done individually. Therefore, 0.05kg or 50g.
such system is often used in some A high accuracy hand dispensary
▪▪ “Gain in Weight” system – specific applications. scale will be able to be within 1g to
where the automated con- 5g on a 60kg scale. These are typ-
trol system measures the in- ical tolerances, but a good weigh-
Premixtures -36- -37-
5. Premixture Mixing (types of The following types of mixers are 6. Mixing Procedures
mixers) the most commonly used within
the premix production industry: The following steps should be fol-
A mixer intended for preparation lowed:
of premixtures must be able to ▪▪ Rotating mixers: V-blender or
provide homogeneous mixtures of Y-blender and cubic contain- ▪▪ Ensure that the equipment
physically diverse particles incor- ers turning on an axle is well suited to the type of
porated at various inclusion levels ▪▪ Ribbon mixers, with a double product(s) to be mixed
in the mix. spiral on the same axle, or ▪▪ Make sure that static parts and
with a single spiral in two sep- Picture 9: mobile parts of the mixer are
Specification for a premixture mix- arate screws within an omega Twin-axle paddle mixer. Source: fully grounded with the rest of
er: shaped mixer Forberg the equipment
▪▪ Turning –screw vertical cone ▪▪ Verify that the amount to be
▪▪ Affords good homogeneity mixer ▪▪ Pneumatic mixers with air-flow mixed is in accordance with
with the component included mixing are conventionally in- the mixer specification and
at the lowest possible content cluded in this category. This the sufficient mixing time (in-
▪▪ Affords good homogeneity equipment is mainly used by sufficient or excess filling will
with components of different the animal feed industry for make it impossible to perform
particle size mixing very fragile re-fatted correct mixing and reach suit-
▪▪ Short mixing duration powders which require work- able homogeneity)
▪▪ Variable degree of filling, with ing with cold air.
no loss of mixing efficiency
▪▪ Complete emptying All these mixers are available in
▪▪ Easy cleaning various sizes, typically ranging
▪▪ Possibility to add liquids Picture 8: from the liter size to 10,000 liters
▪▪ Ability to disintegrate clumps Vertical cone mixer. according to the required applica-
Source: Hosokawa –Nauta tion. Mixers are generally availa-
▪▪ Absence of heating during
mixing ble in mild steel or stainless-steel.
▪▪ Twin-axle paddle mixers. There is no one-fit-all type of mix-
▪▪ Low consumption of energy These machines perform well
when starting and during mixing er; the actual choice of the type of
for preparing vitamin premix- mixer is dependent on many fac-
▪▪ Low maintenance costs tures tors including plant design, capac-
ity required, types of raw materials
and final type of premix etc.
Premixtures -38- -39-
7. Production / dosing tamination is most liable to occur 8. Hygiene and Cleaning Care should be taken to prevent
sequence are elevator heads, worm convey- product contamination when
ors, dust collectors and pneumat- Cleaning programs should be es- cleaning is being carried out. For
Production and dosing sequence ic elevators. These parts of the tablished and documented to main- example, mixer openings should
can be relevant to reduce or elimi- equipment should be permanently tain hygienic conditions. Programs be covered to prevent entry of de-
nate unwanted contamination or controlled and kept clean. should be monitored for continuing bris.
carry over. Generally speaking, Nowadays a lot of equipment is suitability and effectiveness. Periodic cleaning and sanitiz-
any variation in the quantities or designed in such a way, that it is Where identified in the hazard as- ing activities should be recorded.
properties of each ingredient, not free or at least almost free of any sessment, sanitizing programs Routine housekeeping activities
foreseen in the composition of the contamination, as well as easy should be established and docu- are not considered periodic and
premix, can be regarded as a form to inspect and clean. In any case mented for wet cleaning and for do not need to be recorded.
of contamination. where no possibility to change the wet-process areas. Cleaning and sanitizing programs
Contamination may be due firstly production sequence and where Cleaning and sanitizing agents should be verified for their contin-
to the nature of the ingredients the system is not cross-contam- should be fit for purpose, clearly uing suitability and effectiveness.
which are mixed; secondly to the ination free (between product identified, stored separately and ap-
production procedures and third- types), a cleaning/flushing batch plied properly to avoid contamination
ly to subsequent processing by should always be run in between. of raw materials or finished products.
the compound feed manufactur- Dust is an important source of con- Cleaning and sanitizing tools should
ers. Special attention is needed tamination in premixture plants. it be designed and maintained in a
for correct packing of ingredients can however be controlled and condition that does not present a po-
and premixtures to protect them eliminated with the choice of suit- tential source of extraneous matter.
against any contamination. able ingredients and carriers, as
It should be noted that premix- well as anti-dust agents. Cleaning and sanitizing programs
tures contain concentrations hun- should specify, as a minimum:
dreds of times higher than those in
the final feed. Any dust, residues ▪▪ Areas, items of equipment and
in the equipment, or wastage dur- utensils to be cleaned and/or
ing premix production can be the sanitized
cause of contamination. For this ▪▪ Responsibility for the tasks
reason too, it is very important to specified
carry out the production of pre- ▪▪ Cleaning/sanitizing method
mixtures at producers with dedi- and frequency
cated equipment that is carefully ▪▪ Monitoring and verification
cleaned from time to time. (e.g. post-cleaning and/or pre-
The points in a plant where con- start- up inspections)
Premixtures -40- -41-
9. Maintenance and inspection there is a risk of direct or indirect that would invalidate the meas- V. Packaging and
contact with the product. The pro- urement result transport
Equipment for manufacturing of cedure for releasing maintained ▪▪ Protected from damage and
premixtures should be fit for pur- equipment back to production deterioration during handling, 1. Packaging types
pose and designed and construct- should specify sanitation and pre- maintenance and storage
ed to facilitate cleaning and main- use inspection measures. In most cases, premixtures are
tenance. Surfaces in contact with Site-specific prerequisite program being packed and transported in
product shall be constructed from requirements should apply to small units, such as bags or con-
materials suitable for animal feed maintenance areas and mainte- tainers of 25 kg each. In some in-
and able to resist repeated clean- nance activities in process areas. stances, however, bulk shipments
ing. Equipment in contact with Maintenance personnel should be are the norm. How do we know
product should be smooth, acces- trained in the product hazards as- which packing is the most suit-
sible, cleanable and constructed sociated with their activities. able one for feed premixtures? As
of materials compatible with the All scales and metering devices straightforward as this question
intended use. used in the manufacture of pre- may seem, choosing the “right”
A preventive maintenance pro- mixtures should be fit for purpose Picture 10: packaging is actually a highly
Routine equipment inspection
gram should be in place and in- for the range of weight or volume specialized area of the premix
clude all devices used to monitor to be measured and tested for ac- business that needs to take into
and/or control feed safety haz- curacy regularly according to the account both the special require-
ards. Examples of such devices risks. ments of the goods as well as cus-
include screens and filters (includ- Where necessary to verify results, tomers’ wishes.
ing air filters), magnets and metal measuring equipment should be: Table on the next page provides
detectors. an overview of possible character-
Corrective maintenance should ▪▪ Calibrated or verified at speci- istics of premixes. Each of these
be carried out in such a way that fied intervals or prior to use, brings with it certain requirements
production on adjoining lines or against measurement stand- as to suitable packaging types. In
equipment is not at risk of contami- ards traceable to international this context it is also important to
nation. Maintenance requests that or national measurement stand- remember that the premix mar-
affect product safety should be giv- ards. Where no standards exist, ket is an international one, and
en priority. Temporary fixes should the basis for calibration or verifi- that climatic conditions, process-
not put product safety at risk. A re- cation shall be recorded ing equipment as well as human
quest for replacement by a perma- ▪▪ Adjusted or readjusted as nec- preferences vary from country to
nent repair should be included in essary country. The packaging solution of
the maintenance schedule. ▪▪ Identified to enable the calibra- choice in one location will not nec-
Lubricants and heat transfer fluids tion status to be determined essarily work in another.
should be fit for purpose where ▪▪ Safeguarded from adjustments
Premixtures -42- -43-
Pictures 12:
Bag filling process
up by suction cups, positioned 3. Packaging in IBC ll Can be used as a disposable The Big Bags here depicted have
under the filling station and then or reusable packaging an approximate capacity of 1000
filled (see Pictures). Weighing IBCs, or Intermediate Bulk Contain- ll Big Bags for dangerous goods to 1300 litres. The filling process of
can either be done on a net basis ers, are a group of packaging that (UN-approved) Big Bags is similar to that of paper
(weighing of content only) or on a can be used for the packing, trans- ll Classified as without static pro- bags, but due to their larger size fill-
gross basis, which takes into ac- port, and storage of liquid, granulated tection or with full static protection ing usually is semi- rather than fully-
count the weight of the bag. and powder premix products. In par- ll Closed top with filler plug automatic.
Modern filling lines will often be ticularly, if a feed miller handles larger ll Closed bottom with drain outlet While the filling process itself can be
equipped with aspiration systems quantities of premixes IBCs can be handled by an automatic control unit,
for dust control, a vibration sys- very useful. The normal gross weight Big Bags first need to be hooked up
tem for efficient filling and finally of an IBC ranges from 90 to 1300 kg. to the filling station by hand.
a filling control system. Bags are The biggest benefit of IBCs is that A fully-automatic filling system
closed either by sewing or by their footprint is similar to a EURO pal- would be fitted with a floor scale or
welding. let – a quadratic format containing a an overhead scale. When the des-
Before or after the filling process, large amount of premix. IBCs can be ignated net weight is reached the
bags are labelled to clearly identify handled by hand lift or a forklift truck. filling system will automatically stop
their content. Label systems can In the premix business two types of the filling process. To optimise the
be automatic or semi-automatic. In IBC types are in practical use: filling process a vibration system is
an automatic system, the label in- frequently employed, especially for
formation is generated by a formu- Type 1: FIBC - Flexible Intermedi- more voluminous premixes. An ef-
lation and label software system. ate Bulk Container (also known as- fective aspiration is imperative for
The system prints the information Big Bags) proper dust control.
directly into a label area on the Big Bags are made of synthetic fibre Static electricity and the possibility
bag. In a semi-automatic system, and carry loops on which they can of dust explosions pose the great-
labels are first batch-printed and easily be picked up by a forklift truck. est risks in the filling and emptying
then stuck onto the bags either Typical specifications in the premix of Big Bags. It is therefore impor-
by hand or machine. In all cases, business include the following: tant to choose a suitable kind of
labelling systems must be able to Big Bag, depending on the opera-
handle a large variety of different ll Recyclable, hygienic material tional conditions in the plant:
formulations and translate it into ll Material is UV stable
compliant labels. The system must ll Large Containers with predom- ▪▪ Type A FIBC
also be flexible enough to cope inantly four carrying handles Big Bag with no measures against
with any change in formulations ll With or without inlay to mini- build up of static electricity.
and legal requirements. mise product exposure to air Only to be used for ingredients
Picture 13:
and moisture Flexible Intermediate Bulk Container that are not sensitive to dust ex-
Premixtures -46- -47-
plosion (like minerals) and that are ▪▪ Type C FIBC products are manufactured it may flavours
used in areas in which an explo- Type C Big Bags, conceived with be more economical to print the rel- ll Highly effective barrier against
sive atmosphere in the form of a conductive elements interwoven evant information directly onto the gases (e.g. oxygen), dioxin
cloud of combustible dust in air is in the packing material (carbon Big Bags. A purpose-built emptying and other undesirable sub-
not likely to occur in normal opera- threads) are designed to prevent station greatly facilitates the dis- stances
tion but, if it does occur, will persist incendiary sparks, brush dis- charge of product from Big Bags. ll Transportable with all com-
for a short period only. charges and propagating brush mercial industrial trucks
It is essential that they are not discharges. They must be earthed ll Stackable
used to store or transport combus- during filling and emptying! To be ll Can be used as a disposable
tible materials or used in flamma- used for product with a low so or reusable packaging
ble or combustible environments. called minimum ignition energy. ll Can be used for storage and
Many organic materials such as transportation of dangerous
sugar, flour, corn starch, milk pow- ▪▪ Type D FIBC goods (UN-approved)
der, wood pulp, etc, can form com- Dissipative, made from static pro- ll Can be reconditioned
bustible dust clouds or layers that tective fabric to prevent incendi- ll Closed top with filler plug
can be ignited by electrostatic dis- ary sparks, brush discharges and ll Closed bottom with drainage
charges from Type A FIBC. propagating brush discharges. No outlet
earthing needed. The use of Type
▪▪ Type B FIBC D FIBC in antistatic bulk bags
Type B FIBC is similar to Type A eliminates the risk of human error
FIBC. The difference is that Type associated with the manufactur-
B bulk bags are made from mate- ing and use of groundable Type C
rials that have a low breakdown FIBC.
voltage to prevent the occurrence
of highly energetic, and danger- It is the responsibility of the premix Picture 14:
ous propagating brush discharges producer to use a suitable Big Bag FIBC for dangerous goods
designed to prevent occurrence of type.
sparks and propagating brush dis- A filled standard Big Bag will have Type 2: Composite IBC Picture 15:
Due to its cubic shape, this type of Composite IBC
charges and should be used as a a footprint similar to a Euro pal-
standard FIBC for all non-mineral let and will be 1,5 metres high. To IBC is widely used for storage and
transportation of liquid premixes. The IBC depicted above is a com-
type of products. clearly identify their contents, Big bination of a cubic synthetic tank
Bags must be labelled. Labels will Typical specifications of this IBC
for use in the premix industry in- boxed inside a caged frame. The
usually be put into the information inner container has a standard vol-
pockets provided on the bags, but clude the following:
ume of 1060 litres and dimensions
when large amounts of recurrent of 1200 x 1000 x 1160 mm. Fill-
ll Impermeable to odours and
Premixtures -48- -49-
ing is done by either of two meth- 4. Packaging in Drums 5. Packaging should protect
ods, depending on the structure of the premixes during
the liquid premix to be filled. For Since ancient times, drums have transport and storage
products which are prone to foam been used for packaging of pow-
easily or that are susceptible to der, granular and liquid products. All packaging has one thing in
static charges during filling, the Drums come in many, often stand- common: it should protect the
below-level filling method prefer- ardized shapes and sizes, and workers, the general environment
ably should be used. For products therefore have many applications as well as the product contained
that are easier to fill, however, it in the feed industry as well. On the in the packaging, throughout stor-
is common to use the above-level negative side must be noted their Picture 16: age, transport and handling of the
filling method. Both systems can relative bulkiness which can make Plastic and metal drums goods. To fulfil this, the packaging
be employed either fully- or semi- storage and transportation difficult must be appropriate for the in-
automatically, either with or with- or expensive. In the premix industry, drums could tended use, and should be sturdy
out filling and weight control. To Following are some typical specifi- be of particular importance whenev- and strong enough to withstand
clearly identify IBC’s content, a cation for drums: er a premix contains a high content even a certain amount of abuse.
label must be added directly onto of hazardous material or in case of Unfortunately, packaging material
the IBC. ▪▪ Wide range of capacities, from liquid premixtures. In order to pro- that has withstood some standard-
6 litre to > 200 litre tect workers and the environment ized tests and conforms to certain
▪▪ Different materials, such as during transport and storage, drums safety norms is difficult to come
plastic, metal or fibre may be the packaging of choice for by. The notable exception is pack-
▪▪ High barrier against gases, these premixtures. aging that has been approved for
such as oxygen Drums can be filled in an automated use with dangerous goods and
▪▪ Can be used both as a dispos- process, even when a plastic bag carries a UN number.
able or reusable packaging as inner packaging is called for. In When choosing a packaging ma-
▪▪ Drums for dangerous goods this scenario the bag first is inserted terial, there often is a trade-off be-
(UN-approved) into the drum, either semi- or fully tween practical aspects and safety
▪▪ Can be reconditioned automatically, and then filled. Filling provisions, especially during trans-
typically is optimized by a vibrating port. Bags and Big Bags have no
system, weight control and aspira- hard sidewalls and so are prone
tion. In the final step, which again to shift; drums can easily tip over
can be automated, the drum will be when not properly secured. Apart
closed by a lid. from the obvious fact that packag-
ing itself must be strong enough
to prevent leakages, there are a
variety of measures that can be
Premixtures -50- -51-
taken to prevent this and to ensure 6. Waste management remnants of its previous content. 7. Premixtures in Bulk
a safe transport: palletized bags In determining whether a packag-
can be wrapped in stretch foil; filler Much emphasis is today placed ing can be re-used or must be re- It is common practice in many
material and braces can be used to on the re-usability of packag- cycled, the label of its last content countries to deliver premixtures
prevent individual packaging units ing material, or whether it can be is a good indicator and helps in in bulk transport; in this case, the
from shifting against each other; properly recycled. Apart from its the efficient sorting of previously Premix producer pays strict atten-
ratchet tie-downs and supporting primary function of protecting the used packaging material. Special tion to the loading procedure, in
edges keep cargo in place when contents, packaging material to- care to protect both humans and order to avoid contaminations with
transported on flat-beds, etc. A day needs to fulfil the additional the environment must be taken previous loads. Before loading, the
multitude of securing aids are com- function of helping to save scarce with packaging that previously transport certifies which previous
mercially available but, as with the resources and protecting our com- contained hazardous substances. loads have been carried by the
choice of packaging material, it is mon environment. As such, pack- If in any doubt, it is wise to have applicable truck, what cleaning re-
the responsibility of the shipper to aging material has become an a specialized recycling company gime has been applied and finally,
determine which measure will en- important step in the industry’s taking care of the sorting. the truck is inspected prior to load-
sure a safe transport. sustainability efforts. As a conclusion it can be said that ing. In this way, it is guaranteed
While the different EU Member awareness of the locally applicable that premixtures are transported
States operate different re-use laws and the available options is and delivered in clean and non-
and recycling systems, they all the key to an effective waste man- contaminated bulk trucks.
are based on the premise that agement in the premix industry. There are defined specific require-
re-use is preferable to recycling. ments for cleaning and disinfection
This, however, needs to take into for the cases where the prior loads
account that not all packaging ma- can be regarded as high risk ma-
terial can be re-used (depending terials, potentially microbiologically
on the material itself, or what it contaminated material or materi-
previously contained), that some als constituting a physical and/or
Picture 17: packaging is more environmental- chemical risk.
Example from European Best Practice
Guidelines on Cargo Securing for Road
ly friendly to produce than others,
Transport and that the cost of cleaning or re-
conditioning a container, including
water consumption thereof, must
be balanced against the cost of
recycling it.
If a packaging is to be re-used it
must first be completely emptied,
meaning that it must be free of any
Premixtures -52- -53-
VI. Quality Management HACCP team to focus on the few it out, how its efficacy is to be veri- control of each CCP
critical issues that may not be ad- fied and how it should be audited, ll Establish the corrective action to
HACCP (Hazard Analysis and dressed as part of the daily pro- is should to be in place. be taken if controls should fail
Critical Control Points) is a risk gram but still require special care. ll Establish a procedure to verify
that all the aspects of the HACCP
analysis tool that helps an opera- ▪▪ HACCP purpose
system are working effectively
tor identify feed safety hazards Common topics in a PRP are: ll Document all procedure and re-
and evaluate the risk associated The purpose of a HACCP pro-
cords to demonstrate the HACCP
with their product(s) and process- ▪▪ Buildings & environment gram is to ensure product (feed)
system is working effectively
es with the view of controlling their ▪▪ Processes and workspaces safety in a controlled manner
based on systematic procedures.
occurrence. The system enables ▪▪ Utilities For more detailed information on
The program comprises any ac-
the operator to document, con- ▪▪ Waste disposal tivities and process steps ranging
how HACCP principles can be
trol and verify the effectiveness of ▪▪ Equipment, suitability and applied and specific definitions on
from purchase of raw materials to
these control measures. maintenance HACCP, see the annexes in the
transport of the finished products.
▪▪ Selection and Management of guidance to the FAMI-QS Code
In the hazard analysis a survey
of Practice (www.fami-qs.org).
It puts in place an effective Prereq- suppliers should be conducted to identify
uisite program (PRP) to manage ▪▪ Incoming material require- all potential hazards.
the daily tasks of good hygienic ments Based on this analysis, hazards
practice, good manufacturing ▪▪ Management of medications should be classified according to
practice (GMP) or other equiva- ▪▪ Prevention of contamination risk, possible Critical Control
Points (CCP’s) identified and
lent prerequisite program. The ▪▪ Cleaning and sanitation
control procedures established.
PRP is the backbone of any qual- ▪▪ Pest control Special attention should be paid
ity or safety system and without it ▪▪ Personnel hygiene and em- to hazards requiring specific con-
no management program is likely ployee facilities trol measures.
to be successful. ▪▪ Rework It is mandatory that operators fol-
▪▪ Product withdrawal low the guidance for application
The PRP defines the basic con- ▪▪ Warehouse and transportation of HACCP provided in the Codex
ditions and activities which are ▪▪ Formulation Alimentarius Guidelines, and also
necessary to maintain a hygienic ▪▪ Specifications for services taken up by European Union leg-
environment throughout the feed/ ▪▪ Training and supervision of islation, which is based on the fol-
lowing 7 principles:
food chain suitable for the pro- personnel
duction, handling and provision of ▪▪ Product information ll Conduct a hazard analysis
safe premixtures. ▪▪ Traceability ll Determine the critical control
points (CCPs)
These procedures give a solid For all applicable prerequisites, a ll Establish critical limits
operating foundation allowing the written procedure on how to carry ll Establish a system to monitor the
Premixtures -54- -55-
1. Finished product 2. Quality standards cesses / process lines where pro- 3. Quality Manual
specifications duction, treatment, processing,
Premixture manufacturers have trade, storage, trans-shipment A quality manual describes the
Full and detailed information re- in general set up a feed safety and transport of premixtures are scope of a feed safety system
garding each premixture or group system that complies with the re- carried out, must be brought un- for premixtures manufacturers or
of premixtures is required in order quirements of EU standards like der the scope of the feed safety traders, including the details of
to assess hazards presented by FAMI-QS, GMP+ International, system. and clear justification for any ex-
the process or delivery to the end OVOCOM or UFAS. clusion. There are documented
user. Main issues to be consid- procedures required, like for ex-
ered are: They must document the system, ample for document manage-
implement it and maintain it as ment, registrations, internal audit-
▪▪ Composition (e.g. raw materi- well as continuously improve its ing, purchase, recall, complaint
als, ingredients, additives etc.) effectiveness. handling, yearly review, mainte-
▪▪ Physical and chemical charac- nance and hygiene, corrective
teristics It is important to establish and re- and preventive actions as a mini-
▪▪ Processing cord the scope of the feed safety mum under the different Quality
▪▪ Packaging / labelling system. The scope must at least and Feed safety standards, which
▪▪ Storage and distribution con- include the activities related to have been established for the
ditions feed for which the operator is re- feed safety system or a reference
▪▪ Required shelf life sponsible. to them.
▪▪ Instructions for intended use /
known unintended use The responsibility of the premix- A description of the interactions
▪▪ Any microbiological or chemi- ture manufacturer begins where between the processes of the
cal criteria applicable the responsibility of the previous feed safety system as well as the
▪▪ Quality control program link (the supplier) ends, and ends structure of the documentation is
where the responsibility of the fol- required.
lowing link (the customer) in the
feed chain begins.
4. Communication to In the application of this code of 5. Quality Control program for light, perishable materials should
customers: code of practice practice, FEFANA endorses the incoming ingredients be treated as appropriate to en-
for labelling issue of separate product speci- sure their wholesomeness before
fication sheets ( including full ad- Each batch entering a site is use.
Key European associations (FEFA- ditive listings, carrier lists, gen- normally uniquely registered by If incoming materials are rejected
NA representing specialty feed in- eral directions for use etc.) when means of a batch number, full and thus not incorporated for any
gredients manufacturers, FEFAC a product is first purchased and name of product, date of receipt reason related to product quality
representing compound feed man- subsequently when a specification and quantity received. Any dam- and safety, their disposal, destina-
ufacturers, and EMFEMA repre- changes. age is reported to an appropriate tion, or return to supplier shall be
senting mineral and trace element responsible unit, e.g. the quality recorded.
producers) have drafted an agreed As a minimum, such a specifica- control (QC) unit.
Code of Practice for the labelling of tion sheet will provide all of the If the incoming material is deliv-
feed additives and premixtures. mandatory information required ered in bulk, a receipt and storage
on a premixture labelling. procedure is in place. If silos are
Drawing on regulatory principles The advantage of this approach is emptied, this will be recorded and
introduced by regulation 767/2009 that: cleaning is evaluated.
which distinguishes a feed ‘label’ Incoming materials are checked
(the document attached to each ▪▪ Premixture labels will be clear- and formally approved prior to use
pack) from ‘labelling’ (general docu- er and more relevant to us- according to written procedures.
mentation using any medium), the ers of the product, enhancing Samples of these materials are
proposal is for premixture labels safety retained. Where appropriate, a re- Picture 18:
QC laboratory
(fixed to each pack) to focus on: ▪▪ Full product specifications will tained sample should be available
remain confidential, but avail- for at least the shelf life of the ma-
▪▪ Identification (for example able for inspection by the con- terial, either at the suppliers or the
product identification number, trol authorities at the site of operators.
net weight) use The different applicable codes for
▪▪ Traceability (for example man- premixture producers have guid-
ufacturers identification, batch ance on sampling.
number) Handling of incoming product
▪▪ Safety (for example details should be in accordance with its
of target species, use rate, status, for example, a received
contra-indications & warnings, product which is deemed unfit for
withdrawal periods, expiry use must be identified as such
dates and hazard warnings) and segregated from those prod-
ucts released for use. In the same
Premixtures -58- -59-
Apparatus recommended for sam- geneously distributed in the feed Packaged premixtures scribed above. Each sample should
pling of liquid premixtures: or not. At the time of writing this Having selected the required number be put into an appropriate container.
booklet, Annexes of Regulation of packages for sampling as indicated All necessary precautions should be
▪▪ Agitator, sampling bottle, zone 152/2009 are under revision in the table above, part of the contents taken to avoid any change of compo-
sampler and dipper, of appro- of each package should be removed sition of the sample, contamination or
b. Instructions for taking, preparing using a spear or shovel. Where neces- adulteration which might arise during
priate size
and packaging the samples sary, the samples should be taken af- transportation or storage.
ter emptying the packages separately.
a. Quantitative requirements
General 9. Validation of the system
The samples must be taken and pre- Liquid premixtures
The size of the sampled portion
pared as quickly as possible bearing Having selected the required number Manufacturers of premixtures will
must be such that each of its con-
in mind the precautions necessary of containers for sampling, the con- validate their HACCP system to
stituent parts can be sampled.
to ensure that the product is neither tents shall be homogenised if neces-
The quantity, frequency and loca- ensure that the hazards which
changed nor contaminated. Instru- sary and an amount taken from each
tion of sampling should be based
container. were originally established by the
ments and also surfaces and contain-
on the criteria below and a statis- HACCP team are complete and
ers intended to receive samples must The incremental samples may be
tical approach may be followed correct.
be clean and dry. taken when the contents are being
where deemed appropriate: Defined hazards will be effec-
discharged.
Incremental samples tively controlled using the devel-
ll expected uniformity of the mate-
In relation to the control of substanc- Preparation of aggregate samples oped general and specific control
rial
es or products uniformly distributed In relation to the control of substanc- measures, as well as the monitor-
ll parameters to be tested
throughout the premixture, incremen- es or products distributed uniformly ing plan and the corrective actions
ll packaging unit size or volume
tal samples must be taken at random throughout the feed the incremental and measures.
ll confidence in the product source
throughout the whole sampled portion samples shall be mixed to form a sin-
ll manufacturing processes em- In addition to the HACCP, one or
and they must be of approximately gle aggregate sample.
ployed more independent members are
equal sizes.
ll product risk analysis added for the validation process.
Preparation of final samples
Bulk premixtures The material in each aggregate sam- Management is clearly involved in
For the purpose of official controls, this process.
An imaginary division should be ple should be carefully mixed to ob-
specific quantities are set by Regu-
made of the sampled portion into a tain a homogenised sample. If nec- Implemented corrective measures
lation (EC) No. 152/2009 for each
number of approximately equal parts. essary the aggregate sample should must show that they are satisfac-
types of samples, taking into ac-
A number of parts corresponding to first be reduced to at least 2 kg or two tory and prevent an unsafe feed
count the product form (liquid/solid,
the number of incremental samples litres (reduced sample) either by us- from being released and provide
bulk/packaged) and batch size
required should be selected at ran- ing a mechanical or automatic divider proof that the situation can be im-
(tonnage or number of packages
dom and at least one sample taken or by the quartering method.
and package size). Different values mediately corrected.
from each of these parts. Where ap- At least three final samples should
are also set depending whether or
propriate, sampling may be carried then be prepared, of approximately
not the product or substance to be
out when the sampled portion is being the same amount and conforming
analyzed is expected to be homo-
moved (loading or unloading). to the quantitative requirements de-
Premixtures -62- -63-
VII. Safety adopted at international level by of using dosages higher than tor is provided with the adequate
the United Nations. The GHS pro- recommended or lower than instructions for handling every
Feed is considered unsafe for its vides a system to harmonize the necessary for the animals component of the premixture. The
intended use if it is likely to pose a criteria for classification of sub- ▪▪ Some additives may be con- premixture operator is able to im-
risk to human or animal health, or if stances and mixtures relating to sidered dangerous for the plement the objectives of the feed
its use may lead to animal products physical and health hazards dur- user or the environment when hygiene Regulation (Regulation
unsafe for human consumption. ing handling (e.g. worker safety), used in very high concentrated (EC) No 183/2005). Contamina-
environmental hazards, as well as forms; the risk is reduced when tion and cross contamination dur-
All premixtures produced inside the rules of labelling and packag- these hazardous substances ing production are avoided by cor-
the EU must follow the strict norms ing for hazardous substances and are included in a premixture, rect identification, labelling and
that the European Commission´s mixtures. It introduces the use of and the possibility of incident coding. If for any reason, the final
food safety policy has placed and pictograms as those provided as is much lower. Also, the trans- product is considered unsafe, it is
set out primarily in the White Pa- an example in the pictures over- port of dangerous additives is discarded. Finally, the premixture
per on Food Safety. leaf. safer inside a premixture, as is packaged and labelled with a
The aim of the premixture pro- the dilution reduces the con- batch number that ensures the
During the production the worker ducer is to ensure safety of pre- tamination possibilities in case traceability of all the components
safety is assured, as the premixture mixtures by minimizing the risk of of accident from the supplier to the final user
producers have the experience of adulterated feed additives, func- ▪▪ All products included in the of the feed.
handling all the individual ingredi- tional feed ingredients, carriers premixture are considered safe Tracking and traceability: Every
ents, with their different character- and premixtures entering the feed/ for the animals at the recom- product has unique written speci-
istics, the necessary equipment food chain by providing measures mended dosages. The premix- fications, as well as name and
complying with relevant standards to ensure that other applicable ture offers all the ingredients code. All the information related
(eg ATEX - protection against oc- regulatory feed safety require- already mixed at the correct to the production and ingredients
cupational explosions), and the in- ments are met. dose in correct proportions used in the manufacturing of the
telligence for knowing the best way premixture is kept in files with the
of application,mixing and produc- The use of premixtures is the best The safety in the premixtures is code number of the production.
tion of the final premixture. way to apply additives into a feed controlled from the reception of In this way, the final user of the
for several reasons: the ingredients to the delivery of premixture has, with one code, all
Furthermore, and in order to en- the final product in the feed pro- the required information about the
sure the safety of the users, Reg- ▪▪ The level of inclusion of every ducer factory. All components are components of the premixture, to
ulation (EC)No 1272/2008 regu- component is more controlled, controlled upon arrival, and stored avoid mistakes.
lates the Classification, Labelling as the premixture facility is according to the individual specific
and Packaging of substances better prepared to work with requirements they may have until
and mixtures, according the Glob- low dosages. This process they are included in the final pre-
ally Harmonized System (GHS) diminishes the possibilities mixture. At the moment of applica-
tion in the premixture, the opera-
Premixtures -64- -65-
2. HAZARDS IDENTIFICATION
Picture 19:
Examples of pictograms according to the
Globally Harmonized System 3. COMPOSITION / INFORMATION ON INGREDIENTS
VIII. Physical and chemical The above problems are all com- Each carrier or combination of ▪▪ When the mixing is completed
characteristics monly found in most processes. carriers appears to have a specific and packaged (but not sealed)
Common areas where they occur tolerance for powders. Well known samples should be taken from
1. Homogeneity and are: carriers of similar 30-80 mesh throughout the batch to check
segregation range (150 - 600 µm) show widely for consistency
▪▪ equipment vibration different powder holding capacities ▪▪ A sample must be taken from
A homogenous mix is attained ▪▪ electrostatic hang up of between 15 -50%. the first bag of product made
when all of the ingredients in a ▪▪ changes in air pressure and regularly thereafter
product are present, in the same ▪▪ free fall through or from equip- If the carrier itself contains a high ▪▪ Each retention sample must
ratios they were added, through- ment proportion of fine particles, such be tested for the active ingre-
out the product. This is an impor- ▪▪ angle of repose, funnelling as flour in wheat middlings, this will dients and results recorded
tant concept as a processing run ▪▪ dust collection points decrease its ability to hold active in- ▪▪ The efficacy of the mixing pro-
that is not homogeneous may re- gredients in powder form. cess should be determined by
sult in an overdose of additives No matter how carefully or how calculating the standard de-
in some instances and an under- thoroughly a premixture is blend- ▪▪ How to test for segregation viation and coefficient of vari-
dose in others, both of which can ed, it will not remain uniform if it during production and stor- ation of the results
be dangerous to animals and the can be physically segregated. age? ▪▪ Records of testing should be
consumer. Some of the factors influencing maintained in accordance with
segregation include: This is an example of a procedure documented procedures
To prevent ingredient segregation that can be used to determine the ▪▪ The coefficient of variation of
(loss of homogeneity), the premix- ▪▪ Carrier components exhibiting efficacy of blending to ensure all in- samples are usually around 5
tures industry takes into account marked differences in physical gredients are uniformly distributed: to 10%
some parameters related to physi- properties ▪▪ In case of doubt regarding
cal properties and process areas: ▪▪ Single carrier particles cover- ▪▪ Determine the product to be sieve performance it is sug-
ing too wide particle size range tested. Use a product that has gested to take samples from
▪▪ the particle size, shape and ▪▪ Smooth surfaces on carrier an ingredient that can be test- the mixer after mixing, from
distribution of the ingredient particles ed with a high degree of accu- the sieve (if possible) and from
▪▪ the design of the process line ▪▪ Zero or negative electrostatic racy. Tracers such as zinc or the bags and compare
including extraction points and attraction between carrier par- manganese can be used
aspiration ticles and active ingredients ▪▪ Take and test retention sam-
▪▪ mixing time, overfill or appara- ▪▪ Lack of oil on surface of carrier ples of each raw material be-
tus failing to move ingredients ▪▪ Too high a proportion of pow- fore production commences
through the mixing area such dered active ingredients ▪▪ Mix the raw materials in ac-
as gaps between mixing pad- ▪▪ Inappropriate sieve between cordance with normal proce-
dles and the mixer wall mixer and packing unit dure
Premixtures -68- -69-
and is essential to prevent or elimi- and premixtures, which are intention- Feed hygiene: are used in feed in order to perform
nate a food safety hazard or reduce ally added to feed or water in order to The measures and conditions neces- one of the following functions: micro-
it to an acceptable level (ISO 22000). perform, in particular, one or more of sary to control hazards and to ensure nutrition, technological, sensory, and
the following functions: fitness for animal consumption of a zootechnical.
Emulsifiers: ll favourably affect the characteris- feed, taking into account its intended
Substances that make it possible to tics of feed; use (Regulation EC No. 183/2005). GMP+:
form or maintain a homogeneous ll favourably affect the characteris- Scheme for assuring feed safety in all
mixture of two or more immiscible tics of animal products; Feed materials: the links in the feed chain. It is also
phases in feedingstuffs (Regulation ll favourably affect the colour of or- Products of vegetable or animal ori- an international scheme, applicable
EC No. 1831/2003). namental fish and birds; gin, whose principal purpose is to worldwide.
ll satisfy the nutritional needs of meet animals’ nutritional needs, in
Enzymes: animals; their natural state, fresh or preserved, Good manufacturing practice:
Proteins that catalyze (i.e., increase ll favourably affect the environmen- and products derived from the indus- Series of procedures in a branch or
the rates of) chemical reactions. They tal consequences of animal pro- trial processing thereof, and organic sector in which the standard of con-
are classified as technological and duction; or inorganic substances, whether or duct is laid down (often with respect
zootechnical feed additives. ll favourably affect animal produc- not containing feed additives, which to hygiene and safety).
tion, performance or welfare, par- are intended for use in oral animal-
Expiry date: ticularly by affecting the gastro- feeding either directly as such, or HACCP (Hazard Analysis and Criti-
Date after which the quality of the intestinal flora or digestibility of after processing, or in the prepara- cal Control Points):
product cannot be guaranteed in rela- feedingstuffs; or tion of compound feed, or as carrier A system which identifies, evaluates,
tion to specification. ll have a coccidiostatic or histo- of premixtures (Regulation EC No. and controls hazards related to feed
monostatic effect. 767/2009). safety. (Codex Alimentarius).
Extrusion: (Regulation EC No. 1831/2003)
A continuous process by which mois- FEMAS: Hazard warnings:
tened, expansible, starchy, and/or They can be classified in the following Feed Materials Assurance Scheme. Series of labelling measures in order
proteinaceous materials are plasti- categories: to communicate on hazards (picto-
cized and cooked by a combination of (a) technological additives, (b) senso- Flowability: gram, words, statements …), in line
moisture, pressure, temperature, and ry additives, (c) nutritional additives, Capability of a liquid or loose par- with the GHS (Global Harmonised
mechanical shear. Extruded feed are (d) zootechnical additives or (e) coc- ticulate solid (powder) to move by. System) for labelling of dangerous
mainly used for pets and fish. cidiostats and histomonostats. Flowability depends on flow proper- goods.
ties of the material and equipment
FAMI-QS: Feed business operators: used. Flow properties of a powder are Label :
The Quality and Safety System for The natural or legal persons responsi- linked to its physical characteristics Any tag, brand, mark, pictorial or oth-
Specialty Feed Ingredients and their ble for ensuring that the requirements (density, compressibility, cohesive er descriptive matter, written, printed,
Mixtures. of food law are met within the feed strength, etc). stencilled, marked, embossed, im-
business under their control (Regula- pressed on, or attached to the pack-
Feed additives: tion EC No. 178/2002). Functional feed ingredients: aging or the container of feed (Regu-
Substances, micro-organisms or Products which are not legally de- lation EC No. 767/2009).
preparations, other than feed material fined as feed additives and which
Premixtures -76- -77-
UFAS:
Universal Feed Assurance Scheme. References
Vitamins:
▪▪ Microvittm User’s Guide (Rhone Premixes and Feeds, A Practical
Organic substances indispensable
Poulenc /Adisseo) Approach in Ruminant Diets.
to the normal metabolic processes of
▪▪ Micro Nutrients Premixing Michael Coelho, Ph.D., MBA,
animal organisms.
technology – Phuah, C.H. (Agr. Marketing Manager, BASF
Divison Pfizer Private Ltd) – Corporation
Withdrawal period :
proc.10th Ann.Conf.MSAP (1987) ▪▪ FAMI-QS code of practice
Period necessary between the last
▪▪ ROCHE – Information Service – (www.fami-qs.org)
administration of the feed additive to
Premixes in the compound Feed ▪▪ European legislation on Feed
animals under normal conditions of
Industry Additives (http://ec.europa.
use and the production of foodstuffs
▪▪ Proceedings 13th Annual Florida eu/food/food/animalnutrition/
from such animals, in order to protect
Ruminant Nutrition Symposium, feedadditives/legisl_en.htm )
public health by ensuring that such
pp 127-145, Vitamin Stability in
foodstuffs do not contain residues in
quantities in excess of the maximum
residue limits set for the feed additive.
Zootechnical additives:
Any additive used to affect favourably
the performance of animals in good
health or used to affect favourably the
environment.
Premixtures -80-
Acknowledgements
This booklet is the result of efforts quet / DSM, Mario Döpker / Miavit,
and commitment of the members of and Juan José Mallo / Norel y Nature.
the FEFANA Working Group Pre- Thanks go also to the FEFANA Sec-
mixtures. Acknowledgements should retariat staff and to the Communica-
go in particular to the chair-person, tion Team for the finalization and pub-
Peter Fidder / Nutreco, as well as to lication of this booklet.
Cédric Martin / DSM, Philippe Bec-
Disclaimer
This booklet is intended to provide the However, FEFANA does not take any
best-of-our-knowledge information to responsibility for whatever use of the
anyone interested to get a better un- information provided herewith, by ei-
derstanding about Premixtures. ther the general public or any actor in
the food and feed chain.
www.fefana.org
ISBN 978-2-9601289-0-1