Premixtures Fefana Publication

Fefana Publication

Premixtures

Contributors:

FEFANA Working Group Premixtures, and in particular:

Peter Fidder, Nutreco Philippe Becquet, DSM Cédric Martin, DSM Mario Döpker, Miavit Juan José Mallo, Norel y Nature

ISBN 978-2-9601289-0-1 © FEFANA 2013 -03-

Table of Contents

Preamble 7 b. pH 17 Introduction 9 c. Moisture 18 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

II. Sourcing and III. Formulation of procurement 13 premixtures 20

1. Legal, Quality system, 1. Product types 20 Customer requirements 13 a. Pre-dilutions 21 a. Registered and approved b. Specific blends 21 feed business operators 13 c. Complex premixtures 22 b. Legal requirements 14 c. Quality system 15 2. Nutritional aspects 23 d. Customer requirements 15 3. Characteristics of the ingredients 24 e. Sourcing of incoming 4. Choice of carrier(s) 25 materials 15 5. Handling properties 27 6. Safety and quality aspects 27 2. Ingredients specifications 7. Regulatory requirements 28 (feed additives, feed 8. Specific customer requirements 29 materials used as carriers) 9. Logistic aspects 29 and packaging materials 16 10. Conclusions 29

a. Management requirements IV. Manufacturing 30 for premixture ingredients 16 b. Specifications for 1. Intake and storage 30 packaging materials 16 2. Suitable equipment 31 3. Conveying 33 3. Specific requirements for 4. Weighing and dosing 34 premix ingredients 17 5. Premixture mixing (types of mixers) 36 a. Particle size 17 6. Mixing procedures 37 -05-

7. Production / dosing sequence 38 VII. Safety 62 8. Hygiene and cleaning 39 9. Maintenance and inspection 40 VIII. Physical and chemical characteristics 66 V. Packaging and transport 41 1. Homogeneity and segregation 66 1. Packaging types 41 2. Packaging in bags 43 ▪▪ How to test for segregation 67 3. Packaging in IBC 44 4. Packaging in drums 48 2. Stability in premix 68 5. Packaging should protect 3. Dustiness 69 the premixes during 4. Flowability 69 transport and storage 49 5. Carryover 70 6. Waste management 50 7. Premixtures in bulk 51 Glossary 73 References 79 VI. Quality management 52 Acknowledgements 80 ▪▪ HACCP purpose 53 Disclaimer 80

1. Finished product specifications 54 2. Quality standards 54 3. Quality manual 55 4. Communication to customers: code of practice for labelling 56 5. Quality Control program for incoming ingredients 57 6. Quality Control program for finished products 58 7. Analytical / Technical tolerances 58 8. Sampling 59

a. Quantitative requirements 60 b. Instructions for taking, preparing and packaging the samples 60

9. Validation of the system 61 -07-

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 different 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: tion of the feed additives in Manufacturing flowchart of compound 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- islation, premixtures of feed but most important for a good dis- sued by the supplier is needed. tribution in the final feed. a. Management requirements for Documentation is required that additives do not require spe- Ingredients with low particle size premixture ingredients these feed additives are produced cific product authorization. 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 ments. and placed on the market, 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- approved suppliers and each sup- (moisture, electrostatic charges, ments for approval of purchased ditives duly authorized (includ- plier shall be subject to periodical particle size distribution and shape, product. ing specific restrictions of use review. etc...), may have more tendency to Selection and approval of all raw when applicable) and carriers Premixture operators evaluate cake and be more difficult to pro- materials shall include their origin, that comply with the EU legis- 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 accordance with the operator’s re- ument that he/she complies concerns, especially when they with ingredients shall be docu- quirements. Criteria for selection, with these requirements. 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). physical properties of the used in- or limitations associated with the preparation. Microscopic picture of Packaging materials shall not gredients and the desired flowing ingredient material which have Vitamin D3 beadlets. 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-

III. Formulation Of 1. Product types a. Pre-dilutions carbonate) or plant origin (e.g. Premixtures wheat middlings). However, pos- Premixtures can serve different These “pre-dilutions” are simple sible interactions with the carrier Formulation is a critical step in the purposes and can exert several mixtures of one feed additive, ei- should be anticipated, including delivery of a premixture. Although functions in feed, so the complex- ther as pure active substance or the presence of free-water activ- as a formulated preparation, and ity (e.g. in carriers of plant origin) some standard branded blends ity and particular features of the usually a single carrier. They may for water soluble and sensitive are used for specific purposes, formulation exercise depends on be required for additives that are additives. in practice, premixture manufac- the type of premixture and its pur- incorporated in small amounts in turers usually handle hundreds pose: the feed or premixtures in order b. Specific blends of different specific formulations, to guarantee a good homogene- which are often exclusive and tai- ▪▪ “Pre-dilutions” are aimed at fa- ity in the end-product. This may These blends are designed to ful- lor-made for each customer. cilitating the use and handling also be a regulatory requirement fil a specific function in the feed. Therefore, formulators should of a specific feed additive, in for some feed additives in order The following types of formulation take into account many different particular its homogeneous to avoid the risk of overdose in can be cited as examples: l parameters in order to define the mixture in specific blends, compound feed. l Antioxidant blends are com- Basic nutritional blends contain- posed of feed additives aimed right composition of a blend: complex premixtures or com- ing several nutritional additives at protecting feed, and primarily pound feeds (vitamins, trace elements) can unsaturated fats and oils, from ▪▪ Types of premixtures and pur- ▪▪ Specific blends have specific also be prepared in advance for oxidation. Antioxidants are not pose of use functional objectives in the fi- later use in the formulation of dif- equally efficient on different feed ▪▪ Nutritional aspects nal feeds or can be used in different complex premixtures with materials, but combination of sev- ▪▪ Physical and chemical charac- ferent complex premixtures the same basic nutrients’ levels, eral antioxidants usually provides teristics of the ingredients ▪▪ Complex premixtures contain in order to improve production synergy (1+1=3). Hence the for- ▪▪ Choice of suitable carrier(s) different types of additives and throughput and reactivity of sup- mulation of the blend depends ▪▪ Handling properties minerals, and are usually pur- ply. on the specific ‘mode of action’ of ▪▪ Production constraints suing different objectives Formulation is usually not com- each additive and the composi- plex; the choice of the carrier tion of the final feed, based on a ▪ ▪ Safety aspects depends on the particular char- specific balance defined by expe- ▪▪ Regulatory requirements acteristic of the feed additive(s). rience. As these substances are ▪▪ Specific requirements of the For liquid/oily forms of additives, very reactive the carriers are usu- customer a carrier with good adsorption ally neutral. ▪▪ Economic and logistic aspects properties will be required, while ll Acidity regulator blends are for additives in solid form, a car- composed of organic and/or in- rier with similar particle size organic acids. The primary func- distribution and shape will be tions of these blends are buffering selected. The carriers used for capacity and preservation of the these blends are usually neutral feed. It is of utmost importance to materials of mineral (e.g. calcium formulate them in a proper way Premixtures -22- -23-

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- l l l Flavouring blends formulation l 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 carrier, 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-

▪▪ Neutralising water activity to 5. Handling properties 6. Safety and quality aspects protect water-sensitive ingredients Handling properties of pow- As concentrated blends of ▪▪ Increasing the density of the ders are important throughout different substances, premix- premixture to reach the de- the production process, from tures can present specific sired level the starting materials up to the hazards and it is important for ▪▪ Increasing the minimum igni- final product: formulators (and users) to be tion energy of the blend and ▪▪ Products having poor flowa- aware: therefore reduce the risk of bility may result in bridging, ▪▪ Physical hazards: the main dust explosion Picture 3: caking and product losses in physical hazard for premix- ▪▪ Increasing flowability and im- Organic carrier the production process. This tures is dust explosion, relat- proving handling properties of the conditions the throughput and ed to electrostatic properties product (can also be achieved by good functioning of the proof the components. Although the use of specific additives) duction lines the risk is less with premix- ▪▪ Dustiness of the additives and tures compared to pure sub- Water can also be used as carriers is also an important stances, because of the dilu- carrier for premixtures (liquid aspect in the choice of the in- tion with inert carriers, some blends). Other formulation gredients, as dusty products concentrated blends of spe- aids/technological additives will result in product losses, cific ingredients may have an (emulsifiers, acidity regulators, risk of explosions and higher important explosive potential. preservatives, etc) are usually worker exposure (skin/eye ir- It may therefore be useful to necessary to reach homoge- ritation, inhalation exposure) use mineral carriers to dilute neous emulsion/ suspension, these blends if possible. Spe- limit contamination and stabi- Improved handling properties can cific packaging types are also lise the pH of the premixture. be achieved by the selection of the selected according to the level Naturally the behaviour of right ingredients and carrier(s). of risk feed additives in a liquid envi- ▪▪ Health hazards: some feed ronment is very different from additives can present risks the behaviour in a solid blend for the professional users/ and predicting interactions workers, especially when ex- and stability requires specific posed daily to concentrated experience and know-how. blends and pure ingredients. The choice of non dusty ingredients (e.g. preparation of additives) and formulation Premixtures -28- -29-

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 management system. Premixtures -30- -31-

IV. Manufacturing 2. Suitable Equipment standards for comparison are needed. 1. Intake and storage Since production of premixtures is ▪▪ Silos are commonly used for the generally regarded as a batch op- storage of carriers and macro Facilities used to store ingredients, eration, only equipment for batch ingredients like minerals. packaging and products shall pro- mixing will be considered in this ▪▪ Where supply of carriers with vide protection against contamina- chapter. As a rule, premixtures a certain particle size distribution from e.g. dust, condensation, are produced in specialized and tion is not possible, a suitable drains, waste and pests. Storage well equipped plants with trained mill for finer grinding of the areas for dry ingredients and pre- personnel. carrier or mineral substances mixtures shall be kept dry and well The production of premixtures, al- could be installed ventilated. though diversified, is not in itself a ▪▪ Screens for the separation of All packaged materials shall be very complex process. Neverthe- lumps from some ingredients stored off the floor and with suffi- less the whole process of premix- ▪▪ A number of accurate scales cient space between the material ture production must be able to of various sizes, suitable for and the walls to allow inspection handle complexity. rapid and precise weighing and pest control activities to be Basically a standard premixture and/or an installation based carried out. plant could consist of the following: on loss in weight principles The storage area shall be man- ▪▪ A small ‘’laboratory’’ mixer, ca- aged to allow maintenance and Picture 4: ▪▪ An area for the storage and pacity 20kg cleaning, prevent contamina- Example of storage of premixtures preservation of micro ingredi- ▪▪ A mixer for the final premix- tion and minimize deterioration. ents, concentrates and vari- tures, capacity 500- 2000kg. Chemicals not intended for prod- ous preparations. The depart- Opinions differ as to the best uct inclusion (e.g. cleaning materi- ment has to be equipped with type of mixer, but horizon- als, pesticides) shall be stored in suitable storage facilities and tal mixers are (still) the most a separate and secure (locked or equipment. Extreme tempera- common. The mixing capabil- otherwise access controlled) stor- tures and high relative humidity is of vital importance and is age area when not in use. Moni- ity must be avoided typically 1: 100 000 toring and control of temperature ▪▪ An analytical laboratory able to ▪▪ Equipment for bagging or can be applied where specified for run diverse routine analyses, packing premixtures, as well stored ingredients. including control of the addi- as a suitable way to transfer tives in respect of uniformity, premixtures to bulk trucks, appearance, color, moisture when delivered in bulk and temperature where appli- ▪▪ The above machinery and cable. Various equipment and equipment for conveying, trans- Premixtures -32- -33-

port and storage should be so In addition it is very important to 3. Conveying installed and arranged as to control all risks of dust explosion. minimize labour requirements. In order to do this, the equipment There are many different types of and layout of the plant must be equipment for conveying ingre- When considering installation and designed to take into account the dients from one part of a premix the choice of equipment, the plant European Directives concerning plant to another, or from one piece designer should bear the following equipment and avoidance of dust of equipment to another. Some are features in mind: explosion at the workplace, known designed to operate horizontally, as ATEX Directives (“ATmos- some on a slope, others elevate ▪▪ Safe and convenient access pheres EXplosives” - Directives the material vertically to a different Picture 6: to the mixer for sampling and 94/9/EC and 1999/92/EC). level of the building. The require- Bulk delivery with a truck inspection, as well as the pos- ment for elevators and conveyors sibility for cleaning must be will depend on how automated the provided. design and the plant layout are. ▪▪ Possibility of supervising the The utmost use of such equip- cleaning and inspection of the ment is made in the modern ani- system, emptying the mixer, mal feed mill (often using pneu- transporting, sacking and stor- matic systems) to minimize labour ing premixtures. needs and to maximise the use of ▪▪ Design of the production pro- available space by building multi- cess to provide the shortest storey, rather than horizontally ar- and most direct route of con- ranged plants. veyance, especially in case of For premixture ingredients and final premixtures. premixtures as such, a lot of specialized equipment is available. However, in general premix manufacturers seek to avoid conveying as much as possible.

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: ▪▪ Number of products in a pre- imal feed plants, the normal meth- tors, for example: Weigher in a weigher. The combination 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 ▪▪ Absence of heating during tion. Mixers are generally available in mild steel or stainless-steel. mixing ▪▪ Twin-axle paddle mixers. ▪▪ Low consumption of energy There is no one-fit-all type of mix- These machines perform well er; the actual choice of the type of when starting and during mixing for preparing vitamin premix- ▪▪ Low maintenance costs mixer is dependent on many fac- tures tors including plant design, capacity 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 gram should be in place and in- for the range of weight or volume Routine equipment inspection 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-

Additive Characteristics: Specific Challenge for Packaging 2. Packaging in bags Powder, granulated and liquid forms Different characteristics = not all packaging types are appropriate Bags made of paper or other ma- Voluminous or very dense products Packaging must be sturdy enough for the terials, of various constructions, in product it contains capacities from 1 to 30 kg. Char- High content of feed additives that are Packaging must be airtight and provide a acteristics may include: sensitive to direct light and air barrier against light and / or UV rays ▪▪ Reinforced paper bags Hygroscopic products or product compo- Packaging must protect the additives ▪▪ Sometimes laminated with nents against humidity. Since air carries mois- plastics, to provide moisture ture, packaging must be air-tight barriers, or to prevent direct Aggressive products (e.g. acids) Packaging must securely contain the contact of product with paper contents in order to protect the environ- / outer wall ment from an aggressive medium ▪▪ Valve bags with outside-/ in- Products with a high content of aroma or Flavours and aromas are volatile. A sui- flavour additives table packaging must protect the aroma side- / thermovalve until it reaches its intended target, i.e. the ▪▪ Sewn round bottom bags feed ▪▪ Flat hexagonal bottom bags Premixes which contain concentrations Packaging must be strong and safe ▪▪ Bags for dangerous goods of ingredients that may be harmful upon enough to protect people handling the (UN-approved) direct contact product ▪▪ For special requirements it is sometimes necessary to use In order to comply with the different requirements of their products, pre- bags made of materials other mix businesses work with a host of packaging types. The following are than paper, e.g. aluminium or some of the most common packaging systems. plastic ▪▪ Sometimes it may be important to ensure complete imper- meability to air and liquids

Pictures 12: Bag filling process

Filling of bags with premix is typically done on automatic or semi- automatic bag filling lines (sta- Picture 11: tions). In fully automatic lines, and Process control screen packaging line for filling weights from 1 to 30 kg, empty bags are typically picked Premixtures -44- -45-

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: charges and should be used as a a footprint similar to a Euro pal- Due to its cubic shape, this type of Composite IBC IBC is widely used for storage and standard FIBC for all non-mineral let and will be 1,5 metres high. To The IBC depicted above is a com- type of products. clearly identify their contents, Big transportation of liquid premixes. Typical specifications of this IBC bination of a cubic synthetic tank Bags must be labelled. Labels will boxed inside a caged frame. The usually be put into the information for use in the premix industry include the following: inner container has a standard vol- pockets provided on the bags, but ume of 1060 litres and dimensions when large amounts of recurrent ll Impermeable to odours and of 1200 x 1000 x 1160 mm. Fill- 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 packaging 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 material 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 ly friendly to produce than others, Guidelines on Cargo Securing for Road 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 analysis tool that helps an opera- ▪▪ HACCP purpose that all the aspects of the HACCP system are working effectively tor identify feed safety hazards Common topics in a PRP are: ll Document all procedure and re- The purpose of a HACCP pro- and evaluate the risk associated cords to demonstrate the HACCP gram is to ensure product (feed) with their product(s) and process- ▪▪ Buildings & environment 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- how HACCP principles can be the operator to document, con- ▪▪ Waste disposal tivities and process steps ranging applied and specific definitions on trol and verify the effectiveness of ▪▪ Equipment, suitability and from purchase of raw materials to HACCP, see the annexes in the these control measures. maintenance transport of the finished products. guidance to the FAMI-QS Code ▪▪ Selection and Management of 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 following 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.

The premixture manufacturer must specify every premixture which he puts on the market, processes, treats or trades.

All business locations and pro- Premixtures -56- -57-

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: (fixed to each pack) to focus on: ▪▪ Full product specifications will tained sample should be available QC laboratory 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 products released for use. In the same Premixtures -58- -59-

6. Quality Control program for 7. Analytical / Technical 8. Sampling finished products tolerances The sampling apparatus must be When executing an analysis on made of materials which cannot con- ▪▪ Each product shall have a Tolerances include technical and premixtures or incoming ingredi- taminate the products to be sampled. written specification, which is analytical deviations, although it ents, one of the most important amended when any change is apparent that the calculation of things is to do that in a represent- Apparatus recommended for sam- takes place the total tolerance differs between ative sample. Written sampling pling of solid premixtures: ▪▪ All finished products should be control authorities in different procedure should be available inspected prior to dispatch, in Member States in the absence of and adapted to the intended pur- Manual sampling accordance with written pro- harmonized legislation and har- pose (batch release, acceptance ▪▪ Flat-bottomed shovel with ver- cedures, to ensure they meet monized analytical methods for all of consignments, special controls, tical sides specification. A retention sam- feed additives. etc.), to the type of controls (iden- ▪▪ Sampling spear with a long ple of adequate size shall be tity, composition, monitoring of split or compartments. The taken of each product and Analytical tolerances covering contaminant, etc.), and to the ma- dimensions of the sampling held, as a minimum, for a time measurement of uncertainties and terial to be sampled (liquid/solid, spear must be appropriate to equivalent to the defined shelf procedural variations are not fixed bulk/packages, etc.). Operators the characteristics of the sam- life of the product. The samples at EU level for feed additives. The taking samples should be trained pled portion (depth of contain- must be sealed and labelled, analytical tolerance of the individu- and have sufficient knowledge of er, dimensions of sack, etc.) stored in a manner that should al laboratory is used in the calcula- the practical aspects and materi- and to the particle size of the prevent abnormal change, and tion that may vary from a labora- als or products in order to work ef- premixture kept at the disposal of the au- tory to another. fectively and safely. thorities for a period appropri- Technical tolerance, covering nat- Mechanical sampling ate to the use ural variation in feed materials, Type of samples: ▪▪ Approved mechanical appara- weighing and mixing errors (pre- tus may be used for the sam- mixtures and feeds) and losses ▪▪ Sampled portion: A quantity pling of moving premixtures during processing and shelf-life of product constituting a unit, are fixed at EU level only for com- and having characteristics Divider pound feed and not for premix- presumed to be uniform ▪▪ Apparatus designed to divide tures. ▪▪ Incremental sample: A quan- the sample into approximately tity taken from one point in the equal parts may be used for Nevertheless, it should be logical sampled portion taking incremental samples to harmonize this approach for ▪▪ Aggregate sample: An aggre- and for the preparation of re- premixtures as well. gate of incremental samples duced and final samples taken from the same sampled portion Premixtures -60- -61-

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 priate size b. Instructions for taking, preparing using a spear or shovel. Where neces- adulteration which might arise during 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 must be such that each of its con- Manufacturers of premixtures will in mind the precautions necessary of containers for sampling, the con- stituent parts can be sampled. validate their HACCP system to 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 were originally established by the ments and also surfaces and contain- container. on the criteria below and a statis- ers intended to receive samples must The incremental samples may be HACCP team are complete and tical approach may be followed be clean and dry. taken when the contents are being correct. where deemed appropriate: discharged. Defined hazards will be effec- 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- ll parameters to be tested measures, as well as the monitor- throughout the premixture, incremen- es or products distributed uniformly ll packaging unit size or volume ing plan and the corrective actions tal samples must be taken at random throughout the feed the incremental ll confidence in the product source and measures. 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 Preparation of final samples added for the validation process. Bulk premixtures The material in each aggregate sam- Management is clearly involved in For the purpose of official controls, An imaginary division should be ple should be carefully mixed to ob- this process. 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 count the product form (liquid/solid, tory and prevent an unsafe feed the number of incremental samples litres (reduced sample) either by us- bulk/packaged) and batch size from being released and provide required should be selected at ran- ing a mechanical or automatic divider (tonnage or number of packages proof that the situation can be im- 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 application in the premixture, the opera- Premixtures -64- -65-

The MSDS covers the following chapters:

SAFETY DATA SHEET ACCORDING TO REGULATION (EU) Nº453/2010

Revision: __ (EN) Print date: ______Revision date: ______

1. IDENTIFICATION OF THE PRODUCT AND OF THE COMPANY

Picture 19: 2. HAZARDS IDENTIFICATION Examples of pictograms according to the Globally Harmonized System 3. COMPOSITION / INFORMATION ON INGREDIENTS

The premixture producer must 4. FIRST AID MEASURES calculate the hazardous level of 5. FIREFIGHTING MEASURES the product applying the legislation in force (hazards and concen- 6. ACCIDENTAL RELEASE MEASURES tration factors laid down in GHS), and label the product accordingly. 7. HANDLING AND STORAGE Finally, at the end of the production process, a Material Safety 8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Data Sheet that follows regula- 9. PHYSICAL AND CHEMICAL CHARACTERISTICS tion 453/2010 is produced. In this MSDS, all the aspects related to 10. STABILITY AND REACTIVITY the handling and safe uses of the product are described, and are 11. TOXICOLOGICAL INFORMATION provided to the industrial user of 12. ECOLOGICAL INFORMATION the premixture. 13. DISPOSAL CONSIDERATIONS

14. TRANSPORT INFORMATION

15. REGULATORY INFORMATION

16. FURTHER INFORMATION Premixtures -66- -67-

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-

2. Stability in premix tamins is redox reactions by trace 3. Dustiness 4. Flowability minerals. Trace minerals also vary To control stability of feed additives in redox potential. The type of trace Premixtures are usually prepared Free flowing properties are par- in premix it is essential to pay at- mineral molecular structure, with by dry blending of active ingredi- ticularly important in a premix to tention to the specification of the copper, zinc and iron being the most ents with carrier. be mixed in a feed by a continu- product on the market as well as to reactive and manganese and sele- The active ingredients in the form ous process via automatic dosing the formulation of the premixtures. nium the least reactive, has a sig- of fine powders will adhere to the systems. Essential are the choice of nificant impact on vitamin stability. coarser particles up to a certain carrier(s) and their properties (like Free metal ion is the most reactive limit. This limit is called Powder Premixtures must pass through moisture content, pH) and aware- (metal filings) followed by sulphate, carrying Capacity (PCC). feed milling equipment freely, ness of incompatibilities between carbonate, oxide and the least re- The PCC of a carrier is influenced without bridging or clogging. Prop- the different feed additives. active form is chelated. Chelated by its particle size, particle shape er carriers can be most effective The stability of micro ingredients forms become incapable of initiat- and surface texture. in improving to improve the free depends on various factors. There ing formation of free radicals. Hence, two carriers having identi- flowing properties of the premix. are no clearly defined standards In fat-soluble vitamins, esters are cal particle sizes may show widely for all micro ingredients. All vary in significantly more stable than al- different PCC’s. Free flowing agents can be added their stability. The destructive ac- cohols. The hydroxyl group of al- This difference is largely a matter up to 5% to improve the flowability tion of the other ingredients of the cohols is extremely sensitive to of the surface area of the particles, of premixes. mixture on micro ingredients var- oxidation. The five double bonds which in turn is a function of par- ies according to its moisture and in retinyl acetate (vitamin A) still ticle shape and surface texture. In Another way to define flowability is mineral content. make the compound sensitive to general particles with smooth flat compressibility. In the case of vitamins, as biologi- oxidations. Vitamin A is significant- surfaces have low PCC whereas cally active biochemicals, they are ly more stable in vitamin premixes those with highly irregular surfac- Compressibility (Cp) is calculated in general quite sensitive to their than in vitamin-trace mineral pre- es will hold powder better. by the formula physical and chemical environment. mixes because trace minerals cat- In addition to the powder carry- Feed manufacturing processes alyze oxidation of the five double ing effects caused by the particle (td-ad) 100 tend to improve the distribution bonds. Specific protected forms size and shape, the oil content of Cp = of nutrients (premixing) and the are available to overcome this the carrier has a pronounced ef- td digestibility of carbohydrates (pel- problem to a certain extent. fect on the ability of the carrier to leting, extrusion). However, these Friction is also an important factor hold powders. The oil content may Apparent density (ad) or non processes can be harmful to labile because it erodes the coating that be of natural origin, such as that tapped density is determined by nutrients, such as vitamins, that protects several vitamins, includ- found in grains, or it may be the weight of product freely filling can be easily oxidized. ing vitamin A, and reduces vitamin added. So it is possible to prepare an a standard volume In vitamin/trace mineral premixes, crystals to a smaller particle size. oiled rice hull carrier which will have a the dominant effect exerted on vi- higher PCC than that of ground corn. Premixtures -70- -71-

Operators must ensure that formal maintenance and cleaning of Weight 5. Carryover ad = systems are in place to minimize the equipment (verification of Volume Carryover is the contamination of the risk of carryover of feed ad- the mixer total opening, veri- a product with another material or ditives and premixtures between fication of the cleaning pro- The tapped density (td) is deter- product that originates from previ- them and/or with other products. gram, etc.) mined by the weight of the product ous use of the same equipment. Operators are required to take ▪▪ Record the corrective meas- filling this same standard volume measures to avoid this carryover ures taken, including their ef- after removal of the air between Carryover has to be controlled by providing, among others: ficiency, in order to prevent or the particles during the production process in eliminate carryover order to minimize and avoid its oc- ▪▪ thorough and complete clean- Weight (tapped) currence, until an acceptable level ing of all equipment used be- Where process lines may some- td = is reached. The operator should tween batches times carry non-EU authorised Volume follow documented procedures ▪▪ use of suitable sequencing products, this process must be and actions that have been taken and flushing techniques to used to demonstrate that there For most powders, the compress- to prevent carryover. prevent traces of restricted is no carry-over of this unap- ibility makes it possible to evalu- material entering the produc- proved material into EU destined ate the behaviour of a powder in a In order to limit carryover, special tion line products. static state (i.e. in a silo). attention should be paid to the fol- ▪▪ use of separate dedicated lowing: storage bins to store stock Instructions for testing carry over: If the compressibility is low feed additives and premix- (<20%), the product normally ▪▪ Transport (contamination with tures, and to label each bin 1. Determine product to be test- flows freely. If the compressibility previous cargoes) ed. Use a product that has a is high (>40%), the product packs ▪▪ Dosage Any operator shall have written low inclusion rate of an ingre- and has a higher tendency to ▪▪ Transport through the circuits procedures specifying: dient that can be tested with a bridge in silo. within the factory high degree of accuracy. Trac- ▪▪ Mixing ▪▪ Control of the carryover critical ers such as zinc or manga- ▪▪ Delayed dust return points nese can be used ▪▪ Electrostatic hang up ▪▪ Sampling and analytical re- 2. Retain samples of all raw ma- ▪▪ Residue in equipment lines, sults terials to be used in the test. walls, moving parts ▪▪ Cleaning of the equipment 3. Batch A containing the select- ▪▪ Leaking valves/gates when changing to a product ed active raw material/tracer, ▪▪ Poor cleaning/flushing with different characteristics must be produced in accord- ▪▪ Preparation and storage from the product previously ance with normal production manufactured procedures ▪▪ Verification of the adequate Premixtures -72- -73-

4. A sample of Batch A must be tested and retained Glossary 5. If a flush takes place between Batches A and B, samples of Acidity regulators: Caking: the flush material should be Substances which adjust the pH of Tendency of individual particles to ad- taken from the very beginning feedingstuffs (Regulation EC No. here. and end of the flush 1831/2003). They are classified as 6. When Batch B is completely technological feed additives. Carrier: mixed and packaged (but not Substance used to dissolve, dilute, Batch: disperse or otherwise physically mod- sealed) representative sam- An identifiable quantity of feed deter- ify a feed additive in order to facilitate ples should be removed from mined to have common characteris- its handling, application or use with- the batch tics, such as origin, variety, type of out altering its technological function 7. All samples (including sam- packaging, packer, consignor or la- and without exerting any technologi- ples of flush materials) must belling, and, in the case of a produc- cal effect itself (Regulation EC No. be tested in accordance with tion process, a unit of production from 767/2009). prescribed procedures a single plant using uniform produc- 8. Batch B should not contain tion parameters or a number of such Coccidiostats: levels of the active ingredient units, when produced in continuous Substances intended to kill or inhibit contained in Batch A to an ex- order and stored together (Regulation protozoa (coccidiosis parasites). EC No. 767/2009). tent that it poses a risk to the Complementary feed: end user (Apply HACCP prin- Biomass: Compound feed which has a high ciples) Biological material derived from liv- content of certain substances but 9. Records of testing should be ing, or recently living organisms. In which, by reason of its composition, maintained in accordance with animal feed, biomasses usually con- is sufficient for a daily ration only if documented procedures sist in products which act as direct used in combination with other feed or indirect protein sources and are (Regulation EC No. 767/2009). manufactured by certain technical processes, especially fermentation. Compound feed: A mixture of at least two feed materi- Buffering: als, whether or not containing feed ad- Action of adjusting and limiting the ditives, for oral animal-feeding in the variations of the pH. form of complete or complementary feed (Regulation EC No. 767/2009). Bulk: Unpackaged cargo or goods. Critical Control Points: Steps at which control can be applied Premixtures -74- -75-

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-

Labelling : ganic molecules; in Europe, macro- Attribution of any words, particulars, elements (i.e. phosphorus, calcium, Premixtures : Sensory additives: trademarks, brand name, pictorial magnesium, potassium, sodium, sul- Mixtures of feed additives or mixtures Any substance, the addition of which matter or symbol to a feed by placing phur,… ) are feed materials whereas of one or more feed additives with feed to feed improves or changes the or- this information on any medium refer- micro-elements are feed additives materials or water used as carriers, ganoleptic properties of the feed, or ring to or accompanying such feed, (see definition of trace elements). not intended for direct feeding to ani- the visual characteristics of the food such as packaging, container, notice, mals (Regulation EC No. 1831/2003). derived from animals (e.g. colorants label, document, ring, collar or the Nutritional additives: or flavouring substances). Internet, including for advertising pur- Additives that satisfy the nutritional Preparation (of feed additive(s)): poses (Regulation EC No. 767/2009). needs of animals. They include the Combination of one or more feed Shear effect: following functional groups: additives with technological feed ad- Effect obtained by friction of materi- Material Safety Data Sheet (MSDS): a. vitamins, pro-vitamins and chem- ditives, feed materials and/or water als. Document that contains information ically well-defined substances used as formulation aids, and inten- on the potential health effects of ex- having similar effect; tionally formulated or processed in or- Shelf life: posure to chemicals, or other poten- b. compounds of trace elements; der to (i) improve handling properties, Defined time period for which a prod- tially dangerous substances, and on c. amino acids, their salts and ana- safety of use or stability of the addi- uct fully complies with its specification safe working procedures when han- logues; tive or additives, or (ii) synergistically if stored appropriately. dling chemical products. d. urea and its derivatives perform a feed additive function. (Regulation EC No. 1831/2003) Silo: Mesh (scale): Preservatives: Structure for storing bulk materials. Measure for particle sizes of powders OVOCOM: Substances or, when applicable, Specialty feed ingredients: Feed addi- and granular materials. Consultation Platform for the animal micro-organisms which protect feed tives and functional feed ingredients. feed chain. OVOCOM is the scheme against deterioration caused by mi- Trace elements: Dietary mineral that Micro-organisms: owner for the Belgium GMP certifica- cro-organisms or their metabolites is needed in very minute quantities Microscopic organism that comprises tion scheme. (Regulation EC No. 1831/2003). for the proper growth, development, either a single cell (unicellular), cell and physiology of the organism. They clusters, or no cell at all (acellular). Pelleting (feed pelleting): QS: are classified as nutritional feed addi- They are classified as zootechnical Processes consisting in forcing a soft Qualität und Sicherheit Gmbh, Ger- tives (iodine, iron, selenium, copper, additives. feed through holes in a metal die plate many quality scheme for food. zinc, manganese, cobalt and molyb- to form compacted pellets, which are denum). Mineral feed: then cut to a pre-determined size. Reworking: Complementary feed containing at Feed are usually grinded and con- Any appropriate manipulation steps in Technological additives: least 40 % crude ash. ditioned with different liquids and/or order to ensure a feed additive or pre- Any substance added to feed for a steam to improve pelleting. Pelleted mixture will conform to specifications. technological purpose (e.g. preserva- Minerals: feed (granulates) are used for many tives, antioxidants, emulsifiers, sta- Chemical elements required by liv- different animal species. Sample: bilisers, anti-caking agents, binders, ing organisms, other than the four Quantity of product constituting a unit, acidity regulators …). elements carbon, hydrogen, nitrogen, Perishable materials: and having characteristics presumed to and oxygen present in common or- Material subject to decay or spoilage. be uniform and representative of a whole. Premixtures -78- -79-

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.

Xanthophylls (or phylloxanthins): Yellow pigments that form one of two major divisions of the carotenoids group (the other one being caro- tenes).

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

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