1. Safe Use of Feed Additives and Micro Ingredients
Marek Kumprecht
Member of FEFAC Presidium,
Trouw Nutrition Biofaktory - member of ČMSO ZZN
16 September 2010
TAIEX Sofia, Bulgaria

2. Feed additives – legislative framework
Reg. 1831/2003
on Feed Additives
Reg. 787/2010 on Marketing and Use of Feed
Reg. 183/2005 on Feed Hygiene
Reg. 178/2002 – General Food Law
Others
16 September 2010
TAIEX Sofia, Bulgaria

3. Legislative framework - Feed additive Regulation (EC) No 1831/2003
Principles
Replaced Directive 70/524/EEC
Includes amino acids and silage agents
Brand specific approval for coccidiostats
Maintaining of coccidiostats as feed additives
Withdrawal of antibiotic growth promoters by 1 January 2006
Five categories of feed additives
Fixation of MRLs and withdrawal period
Notification of existing feed additives
Re-evaluation of all feed additives every 10 years
In force since 2004
16 September 2010
TAIEX Sofia, Bulgaria

4. Legislative framework – Reg. 787/2010 on Marketing and Use of Feed
Includes some provisions related to
feed additives
Establishes the maximum concentration of feed additives in feed materials and complementary feed (factor 100; 5 for coccidiostats & histomonostats)
Exception for feed intended for particular nutritional purposes
Amends the labeling rules for premixtures (Art.16, Reg.1831/2003) – no more detailed information on single feed additives incorporated in premixtures
16 September 2010
TAIEX Sofia, Bulgaria

5. Legislative framework – Feed Hygiene Reg. (EC) No 183/2005
Obligatory registration / approval of all feed business operators
Implementation of minimum hygiene requirements (annex II) and implementation and maintenance of HACCP principles for all feed manufacturers using feed additives (except silage additives) and/or premixtures
Approval of feed business establishments – 3 levels (Annex IV)
16 September 2010
TAIEX Sofia, Bulgaria

6. Safe use of feed additives – European industry approach (EFMC)
Official approval requirements
Premixtures and compound feed manufacturers who incorporate additives and/or certain premixtures must be approved (in possession of an authorisation issued) by competent authorities.
Companies using additives and/or certain premixtures shall comply with the legal criteria regarding facilities and equipment, personnel, production, quality control, storage and transport, traceability, record keeping, product recall, etc.
Voluntary guides to good hygiene practice
Sector guides to good hygiene practice (e.g. EFMC for compound feed and premixtures manufacturers) can be used by operators as a tool to comply with legal hygiene requirements.
Extract of EFMC:
“Use of Additives: Additives and premixtures must be mixed in appropriate quantity and in a homogeneous way following the manufacturer's instructions of use to ensure that finished feed contains the quantity as specified”
16 September 2010
TAIEX Sofia, Bulgaria

7. Feed additives – Definition
„Feed additives“ means substances, micro-organisms or preparations, other than feed material and premixtures which are internationally added to feed or water in order to perform, in particular one or more of the functions mentioned in Article 5(3).
The feed additive shall:
favourably affect the characteristics of feed
favourably affect the characteristics of animal products
favourably affect the colour of ornamental fish and birds
Satisfy the nutritional needs of animals
favourably affect the environmental consequences of animal production
favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedingstuffs, or
have a coccidiostatic or histomonostatic effects
16 September 2010
TAIEX Sofia, Bulgaria

8. Definitions
Carry-over: The level of transfer of any substance or product from one production batches to the immediate subsequent batch in a particular section of the plant, for example, a mixer or a hand tip point.
Contamination: The undesired introduction of impurities of a chemical or microbiological nature or foreign matter into or onto an incoming or a finished feed during production, sampling, packaging or repackaging, storage or transport.
Control Measure: Any action and activity that can be used to prevent or eliminate a food / feed safety hazard or reduce it to an acceptable level.
16 September 2010
TAIEX Sofia, Bulgaria

9. Use o feed additives – risks (1)
The inclusion of not permitted additives
additives, the use of which for feeding a given species is not authorised by EU law,
additives with levels of undesirable substances exceeding legal maximum limits.
16 September 2010
TAIEX Sofia, Bulgaria

10. Use o feed additives – risks (2)
Exceeding of specified
limit levels of additives
in feedingstuffs or departure from
declared levels of additives in
premixtures due to:
the incorrect functioning of scales working in automatic regime
the use of manual scale with an insufficient working accuracy
the use of scales in contradiction with the current metrological rules
the losses during the production process due to insufficient aspiration of manufacturing equipment or non-compliance with instructions for the application of additives into compound feedingstuffs or premixtures.
16 September 2010
TAIEX Sofia, Bulgaria

11. Use o feed additives – risks (3)
Non-homogenous distribution
of additives in premixtures or
compound feedingstuffs caused by:
the incorrect functioning of mixers or an insufficient mixing time with respect to a product being worked
the addition of insufficient doses of additives or premixtures into the each batch
an unsuitable construction of conveying lines or storage bins for finished products
16 September 2010
TAIEX Sofia, Bulgaria

12. Use o feed additives – risks (4)
Cross-contamination between finished
products, caused mainly by:
non-compliance with production procedures, i.e. no checks or cleaning of manufacturing equipment after the manufacture of premixtures or feedingstuffs containing hazardous additives are performed
an incorrect prescribed sequence of different products in the production process that does not assure that cross-contamination is avoided (decontamination programme)
the use of unsuitable and unverified manufacturing equipment that due to its construction or operation can cause cross-contamination,
no consistent on-receipt examination for content of undesirable substances in incoming materials intended for use in the manufacture of feedingstuffs such as premixtures
16 September 2010
TAIEX Sofia, Bulgaria

13. Use of feed additives requires safety precautions in order to minimize possible adverse effects on animal and human health
Additives, premixtures and medicated premixtures must be mixed in appropriate quantity and in a homogeneous way.
Storage, production facilities and manufacturing equipment must be clean and in a good state.
The process flow within the manufacturing facility must be designed to minimize the potential for contamination and carry-over.
Reasonable precautions must be taken against dust accumulation and other residual materials in place of processing and storage.
For feed additives and medicated premixtures with high propensity to generate dust specific measures must be defined to minimize the impact of such dust on the level of carry-over.
16 September 2010
TAIEX Sofia, Bulgaria

14. Use of feed additives requires safety precautions in order to minimize possible adverse effects on animal and human health
Tolerances must be defined for the dosing of each feed material and feed additive.
A production schedule must be established in order to minimize the risk in relation to carry-over.
Where required, equipment must be cleaned and/or flushed so as to avoid contamination between batches.
Flushing must be collected into clearly identified containers and dealt with in accordance with written procedures, unless flushed into the original batch.
Locking or warning system should be applied in order to ensure that the targeted additive is included in the target premixture at the suitable dose.
16 September 2010
TAIEX Sofia, Bulgaria

15. Control of carry-over
A list of critical substances for the purpose of control of carry-over should be established.
Carry-over has to be measured with an appropriate method (every 2 years) or after adaptation of the installation.
Where a hazard presents a significant risk to the product, control measures to reduce or minimize it (scheduling of manufacturing) must be established and documented
16 September 2010
TAIEX Sofia, Bulgaria

16. Potentially dangerous additives
Coccidiostats and histomonostats
Nutritional additives - Chapter 2 Annex IV Reg. 183/2005
- vitamins A,D
- trace elements Cu, Se
Antibiotics, other medications
16 September 2010
TAIEX Sofia, Bulgaria

17. Toxicity of feed additives – examples of overdosing
Category of animals
% of overdosing
Appearance
Monensin sodium
Chicks
350
Reduced feed intake & gain
600
As above plus mortality
Turkeys
200
Reduced feed consumption & gain
300
Deaths in 3/5 days; muscle weakness, diarrhoea, dyspnoea
Lasalocid sodium
Depressed body weight gain
750
Selenium
Swine
Toxicity - death
Chickens
16 September 2010
TAIEX Sofia, Bulgaria

18. Toxicity of feed additives for non target species
Category of animals
Dose (ppm)
Appearance
Narasin
Layers/ Breeders 70
Reduced egg production & hatchability
Turkeys 11 w.o. 28
30% mortality
Turkeys 18 w.o. 25
>80% mortality
Rabbits 10
30-40% mortality
Salinomycin sodium
Layers
Reduced feed intake & egg production
Turkey breeders
15-30
Mortality up to 15%
Copper
Sheep
Anorexia, excessive thirst, and depression, death
16 September 2010
TAIEX Sofia, Bulgaria

19. Use of feed additives – methods of addition to compound feeds
Individual additive dosing
Single additive premixtures (with carrier)
Specific premixtures (e.g. vitamin concentrates)
Compound premixtures (e.g. Vitamin, trace elements, amino acids e.t.c.)
Mineral or complementary feed (contains also macro elements)
16 September 2010
TAIEX Sofia, Bulgaria

20. Sequence of production
Sequencing (or scheduling) of production does not allow for a reduction of carry-over but enables to manage carry-over in order to prevent any adverse impact on animal or public health.
Each plant must establish its own rules for drawing up production schedules, the characteristics of the substances and the species for which they are authorized. The schedules should include exclusions like e.g. no production of horse feed after a batch of feed containing ionophores.
The number of batches to be produced between a batch containing a given additive and a batch for a non target species is given in a (so called ) cross-contamination table which is a basis for production order planning.
16 September 2010
TAIEX Sofia, Bulgaria

21. Carry over of feed addtitives – decontamination plan - EXAMPLE
Compound feed
Additive
Following compound feed
Piglet prestarter
ZnO
Piglet starter,
Link feed for pigs
Pullet starter
Halofuginone
Pullet grower ,
Broiler starter, grower
Pullet grower
Monensin sodium
Broiler grower,
Pullet grower, starter
Broiler starter
Diclazuril
Pullet starter, Broiler grower, Pullet grower
Broiler grower
Lasalocid sodium
Pullet grower, Broiler starter, Pullet starter
Rabbits
Salinomycine sodium
Broiler grower, Broiler starter
16 September 2010
TAIEX Sofia, Bulgaria

22. Requirements for Premixture Labelling
Name and address of the responsible business
Net weight
Approval/registration number
Directions for use (safety recommendations , animal species and categories for use)
Identification Number
Batch reference number, date of manufacture
PREMIX (PREMIXTURE) in Capitals
Carrier substance
16 September 2010
TAIEX Sofia, Bulgaria

23. Requirements for Premixture Labelling
Function
Group
Specific Authorised Additive Name
Expiry Date
Directions for use
Concentration (active subst. level)
Activity units
Inclusion rate in premixes
EC or strain ID No
Specific name of Active Component
Zootechnical additives, coccidiostats, histomonostats X
Enzymes
Micro-organisms
Nutritional additives
Technological additives
Flavouring compounds
16 September 2010
TAIEX Sofia, Bulgaria

24. Joint EMFEMA/FEFAC/FEFANA Code of Practice for Labelling of feed additives and premixtures
FEFAC, FEFANA & EMFEMA have divided this Code of Practice in four main parts:
- Code of Practice for Labelling Feed Additives
- Code of Practice for Labelling Premixtures
- Templates for Product Specification Sheets for feed additives and premixtures
- Label Templates taking into account the different options recommended in the Code.
This document is foreseen as a support for the Feed Additive and Premixture Operators for the preparation of their labels. It shall also be used as a guide for Member States’ Control Authorities, when visiting the feed additives and premixtures operators’ facilities.
This document shall be a living document, to be updated with new requirements; new
developments or issues faced by the Operators or the Control Authorities.
16 September 2010
TAIEX Sofia, Bulgaria

25. Thank you for your attention!
16 September 2010
TAIEX Sofia, Bulgaria