1. FEFAC Safe Use of Feed Additives and Micro Ingredients Marek Kumprecht Member of FEFAC Presidium, Trouw Nutrition Biofaktory - member of ČMSO ZZN

2. 2 Feed additives – legislative framework Reg. 1831/2003 on Feed Additives Reg. 183/2005 on Feed Hygiene Reg. 178/2002 – General Food Law Reg. (Draft) on the placing on the market and use of feed Others

3. 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 since2004

4. 4 Legislative framework – Feed Hygiene Reg. (EC) No 183/2005 Obligatory approval for all feed business operators using additives or premixtures of additives Implementation and maintenance of HACCP principles for all feed business operators using additives or premixtures of additives Approval of feed business establishments – 3 levels (Annex IV)

5. 5 Legislative framework – Reg. (Draft) on the placing on the market and use of feed Amends Reg.1831/2003 Establish 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 premixes (Art.16, Reg.1831/2003) – no more detailed information on single feed additives incorporated in premixes

6. 6 Save use of feed additives – European industry approach (EFMC) Additives and veterinary medicinal substances Use of additives and veterinary medicinal substances Additives and veterinary medicinal substances must be mixed in appropriate quantity and in a homogeneous way following the manufacturer's recommendations to ensure that finished feed contain the quantity as specified. Official approval requirements Premixtures and compound feed manufacturers who incorporate additives and veterinary medicinal substances must be in possession of an authorisation issued by competent authorities. Reference must be paid to Annex II of Directive 84/587/EEC (antibiotics, coccidiostats and veterinary medicinal substances): - Companies using these products must comply with the legal criteria regarding the installations, the management and administration of the plant, as well as with the qualification of the employees. - Veterinary medicinal substances must only be incorporated in compound feed in the form of premixtures.

7. 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: a)favourably affect the characteristics of feed b)favourably affect the characteristics of animal products c)favourably affect the colour of ornamental fish and birds d)Satisfy the nutritional needs of animals e)favourably affect the environmental consequences of animal production f)favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedingstuffs, or g)have a coccidiostatic or histomonostatic effect

8. 8 Definitions Carry-over: Contamination of a material or product with another material or product that originates from previous use of equipment. 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.

9. 9 Use o feed additives – risks (1) The inclusion of not permitted additives - additives, a suitability of which for animal nutrition has not been confirmed, - additives with levels of undesirable substances exceeding critical limits.

10. 10 Use o feed additives – risks (2) The 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.

11. 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

12. 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 premixes

13. 13 Use of feed additives requires safety precautions in order to minimize possible adverse effect 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.

14. 14 Use of feed additives requires safety precautions in order to minimize possible adverse effect 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.

15. 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. 16 Potentially dangerous additives Coccidiostats and histomonostats (AGP – in EU until 31.12.2005) Nutritional additives - Chapter 2 Annex IV Reg. 183/2005 - vitamins A,D - trace elements Cu, Se

17. 17 Toxicity of feed additives – examples of overdosage Feed AdditiveCategory of animals % of overdosing Appearance Monensin sodiumChicks350Reduced feed intake & gain 600As above plus mortality Turkeys200Reduced feed consumption & gain 300Deaths in 3/5 days; muscle weakness, diarrhoea, dyspnoea Lasalocid sodiumChicks200Depressed body weight gain Turkeys750Depressed body weight gain SeleniumSwine1000-2000Toxicity - death Chickens1000-4000Toxicity - death

18. 18 Toxicity of feed additives for non target species Feed AdditiveCategory of animals Dose (ppm) Appearance NarasinLayers/ Breeders70Reduced egg production & hatchability Turkeys 11 w.o.2830% mortality Turkeys 18 w.o.25>80% mortality Rabbits1030-40% mortality Salinomycin sodium Layers25Reduced feed intake & egg production Turkey breeders15-30Mortality up to 15% CopperSheepAnorexia, excessive thirst, and depression, death

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

20. 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.

21. 21 Carry over of feed addtitives – decontamination plan - EXAMPLE Compound feedAdditiveFollowing compound feed Piglet prestarterZnOPiglet starter, Link feed for pigs Pullet starterHalofuginonePullet grower, Broiler starter, grower Pullet growerMonensin sodiumBroiler grower, Pullet grower, starter Broiler starterDiclazurilPullet starter, Broiler grower, Pullet grower Broiler growerLasalocid sodiumPullet grower, Broiler starter, Pullet starter RabbitsSalinomycine sodiumBroiler grower, Broiler starter

22. 22 Requirements for the labelling of Premixes 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

23. 23 Requirements for the labelling of Premixes 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 XXXXX Enzymes XXXXXXX Micro-organisms XXXXXX Nutritional additives XXXX Technological additives XXX Flavouring compounds XXX

24. 24 Joint EMFEMA/FEFAC/FEFANA Code of Practice for Labeling 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.

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