1. Regulation (EC) N° 183/2005 on Feed Hygiene: General Principles Dr. Wolfgang Trunk EU Commission, DG SANCO

2.  Regulation (EC) No 183/2005 laying down requirements on feed hygiene came into effect in January 2006.  It applies to businesses that manufacture, use or market animal feeds. Apart from the feed industry, this includes most livestock farms, arable farms that grow, use or sell crops for feed use, and also fish farms.

3. Activities not covered by Regulation 183/2005 the private domestic production of feed for food-producing animals kept for private domestic production and for animals not kept for food production the feeding of food-producing animals kept for private domestic consumption the feeding of animals not kept for food production the direct supply of small quantities of primary production of feed at local level by a producer to local farms for use on those farms the direct supply, by the producer, of small quantities of primary products to local establishments directly supplying the final consumer (e.g. farms) the retailing and wholesaling of pet food => businesses carrying out these activities do not need approval or registration

4. Primary producers: (a) transport, storage and handling of primary products at the place of production; (b) transport operations to deliver primary products from the place of production to an establishment; (c) mixing of feed for the exclusive requirements of their own holdings without using additives or premixtures of additives with the exception of silage additives, => Requirements in Annex I:

5. I. Hygiene provisions Feed operators shall ensure that operations are carried out in such a way as to prevent or minimize hazards that can compromise feed safety. Feed operators shall ensure, that primary products produced, prepared, cleaned, packed, stored and transported under their responsibility are protected against contamination and spoilage. In concrete: to control hazardous contamination such as that arising from the air, soil, water, fertilizers, plant protection products, biocides, veterinary medicinal products and handling/disposal of waste Annex-I-requirements

6. Feed operators shall: keep clean and, where necessary to disinfect in an appropriate manner, facilities, equipment, containers, crates and vehicles used for producing, preparing, grading, packing, storing and transporting feed; ensure hygienic production, transport, storage conditions for feeds use clean water prevent animals and pests from causing contamination store and handle wastes and hazardous substances, securely to prevent contamination ensure that packaging materials are not a source of hazardous contamination of feed take account of the results of any relevant analyses carry out on samples taken from primary products or other samples relevant to feed safety. Annex-I-requirements

7. II Record-keeping shall keep records relating to measures put in place to control hazards and make it available to the competent authority on demand must keep records on: (a) any use of plant protection products and biocides (b) use of genetically modified seeds (c) any occurrence of pests or diseases that may affect the safety of primary products Annex-I-requirements

8. (d) the results of any analyses carried out on samples on products that have importance for feed safety; (e) the source and quantity of each input of feed and the destination and quantity for each output of feed. Other persons, such as veterinarians, agronomists and farm technicians, may assist the feed business operators with the keeping of records relevant to the activities they carry out on the farm. Annex-I-requirements

9. Plant and Facilities Location of plant and equipment Plan of the establishment, scale not less than 1:1.000 Should define the position of the Plant with details concerning where machinery is located and a general flow chart of major activities Design and characteristics of equipment Ceilings, floors and walls Silos and storage areas Internal transport systems, grinding mills Weighting, mixing and pelletting Mechanical bagging Dust and ventilation General services Requirements for other FBOs

10. Maintenance: Transport system Silos Scales Pelletting machines, other processing equipment (extruder, expander) Grinding equipment, mills, Mixers Baggers Requirements for other FBOs

11. Quality control Head of quality control Analitical lab Equipment Personell Quality Control layout Sampling Methods of Analyses Control of ingredients and premixes Control of processing and critical points Control of end product Storing of end product samples Requirements for other FBOs

12. Information For all equipment: the manufacturer’s description, specifications, and maintenance requirements. Key equipment should have a maintenance book where repairs and service is written SOP (Standard Operationg Procedures) for cleaning working areas. SOPs fot the sampling of ingredients, premixes, additives, semi finished products and finished feeds, as well as type of analyses to be carried out and frequency. Requirements for other FBOs

13. Rodents and Insects Action Plan on how, when and where surveillance and interventions are carried out Written records on how, when and where actions where carried out Requirements for other FBOs

14. Personell Organigram with all persons which are involved in the production chain. Together with the Organigram and for each worker a brief summary of personal data, experience relevant to his activity, and clear description of the work assignements and responsabilities Such data must be regularly updated and made available if requested during any official inspection Each worker must receive a job description in which his/her tasks are defined and described. His position within the organigram should be defined. If any SOPs (Standard Operating Procedures) concerning his duties exist these should be made available to the worker Requirements for other FBOs

15. Article 6: Feed business operators other than those referred to in Article 5(1) shall put in place, implement and maintain, a permanent written procedure or procedures based on the HACCP principles. HACCP is a process control system relating to feed and food safety and may be set up and applied in combination with other quality systems. The HACCP plan consists of the following phases: HACCP

16. Phase 1: Forming HACCP team and validation team Phase 2: Description of products Phase 3: Record intended use Phase 4: Determine process information Phase 5: Testing process information Phase 6: Define prerequisite program Phase 7: Principle 1 - Hazard analysis (based on probability x seriousness) Phase 8: Principle 2 - Determine CCP’s based on decision tree HACCP

17. Phase 9: Principle 3 - Determine standards for CCP’s Phase 10: Principle 4 - Monitoring CCP’s Phase 11: Principle 5 - Define corrective measures Phase 12: Principle 6 - Validation and verification of HACCP plan Phase 13: Principle 7 - Documentation and registration of HACCP plan HACCP

18. Major Critical Points Unloading of raw materials Transfer to storage/storage bins dosing Batch production (sequence between batches) Cleaning of production line Management of production residues Requirements for other FBOs

19. The feedmill must have written evidence concerning all ingredients and additives entering its premises which include: transport document, type of product, quantity, date and time of arrival, supplier, lot number, if applicable, controls carried out and any other relevant information. Ingredients, premixes, additives must have a fact and safety sheet. (Method of analysis, disposal of residues, etc.) The fact sheet must contain the following information: commercial name, active ingredient, product description, lot number, certificate of analysis and tolerances (according to the law or if missing according to the manufacturer) and information on any other analytical control which has been done. Requirements for other FBOs

20. All batches must be traceable and identified (lot number, date of production) which can enable later identification of raw materials used, premixes, additives. For feeds with additives and premixes there must be satisfactory documentation that will enable to trace back the whole production process. Requirements for other FBOs

21. Recall plan To prevent that clients and others experience damages of a product delivered by the mill through picking up the dangerous and faulty product. To protect the image of the product and the company and to prevent sales losses. To satisfy the product standards with regard to safety and essential requirements especially in GMP or ISO certified operators A recall plan must therefore be devised and set in place Requirements for other FBOs

22. Components of a recall plan: Introduction with scope and objectives Flow chart of a recall action Reasons for a recall action Responsibilities and powers of the recall coordinator and the recall team Criteria for starting and ending a recall Planning and establishing procedures for an effective and fast recall action. (Proper traceability system must be in place) Emergency measures Information for employees Requirements for other FBOs

23. In case of extensive damage, external information, clients, parties in the chain, certification bodies, branch organisations, government, media, etc. Sample texts for press releases, advertisements, warnings, letters Follow-up lists, lists of contact persons, media lists, lists of external experts Registration of data and experiences Reporting and evaluation After-care Requirements for other FBOs

24. Article 8 - Financial guarantees To prepare for an effective system of financial guarantees (… should provide cover for the total costs for which operators could be held liable as a direct consequence of the withdrawal from the market, treatment and/or destruction of any feed, animals and food produced thereof…) for feed business operators, the Commission shall submit to the European Parliament and to the Council by 8 February 2006 a report on financial guarantees in the feed sector… => Nothing in the pipeline

25. … by the competent authority according to Art 13 for following activities: (a) manufacturing and/or placing on the market of feed additives covered by Regulation (EC) No 1831/2003 and referred to in Chapter 1 of Annex IV to this Regulation; (b) manufacturing and/or placing on the market of premixtures prepared using feed additives referred to in Chapter 2 of Annex IV to this Regulation; (c) manufacturing for placing on the market, or producing for the exclusive requirements of their holdings, compound feedingstuffs using feed additives or premixtures containing feed additives and referred to in Chapter 3 of Annex IV to this Regulation; and if (2) approval is required under the national law of the Member State where the establishment is located; or (3) approval is required by a Regulation adopted in accordance with the procedure referred to in Article 31(2). Approval required

26. Article 19 List of registered and approved establishments 1. For each activity, the competent authority shall record in a national list or lists the establishments it has registered in accordance with Article 9. 2. Establishments approved by the competent authority in accordance with Article 13 shall be recorded in a national list, under an individual identifying number.

27. … The Commission shall encourage the development of Community guides to good practice in the feed sector and for the application of HACCP principles… The Standing Committee assessed the following Community guides: - Community guide to good practice for the EU industrial compound feed and premixtures manufacturing sector for food-producing animals - European Feed Manufacturers Guide - Community guide to good practice for feed additive and premixture operators - FAMI-QS - Guide to good practice for the manufacture of safe pet foods A Register for National Guides to Good Practice has been set up by the Commission to make them available to Member States and feed and food business operators. Guides to good practice

28. Art 23: (a) … the third country of dispatch must appear on a list, … of third countries from which imports of feed are permitted; (b) the establishment of dispatch appears on a list, drawn up and kept updated by the third country … of establishments from which imports of feed are permitted; Art 24 pending the drawing up of the lists provided for in Article 23(1)(a) and (b), imports shall continue to be authorised under the conditions laid down in Article 6 of Directive 98/51/EC. Imports

29. Thank you for your attention !