1. Implementation of Legislation at National Level Multi-beneficiary Workshop on Veterinary Drugs Residue and Antimicrobial Resistance Zagreb, 09 to10 February 2015 Zagreb, 09 to10 February 2015 Zlatko Krovina, DVM Zlatko Krovina, DVM Ministry of Agriculture, Veterinary and Food Safety Directorate Ministry of Agriculture, Veterinary and Food Safety Directorate

2. Participants Ministry of Agriculture - Veterinary and Food Safety Directorate Authorised Veterinary organizations and Control Bodies Laboratories Ministry of Health - Directorate for Sanitary Inspection Farmers, Food Business Operator, Fairs Wholesale and Retail sale

3. Veterinary Service (structure) MINISTRY OF AGRICULTURE (other directorates) FACULTY OF VETERINARY MEDICINE CROATIAN VETERINARY CHAMBER CROATIAN VETERINARY INSTITUTE VETERINARY INSPECTION (regional offices – branches) VETERINARY INSPECTION (regional offices – branches) AUTHORISED VETERINARY ORGANISATIONS (CONTROL BODIES) VETERINARY AND FOOD SAFETY DIRECTORATE (central level) VETERINARY AND FOOD SAFETY DIRECTORATE (central level) CROATIAN AGRICULTURAL AGENCY PUBLIC HEALTH (central and local level) CROATIAN FOOD AGENCY

4. Legal base - general Legal base - general Veterinary Act (OG 82/13,148/13) (national legislation) Food Act (OG 81/13) transposed Regulation (EC) No. 178/2002 Act on VMP (OG 84/08, 56/13) transposed Directive 2001/82/EC and amendments as modified by Directive 2004/28/EC Act on food hygiene and microbiological criteria for foodstuffs (OG 81/13) transposed Commission Regulation (EC) No. 2073/2005 as last amended by Commission Regulation (EU) No. 209/2013 Official controls low performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OG 81/13, 14/14) transposed Regulation (EC) No. 882/2004

5. Legal base - VMP Legal base - VMP 1. Ordinance on the Veterinary Medicinal Products (OG 30/09, 73/09, 14/10, 146/10, 32/11, 67/13) (transposed Directive 2001/82/EC and amendments as modified by Directive 2004/28/EC and Directive 2009/9/EC) 2. Ordinance on conditions regarding retail sale and wholesale of proprietary medicinal products, medicinal additives and veterinary medical products carrying out by legal or natural persons (OG 73/99) 3. Ordinance on the prescription and dispensing of veterinary medicinal products (OG 149/05) 4. Ordinance on good laboratory practice (GLP) and verification of application of the principles of good laboratory practice for tests on veterinary medicinal products (OG 69/07) (transposed Directive 2004/10/EC) 5. Ordinance on principles and guidelines of good manufacturing practice for veterinary medicinal products (OG 120/07) (transposed Commission Directive 91/412/EEC) 6. Ordinance on veterinary medical products which are dispensed without veterinary prescription for animals intended for human consumption (OG 67/09) (transposed Commission Directive 2006/130/EC of 11 December 2006, Implementing Directive 2001/82/EC) 7. Ordinance on advertising of veterinary medical products (OG 146/09) (transposed Directive 2001/82/EC)

6. Legal base - VMP Legal base - VMP 8. Act on implementing Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (OG 94/13) 9. Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae 10. Commission Regulation (EC) No 540/95, of 10 March 1995, laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human or veterinary use authorized in accordance with the provisions of Council Regulation (EEC) No 2309/93

7. Distribution of veterinary medicinal products Distribution of veterinary medicinal products Wholesale Veterinary practice Veterinary clinic Veterinary station Veterinary hospitals Veterinary medicine Retail sale Veterinary pharmacy According to: Veterinary Act (OG 41/07,148/13) Act on VMP (84/09,56/13)

8. Official control of veterinary medicinal products – Distribution Official control of veterinary medicinal products – Distribution Plan of official controls on veterinary inspectors Veterinary inspectors conduct official control in accordance with (Act on VMP 84/08, 56/13, Official controls low OG 81/13, 14/14) Wholesale Retail VMP Supervision of facilities for the production of VMP's

9. Official control of veterinary medicinal products – Farm lavel Official control of veterinary medicinal products – Farm lavel Records on the treatment of animals and withdrawal period The records of treatment of animals, the application of medicated feed and withdrawal periods The records using the VMP's Records of visits to the economy

10. Legal base - Rezidue Legal base - Rezidue 1. Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin 2. Commission Regulation (EC) No 124/2009 setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed 3. Council Regulation (EEC) No 315/93 laying down Community procedures for contaminants in food 4. Commission Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in foodstuffs 5. Commission Regulation (EC) No 401/2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs 6. Commission Regulation (EC) No 252/2012 laying down methods of sampling and analysis for the official control of levels of dioxins, dioxin- like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EC) No 1883/2006 7. Commission Regulation (EC) No 333/2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and polycyclic aromatic hydrocarbons in foodstuffs

11. Legal base - Rezidue Legal base - Rezidue 8. Regulation (EC) No 396/2005 of the European Parliament and of the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC 9. Commission implementing Regulation(EU) No 788/2012 concerning a coordinated multiannual control programme of the Union for 2013, 2014 and 2015 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin 10. Ordinance on the monitoring of certain substances and residues thereof in live animals and animal products (OG 79/08, 51/13) (transposed Council Directive No 96/23/EC) 11. Ordinance on detail rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products (OG 138/08, 142/12) (transposed the Commission Decision No 98/179/EC) 12. Ordinance on the levels and frequencies of sampling for the monitoring of certain substances and residues thereof in certain animal products (OG 15/10)

12. Legal base - Rezidue Legal base - Rezidue 13. Order prohibiting the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists (OG 51/13) (transposed Council Directive No 96/23/EC) 14. Order prohibiting the placing on the market and use of bovine somatotropin (OG 93/08) (transposed Council Decision No. 1999/879/EC) 15. Ordinance on the performance of analytical methods and the interpretation of results (OG 02/05) (transposed Commission Decision No 2002/657/EC) 16. Ordinance laying down harmonised standards for testing for certain residues in products of animal origin imported from third countries (OG 145/08) (transposed Commission Decision No 2005/34/EC) 17. Ordinance on the methods of sampling for the official control of pesticide residues in and on products of plant and animal origin (OG 77/08) (transposed Commission Directive No 2002/63/EC)

13. Official control of veterinary medicinal products – Residue Official control of veterinary medicinal products – Residue National residue control plan (NRCP) Group of substances on which samples have to be analyzed Sampling procedure (who is authorized to take samples, how to chose sample, how to take them and what information has to follow a sample) Minimum No. of samples to be taken Laboratory analysis and interpretation of the results Measures in case in a case of non-compliant result

14. Official control of veterinary medicinal products – Residue Official control of veterinary medicinal products – Residue GROUP A Substances having anabolic effect and unauthorized substances Stilbenes, stilbene derivatives and their salts and esters Antithyroid agents Steroids Resorcylic acid lactones including zeranol Beta-agonists VMP’s & contaminants GROUP B VMP’s & contaminants Antibacterial substances, including sulphonomides, quinolones Other veterinary drugs (Anthelmintics, Anticoccidials, including nitroimidazoles, Carbamates and pyrethroids, Sedatives, Non-steroidal anti-inflammatory drugs (NSAIDs),Other pharmacologically active substances) Other substances and environmental contaminants (Organochlorine compounds including PcBs, Organophosphorus compounds, Chemical elements, Mycotoxins, Dyes, Others)

15. Official control of veterinary medicinal products – Residue Official control of veterinary medicinal products – Residue

16. Legal base - Feed Legal base - Feed 1. Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene 2. Commission Regulation (EU) No 225/2012 of 15 March 2012 amending Annex II to Regulation (EC) No 183/2005 of the European Parliament and of the Council as regards the approval of establishments placing on the market, for feed use, products derived from vegetable oils and blended fats and as regards the specific requirements for production, storage, transport and dioxin testing of oils, fats and products derived thereof 3. Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition 4. Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC 5. Commission Regulation (EU) No 56/2013 of 16 January 2013 amending Annexes I and IV to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies – Feed ban

17. Legal base - Feed Legal base - Feed 6. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety 7. Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules 8. Ordinance on registration and approval of establishments dealing with feed (OG 72/08) 9. Ordinance on undesirable substances in animal feed (OG 80/10, 124/12) transposed Cuncil Directive No 2002/32/EC) 10. Ordinance of operators responsible for primary production of feed (OG 153/11) 11. Ordinance on medicated feedingstuffs (OG120/11) transposed Cuncil Directive No 90/167/EEC of 26 March

18. Official control of veterinary medicinal products – Feed Official control of veterinary medicinal products – Feed Annual Plan for monitoring feed (Legal basis Food Act (OG 81/13), Act on Official controls low (OG 81/13, 14/14) Official controls shall be subject to all objects in the food business for the animals at all stages of production, processing and distribution of feed.

19. Official control of veterinary medicinal products – Feed Official control of veterinary medicinal products – Feed

20. Border veterinary inspection control of import consignments Border veterinary inspection control of import consignments Annual sampling plan for imported consignments of animal products Number of samples for all compounds (veterinary drugs, pesticides and unavoidable environmental contaminants) Monitoring of imported live animals intended for slaughter Official controls at slaughterhouses

21. Border veterinary inspection control of import consignments Border veterinary inspection control of import consignments

22. Legal base - AMR Legal base - AMR 1. Ordinance on the monitoring of zoonoses and zoonotic agents (OG 42/13) transposed Directive No 2003/99 2. Order on measures to protect animals from infectious and parasitic diseases and the financing thereof in 2015 (OG 3/15) 3. Implementation Decision (2013/652/EU) 4. Regulation (EC) No 2160/2003 5. Regulation (EU) No 517/2011 6. Regulation (EU) No 200/2012 7. Regulation (EU) No 1190/2012 8. Regulation (EU) No 1117/2016

23. AMR monitoring programmes AMR monitoring programmes Elements of a monitoring scheme (Legal basis (2013/652/EU) Bacterial species Animal species/populations and food categories Antimicrobial agents Sampling strategy Sample size Isolation procedures Susceptibility testing methods Interpretive criteria (cut-off values) Data collection, recording and reporting

24. AMR monitoring programmes AMR monitoring programmes Zoonotic bacterial species – animals and food Bacteria of the genus Salmonella and Campylobacter Identification to the serovar level for Salmonella (S. Typhimurim and S. Enteritidis isolates) Identification to the species level for Campylobacter (Campylobacter jejuni and Campylobacter coli) Indicator (commensal) organisms Escherichia coli, Enterococcus faecium, Enterococcus faecalis

25. AMR monitoring programmes AMR monitoring programmes National monitoring programmes (tool for the implementation) Isolates collected at: - The level of primary production (faeces, swabs) - In the slaughterhouse (caecum, broiler carcasses ) Animal species Gallus gallus Turkeys Slaughter pigs Cattle for slaughter

26. AMR monitoring programmes AMR monitoring programmes Veterinary add Food Saffety Directorate (Veterinary Inspector ) Directorate for Sanitary Inspection (Sanitary Inspector ) Isolates (preferably) collected at retail/cutting plant Other animal populations (lamb, veal calves, rabbit. etc ) Meat of : Broiler meat Pig meat Bovine meat

27. Thank you for your attention