REZI DUE CONTROL I N SERBI A & MRLs Presented by: Slobodan ŠIBALIC,DVM and Tamara BOŠKOVI Ć ,DVM, MAFWM-Veterinary Directorate
Legislation I n- - Force Force Legislation I n Law on Veterinary Matters (OG RS, No. 91/ 2005 + amend. OG RS, No. 30/ 2010) Food Safety Law (OG RS, No. 41/ 2009) Law on Medicinal Products and Medical Devices (OG RS, No. 30/ 2010) 2 Rezidue control in Serbia & MRLs
Legislation I n- - Force Force Legislation I n ( In compliance with Directive In compliance with Directive 9 6 / 2 3 / EC 9 6 / 2 3 / EC & & Commission Decision Commission Decision 9 7 / 7 4 7 / EC 9 7 / 7 4 7 / EC ) ) ( Regulation Regulation on the Programme on the Programme of Systematic Monitoring of Residues of Systematic Monitoring of Residues of Pharmacologically Active Substances, Hormones of Pharmacologically Active Substances, Hormones and Other Harmful Matters and Other Harmful Matters in Live Animals, Products of Animal Origin and Animal Feedingstuffs Feedingstuffs in Live Animals, Products of Animal Origin and Animal ( OG RS, No. 9 1 / 2 0 0 9 , 6.11.2009.) 9 8 / 1 7 9 / Е Е C ( In compliance with Commission In compliance with Commission Decision Decision 9 8 / 1 7 9 / C ) ) ( I nstruction I nstruction laying down rules on official sampling for laying down rules on official sampling for the monitoring of certain substances and residues thereof the monitoring of certain substances and residues thereof in live animals and products of animal origin animal origin in live animals and products of ( No. 3 2 3 -0 7 -0 1 5 7 7 / 2 0 1 0 -0 5 , 6.04.2010.) 3 Rezidue control in Serbia & MRLs
Legislation I n- - Force Force Legislation I n (In line with Council Directive 96/ 22/ EC ) DECI SI ON DECI SI ON on ban on use of ce certain rtain substances substances of of on ban on use of veterinary y medicinal products medicinal products veterinar for treatment of food producing animals for treatment of food producing animals (OG RS, No 96/ 2009 2009) Bans on the use of hormones and beta-agonists for growth promotion 4 Rezidue control in Serbia & MRLs
Related regulations Related regulations Maxim um levels for pesticides in foodstuffs of anim al origin ( In line with Regulation (EC) No 396/ 2005 ) Regulation on maximum residue levels of pesticides in or on food and feed of plant and animal origin ( OG RS, No. 2 5 / 2 0 1 0 ) Maxim um levels for Contam inants ( Partly in line with Regulation (EC) No 1881/ 2006 ) Regulation on the quantities of pesticide, metals, metalloids and other toxic substances, drugs, anabolic and other substances that could be found in foods ( OG SFRY No. 5 / 9 2 , am end. 1 1 / 9 2 and 3 2 / 0 2 ) . MRL for veteri n ary m edicines in foodstuffs of anim al origin ( Not in line with Regulation (EC) 37/ 2010 ) Regulation on the quantities of pesticide, metals, metalloids and other toxic substances, drugs, anabolic and other substances that could be found in foods 5 ( OG SFRY No. 5 / 9 2 , am end. 1 1 / 9 2 and 3 2 / 0 2 ) . Rezidue control in Serbia & MRLs
Related regulations Related regulations Medicated feedingstuffs and additives ( Not in line with Council Directive 90/ 167/ EEC ) Regulation on quality and other requirements for animal feed ( OG SRY No. 2 0 / 2 0 0 0 , am end. OG SRY No. 3 8 / 2 0 0 1 ) Regulation on the maximum levels of harmful substances and compounds in animal feedingstuffs ( OG SFRY No. 2 / 9 0 ) 6 Rezidue control in Serbia & MRLs
Responsibility Responsibility Chief Veterinary Officer/ Veterinary Directorate ( Departm ent of Veterinary Public Health ) within the Ministry of Agriculture, Forestry and Water Management is the CCA for the National Residue Control Plan in Serbia Medicines and Medical Devices Agency (ALIMS) is the Competent Authority for Veterinary Medicines Controls I nstitute of Meat Hygiene and Technology (IMHT) is the only one laboratory currently being employed by Veterinary Directorate for laboratory analysis of samples within the National Residues Monitoring Plan (NRMP) 7 Rezidue control in Serbia & MRLs
W ho is involved in planning? W ho is involved in planning? Institute of Meat Veterinary Public Hygiene and Tech. Health Dept. – Planning – WG Meetings Vet.Inspection Medicines and Medical Devices Agency-ALIMS Experts 8 Rezidue control in Serbia & MRLs
Statutory Surveillance for Veterinary Residues Statutory Surveillance for Veterinary Residues Regulation OG RS, No. 9 1 / 2 0 0 9 (Dir. 96/ 23/ EC) set out the groups of veterinary residues that Member States/ Third Countries are obliged to look for: Group A: Group B: • antimicrobials • stilbenes • coccidiostats • thyrostats • anthelmintic agents • steroids • carbamates and pyrethroids • zeranol • NSAIDs • beta agonists • organochlorines and PCBs • prohibited substances • organophosphates • heavy metals • mycotoxins • dyes (including malachite green)) 9 Rezidue control in Serbia and MRLs
SERBI A - - REZI DUE REZI DUE MONI TORI NG PROGRAMME MONI TORI NG PROGRAMME SERBI A 2 0 0 6 / 2 0 1 0 / 2 0 1 0 2 0 0 6 EU APPROVED Bovine Decision 2004/ 432/ EC Ovine/Caprine on the approval of Swine residue monitoring plans Equine (Live) submitted by third countries in accordance with Poultry Council Directive 96/ 23/ EC Aquaculture Milk LAST AMENDED Eggs Rabbit Commission Decision Wild game 327/ 2010/ EC Farmed game Honey 10 Rezidue control in Serbia & MRLs
I m plem entation I m plem entation In general, the NRMP is broken down on the basis of number of establishments and their production data. (No. of slaughtered animals; Production quantity) Based on the approved NRMP, DVPH issues weekly orders for sampling to the Regional Veterinary Inspectors ( RVI s ), who then forward orders to local inspection level – Local Veterinary Inspectors ( LVI s ) Establishments who have had non-compliant results under official residue testing program in current year are included in NRMP for the next year! 11 Rezidue control in Serbia & MRLs
Procedure follow ed in Serbia Serbia for identifying for identifying Procedure follow ed in risks: risks: On the basis of the m onitoring results, the m ain risks are defined as : Illegal use of chloramphenicol, Cross-contamination of feed for laying-hens with coccidiostats, Disrespect withdrawal period during treatment of broilers with coccidiostats, Antibiotics in muscle tissue - quinolones, Suspicion if animals are treated against certain diseases, e.g. salmonellosis Chemical elements/ heavy metals (mainly cadmium) in offals of wild game and horses for slaughter. 12 Rezidue control in Serbia & MRLs
I m plem entation I m plem entation The follow ing criteria have been used for selection of substances to be tested: Authorized veterinary medicines in Serbia (Group B), Available information on certain veterinary medicines used in practice, Available relevant data on veterinary medicines from the market, Available information on potential misuse of veterinary medicines, Available information from EMEA, EFSA and RASFF sites. 13 Rezidue control in Serbia and MRLs
I m plem entation I m plem entation Trainings: Regular trainings and educational sem inars are organized for official veterinarians ( veterinary inspectors) by the Veterinary Directorate and through different internationally funded Projects/ Program m es. 14 Rezidue control in Serbia & MRLs
NATIONAL REZIDUE MONITORING PROGRAMME Veterinary Law Production OGRS 91/05,30/10 • Farms Reg. residue • Est-s monitoring OGRS 91/09 Dept. for Instruction VD April 2010. VPH • List of VMP (B) • VMP used in practice Residue Written • Data on VMP – Market Monitoring Order • Data on VMP misuse Plan • EMEA, EFSA, RASFF • History of results Vet Insp: Reg/Local Report Sampling Ref. Lab. Request &Transport Lab Testing Report 15 Rezidue control in Serbia & MRLs
FVO OVERALL CONCLUSION (Nov 2009) “The system of residues controls in Serbia offers guarantees w ith an effect equivalent to those provided for by Com m unity rules. This is supported by the high rate of com pliant results in the national residue control plan”!
CHALLENGES ! CHALLENGES Further transposition of EU legislation, Upgrading of planning process, Upgrading of procedure followed for identifying (main) risks, Implementation of principle – FBOs self-monitoring of residues, Upgrading of communication/ exchange data between different CA, Continuous Training programs for vet inspectors, Outsourcing of residue testing to foreign laboratories, Monitoring of feedingstuffs, Establishing of all relevant MRLs! 17 Rezidue control in Serbia & MRLs
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