Regulation on the monitoring of zoonoses and zoonotic agents

Opozorilo: Besedilo osnovnega predpisa Disclaimer: All of the translations contained on this website are unofficial. Only the original Slovene texts of the laws and regulations have legal effect, and the translations are to be used solely as reference materials to aid in the understanding of Slovene laws and regulations. The Government of the Republic of Slovenia is not responsible for the accuracy, reliability or currency of the translations provided on this website, or for any consequence resulting from the use of information on this website. For all purposes of interpreting and applying law to any legal issue or dispute, users should consult the original Slovene texts published in the Official Gazette of the Republic of Slovenia. Na podlagi četrtega, sedmega in osmega odstavka 56. člena Zakona o veterinarskih merilih skladnosti (Uradni list RS, št. 93/05, 90/12 – ZdZPVHVVR in 23/13 – ZZZiv-C) ter drugega odstavka 6. člena Zakona o nalezljivih boleznih (Uradni list RS, št. 33/06 – uradno prečiščeno besedilo) izdajata minister za kmetijstvo in okolje ter minister za zdravje Pursuant to paragraphs four, seven and eight of Article 56 of the Veterinary Compliance Criteria Act (Official Gazette of the Republic of Slovenia [Uradni list RS], Nos 93/05, 90/12 – ZdZPVHVVR and 23/13 – ZZZiv-C) and paragraph two of Article 6 of the Contagious Diseases Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 33/06 – official consolidated text), the Minister of Agriculture and the Environment and the Minister of Health issue the following P R A V I L N I K R U L E S o monitoringu zoonoz in povzročiteljev zoonoz on the monitoring of zoonoses and zoonotic agents 1. člen Article 1 (vsebina) (Subject) Ta pravilnik v skladu z Direktivo 2003/99/ES Evropskega parlamenta in Sveta z dne 17. novembra 2003 o spremljanju zoonoz in povzročiteljev zoonoz, ki spreminja Odločbo Sveta 90/424/EGS in razveljavlja Direktivo Sveta 92/117/EGS (UL L št. 325 z dne 12. 12. 2003, str. 31), zadnjič spremenjeno z Direktivo Sveta 2013/20/EU z dne 13. maja 2013 o prilagoditvi določenih direktiv na področju varnosti živil, veterinarske in fitosanitarne politike zaradi pristopa Republike Hrvaške (UL L št. 158 z dne 10. 6. 2013, str. 234), (v nadaljnjem besedilu: Direktiva 2003/99/ES) ureja natančnejšo vsebino skupnega programa monitoringa zoonoz. These Rules regulate the detailed content of the joint zoonoses monitoring programme in accordance with Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325, 12. 12. 2003, p. 31) as last amended by Council Directive 2013/20/EU of 13 May 2013 adapting certain directives in the field of food safety, veterinary and phytosanitary policy, by reason of the accession of the Republic of Croatia (OJ L 158, 10. 6. 2013, p. 234) (hereinafter: Directive 2003/99/EC). 2. člen Article 2 (pomen izrazov) (Definitions) (1) Izrazi, uporabljeni v tem pravilniku, imajo naslednji pomen: (1) For the purposes of these Rules, the following definitions shall apply: 1. izbruh ali epidemija okužbe z živili (v nadaljnjem besedilu: izbruh alimentarne infekcije) je pojav dveh ali več primerov iste bolezni ali okužbe pri ljudeh ali stanje, v katerem število primerov presega pričakovano število in pri katerem so primeri vezani ali verjetno vezani na isti vir živila; 1. an outbreak or epidemic of food-borne infection (hereinafter: food borne outbreak) shall mean an incidence of two or more cases of the same disease or infection in humans or a situation in which the number of cases exceeds the expected number where the cases are linked or are probably linked to the same food source; 2. monitoring je sistem zbiranja, spremljanja, analiziranja in posredovanja podatkov o pojavu zoonoz, njihovih povzročiteljev in s tem povezane odpornosti proti protimikrobnim zdravilom; 2. monitoring shall mean a system of collecting, monitoring, analysing and disseminating data on the occurrence of zoonoses, zoonotic agents and antimicrobial resistance related thereto; 3. odpornost proti protimikrobnim zdravilom je sposobnost mikrobov določene vrste, da preživijo ali se celo razmnožujejo v prisotnosti dane koncentracije protimikrobnega zdravila, ki običajno zadošča, da inhibira ali ubije mikrobe te vrste; 3. antimicrobial resistance shall mean the ability of micro-organisms of a certain species to survive or even reproduce in the presence of a given concentration of an antimicrobial agent that is usually sufficient to inhibit or kill micro-organisms of the same species; 4. povzročitelj zoonoze je virus, bakterija, gliva, parazit ali druga biološka enota, za katero je verjetno, da povzroča zoonozo; 4. a zoonotic agent shall mean any virus, bacterium, fungus, parasite or other biological entity likely to cause a zoonosis; 5. zoonoza je bolezen oziroma okužba, ki se naravno neposredno ali posredno prenaša med živalmi in ljudmi. 5. a zoonosis shall mean any disease or infection naturally transmissible directly or indirectly between animals and humans. (2) Drugi izrazi, uporabljeni v tem pravilniku, imajo enak pomen kot ga določa Uredba (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane (UL L št. 31 z dne 1. 2. 2002, str. 1), zadnjič spremenjena z Uredbo (ES) št. 596/2009 Evropskega parlamenta in Sveta z dne 18. junija 2009 o prilagoditvi nekaterih aktov, za katere se uporablja postopek iz člena 251 Pogodbe, Sklepu Sveta 1999/468/ES glede regulativnega postopka s pregledom – Prilagoditev regulativnemu postopku s pregledom – Četrti del (UL L št. 188 z dne 18. 7. 2009, str. 14), (v nadaljnjem besedilu: Uredba 178/2002/ES). (2) Other terms used in these Rules shall have the same meaning as specified in 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 (OJ L 31, 1. 2. 2002, p. 1), as last amended by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Four (OJ L 188, 18. 7. 2009, p. 14) (hereinafter: Regulation 178/2002/EC). 3. člen Article 3 (priprava programa monitoringa zoonoz) (Drawing up a zoonoses monitoring programme) (1) Uprava Republike Slovenije za varno hrano, veterinarstvo in varstvo rastlin (v nadaljnjem besedilu: Uprava), Zdravstveni inšpektorat Republike Slovenije (v nadaljnjem besedilu: ZIRS) in Nacionalni inštitut za javno zdravje (v nadaljnjem besedilu: NIJZ), v okviru svojih pristojnosti in v skladu s predpisi, ki urejajo veterinarstvo, zdravstveno dejavnost, zbirke podatkov s področja zdravstvenega varstva, nalezljive bolezni in varnost živil, pripravijo skupni letni program monitoringa zoonoz in njihovih povzročiteljev (v nadaljnjem besedilu: program monitoringa zoonoz), in sicer: (1) The Administration of the Republic of Slovenia for Food Safety, Veterinary and Plant Protection (hereinafter: Administration), the Health Inspectorate of the Republic of Slovenia (hereinafter: HIRS) and the National Institute of Public Health (hereinafter: NIPH), within their respective competences and in accordance with the regulations governing veterinary medicine, health care, databases relating to health care, infectious diseases and food safety, shall draw up a joint annual programme for the monitoring of zoonoses and zoonotic agents (hereinafter: zoonoses monitoring programme), as follows: Uprava v delu, ki se nanaša na živali, krmo in živila, razen živil iz druge alinee tega odstavka, the Administration, in the part relating to animals, feed and food, except the food referred to in indent two of this paragraph, ZIRS v delu, ki se nanaša na prehranska dopolnila, živila za posebne prehranske oziroma zdravstvene namene ter pitno vodo, the HIRS, in the part relating to food supplements, food for specific nutritional or health purposes and drinking water, NIJZ v delu, ki se nanaša na ljudi. - the NIPH, in the part relating to humans. (2) Pri pripravi programa monitoringa zoonoz sodelujeta Nacionalni veterinarski inštitut Veterinarske fakultete Univerze v Ljubljani (v nadaljnjem besedilu: NVI) in Nacionalni laboratorij za zdravje, okolje in hrano (v nadaljnjem besedilu: NLZOH). (2) The drawing up of a zoonoses monitoring programme shall be carried out through cooperation between the National Veterinary Institute of the Veterinary Faculty, University of Ljubljana (hereinafter: NVI) and the National Laboratory of Health, Environment and Food (hereinafter: NLHEF). (3) Če podatki, zbrani s programi monitoringa zoonoz držav članic Evropske unije, ne zadostujejo za oceno tveganja in Evropska komisija predpiše usklajen program monitoringa za celotno Evropsko unijo, ga za Republiko Slovenijo pripravijo Uprava, ZIRS in NIJZ v okviru svojih pristojnosti ter ob sodelovanju NVI in NLZOH. (3) If the data collected through the zoonoses monitoring programmes of EU Member States are not sufficient for risk assessment and the European Commission prescribes a coordinated monitoring programme for the entire European Union, such programme shall be drawn up for the Republic of Slovenia by the Administration, the HIRS and the NIPH, within their respective competences, in cooperation with the NVI and the NLHEF. (4) Koordinacijo pri pripravi programa monitoringa zoonoz izvaja Uprava, ki je obenem tudi kontaktna točka za sodelovanje z Evropsko komisijo. (4) Coordination of the drawing up of a zoonoses monitoring programme shall be carried out by the Administration, which shall also serve as the contact point for cooperation with the European Commission. 4. člen Article 4 (program monitoringa zoonoz) (Zoonoses monitoring programme) (1) Na podlagi programa monitoringa zoonoz Uprava, NVI, ZIRS, NIJZ in NLZOH v okviru svojih pristojnosti zagotavljajo zbiranje primerljivih podatkov, ki omogočajo opredelitev in oceno nevarnosti, (1) Based on a zoonoses monitoring programme, the Administration, the NVI, the HIRS, the NIPH and the NLHEF shall, within their respective competences, carry out the collection of comparable data izpostavljenosti in tveganja, povezanih z zoonozami in njihovimi povzročitelji. that enable the identification and assessment of threats, exposure and risks related to zoonoses and zoonotic agents. (2) Program monitoringa zoonoz zajema vse faze v živilski verigi, pri čemer mora potekati v tisti fazi ali fazah, kjer se lahko pridobi največ ustreznih podatkov glede določene zoonoze ali njenega povzročitelja. Monitoring tako poteka v primarni proizvodnji oziroma v drugih fazah živilske verige, vključno z živili in krmo. (2) A zoonoses monitoring programme shall comprise all stages of the food chain. It must be carried out at the stage or stages where the greatest quantity of relevant data as regards certain zoonoses or their agents can be obtained. Thus, the monitoring shall be carried out in primary production or other stages of the food chain, including food and feed. (3) V program monitoringa zoonoz se vključujejo tudi nosilci živilske dejavnosti, kadar je tako določeno s predpisi s področja posameznih zoonoz in povzročiteljev teh zoonoz. Nosilci živilske dejavnosti morajo na zahtevo Uprave oziroma ZIRS, glede na pristojnosti iz prvega odstavka prejšnjega člena, sporočiti rezultate ter shraniti in posredovati izolate, če se preiskave ne opravljajo v laboratoriju, imenovanem v skladu z 12. členom Uredbe (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali (UL L št. 165 z dne 30. 4. 2004, str. 1), zadnjič spremenjene z Uredbo Sveta (EU) št. 517/2013 z dne 13. maja 2013 o prilagoditvi nekaterih uredb ter odločb in sklepov na področjih prostega pretoka blaga, prostega gibanja oseb, prava družb, politike konkurence, kmetijstva, varnosti hrane, veterinarske in fitosanitarne politike, prometne politike, energetike, obdavčitve, statistike, vseevropskih omrežij, pravosodja in temeljnih pravic, pravice, svobode in varnosti, okolja, carinske unije, zunanjih odnosov, zunanje, varnostne in obrambne politike ter institucij zaradi pristopa Republike Hrvaške (UL L št. 158 z dne 10. 6. 2013, str. 1), (v nadaljnjem besedilu: Uredba 882/2004/ES). Izolati se posredujejo v laboratorij, ki ga izmed imenovanih laboratorijev določi Uprava oziroma ZIRS glede na pristojnost iz prvega odstavka prejšnjega člena. (3) A zoonoses monitoring programme shall also include food business operators when so provided by regulations in the field of individual zoonoses and their agents. Food business operators must, at the request of the Administration or the HIRS, with regard to the competences referred to in paragraph one of the preceding Article, report the results as well as store and transfer isolates when examinations are not conducted in a laboratory designated in accordance with Article 12 of 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 (OJ L 165, 30. 4. 2004, p. 1) as last amended by Council Regulation (EU) No 517/2013 of 13 May 2013 adapting certain regulations and decisions in the fields of free movement of goods, freedom of movement for persons, company law, competition policy, agriculture, food safety, veterinary and phytosanitary policy, transport policy, energy, taxation, statistics, trans-European networks, judiciary and fundamental rights, justice, freedom and security, environment, customs union, external relations, foreign, security and defence policy and institutions, by reason of the accession of the Republic of Croatia (OJ L 158, 10. 6. 2013, p. 1 (hereinafter: Regulation 882/2004/EC). The isolates shall be transferred to the laboratory selected from among the designated laboratories by the Administration or the HIRS with regard to the competences referred to in paragraph one of the preceding Article. (4) Program monitoringa zoonoz zajema zoonoze in njihove povzročitelje iz točke A. Priloge I Direktive 2003/99/ES. Na podlagi ocene epidemiološkega stanja pri ljudeh, živalih, živilih oziroma krmi se v program monitoringa zoonoz vključijo tudi posamezne zoonoze iz točke B. Priloge I Direktive 2003/99/ES. (4) A zoonoses monitoring programme shall include zoonoses and zoonotic agents under point A, Annex I to Directive 2003/99/EC. Based on the assessment of the epidemiological situation with regard to humans, animals, food and/or feed, individual zoonoses under point B, Annex I to Directive 2003/99/EC shall also be included in the zoonoses monitoring programme. 5. člen Article 5 (dolžnosti uradnih laboratorijev) (Obligations of official laboratories) Uradni laboratoriji, imenovani v skladu z 12. členom Uredbe 882/2004/ES, so dolžni hraniti izolate povzročiteljev zoonoz v skladu s programom monitoringa zoonoz. Official laboratories designated in accordance with Article 12 of Regulation 882/2004/EC shall be obliged to keep isolates of zoonotic agents pursuant to the zoonoses monitoring programme. 6. člen Article 6 (spremljanje odpornosti proti protimikrobnim zdravilom) (Monitoring of antimicrobial resistance) Program monitoringa zoonoz mora vsebovati tudi spremljanje odpornosti proti protimikrobnim zdravilom v skladu z zahtevami iz Priloge II Direktive 2003/99/ES in predstavlja dopolnitev spremljanja odpornosti izolatov proti protimikrobnim zdravilom, ki se izvaja v skladu s Sklepom št. 1082/2013/EU Evropskega parlamenta in Sveta z dne 22. oktobra 2013 o resnih čezmejnih nevarnostih za zdravje in o razveljavitvi Odločbe št. 2119/98/ES (UL L št. 293 z dne 5. 11. 2013, str. 1). A zoonoses monitoring programme must also include the monitoring of antimicrobial resistance in accordance with the requirements set out in Annex II to Directive 2003/99/EC and represents a supplement to the monitoring of the antimicrobial resistance of isolates carried out in accordance with Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5. 11. 2013, p. 1). 7. člen Article 7 (izbruh alimentarne infekcije) (Outbreaks of food-borne infections) (1) Program monitoringa zoonoz mora vsebovati tudi podatke o epidemioloških preiskavah izbruhov alimentarnih infekcij. (1) A zoonoses monitoring programme must also contain data on epidemiological examinations of food-borne infection outbreaks. (2) Če nosilec živilske dejavnosti ugotovi ali utemeljeno sumi, da bi lahko živilo škodljivo vplivalo na zdravje ljudi, mora obvestiti organ, pristojen za uradni nadzor glede na vrsto živila v skladu s prvim odstavkom 3. člena tega pravilnika, in zagotoviti hranjenje živila ali primernega vzorca tega živila do odločitve tega organa o nadaljnjih ukrepih. Če je to živilo že dano na trg in je lahko vzrok za izbruh alimentarne infekcije, organ iz tega odstavka obvesti NIJZ. (2) If a food business operator establishes or reasonably suspects that a food could adversely affect human health, it must notify a body responsible for official control with regard to the type of food in accordance with paragraph one of Article 3 of these Rules, and ensure the storage of such food or a suitable sample thereof until the body issues a decision on further measures. If such food has already been placed on the market and may cause food-borne infection, the body referred to in this paragraph shall notify the NIPH. (3) NIJZ v primeru izbruha alimentarne infekcije izvede epidemiološko preiskavo v skladu z zakonom, ki ureja nalezljive bolezni, in veljavno strokovno doktrino. O rezultatih epidemiološke preiskave NIJZ (3) In the event of a food-borne infection outbreak, the NIPH shall conduct an epidemiological examination pursuant to the Act regulating infectious diseases and the valid professional doctrine. With obvesti Upravo oziroma ZIRS glede na vrsto živila v skladu s prvim odstavkom 3. člena tega pravilnika. regard to the type of food, the NIPH shall notify the Administration or the HIRS of the results of the epidemiological examination pursuant to paragraph one of Article 3 of these Rules. (4) Nosilec živilske dejavnosti mora omogočiti odvzem vzorcev živil, za katere se sumi, da so vzrok za izbruh alimentarne infekcije. Za potrebe epidemiološke preiskave se lahko uporabijo tudi rezultati analiz vzorcev uradnega nadzora. (4) A food business operator must enable the taking of samples of food suspected of causing an outbreak of food-borne infection. For the purposes of an epidemiological examination, the results of an analyses conducted during an official control may be used. 8. člen Article 8 (izmenjava podatkov) (Data exchange) (1) V programu monitoringa zoonoz se določi način izmenjave zbranih podatkov monitoringa zoonoz in povzročiteljev zoonoz ter izvajanja epidemioloških preiskav med Upravo, ZIRS, NIJZ in NLZOH. (1) A zoonoses monitoring programme shall determine the manner of exchanging data collected within the programme foe the monitoring of zoonoses and zoonotic agents and during epidemiological examinations between the Administration, the HIRS, the NIPH and the NLHEF. (2) Uradni in drugi laboratoriji, ki opravljajo analize vzorcev nosilcev živilske dejavnosti, morajo o nenavadnem pojavu povzročiteljev (neobičajno število, virulenca, odpornost proti protimikrobnim zdravilom), ki ima lahko posledice za javno zdravje, takoj obvestiti Upravo, ZIRS oziroma NIJZ, glede na njihove pristojnosti iz prvega odstavka 3. člena tega pravilnika, oziroma so jim v takih primerih dolžni posredovati zahtevane podatke. Pristojni organ oziroma organizacija iz tega odstavka podatke preveri in jih oceni. Uprava, ZIRS in NIJZ se morajo o primerih iz tega odstavka medsebojno obveščati. (2) Official and other laboratories conducting analyses of samples of food from business operators shall immediately notify the Administration, the HIRS or NIPH, in accordance with their respective competences referred to in paragraph one of Article 3 of these Rules, of any unusual occurrence of agents (an unusual number, virulence, antimicrobial resistance) with potential consequences for public health and shall be obliged to provide requested data in such cases. The competent body or organisation referred to in this paragraph shall verify and assess the data. The Administration, the HIRS and NIPH shall notify each another of the cases referred to in this paragraph. 9. člen Article 9 (poročanje) (Reporting) (1) Uprava, NVI, ZIRS, NIJZ in NLZOH za preteklo leto izdelajo ocene trendov in virov zoonoz, njihovih povzročiteljev in odpornosti proti protimikrobnim zdravilom ter sodelujejo pri pripravi poročila, vsak v skladu s svojimi pristojnostmi. Uprava pošlje poročilo o trendih in virih zoonoz, skupaj s podatki, zbranimi na podlagi 4., 6. in 7. člena tega pravilnika, za preteklo leto do konca maja Evropski komisiji. Poročilo o trendih in virih zoonoz mora vsebovati podatke, navedene v Prilogi IV Direktive (1) The Administration, the NVI, the HIRS, the NIPH and the NLHEF, each in accordance with their respective competences, shall draw up assessments of trends, sources of zoonoses and zoonotic agents and antimicrobial resistance for the previous year and participate in the drawing up of a report. By the end of May, the Administration shall send the report on trends and sources of zoonoses for the previous year, along with the data collected pursuant to Articles 4, 6 and 7 of these 2003/99/ES. Rules, to the European Commission. The report on trends and sources of zoonoses must contain the data listed in Annex IV to Directive 2003/99/EC. (2) Poročilo mora poleg zoonoz in njihovih povzročiteljev iz Priloge I Direktive 2003/99/ES vsebovati tudi podatke, zbrane na podlagi točke (b) drugega odstavka 3. člena Uredbe (ES) št. 2160/2003 Evropskega parlamenta in Sveta z dne 17. novembra 2003 o nadzoru salmonele in drugih opredeljenih povzročiteljev zoonoz, ki se prenašajo z živili (UL L št. 325 z dne 12. 12. 2003, str. 1), zadnjič spremenjene z Uredbo Sveta (EU) št. 517/2013 z dne 13. maja 2013 o prilagoditvi nekaterih uredb ter odločb in sklepov na področjih prostega pretoka blaga, prostega gibanja oseb, prava družb, politike konkurence, kmetijstva, varnosti hrane, veterinarske in fitosanitarne politike, prometne politike, energetike, obdavčitve, statistike, vseevropskih omrežij, pravosodja in temeljnih pravic, pravice, svobode in varnosti, okolja, carinske unije, zunanjih odnosov, zunanje, varnostne in obrambne politike ter institucij zaradi pristopa Republike Hrvaške (UL L št. 158 z dne 10. 6. 2013, str. 1). (2) In addition to the zoonoses and zoonotic agents referred to in Annex I to Directive 2003/99/EC, the report must also contain the data collected pursuant to point (b) paragraph two of Article 3 of Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food borne zoonotic agents (OJ L 325, 12. 12. 2003, p. 1) as last amended by Council Regulation (EU) No 517/2013 of 13 May 2013 adapting certain regulations and decisions in the fields of free movement of goods, freedom of movement for persons, company law, competition policy, agriculture, food safety, veterinary and phytosanitary policy, transport policy, energy, taxation, statistics, trans-European networks, judiciary and fundamental rights, justice, freedom and security, environment, customs union, external relations, foreign, security and defence policy and institutions, by reason of the accession of the Republic of Croatia (OJ L 158, 10. 6. 2013, p. 1). (3) Koordinacijo pri pripravi poročila iz prvega odstavka tega člena izvaja Uprava. (3) Coordination of the drawing up of the report referred to in paragraph one of this Article shall be carried out by the Administration. (4) Uprava na lastno pobudo ali na zahtevo Evropske komisije predloži Evropski komisiji dodatne podatke s področja monitoringa zoonoz. (4) On its own initiative or at the request of the European Commission, the Administration shall submit to the European Commission additional data relating to zoonoses monitoring. (5) Na podlagi poročila iz prvega odstavka tega člena Uprava do konca leta za preteklo leto pripravi Letno nacionalno poročilo o zoonozah in povzročiteljih zoonoz v skladu s 7. členom Uredbe 882/2004/ES. (5) Based on the report referred to in paragraph one of this Article, the Administration shall draw up the Annual national report on zoonoses and zoonotic agents pursuant to Article 7 of Regulation 882/2004/EC by the end of each year for the previous year. 10. člen Article 10 (prenehanje veljavnosti) (End of validity) Z dnem uveljavitve tega pravilnika preneha veljati Pravilnik o monitoringu zoonoz in povzročiteljev zoonoz (Uradni list RS, št. 67/04). On the day these Rules enter into force, the Rules on the monitoring of zoonoses and zoonotic agents (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 67/04) shall cease to be in force. 11. člen Article 11 (začetek veljavnosti) (Entry into force) Ta pravilnik začne veljati 1. januarja 2014. These Rules shall enter into force on 1 January 2014. Št. 007-212/2012 No. 007-212/2012 Ljubljana, dne 13. decembra 2013 Ljubljana, 13 December 2013 EVA 2012-2330-0170 EVA 2012-2330-0170 mag. Dejan Židan l.r. Mag. Dejan Židan m.p. Minister Minister za kmetijstvo in okolje of Agriculture and the Environment v funkciji ministra za zdravje in the capacity of the Minister of Health Karl Erjavec l.r. Karl Erjavec m.p. Minister Minister