natgillin/translations-raw huggingface dataset:
Modifications of MRLs following revocation of authorisations of plant protection products
Spremembe MVO zaradi preklica registracije fitofarmacevtskih sredstev
Amendments to Annexes II or III needed to delete an MRL following the revocation of an existing authorisation for a plant protection product may be adopted without seeking the opinion of the Authority.
Spremembe Priloge II ali III, potrebne zaradi izbrisa MVO zaradi preklica obstoječe registracije fitofarmacevtskega sredstva, se lahko sprejmejo brez pridobitve mnenja agencije.
MRLS APPLICABLE TO PRODUCTS OF PLANT AND ANIMAL ORIGIN
MVO, KI SE UPORABLJAJO ZA PROIZVODE RASTLINSKEGA IN ŽIVALSKEGA IZVORA
Compliance with MRLs
Skladnost z MVO
The products covered by Annex I shall not contain, from the time they are placed on the market as food or feed, or fed to animals, any pesticide residue exceeding:
Proizvodi iz Priloge I od trenutka, ko so dani na trg kot hrana ali krma ali se z njimi krmi živali, ne vsebujejo nobenih ostankov pesticidov, ki presegajo:
the MRLs for those products set out in Annexes II and III;
MVO za te proizvode, določene v prilogah II in III;
0,01 mg/kg for those products for which no specific MRL is set out in Annexes II or III, or for active substances not listed in Annex IV unless different default values are fixed for an active substance in accordance with the procedure referred to in Article 45(2) while taking into account the routine analytical methods available.
0,01 mg/kg za proizvode, za katere v Prilogi II ali III ni določena posebna MVO, ali za aktivne snovi, ki niso navedene v Prilogi IV, razen če so v skladu s postopkom iz člena 45(2) za neko aktivno snov ob upoštevanju razpoložljivih rutinskih analiznih metod določene drugačne privzete vrednosti.
Such default values shall be listed in Annex V.
Te privzete vrednosti so določene v Prilogi V.
Member States may not prohibit or impede the placing on the market or the feeding to food-producing animals within their territories of the products covered by Annex I on the grounds that they contain pesticide residues provided that:
Države članice na svojem ozemlju ne smejo prepovedati ali ovirati dajanja v promet proizvodov iz Priloge I ali krmljenja živali, namenjenih prehrani, s temi proizvodi zaradi njihove vsebnosti ostankov pesticidov, pod pogojem, da:
such products comply with paragraph 1 and Article 20; or
so ti proizvodi skladni z odstavkom 1 in členom 20; ali
the active substance is listed in Annex IV.
je aktivna snov navedena v Prilogi IV.
By way of derogation from paragraph 1, Member States may authorise, further to a post-harvest treatment with a fumigant on their own territory, residue levels for an active substance which exceed the limits specified in Annexes II and III for a product covered by Annex I where the active substance/product combinations are listed in Annex VII provided that:
Z odstopanjem od odstavka 1 lahko država članica na svojem ozemlju dovoli pri tretiranju po pobiranju pridelka s fumigantom vrednosti ostankov aktivnih snovi, ki presegajo meje, določene v prilogah II in III za proizvode iz Priloge I, če so te kombinacije aktivna snov/proizvod navedene v Prilogi VII, pod pogojem, da:
such products are not intended for immediate consumption;
ti proizvodi niso namenjeni takojšnji uporabi;
appropriate controls are in place to ensure that such products cannot be made available to the end user or consumer, if they are supplied directly to the latter, until the residues no longer exceed the maximum levels specified in Annexes II or III;
obstaja primeren nadzor, ki zagotavlja, da taki proizvodi ne morejo biti dostopni končnemu porabniku ali potrošniku, če so mu dobavljeni neposredno, vse dokler ostanki presegajo mejne vrednosti, določene v Prilogi II ali III;
the other Member States and the Commission have been informed of the measures taken.
druge države članice in Komisija so bile obveščene o sprejetih ukrepih.
The active substance/product combinations listed in Annex VII shall be defined in accordance with the procedure referred to in Article 45(2).
Kombinacije aktivna snov/proizvod iz Priloge VII se opredelijo v skladu s postopkom iz člena 45(2).
In exceptional circumstances, and in particular further to the use of plant protection products in accordance with Article 8(4) of Directive 91/414/EEC or in pursuance of obligations in Directive 2000/29/EC, a Member State may authorise the placing on the market and/or the feeding to animals within its territory of treated food or feed not complying with paragraph 1, provided that such food or feed does not constitute an unacceptable risk.
V izjemnih okoliščinah in predvsem pri uporabi fitofarmacevtskih sredstev v skladu s členom 8(4) Direktive 91/414/EGS ali pri uresničevanju obveznosti iz Direktive 2000/29/ES lahko država članica dovoli dajanje v promet in/ali krmljenje živali na svojem ozemlju s tretirano hrano ali krmo, ki ni skladna z določbami odstavka 1, pod pogojem, da taka hrana ali krma ne predstavlja nesprejemljivega tveganja.
Such authorisations shall immediately be notified to the other Member States, the Commission and the Authority, together with an appropriate risk assessment for consideration without undue delay in accordance with the procedure referred to in Article 45(2), with a view to setting a temporary MRL for a specified period or taking any other necessary measure in relation to such products.
O teh dovoljenjih se nemudoma uradno obvesti druge države članice, Komisijo in agencijo, vključno z ustrezno oceno tveganja, ki se brez nepotrebnega odlašanja obravnava v skladu s postopkom iz člena 45(2), da bi se določilo začasno MVO za določeno obdobje ali sprejelo kateri koli drug potreben ukrep v zvezi s temi proizvodi.
Prohibition concerning processed and/or composite products
Prepoved glede predelanih in/ali sestavljenih proizvodov
The processing, and/or mixing for dilution purposes with the same or other products, of the products covered by Annex I not complying with Articles 18(1) or 20 with a view to placing them on the market as food or feed or feeding them to animals shall be prohibited.
Proizvode iz Priloge I, ki niso skladni s členom 18(1) ali 20, je prepovedano predelovati in/ali mešati za namene razredčenja z istimi ali drugimi proizvodi, z namenom dati jih na trg kot hrano ali krmo ali z njimi krmiti živali.
MRLs applicable to processed and/or composite products
MVO, ki se uporabljajo za predelane in/ali sestavljene proizvode
Where MRLs are not set out in Annexes II or III for processed and/or composite food or feed, the MRLs applicable shall be those provided in Article 18(1) for the relevant product covered by Annex I, taking into account changes in the levels of pesticide residues caused by processing and/or mixing.
Če MVO niso določene v Prilogi II ali III za predelano in/ali sestavljeno hrano ali krmo, se uporabljajo MVO, navedene v členu 18(1) za ustrezne proizvode iz Priloge I, ob upoštevanju sprememb v vrednostih ostankov pesticidov, ki jih povzročijo predelava in/ali mešanje.
Specific concentration or dilution factors for certain processing and/or mixing operations or for certain processed and/or composite products may be included in the list in Annex VI in accordance with the procedure referred to in Article 45(2).
V seznam iz Priloge VI se lahko vključijo v skladu s postopkom iz člena 45(2) posebni faktorji koncentracije ali redčenja za določene operacije predelave in/ali mešanja ali za določene predelane in/ali sestavljene proizvode.
SPECIAL PROVISIONS RELATING TO THE INCORPORATION OF EXISTING MRLS INTO THIS REGULATION
POSEBNE DOLOČBE GLEDE PREVZEMA OBSTOJEČIH MVO V TO UREDBO
First establishment of MRLs
Prva določitev MVO
MRLs for products covered by Annex I shall be first established and listed in Annex II in accordance with the procedure referred to in Article 45(2), incorporating the MRLs provided for under Directives 86/362/EEC, 86/363/EEC and 90/642/EEC, taking into account the criteria mentioned in Article 14(2) of this Regulation.
MVO za proizvode iz Priloge I se prvič določijo in navedejo v Prilogi II v skladu s postopkom iz člena 45(2) s prevzemom MVO, ki so določene z direktivami 86/362/EGS, 86/363/EGS in 90/642/EGS, in ob upoštevanju meril, omenjenih v členu 14(2) te uredbe.
Annex II shall be established within 12 months from the entry into force of this Regulation.
Priloga II se sestavi v roku dvanajstih mesecev od začetka veljavnosti te uredbe.
First establishment of temporary MRLs
Prva določitev začasnih MVO
Temporary MRLs for active substances for which a decision on inclusion or non-inclusion in Annex I to Directive 91/414/EEC has not yet been taken shall be first established and listed in Annex III to this Regulation, unless already listed in Annex II hereto, in accordance with the procedure referred to in Article 45(2), taking into account the information provided by the Member States, where relevant the reasoned opinion mentioned in Article 24, the factors referred to in Article 14(2) and the following MRLs:
Začasne MVO za aktivne snovi, glede katerih odločitev o vključitvi ali nevključitvi v Prilogo I k Direktivi 91/414/EGS še ni bila sprejeta, se prvič določijo in navedejo v Prilogi III k tej uredbi v skladu s postopkom iz člena 45(2), razen če so že bile navedene v Prilogi II k tej uredbi, ob upoštevanju informacij držav članic, kjer je to primerno obrazloženega mnenja iz člena 24, dejavnikov iz člena 14(2) in naslednjih MVO:
remaining MRLs in the Annex to Directive 76/895/EEC; and
preostalih MVO v Prilogi k Direktivi 76/895/EGS; in
hitherto unharmonised national MRLs.
doslej neusklajenih nacionalnih MVO.
Annex III shall be established within 12 months from the entry into force of this Regulation in accordance with Articles 23, 24 and 25.
Priloga III se sestavi v roku dvanajstih mesecev od začetka veljavnosti te uredbe v skladu s členi 23, 24 in 25.
Information to be provided by the Member States on national MRLs
Informacije, ki jih priskrbi država članica o nacionalnih MVO
Where an active substance is not yet included in Annex I to Directive 91/414/EEC and where a Member State has set, by the date of entry into force of Annex I to this Regulation at the latest, a national MRL for that active substance for a product covered by Annex I to this Regulation, or has decided that no MRL is required for that active substance, the Member State concerned shall notify the Commission, in a format and by a date to be established in accordance with the procedure referred to in Article 45(2), of the national MRL, or the fact that no MRL is required for an active substance, and where relevant and at the request of the Commission:
Če aktivna snov še ni vključena v Prilogo I k Direktivi 91/414/EGS in če je država članica najpozneje do začetka veljavnosti Priloge I k tej uredbi določila nacionalno MVO za to aktivno snov za proizvod iz Priloge I k tej uredbi ali se je odločila, da za to aktivno snov MVO ni potrebna, zadevna država članica uradno obvesti Komisijo v obliki in v roku, ki se določita v skladu s postopkom iz člena 45(2), o nacionalni MVO ali o dejstvu, da MVO za neko aktivno snov ni potrebna, ter kjer je to primerno in na zahtevo Komisije:
the GAP;
o DKP;
where the critical GAP is applied in the Member State and, where available, summary data on supervised trials and/or monitoring data;
o zbirnih podatkih o nadzorovanih poizkusih in/ali podatkih spremljanja, če se v državi članici uporablja kritična DKP in če so na razpolago;
the acceptable daily intake and, if relevant, the acute reference dose used for the national risk assessment, as well as the outcome of the assessment.
o dopustnem dnevnem vnosu in, če je to primerno, o akutnem referenčnem odmerku, ki se uporabljata za nacionalno oceno tveganja, kakor tudi o rezultatih ocene.
Opinion of the Authority on data underlying national MRLs
Mnenje agencije o podatkih, ki so podlaga nacionalnih MVO
The Authority shall provide a reasoned opinion to the Commission on potential risks to consumer health arising from:
Agencija Komisiji predloži obrazloženo mnenje o možnih tveganjih za zdravje potrošnika iz:
temporary MRLs that may be included in Annex III;
začasnih MVO, ki so lahko vključene v Prilogo III;
active substances that may be included in Annex IV.
aktivnih snovi, ki so lahko vključene v Prilogo IV.
In preparing the reasoned opinion referred to in paragraph 1, the Authority shall take into account the scientific and technical knowledge available, and in particular, information provided by the Member States as required by Article 23.
Pri pripravi obrazloženega mnenja iz odstavka 1 agencija upošteva razpoložljivo znanstveno in tehnično znanje ter predvsem informacije, ki jih je posredovala država članica, kot to določa člen 23.
Setting of temporary MRLs
Določitev začasnih MVO
Taking into account the opinion of the Authority, if such an opinion is necessary, temporary MRLs for active substances referred to in Article 23 may be set and listed in Annex III pursuant to Article 22(1) or, as appropriate, the active substance may be included in Annex IV pursuant to Article 5 (1).
Ob upoštevanju mnenja agencije, če je mnenje potrebno, so lahko začasne MVO za aktivne snovi iz člena 23 določene in navedene v Prilogi III v skladu s členom 22(1) ali, če je to primerno, so lahko aktivne snovi vključene v Prilogo IV v skladu s členom 5(1).
Temporary MRLs shall be set at the lowest level that can be achieved in all Member States on the basis of good agricultural practice.
Začasne MVO se določijo na najnižji ravni, ki se na podlagi dobre kmetijske prakse lahko doseže v vseh državah članicah.
OFFICIAL CONTROLS, REPORTS AND SANCTIONS
URADNI NADZOR, POROČILA IN SANKCIJE
Official controls of MRLs
URADNI NADZOR MVO
Official controls
Uradni nadzor
Without prejudice to Directive 96/23/EC, Member States shall carry out official controls on pesticide residues in order to enforce compliance with this Regulation, in accordance with the relevant provisions of Community law relating to official controls for food and feed.
Brez poseganja v Direktivo 96/23/ES države članice z namenom, da zagotovijo spoštovanje te uredbe, izvajajo uradni nadzor nad ostanki pesticidov v skladu z ustreznimi določbami prava Skupnosti o uradnem nadzoru hrane in krme.
Such controls on pesticide residues shall, in particular, consist of sampling and subsequent analysis of the samples and identification of the pesticides present and their respective residue levels.
Nadzor nad ostanki pesticidov pomeni predvsem vzorčenje, naknadne analize vzorcev in identifikacijo prisotnih pesticidov ter vrednosti njihovih ostankov.
Such controls shall also be carried out at the point of supply to the consumer.
Takšen nadzor se izvaja tudi na mestu, kjer potrošnik prevzame proizvod.
Each Member State shall take a sufficient number and range of samples to ensure that the results are representative of the market, taking into account the results of previous control programmes.
Vsaka država članica odvzame zadostno število in obseg vzorcev, da zagotovi reprezentativnost rezultatov za trg, ob upoštevanju rezultatov predhodnih nadzornih programov.
Such sampling shall be carried out as close to the point of supply as is reasonable, to allow for any subsequent enforcement action to be taken.
To vzorčenje se izvaja, kolikor je smiselno blizu točke dobave, da se omogoči naknadno sprejetje izvršilnih ukrepov.
The sampling methods necessary for carrying out such controls of pesticide residues in products other than those provided for in Directive 2002/63/EC shall be determined in accordance with the procedure referred to in Article 45(2) of this Regulation.
Potrebne metode vzorčenja za izvajanje nadzora nad ostanki pesticidov v proizvodih, ki niso navedene v Direktivi 2002/63/ES, se določijo v skladu s postopkom iz člena 45(2) te uredbe.
Methods of analysis
Analizne metode
The methods of analysis of pesticide residues shall comply with the criteria set out in the relevant provisions of Community law relating to official controls for food and feed.
Analizne metode ostankov pesticidov so v skladu z merili, določenimi v ustreznih določbah prava Skupnosti o uradnem nadzoru hrane in krme.
Technical guidelines dealing with the specific validation criteria and quality control procedures in relation to methods of analysis for the determination of pesticide residues may be adopted in accordance with the procedure referred to in Article 45(2).
Tehnične smernice, ki obravnavajo posebna merila veljavnosti in postopek nadzora kakovosti v zvezi z analiznimi metodami določitve ostankov pesticidov, so lahko sprejete v skladu s postopkom iz člena 45(2).
All laboratories analysing samples for the official controls on pesticide residues shall participate in the Community proficiency tests for pesticide residues organised by the Commission.
Vsi laboratoriji, ki analizirajo vzorce v okviru uradnega nadzora ostankov pesticidov, sodelujejo v preizkusih strokovne usposobljenosti Skupnosti za ostanke pesticidov, ki jih organizira Komisija.
Community control programme
Nadzorni program Skupnosti
The Commission shall prepare a coordinated multiannual Community control programme, identifying specific samples to be included in the national control programmes and taking into account problems that have been identified regarding compliance with the MRLs set out in this Regulation, with a view to assessing consumer exposure and the application of current legislation.
Komisija pripravi usklajen večletni nadzorni program Skupnosti, ki opredeljuje določene vzorce, ki jih je treba vključiti v nacionalne nadzorne programe, in upošteva ugotovljene težave z usklajenostjo z MVO, ki jih določa ta uredba, z namenom oceniti izpostavljenost potrošnikov in delovanje veljavne zakonodaje.
The Community control programme shall be adopted and updated every year in accordance with the procedure referred to in Article 45(2).
Nadzorni program Skupnosti se sprejme in vsako leto posodablja v skladu s postopkom iz člena 45(2).
The draft Community control programme shall be presented to the Committee referred to in Article 45(1) at least six months before the end of each calendar year.
Osnutek nadzornega programa Skupnosti bo predložen odboru iz člena 45(1) vsaj šest mesecev pred koncem vsakega koledarskega leta.
National control programmes
NACIONALNI NADZORNI PROGRAMI
National control programmes for pesticide residues
Nacionalni nadzorni programi za ostanke pesticidov
Member States shall establish multiannual national control programmes for pesticide residues.
Države članice pripravijo večletne nacionalne nadzorne programe za ostanke pesticidov.
They shall update their multiannual programme every year.
Večletni programi se vsako leto posodabljajo.
Those programmes shall be risk-based and aimed in particular at assessing consumer exposure and compliance with current legislation.
Ti programi temeljijo na tveganju in njihov cilj je predvsem oceniti izpostavljenost potrošnikov in skladnost z veljavno zakonodajo.
They shall specify at least the following:
Določajo najmanj naslednje:
the products to be sampled;
proizvode, ki jih je treba vzorčiti;
the number of samples to be taken and analyses to be carried out;
potrebno število vzorcev in analize, ki jih je treba izvesti;
the pesticides to be analysed;
pesticide, ki jih je treba analizirati;
the criteria applied in drawing up such programmes, including:(i) the pesticide-product combinations to be selected;
merila priprave teh programov, vključno s:(i) kombinacijami pesticid/proizvod;
the number of samples taken for domestic and non-domestic products respectively;
številom vzetih vzorcev za domače in nedomače proizvode;
consumption of the products as a share of the national diet;
porabo proizvodov kot deležem celotne nacionalne porabe;
the Community control programme; and
nadzornim programom Skupnosti; in
the results of previous control programmes.
rezultati predhodnih nadzornih programov.
Member States shall submit their updated national control programmes for pesticide residues, as mentioned in paragraph 1, to the Commission and to the Authority at least three months before the end of each calendar year.
Države članice predložijo Komisiji in agenciji posodobljene nacionalne nadzorne programe za ostanke pesticidov, navedene v odstavku 1, najmanj tri mesece pred koncem vsakega koledarskega leta.
Member States shall participate in the Community control programme as provided for in Article 29.
Države članice sodelujejo v nadzornem programu Skupnosti, kot je predviden v členu 29.
They shall, on an annual basis, publish all results of national residue monitoring on the Internet.
Letno objavljajo vse rezultate nacionalnega spremljanja ostankov na internetu.
Where MRLs are exceeded, Member States may name the retailers, traders or producers concerned.
V primeru, da so MVO presežene, lahko države članice razkrijejo imena zadevnih trgovcev na drobno, trgovcev na debelo ali proizvajalcev.
Information by the Member States and annual report
INFORMACIJE DRŽAV ČLANIC IN LETNO POROČILO
Information by the Member States
Informacije držav članic
Member States shall submit the following information concerning the previous calendar year to the Commission, the Authority and the other Member States by 31 August each year:
Države članice posredujejo Komisiji, agenciji in drugim državam članicam do 31. avgusta vsako leto naslednje informacije, ki zadevajo prejšnje koledarsko leto:
the results of the official controls provided for in Article 26(1);
rezultate uradnih nadzorov iz člena 26(1);
the LODs applied in the national control programmes referred to in Article 30 and under the Community control programme referred to in Article 29;
MD, ki se uporabljajo v nacionalnih nadzornih programih iz člena 30 in v okviru nadzornega programa Skupnosti iz člena 29;
details of the participation of the analytical laboratories in the Community proficiency tests referred to in Article 28(3) and other proficiency tests relevant to the pesticide-product combinations sampled in the national control programme;
podrobnosti o sodelovanju analitskih laboratorijev v preizkusih strokovne usposobljenosti Skupnosti iz člena 28(3) in drugih preizkusih strokovne usposobljenosti, ki ustrezajo kombinacijam pesticid/proizvod, vzorčenim v nacionalnem nadzornem programu;
details of the accreditation status of the analytical laboratories involved in the controls referred to in point (a);
podrobnosti o stanju akreditacije analitskih laboratorijev, vključenih v nadzore iz točke (a);
where permitted by national legislation, details of enforcement measures taken.
kjer to dovoljuje nacionalna zakonodaja, podrobnosti o izvršilnih ukrepih.
Implementing measures relating to the submission of information by the Member States may be established in accordance with the procedure referred to in Article 45(2) after consultation with the Authority.
Izvedbeni ukrepi o predložitvi informacij s strani držav članic se lahko določijo v skladu s postopkom iz člena 45(2) po posvetovanju z agencijo.
The Annual Report on Pesticide Residues
Letno poročilo o ostankih pesticidov
On the basis of the information provided by the Member States under Article 31(1) the Authority shall draw up an Annual Report on pesticide residues.
Na osnovi informacij, posredovanih s strani držav članic v skladu s členom 31(1), agencija pripravi letno poročilo o ostankih pesticidov.
The Authority shall include information on at least the following in the Annual Report:
Agencija vključi v letno poročilo vsaj naslednje informacije:
an analysis of the results of the controls provided for in Article 26(2);
analizo rezultatov nadzorov iz člena 26(2);
a statement of the possible reasons why the MRLs were exceeded, together with any appropriate observations regarding risk management options;
navedbo možnih razlogov, zakaj so bile MVO prekoračene, skupaj z ustreznimi ugotovitvami glede možnosti obvladovanja tveganja;
an analysis of chronic and acute risks to the health of consumers from pesticide residues;
analizo kroničnih in akutnih tveganj za zdravje potrošnikov zaradi ostankov pesticidov;