natgillin/translations-raw huggingface dataset:
Uporaba teh proizvodov zlasti ne sme imeti škodljivih učinkov na ljudi ali živali.
In particular the use of those products should have no harmful effects on humans or on animals.
Ostanki pesticidov, ki izvirajo iz uporabe fitofarmacevtskih sredstev, lahko imajo škodljive posledice za zdravje potrošnikov.
Pesticide residues resulting from uses of plant protection products may have harmful effects on the health of consumers.
Zato je primerno, da so pravila za MVO za proizvode, namenjene za prehrano ljudi, določena v povezavi z registracijo načinov uporabe teh fitofarmacevtskih sredstev, kakor je opredeljena v Direktivi 91/414/EGS.
It is therefore appropriate that rules for MRLs for products intended for human consumption be defined that are linked to the authorisation for use of plant protection products as defined under Directive 91/414/EEC.
Strokovno znanje in izkušnje v tej državi članici je primerno uporabljati tudi za namene te uredbe.
It is appropriate to use the expertise in that Member State for the purposes of this Regulation.
Primerno je uvesti posebna pravila glede nadzora ostankov pesticidov, ki bodo dopolnjevala splošne določbe Skupnosti glede nadzora hrane in krme.
It is appropriate that specific rules concerning the control of pesticide residues be introduced to complement the general Community provisions on the control of food and feed.
Pri obravnavi MVO pesticidov je treba tudi poudariti, da se redki potrošniki zavedajo tveganj zaradi uporabe pesticidov.
Whilst considering MRLs of pesticides, it should also be recognised that few consumers are aware of the risks arising from pesticides.
Ustrezno bi bilo popolnoma razložiti tovrstna tveganja javnosti.
It would be valuable to fully explain such risks to the public.
Države članice morajo pretehtati možnosti objave imen podjetij, katerih proizvodi vsebujejo več ostankov pesticidov, kot je najvišja dovoljena vrednost.
Member States should look into the possibility of publishing the names of companies whose products contain higher pesticide residues than the maximum permitted levels.
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 2003/100/ES (UL L 285, 1.11.2003, str.
Directive as last amended by Commission Directive 2003/100/EC (OJ L 285, 1.11.2003, p.
Zato morajo biti ostanki pesticidov v teh proizvodih v mejah, ki ne predstavljajo nevarnosti za ljudi in, kjer je
For certain products it is not possible to determine whether they will be transformed into food or animal feed.
pogoje, ki se bodo uporabljali za določitev, nadzor MVO
setting, control, and reporting on controls
za proizvode rastlinskega in živalskega izvora.
of MRLs for products of plant and animal origin.
Za države članice je pomembno, da uporabijo primerne sankcije v skladu z Uredbo (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o uradnih nadzorih, ki se izvajajo za zagotovitev preverjanja usklajenosti s pravom o hrani ter pravili o zdravju in dobrem počutju živali
It is important that Member States apply proper sanctions in accordance with 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
Direktiva 76/895/EGS predvideva, da države članice lahko dovolijo višje vrednosti MVO, kot so trenutno dovoljene na ravni Skupnosti.
Directive 76/895/EEC provides that Member States may authorise higher levels of MRLs than are currently authorised at Community level.
To možnost bi bilo treba ukiniti, saj bi lahko na notranjem trgu povzročala ovire v trgovanju znotraj Skupnosti.
That possibility should cease to exist as, in view of the internal market, it could create obstacles to intra-Community trade.
Določitev MVO za pesticide zahteva dolgotrajno strokovno preučevanje in vključuje presojo možnih tveganj za potrošnike.
The determination of MRLs for pesticides requires lengthy technical consideration and includes an assessment of potential risks to consumers.
Zato MVO za ostanke pesticidov, ki jih trenutno ureja Direktiva 76/895/EGS, ali za pesticide, za katere MVO na ravni Skupnosti še niso bile določene, ni mogoče določiti nemudoma.
Therefore, MRLs cannot be set immediately for the residues of pesticides currently regulated by Directive 76/895/EEC or for pesticides for which Community MRLs have not yet been set.
Primerno je, da se minimalni zahtevani podatki, ki se uporabljajo pri določitvi MVO za pesticide, določijo na ravni Skupnosti.
It is appropriate that the minimum data requirements to be used when considering the setting of MRLs for pesticides be laid down at Community level.
V izjemnih okoliščinah in predvsem za neregistrirane pesticide, ki bi lahko bili prisotni v okolju, je primerno pri določitvi MVO dovoliti uporabo podatkov spremljanja.
In exceptional circumstances and in particular for unauthorised pesticides that may be present in the environment, it is appropriate to permit the use of monitoring data in setting MRLs.
MVO za pesticide je treba nenehno spremljati in jih na podlagi novih informacij in podatkov spremeniti.
MRLs for pesticides should be continually monitored and should be changed to take account of new information and data.
MVO je treba določiti na nižji stopnji analitične določitve, kjer pri registriranem načinu uporabe fitofarmacevtskih sredstev ni mogoče odkriti vrednosti ostankov pesticidov.
MRLs should be set at the lower level of analytical determination where authorised uses of plant protection products do not result in detectable levels of pesticide residues.
Kjer način uporabe pesticidov ni registriran na ravni Skupnosti, morajo biti MVO določene na primerno nizki ravni za varstvo potrošnikov pred vnosom nedovoljene ali prevelike vrednosti ostankov pesticidov.
Where uses of pesticides are not authorised at Community level, MRLs should be set at an appropriately low level to protect the consumer from the intake of unauthorised or excessive levels of pesticides residues.
Za olajšanje nadzora ostankov pesticidov se določi privzeta vrednost za ostanke pesticidov v proizvodih ali skupinah proizvodov iz Priloge I, za katere MVO niso določene v Prilogah II in III, razen če so zadevne aktivne snovi navedene v Prilogi IV.
In order to facilitate control of residues of pesticides, a default value is to be set for pesticide residues present in products or groups of products covered by Annex I for which no MRLs have been established in Annexes II or III, unless the active substance in question is listed in Annex IV.
Privzeto vrednost je primerno določiti na 0,01 mg/kg in omogočiti možnost določitve druge vrednosti za aktivne snovi iz Priloge V, ob upoštevanju razpoložljivih rutinskih
It is appropriate to set the default value at 0,01 mg/kg and to provide for the possibility of setting it at a different level for active substances covered by Annex V, taking into account the routine analytical methods available and/or consumer
(ES) št. 178/2002/ES določa postopke za sprejem nujnih ukrepov v zvezi s hrano in krmo, ki izvira iz Skupnosti ali je uvožena iz tretjih držav.
(EC) No 178/2002 establishes procedures for taking emergency measures in relation to food and feed of Community origin or imported from a third country.
Ti postopki dovoljujejo Komisiji sprejetje ukrepov v primerih, ko lahko hrana predstavlja resno tveganje za zdravje ljudi, živali ali okolje in ko takega tveganja ni mogoče na zadovoljiv način obvladati z ukrepi, ki jih sprejme(-jo) zadevna(-e) država(-e) članica(-e).
Those procedures allow the Commission to adopt such measures in situations where food is likely to constitute a serious risk to human health, animal health or the environment and where such risk cannot be contained satisfactorily by measures taken by the Member State(s) concerned.
Pri določitvi MVO Skupnosti je prav tako treba upoštevati MVO, ki jih je na mednarodni ravni določila Komisija za Codex Alimentarius
MRLs set at the international level by the Codex Alimentarius Commission should also be considered when Community MRLs are being set
, ob upoštevanju ustreznih dobrih kmetijskih praks.
, taking into account the corresponding good agricultural practices.
Pri uporabi fitofarmacevtskih proizvodov za hrano in krmo proizvedeno zunaj Skupnosti veljajo različne zakonite kmetijske prakse, zato se ostanki pesticidov razlikujejo od tistih, ki so rezultat zakonite uporabe znotraj Skupnosti.
For food and feed produced outside the Community, different agricultural practices as regards the use of plant protection products may be legally applied, sometimes resulting in pesticide residues differing from those resulting from uses legally applied in the Community.
Zato je primerno, da se za uvožene proizvode določijo MVO, ki upoštevajo take uporabe in iz njih izvirajoče ostanke, in sicer pod pogojem, da je mogoče dokazati varnost proizvoda z uporabo istih meril kot za domači proizvod.
It is therefore appropriate that MRLs are set for imported products that take these uses and the resulting residues into account provided that the safety of the products can be demonstrated using the same criteria as for domestic produce.
Agencija mora preučiti vloge za MVO in ocenjevalna poročila držav članic
It is necessary that the Authority assess MRL applications and the evaluation reports prepared by the Member States
, ob upoštevanju celotnega obsega toksikoloških učinkov, kot so imunotoksičnost, endokrine motnje in reproduktivna toksičnost,
, taking into account the full range of toxicological effects such as immunotoxicity, endocrine disruption and developmental toxicity,
Časovna usklajenost sprejetja odločitev o MVO za aktivne snovi s sprejetjem odločitev o teh snoveh v okviru Direktive 91/414/EGS predstavlja dobro upravno prakso in je priporočljiva s tehničnega vidika.
It is good administrative practice and technically desirable to coordinate the timing of decisions on MRLs for active substances with decisions taken for those substances under Directive 91/414/EEC.
Za številne snovi, za katere MVO na ravni Skupnosti še niso bile določene, naj bi odločitve v okviru direktive ne bile sprejete pred dnem začetka veljavnosti te uredbe.
For many substances for which Community MRLs have not yet been set, decisions are not due to be taken under that Directive before the date of entry into force of this Regulation.
Zato je treba sprejeti ločena pravila za začasne, toda obvezne usklajene MVO, z namenom postopne določitve MVO vzporedno s sprejemanjem odločitev o posameznih aktivnih snoveh v okviru ocen po Direktivi 91/414/EGS.
It is therefore necessary to adopt separate rules providing for temporary but mandatory harmonised MRLs, with a view to setting MRLs progressively as decisions are taken on individual active substances as part of the evaluations under Directive 91/414/EEC.
Te začasne usklajene MVO morajo temeljiti na obstoječih nacionalnih MVO, ki so jih določile države članice, in morajo spoštovati nacionalne ureditve, ki jih določajo, pod pogojem, da te MVO ne predstavljajo nesprejemljivega tveganja za potrošnike.
Such temporary harmonised MRLs should be based, in particular, on existing national MRLs established by the Member States and should respect the national arrangements by which they were established, provided that the MRLs do not present an unacceptable risk to consumers.
Po vključitvi obstoječih aktivnih snovi v Prilogo I k Direktivi 91/414/EGS morajo države članice v štirih letih od dne vključitve ponovno oceniti vsak fitofarmacevtski proizvod, ki vsebuje te aktivne snovi.
Following the inclusion of existing active substances in Annex I to Directive 91/414/EEC, Member States are to re-evaluate each plant protection product containing those active substances within four years of the date of inclusion.
Zadevne MVO je treba ohraniti v obdobju do štirih let, da se zagotovi kontinuiteta registracij, in jih po zaključku ponovne ocene dokončno določiti, če so podprte z dokumentacijo, ki ustreza Prilogi III k Direktivi 91/414/EGS, ali pa jih določiti na privzeto vrednost, če niso podprte z dokumentacijo.
The MRLs concerned should be retained for a period of up to four years to provide for continuity of authorisations and, on completion of re-evaluation, should be made definitive if they are supported by dossiers which satisfy Annex III to Directive 91/414/EEC, or be set to a default level if they are not so supported.
Ta uredba določa MVO za nadzor ostankov pesticidov v hrani in krmi.
This Regulation establishes MRLs for the control of pesticide residues in food and feed.
Zato je primerno, da države članice sestavijo nacionalne programe za nadzor teh ostankov.
It is therefore appropriate that Member States establish national programmes to control these residues.
Rezultati nacionalnih nadzornih programov naj se predložijo Komisiji, agenciji in drugim državam članicam ter se vključijo v letno poročilo Skupnosti.
The results of the national control programmes are to be submitted to the Commission, the Authority and the other Member States and included in the Community annual report.
V skladu z načelom sorazmernosti je za doseganje osnovnih ciljev olajšanja trgovine ob hkratnem varstvu potrošnikov potrebno in primerno določiti pravila o MVO za proizvode rastlinskega in živalskega izvora.
In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objectives of facilitating trade whilst protecting the consumer to lay down rules on MRLs for products of plant and animal origin.
Ta uredba v skladu s tretjim odstavkom člena 5 Pogodbe ne prekoračuje okvirov, ki so potrebni za doseganje zastavljenih ciljev –
This Regulation does not go beyond what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty,
PREDMET UREJANJA, PODROČJE UPORABE IN OPREDELITEV POJMOV
SUBJECT MATTER, SCOPE AND DEFINITIONS
Predmet urejanja
Subject matter
Ta uredba v skladu z splošnimi načeli iz Uredbe (ES) št. 178/2002
This Regulation establishes, in accordance with the general principles laid down in Regulation (EC) No 178/2002
, zlasti da se zagotovi visoka stopnja varstva potrošnikov,
, in particular the need to ensure a high level of consumer protection,
določa usklajene določbe Skupnosti glede mejnih vrednosti ostankov pesticidov v ali na hrani in krmi rastlinskega in živalskega izvora.
harmonised Community provisions relating to maximum levels of pesticide residues in or on food and feed of plant and animal origin.
Ta uredba se uporablja za proizvode rastlinskega in živalskega izvora ali dele le-teh iz Priloge I, ki se uporabljajo kot sveža, predelana ali sestavljena hrana ali krma, v ali na kateri so lahko prisotni ostanki pesticidov.
This Regulation shall apply to products of plant and animal origin or parts thereof covered by Annex I to be used as fresh, processed and/or composite food or feed in or on which pesticide residues may be present.
Ta uredba se ne uporablja za proizvode iz Priloge I, kadar je na podlagi ustreznih dokazil mogoče ugotoviti, da so namenjeni:
This Regulation shall not apply to the products covered by Annex I where it may be established by appropriate evidence that they are intended for:
izdelavi proizvodov, ki niso hrana ali krma, ali
the manufacture of products other than food or feed; or
setvi ali sajenju, ali
sowing or planting; or
v nacionalnem pravu dovoljenemu testiranju aktivnih snovi.
activities authorised by national law for the testing of active substances.
Mejna vrednost ostankov pesticidov, določena v skladu s to uredbo, se ne uporablja za proizvode iz Priloge I, ki so namenjeni izvozu v tretje države in so tretirani pred izvozom, kjer je bilo z ustreznimi dokazili ugotovljeno, da namembna ciljna tretja država zahteva ali dopušča to tretiranje z namenom preprečiti vnos škodljivih organizmov na njeno ozemlje.
Maximum residue levels for pesticides set in accordance with this Regulation shall not apply to products covered by Annex I intended for export to third countries and treated before export, where it has been established by appropriate evidence that the third country of destination requires or agrees with that particular treatment in order to prevent the introduction of harmful organisms into its territory.
Ta uredba se uporablja brez poseganja v Direktivi 98/8/ES Direktiva 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet (UL L 123, 24.4.1998, str.
This Regulation shall apply without prejudice to Directives 98/8/EC Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p.
Uredba, kakor je bila nazadnje spremenjena z Uredbo Komisije (ES) št.
Regulation as last amended by Commission Regulation (EC) No
(UL L
/2004 (OJ L
Prav tako se uporabljajo naslednje opredelitve pojmov:
The following definitions shall also apply:
Prav tako pa pomeni uporabo, v skladu z Direktivo 91/414/EGS, načel integriranega zatiranja škodljivih organizmov v določenem podnebnem območju, pa tudi uporabo najmanjše možne količine pesticidov ter postavitev MVO/začasnih MVO na najnižjo stopnjo, ki omogoča želene učinke
It also implies the application, in accordance with Directive 91/414/EEC, of the principles of integrated pest control in a given climate zone, as well as using the minimum quantity of pesticides and setting MRLs/temporary MRLs at the lowest level which allows the desired effect to be obtained
so opredeljeni v točki 1 člena 2 Direktive 91/414/EGS, ki so prisotni v ali na proizvodih iz Priloge I k tej uredbi, še posebej tisti, ki nastajajo kot posledica uporabe pri zaščiti rastlin, v veterinarski medicini ali kot biocid;
or breakdown or reaction products of active substances currently or formerly used in plant protection products as defined in Article 2, point 1 of Directive 91/414/EEC, which are present in or on the products covered by Annex I to this Regulation, including in particular those which may arise as a result of use in plant protection, in veterinary medicine and as a biocide;
"mejna vrednost ostankov" (MVO) pomeni zgornjo
"Maximum Residue Level"
določene v skladu s trenutno uredbo in temelječo na dobri kmetijski praksi ter najnižji izpostavljenosti potrošnika, nujno za zaščito ranljivih potrošnikov
set in accordance with this Regulation, based on good agricultural practice and the lowest consumer exposure necessary to protect vulnerable consumers
za zadovoljevanje potreb mednarodne trgovine
to meet the needs of international trade
uporaba aktivne snovi v fitofarmacevtskem proizvodu na določenem proizvodu ni dovoljena v Skupnosti
the use of the active substance in a plant protection product on a given product is not authorised in the Community
zaradi drugih razlogov razen javnega zdravja za specifičen proizvod in specifično uporabo
for reasons other than public health reasons for the specific product and specific use
je primerna druga vrednost, ker je bila
a different level is appropriate because the
obstoječa MVO Skupnosti
existing Community MRL
določena zaradi drugih razlogov razen javnega zdravja za specifičen proizvod in specifično uporabo
was set for reasons other than public health reasons for the specific product and specific use
v enem dnevu
during one
občutnega zdravstvenega tveganja
appreciable risk
podatkov iz ustreznih študij in ob upoštevanju ranljivih skupin znotraj populacije (na primer otrok in nerojenih otrok)
the data produced by appropriate studies and taking into account sensitive groups within the population (e.g. children and the unborn)
"dopustni dnevni vnos" pomeni oceno količine snovi v hrani, izražene na osnovi telesne teže, ki je na osnovi vseh znanih dejstev v času ocene lahko zaužita dnevno v celotnem življenju,
"acceptable daily intake" means the estimate of the amount of substances in food expressed on a body weight basis, that can be ingested daily over a lifetime, without
brez občutnega tveganja
appreciable risk
, ob upoštevanju ranljivih skupin znotraj populacije (na primer otrok in nerojenih otrok)
, taking into account sensitive groups within the population (e.g. children and the unborn)
Proizvodi, skupine proizvodov in/ali deli proizvodov iz člena 2(1), za katere se uporabljajo usklajene MVO, se skladno s postopkom iz člena 45(2) opredelijo in zajamejo v Prilogi I.
The products, product groups and/or parts of products referred to in Article 2(1) to which harmonised MRLs shall apply shall be defined in and covered by Annex I in accordance with the procedure referred to in Article 45(2).
Priloga I vključuje vse proizvode, za katere so MVO določene, kakor tudi vse druge proizvode, za katere je primerno uporabljati usklajene MVO predvsem zaradi njihove pomembnosti v prehrani potrošnikov ali v trgovini.
Annex I shall include all products for which MRLs are set, as well as the other products for which it is appropriate to apply harmonised MRLs in particular in view of their relevance in the diet of consumers or in trade.
Proizvodi so razvrščeni na način, ki dopušča, kolikor je to mogoče, določitev MVO za skupino podobnih ali sorodnih proizvodov.
Products shall be grouped in such a way that MRLs may as far as possible be set for a group of similar or related products.
Priloga I se prvič sestavi v roku treh mesecev od začetka veljavnosti te uredbe in se po potrebi, predvsem pa na zahtevo ene izmed držav članic, revidira.
Annex I shall be first established within three months from the entry into force of this Regulation and shall be revised when appropriate, in particular, at the request of a Member State.
Priloga IV se prvič sestavi v roku dvanajstih mesecev od začetka veljavnosti te uredbe.
Annex IV shall be first established within 12 months from the entry into force of this Regulation.
POSTOPEK Z VLOGAMI ZA MVO
PROCEDURE FOR APPLICATIONS FOR MRLS
Predložitev vlog za MVO
Submission of Applications for MRLs
Člen 6 Vloge
Article 6
Če država članica namerava registrirati ali začasno registrirati uporabo fitofarmacevtskega proizvoda v skladu z Direktivo 91/414/EGS, ta država članica preuči, ali je kot rezultat te uporabe treba obstoječe MVO, določene v Prilogi II ali III k tej uredbi, spremeniti, določiti novo MVO ali je treba aktivno snov vključiti v Prilogo IV.
Where a Member State envisages granting an authorisation or a provisional authorisation for the use of a plant protection product in accordance with Directive 91/414/EEC, that Member State shall consider whether, as a result of such use, an existing MRL set out in Annex II or III to this Regulation needs to be modified, whether it is necessary to set a new MRL, or whether the active substance should be included in Annex IV.
Po potrebi država članica od stranke, ki prosi za registracijo, zahteva predložitev vloge v skladu s členom 7.
If necessary it shall require the party requesting the authorisation to submit an application in accordance with Article 7.
za zdravje,
in health,
s civilno-družbenimi organizacijami, pa tudi trgovinsko zainteresirane stranke, kot so
civil society organisations, as well as commercially interested parties such as
in proizvajalci proizvodov iz Priloge I, prav tako lahko državi članici predložijo vlogo v skladu s členom 7.
and producers of products covered by Annex I, may also submit an application to a Member State in accordance with Article 7.
Če država članica meni, da je potrebna določitev, sprememba ali izbris MVO, lahko ta država članica prav tako sestavi in oceni vlogo za določitev, spremembo ali izbris MVO v skladu s členom 7.
Where a Member State considers that the setting, modification or deletion of an MRL is necessary, that Member State may also compile and evaluate an application for setting, modifying, or deleting the MRL in accordance with Article 7.