natgillin/translations-raw huggingface dataset:
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] created the European Food Safety Authority (EFSA) to ensure that the Community has access to high-quality, independent and efficient scientific and technical support in order to achieve a high level of health protection in relation to legislation concerning safety of food and feed.
Z Uredbo (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 [7], je bila ustanovljena Evropska agencija za varno hrano (EFSA) z namenom zagotoviti Skupnosti dostop do visokokakovostne, neodvisne in učinkovite znanstvene in tehnične podpore za dosego visoke ravni zdravstvenega varstva v zvezi z zakonodajo o varnosti živil in krme.
It is therefore appropriate to provide that the EFSA should have a role in the programme of work on active substances.
Torej je treba EFSA omogočiti sodelovanje v delovnem programu z aktivnimi snovmi.
The relationships between producers, Member States, the Commission and the EFSA and the obligations on each of them for the implementation of the programme of work should be laid down, taking into account experience gained during the first and second stages of the programme of work, the objective of separating risk assessment from risk management and the need to organise the work in the most efficient way.
Odnosi med proizvajalci, državami članicami, Komisijo in EFSA ter njihove obveznosti za izvajanje delovnega programa morajo biti določeni ob upoštevanju izkušenj, pridobljenih med prvo in drugo fazo delovnega programa, cilja ločitve ocene tveganja od obvladovanja tveganja ter potrebe po čim bolj učinkoviti organizaciji dela.
Close cooperation between producers, Member States, the Commission and the EFSA and a scrupulous respect of time limits laid down is necessary to ensure the efficiency of the programme of work.
Tesno sodelovanje med proizvajalci, državami članicami, Komisijo in EFSA ter natančno spoštovanje določenih rokov je nujno za zagotovitev učinkovitosti delovnega programa.
Strict time limits for all elements of the fourth stage of that programme should be set in order to ensure its finalisation within an acceptable time period.
Za zagotovitev izvedbe četrte faze programa v sprejemljivem časovnem obdobju morajo biti določeni strogi časovni roki, ki veljajo za vse elemente omenjene faze.
For certain active substances where the dossier requirements are limited, a short deadline for submission of the dossier is appropriate in order to allow the opportunity for further information to be provided within the overall time-frame for completion of the review programme.
Za določene aktivne snovi, pri katerih so zahteve, ki veljajo za njihovo dokumentacijo, omejene, je primerno določiti kratek rok za oddajo dokumentacije in tako omogočiti, da bodo nadaljnji podatki posredovani v celotnem časovnem obdobju, predvidenem za dokončanje programa pregleda.
In order to avoid duplication of work, and in particular experiments involving vertebrate animals, producers should be encouraged to submit collective dossiers.
Proizvajalce je treba spodbujati k oddaji skupne dokumentacije, da bi se izognili podvajanju dela, zlasti poskusov, ki se izvajajo na vretenčarjih.
It is necessary to define the obligations of producers with regard to the formats, time periods and national authorities and the EFSA for the information to be submitted.
Nujno je treba določiti obveznosti proizvajalcev glede oblike, časovnih obdobij in državnih organov ter EFSA za podatke, ki jih morajo oddati.
Many of the active substances covered by stage four of the programme of work are produced in small volume for specialist purposes.
Veliko aktivnih snovi, ki jih zajema faza 4 delovnega programa, se proizvaja v majhnih količinah za posebne namene.
Some are important in organic or other low input farming systems and may be expected to constitute a low risk in terms of human and environmental protection.
Nekatere so pomembne v ekoloških ali drugih kmetijskih sistemih z nizkimi vložki, zato je možno pričakovati, da bodo predstavljale nizko tveganje z vidika varstva ljudi in okolja.
The Commission identified in its progress Report to the European Parliament and the Council — Evaluation of the active substances of plant protection products (submitted in accordance with Article 8(2) of Council Directive 91/414/EEC on the placing of plant protection products on the market) [8] the need for special measures to be adopted in relation to low-risk compounds.
Komisija je v svojem poročilu o napredku, naslovljenem na Evropski parlament in Svet – Ocena aktivnih snovi v fitofarmacevtskih sredstvih (oddanem v skladu s členom 8(2) Direktive Sveta 91/414/EGS o dajanju fitofarmacevtskih sredstev v promet) [8], ugotovila, da je potrebno sprejeti posebne ukrepe glede spojin, ki predstavljajo nizko tveganje.
A modified approach is required for this stage of the programme of work to reduce the risk that large numbers of active substances will be withdrawn for economic reasons alone.
Za to fazo delovnega programa se zahteva spremenjen pristop z namenom zmanjšati tveganje, da bi bilo veliko število aktivnih snovi umaknjenih samo iz ekonomskih razlogov.
For certain groups of active substances it is, therefore, appropriate that the format and requirements for the information to be submitted are different from those developed for active substances in the previous three stages of the programme of work.
Za nekatere skupine aktivnih snovi je tako primerno, da se oblika in zahteve za podatke, ki jih je potrebno predložiti, razlikujejo od tistih za aktivne snovi v prvih treh fazah delovnega programa.
In the interests of consistency of Community legislation it is necessary to ensure that the measures provided for in this Regulation are coherent with measures taken under 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 [9].
V interesu doslednosti zakonodaje Skupnosti je potrebno zagotoviti, da so ukrepi, predvideni s to uredbo, skladni z ukrepi, sprejetimi v skladu z Direktivo 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet [9].
The notification and submission of a dossier should not be a prerequisite for the possibility, after inclusion of the active substance in Annex I to Directive 91/414/EEC, to place plant protection products on the market subject to the provisions of Article 13 of that Directive.
Prijava in oddaja dokumentacije ne bi smela biti predpogoj za možnost, po vključitvi aktivne snovi v Prilogo I k Direktivi 91/414/EGS, dajanja fitofarmacevtskih sredstev v promet v skladu z določbami člena 13 navedene direktive.
Therefore persons who have not submitted notifications should be able to be informed at all stages of the evaluation process of the possible further requirements for continued marketing of plant protection products containing an active substance under evaluation.
Torej bi morale biti osebe, ki niso oddale prijave, v vseh fazah ocenjevalnega postopka obveščene o možnih dodatnih zahtevah glede nadaljnjega trženja fitofarmacevtskih sredstev, ki vsebujejo aktivne snovi v postopku ocenjevanja.
In order to ensure that all relevant information on the potentially dangerous effects of an active substance or its residues are considered, technical or scientific information submitted within the relevant time limits by any person should also be taken into consideration in the evaluations.
Zaradi zagotovitve upoštevanja vseh pomembnih podatkov o potencialno nevarnih učinkih aktivnih snovi ali njihovih ostankov je treba v ocenah upoštevati tudi tehnične ali znanstvene podatke, ki jih je v ustreznih časovnih rokih podala katera koli oseba.
Where cooperation with notifiers ceases, it is impossible to continue further evaluation efficiently and therefore the evaluation of an active substance should be terminated unless a Member State takes over.
V primeru prenehanja sodelovanja s prijavitelji je nemogoče učinkovito nadaljevati ocenjevanje aktivnih snovi, zato je potrebno ocenjevanje prekiniti, razen če ga ne prevzame država članica.
The task of evaluation should be distributed among the competent authorities of the Member States.
Nalogo ocenjevanja bi morali prevzeti pristojni organi v državah članicah.
Therefore, for each active substance a rapporteur Member State should be designated.
Tako bi morala biti za vsako aktivno snov imenovana država članica poročevalka.
Where appropriate the rapporteur Member State should assess the completeness checklist provided by the notifier, and examine and evaluate the information submitted.
Kjer je to primerno, bi morala država članica poročevalka oceniti kontrolno listo popolnosti, ki jo poda prijavitelj, ter pregledati in oceniti posredovane podatke.
It should present to the EFSA the results of the evaluation and make a recommendation to the Commission concerning the decision to be taken with regard to the active substance concerned.
Izide ocenjevanja bi morala predstaviti EFSA ter Komisiji podati priporočilo glede odločitve, ki naj bi bila sprejeta v zvezi z zadevno aktivno snovjo.
For certain groups of active substances it is appropriate that the rapporteur Member States closely cooperate with other rapporteur Member States for that group.
Za določene skupine aktivnih snovi bi bilo primerno, če bi države članice poročevalke tesno sodelovale z drugimi državami članicami poročevalkami, zadolženimi za to skupino.
For each group it is appropriate to identify a lead rapporteur to coordinate such cooperation.
Za vsako skupino bi bilo treba določiti vodilnega poročevalca, ki bi koordiniral takšno sodelovanje.
Rapporteur Member States should send draft assessment reports of their evaluations of active substances to the EFSA.
Država članica poročevalka bi morala poslati osnutke ocenjevalnih poročil o vrednotenju aktivnih snovi EFSA.
The draft assessment reports should be peer reviewed by the EFSA before they are submitted to the Commission.
Osnutke ocenjevalnih poročil bi morala EFSA strokovno pregledati, preden se pošljejo Komisiji.
In case of an apparent imbalance in the responsibilities borne by the Member States as rapporteur in the evaluation and assessment, it should be possible to replace the Member State originally designated as rapporteur for a particular active substance by another Member State.
V primeru očitnega nesorazmerja glede odgovornosti, ki jih države članice nosijo kot poročevalke pri vrednotenju in ocenjevanju, bi bilo treba zagotoviti možnost zamenjave države članice, prvotno imenovane za poročevalko o določeni aktivni snovi, z drugo državo članico.
To ensure the proper resourcing of this stage of the programme of work, a fee should be paid to the Member States for the handling and evaluation of dossiers and draft assessment reports.
Za zagotovitev ustreznega vira za to fazo delovnega programa bi bilo treba državi članici plačati nadomestilo za vodenje in ocenjevanje dokumentacije ter za osnutke ocenjevalnih poročil.
The EFSA has been consulted on the proposed measures.
O predlaganih ukrepih se je treba posvetovati z EFSA.
SUBJECT MATTER AND SCOPE, DEFINITIONS AND THE DESIGNATED MEMBER STATE AUTHORITY
VSEBINA IN NAMEN, POMEN IZRAZOV IN IMENOVANI ORGAN DRŽAVE ČLANICE
Subject matter and scope
Vsebina in namen
This Regulation lays down:
Ta uredba določa:
further detailed rules for the implementation of the fourth stage of the programme of work referred to in the second subparagraph of Article 8(2) of Directive 91/414/EEC (the programme of work) with respect to the continued evaluation of the active substances notified under Regulation (EC) No 1112/2002;
nadaljnja podrobna pravila za izvajanja četrte faze delovnega programa iz drugega pododstavka člena 8(2) Direktive 91/414/EGS („delovni program“) glede stalnega ocenjevanja aktivnih snovi, prijavljenih v skladu z Uredbo (ES) št. 1112/2002;
rules covering the active substances that were on the market before 1 May 2004 in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia and which are not included in stages one to three of the programme of work and which are not covered by Regulation (EC) No 1112/2002.
pravila glede aktivnih snovi, ki so bile na trgu pred 1. majem 2004 na Češkem, v Estoniji, na Cipru, v Latviji, Litvi, na Madžarskem, Malti, Poljskem, v Sloveniji in na Slovaškem in ki niso vključene v faze 1 do 3 delovnega programa ter niso zajete z Uredbo (ES) št. 1112/2002.
Article 6(2) and (3) and the second paragraph of Article 6(4) of Directive 91/414/EEC shall not apply to active substances listed in Annex I to this Regulation as long as the procedures provided for in this Regulation with regard to such substances have not been finalised.
Člen 6(2) in (3) ter drugi odstavek člena 6(4) Direktive 91/414/EGS se ne uporabljata za aktivne snovi, naštete v Prilogi I k tej uredbi, vse dokler postopki v zvezi s temi snovmi, predpisani s to uredbo, ne bodo končani.
This Regulation shall apply without prejudice to:
Ta uredba se uporablja brez poseganja v:
reviews by Member States of active substances listed in Annex I to this Regulation in particular pursuant to renewals of authorisations in accordance with Article 4(4) of Directive 91/414/EEC;
preglede aktivnih snovi, naštetih v Prilogi I k tej uredbi, ki jih opravijo države članice, predvsem v skladu s podaljšanjem registracije skladno s členom 4(4) Direktive 91/414/EGS;
reviews by the Commission in accordance with Article 5(5) of Directive 91/414/EEC;
preglede, ki jih opravi Komisija v skladu s členom 5(5) Direktive 91/414/EGS;
assessments carried out under Directive 79/117/EEC.
ocenjevanja, opravljena v skladu z Direktivo 79/117/EGS.
Definitions
Pomen izrazov
For the purpose of this Regulation, the definitions set out in Article 2 of Directive 91/414/EEC and Article 2 of Regulation (EC) No 1112/2002 shall apply.
Za namen te uredbe se uporabljajo izrazi, določeni v členu 2 Direktive 91/414/EGS in členu 2 Uredbe (ES) št. 1112/2002.
The following definitions shall also apply:
Uporabljajo se tudi naslednji izrazi:
‘notifier’ means the natural or legal person who has submitted a notification in accordance with:
„prijavitelj“ pomeni fizično ali pravno osebo, ki je podala prijavo v skladu z:
Regulation (EC) No 1112/2002, as listed in Annex II to this Regulation, or
Uredbo (ES) št. 1112/2002, kot je navedeno v Prilogi II k tej uredbi, ali
Article 4 of this Regulation;
členom 4 te uredbe;
‘rapporteur Member State’ means the rapporteur Member State for the active substance as set out in Annex I.
„država članica poročevalka“ pomeni državo članico, imenovano za poročanje o aktivni snovi, kot je določeno v Prilogi I.
‘summary dossier’ means a dossier containing the information required under Article 10(2), where summaries are given of the results of the tests and studies referred to in that paragraph.
„povzetek dosjeja“ pomeni dosje, ki vsebuje podatke, zahtevane po členu 10(2), kjer so podani povzetki izidov poskusov in študij iz tega odstavka.
‘complete dossier’ means a dossier containing the information required under Article 10(3), where the results of the tests and study reports referred to in the summary dossier are given in full.
„popoln dosje“ pomeni dosje, ki vsebuje podatke po členu 10(3), kjer so izidi poskusov ter študijska poročila iz povzetka dosjeja podani v celoti.
Designated Member State authority
Imenovan organ države članice
Each Member State shall designate an authority or authorities to carry out the obligations of the Member States as defined in this Regulation.
Vsaka država članica imenuje organ ali organe za izvrševanje obveznosti države članice, kot je določeno s to uredbo.
The national authorities listed in Annex III shall coordinate and ensure all necessary contacts with notifiers, other Member States, the Commission and the European Food Safety Authority (EFSA) in accordance with this Regulation.
Državni organi, navedeni v Prilogi III, sodelujejo in zagotavljajo vse potrebne stike s prijavitelji, drugimi državami članicami, Komisijo in Evropsko agencijo za varno hrano (EFSA) v skladu s to uredbo.
Each Member State shall give the details concerning the designated coordinating national authority to the Commission, the EFSA and the designated coordinating national authority of each other Member State and inform them of any modifications thereof.
Vsaka država članica mora posredovati podrobnosti o imenovanem koordinacijskem državnem organu Komisiji, EFSA in imenovanim koordinacijskim državnim organom vsake države članice ter jih obveščati o morebitnih spremembah.
NOTIFICATIONS BY PRODUCERS IN NEW MEMBER STATES OF ACTIVE SUBSTANCES
PRIJAVE AKTIVNIH SNOVI S STRANI PROIZVAJALCEV V NOVIH DRŽAVAH ČLANICAH
Notifications by producers in new Member States
Prijave s strani proizvajalcev v novih državah članicah
Any producer in a new Member State referred to in Article 1(1)(b) of this Regulation wishing to secure the inclusion in Annex I to Directive 91/414/EEC of an active substance listed in Annex I to this Regulation shall notify the details set out in Annex V of this Regulation to the Commission, other notifiers for that substance and the rapporteur Member State at the latest three months from the date of entry into force of this Regulation.
Vsak proizvajalec v novi državi članici iz člena 1(1)(b) te uredbe, ki želi zagotoviti vključitev aktivne snovi, navedene v Prilogi I k tej uredbi, v Prilogo I k Direktivi 91/414/EGS, prijavi podrobnosti, določene v Prilogi V k tej uredbi, Komisiji, drugim prijaviteljem te snovi in državi članici poročevalki najkasneje v treh mesecih od začetka veljavnosti te uredbe.
Any producer making a notification under paragraph 1 shall fulfil the obligations of producers or notifiers set out in this Regulation for the active substance notified.
Vsak proizvajalec, ki poda prijavo po odstavku 1, mora izpolniti obveznosti proizvajalca ali prijavitelja, določene za prijavljeno aktivno snov s to uredbo.
Where a producer in a new Member State has not submitted a notification for an active substance listed in Annex I to this Regulation, in accordance with paragraph 1, it shall only be permitted to participate in the programme of work collectively with one or more notifiers of the active substance, including a Member State which has notified in accordance with paragraph 4 of this Article.
Če proizvajalec iz nove države članice ni podal prijave za aktivno snov, navedeno v Prilogi I k tej uredbi, v skladu z odstavkom 1, mu bo dovoljeno sodelovati v delovnem programu le kolektivno, z enim ali več prijavitelji aktivne snovi, vključno z državo članico, ki je prijavo podala v skladu z odstavkom 4 tega člena.
Where no notification has been received for an active substance listed in Annex I to this Regulation, a new Member State may declare its interest in supporting the inclusion of that active substance in Annex I to Directive 91/414/EEC by notifying the Commission and the rapporteur Member State.
Če aktivna snov, navedena v Prilogi I k tej uredbi, ni bila prijavljena, lahko nova država članica pokaže zanimanje za podporo vključitvi te aktivne snovi v Prilogo I k Direktivi 91/414/EGS s prijavo Komisiji in državi članici poročevalki.
That notification must be submitted as soon as possible, and no later than three months from the date the Commission has informed the Member States that no notification has been submitted for that active substance.
Prijava mora biti podana čim prej in ne kasneje kot v treh mesecih od dne, ko je Komisija obvestila države članice, da za to aktivno snov ni bila podana nobena prijava.
A Member State submitting such a notification shall thereafter be treated as the producer for the purposes of the evaluation of the active substance concerned.
Država članica, ki odda tako prijavo, bo obravnavana kot proizvajalec za namene ocenjevanja zadevne aktivne snovi.
The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive active substances referred to in Annex I to this Regulation for which no notification has been submitted in accordance with paragraphs 1 or 4 of this Article.
Komisija odloči, kot je predvideno v četrtem pododstavku člena 8(2) Direktive 91/414/EGS, da v Prilogo I navedene direktive ne bo vključila aktivnih snovi iz Priloge I k tej uredbi, za katere ni bila podana nobena prijava v skladu z odstavkoma 1 ali 4 tega člena.
The Decision shall state the reasons for the non-inclusion.
V odločbi morajo biti navedeni razlogi za nevključitev.
Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.
Države članice morajo v roku, predpisanem v odločbi, umakniti registracije za fitofarmacevtska sredstva, ki vsebujejo take aktivne snovi.
CONDITIONS FOR THE SUBMISSION OF DOSSIERS OF ACTIVE SUBSTANCES AND SUBMISSION OF INFORMATION BY THIRD PARTIES
POGOJI ZA PREDLOŽITEV DOSJEJEV AKTIVNIH SNOVI IN PREDLOŽITEV PODATKOV S STRANI TRETJIH OSEB
Submission of dossiers by more than one notifier
Predložitev dosjejev s strani več kot enega prijavitelja
Where for any active substance listed in Annex I there is more than one notifier, the notifiers concerned shall take all reasonable steps to submit the dossier for such substance collectively.
Če za katero koli aktivno snov, navedeno v Prilogi I, obstaja več kot en prijavitelj, morajo zadevni prijavitelji narediti vse razumne korake, da bi dosje za to snov predložili skupno.
Where the dossier is not submitted by all such notifiers, it shall contain details of the efforts made and the reasons why certain notifiers have not participated in the submission of the dossier.
Če dosjeja ne predložijo vsi prijavitelji, mora ta vsebovati podrobnosti o vloženih prizadevanjih in razloge, zaradi katerih določeni prijavitelji niso sodelovali pri predložitvi.
Where an active substance has been notified by more than one notifier, those notifiers shall, for each study involving vertebrate animals, give details of the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.
Če je določeno aktivno snov prijavilo več prijaviteljev, morajo ti za vsako študijo, ki vključuje poskuse z vretenčarji, podati podrobnosti o prizadevanjih, da bi se izognili podvajanju poskusov, v primeru podvajanja poskusov pa navesti razloge zanj.
Submission of dossiers to the rapporteur Member State
Predložitev dosjejev državi članici poročevalki
The notifier shall submit the dossier for the active substance (the dossier) to the rapporteur Member State.
Prijavitelj mora predložiti dosje aktivne snovi („dosje“) državi članici poročevalki.
The dossier shall include the following:
Dosje mora vsebovati naslednje:
a copy of the notification; in the case of a collective notification made by more than one producer as referred to in Article 5(1), it shall include:
kopijo prijave; v primeru skupne prijave s strani več kot enega proizvajalca iz člena 5(1), mora vsebovati:
a copy of the notifications made in accordance with Article 4 or 5 of Regulation (EC) No 1112/2002 or Article 4 of this Regulation;
kopijo prijav, podanih v skladu s členom 4 ali 5 Uredbe (ES) št. 1112/2002 ali členom 4 te uredbe;
the name of the person designated by the producers concerned as being responsible for the collective notification who will act as a contact point during the procedure;
ime osebe, ki jo določijo zadevni proizvajalci, ki bo, kot odgovorna oseba, v času trajanja postopka delovala kot kontaktna točka;