natgillin/translations-raw huggingface dataset:
The lists provided for in paragraphs 1 and 2 shall include information on whether those test and study reports were certified as compliant with the principles of good laboratory practice or of good experimental practice.
Seznami iz odstavkov 1 in 2 zajemajo informacije o tem, ali so bila ta poročila o preskusih in študijah potrjena kot skladna z načeli dobre laboratorijske prakse ali načeli dobre preskusne prakse.
General rules on avoidance of duplicative testing
Splošna pravila o izogibanju podvajanja preskusov
In order to avoid duplicative testing, any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, consult the information referred to in Article 57 to ascertain if and to whom an authorisation has already been granted for a plant protection product containing the same active substance, safener or synergist or for an adjuvant.
Da bi se izognili podvajanju preskusov, osebe, ki želijo pridobiti registracijo za fitofarmacevtsko sredstvo, pred izvajanjem preskusov ali študij preverijo informacije iz člena 57, da ugotovijo, če in komu je bila registracija za fitofarmacevtsko sredstvo, ki vsebuje enako aktivno snov, varovalo ali enak sinergist, ali za pomožno sredstvo že odobrena.
The competent authority shall on request from the prospective applicant provide him with the list of test and study reports prepared in accordance with Article 60 for that product.
Na zahtevo morebitnega vlagatelja mu pristojni organ zagotovi seznam poročil o preskusih in študijah, pripravljenih za to sredstvo v skladu s členom 60.
The prospective applicant shall submit all data regarding the identity and impurities of the active substance he proposes to use.
Morebitni vlagatelj predloži podatke v zvezi z vrsto in nečistočami aktivne snovi, ki jo želi uporabiti.
The enquiry shall be supported by evidence that the prospective applicant intends to apply for an authorisation.
Pri takšni poizvedbi se predložijo dokazi, da namerava morebitni vlagatelj vložiti vlogo za registracijo.
The competent authority of the Member State, where satisfied that the prospective applicant intends to apply for an authorisation, or the renewal or review thereof, shall provide him with the name and address of the holder or holders of previous relevant authorisations and shall at the same time inform the holders of the authorisations of the name and address of the applicant.
Če ima pristojni organ države članice dokaz, da morebitni vlagatelj namerava vložiti zahtevek za registracijo, njeno podaljšanje ali pregled, mu zagotovi ime in naslov imetnika ali imetnikov obstoječih zadevnih registracij ter hkrati sporoči imetnikom registracij ime in naslov vlagatelja.
The prospective applicant for the authorisation, or the renewal or review thereof, and the holder or holders of relevant authorisations shall take all reasonable steps to reach agreement on the sharing of any test and study reports protected under Article 59, in a fair, transparent and non-discriminatory way.
Morebitni vlagatelj registracije, njenega podaljšanja ali pregleda, ter imetnik ali imetniki zadevnih registracij sprejmejo vse ustrezne ukrepe za dosego dogovora o izmenjavi poročil o preskusih in študijah, varovanih v skladu s členom 59, na pravičen, pregleden in nediskriminatoren način.
Sharing of tests and studies involving vertebrate animals
Izmenjava preskusov in študij, ki vključujejo vretenčarje
Testing on vertebrate animals for the purposes of this Regulation shall be undertaken only where no other methods are available.
Preskusi na vretenčarjih za potrebe te uredbe se izvajajo samo takrat, kadar ni na voljo nobena druga metoda.
Duplication of tests and studies on vertebrates undertaken for the purposes of this Regulation shall be avoided in accordance with paragraphs 2 to 6.
V skladu z odstavki 2 do 6 se podvajanju preskusov na vretenčarjih in študij o njih za potrebe te uredbe izogiba.
Member States shall not accept duplication of tests and studies on vertebrate animals or those initiated where conventional methods described in Annex II to Directive 1999/45/EC could reasonably have been used, in support of applications for authorisations.
Države članice ne sprejmejo podvajanja preskusov na vretenčarjih in študij o njih, oziroma začetih preskusov in študij, pri katerih bi se lahko ustrezno uporabljale konvencionalne metode v podporo vlogam za registracijo iz Priloge II k Direktivi 1999/45/ES.
Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated.
Oseba, ki namerava izvajati preskuse in študije, ki vključujejo vretenčarje, sprejme ukrepe, potrebne za potrditev, da se ti preskusi in študije še niso začeli ali so že bili izvedeni.
The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals.
Morebitni vlagatelj in imetnik ali imetniki zadevnih registracij si prizadevajo za zagotovitev izmenjave preskusov in študij, ki vključujejo vretenčarje.
The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way.
Stroški izmenjave poročil o preskusih in študijah se določijo pošteno, pregledno in nediskriminatorno.
The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements.
Morebitni vlagatelj krije stroške le za tiste informacije, ki jih mora predložiti za izpolnitev zahtev za registracijo.
Where the prospective applicant and the holder or holders of the relevant authorisations of plant protection products containing the same active substance, safener or synergist, or of adjuvants cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State referred to in Article 61(1).
Če se morebitni vlagatelj in imetnik ali imetniki zadevnih registracij fitofarmacevtskih sredstev, ki vsebujejo enako aktivno snov, varovalo ali enak sinergist, ali pomožnih sredstev ne morejo sporazumeti o izmenjavi poročil o preskusih in študijah, ki vključujejo vretenčarje, morebitni vlagatelj obvesti pristojni organ države članice iz člena 61(1).
The failure to reach agreement, as provided in paragraph 3, shall not prevent the competent authority of that Member State from using the test and study reports involving vertebrate animals for the purpose of the application of the prospective applicant.
Če morebitni vlagatelj in imetniki zadevnih registracij ne uspejo doseči dogovora, v skladu z odstavkom 3, to pristojnim organom države članice ne prepreči uporabe poročil o preskusih in študijah, ki vključujejo vretenčarje, s strani pristojnega organa za namene vloge morebitnega vlagatelja.
By 14 December 2016, the Commission shall report on the effects of the provisions in this Regulation concerning data protection of tests and studies involving vertebrate animals.
Komisija najpozneje do 14. decembra 2016 poroča o učinkih določb te uredbe, ki se nanašajo na varstvo podatkov o preskusih in študijah na vretenčarjih.
The Commission shall submit this report to the European Parliament and the Council accompanied, if necessary, by an appropriate legislative proposal.
Komisija Evropskemu parlamentu in Svetu skupaj s poročilom po potrebi predloži ustrezen zakonodajni predlog.
The holder or holders of the relevant authorisation shall have a claim on the prospective applicant for a fair share of the costs incurred by him.
Imetnik ali imetniki zadevne registracije lahko od morebitnega vlagatelja zahteva(-jo) plačilo pravičnega deleža stroškov, kot jih je(so) imel(-i) sam(-i).
The competent authority of the Member State may direct the parties involved to resolve the matter by formal and binding arbitration administered under national law.
Pristojni organ države članice lahko zadevnim strankam predlaga, da zadevo reši s formalno in zavezujočo arbitražo v skladu z nacionalno zakonodajo.
Otherwise the parties may resolve the matter through litigation in the courts of the Member States.
Stranke lahko zadevo rešijo tudi v okviru sodnega postopka na sodiščih držav članic.
Awards from arbitration or litigation shall have regard to the principles determined in paragraph 3 and shall be enforceable in the courts of the Member States.
Arbitražne ali sodne odločbe bodo upoštevale načela iz odstavka 3 in bodo izvršljive na sodiščih držav članic.
PUBLIC ACCESS TO INFORMATION
JAVNI DOSTOP DO INFORMACIJ
A person requesting that information submitted under this Regulation is to be treated as confidential shall provide verifiable evidence to show that the disclosure of the information might undermine his commercial interests, or the protection of privacy and the integrity of the individual.
Oseba, ki zahteva, da se informacije, predložene v skladu s to uredbo, obravnavajo kot zaupne, zagotovi preverljivo utemeljitev, da lahko razkritje informacij ogrozi poslovne interese ali varstvo zasebnosti in integritete posameznika.
Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or of privacy and the integrity of the individuals concerned:
Za razkritje naslednjih informacij običajno velja, da ogroža zaščito poslovnih interesov ali zasebnosti in integriteto zadevnega posameznika:
the method of manufacture;
način proizvodnje;
the specification of impurity of the active substance except for the impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;
specifikacija nečistosti aktivne snovi, razen nečistoč, ki se štejejo za toksikološko, ekotoksikološko ali okoljsko relevantne;
results of production batches of the active substance including impurities;
rezultati proizvodnih serij aktivne snovi, vključno z nečistočami;
methods of analysis for impurities in the active substance as manufactured except for methods for impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant;
metode analiz nečistoč v aktivni snovi, kakor je proizvedena, razen metod za nečistoče, ki se štejejo za toksikološko, ekotoksikološko ali okoljsko relevantne;
links between a producer or importer and the applicant or the authorisation holder;
povezave med proizvajalcem ali uvoznikom in vlagateljem ali imetnikom registracije;
information on the complete composition of a plant protection product;
informacije o celotni sestavi fitofarmacevtskega sredstva;
names and addresses of persons involved in testing on vertebrate animals.
imena in naslovi oseb, ki so povezani z izvajanjem preskusov na vretenčarjih.
This Article is without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information [19].
Ta člen ne posega v Direktivo 2003/4/ES Evropskega parlamenta in Sveta z dne 28. januarja 2003 o dostopu javnosti do informacij o okolju [19].
PACKAGING, LABELLING AND ADVERTISING OF PLANT PROTECTION PRODUCTS AND ADJUVANTS
PAKIRANJE, OZNAČEVANJE IN OGLAŠEVANJE FITOFARMACEVTSKIH SREDSTEV IN POMOŽNIH SREDSTEV
Packaging and presentation
Pakiranje in predstavitev
Plant protection products and adjuvants that may be mistaken for food, drink or feed shall be packaged in such a way as to minimise the likelihood of such a mistake being made.
Fitofarmacevtska sredstva in pomožna sredstva, ki jih je mogoče zmotno imeti za hrano, pijačo ali krmo, se pakirajo tako, da se zmanjša verjetnost take zmote.
Plant protection products and adjuvants available to the general public that may be mistaken for food, drink or feed shall contain components to discourage or prevent their consumption.
Fitofarmacevtska sredstva in pomožna sredstva, ki so na voljo splošni javnosti in jih je mogoče zmotno imeti za hrano, pijačo ali krmo, vsebujejo sestavne dele za omejevanje ali preprečevanje njihove porabe.
Article 9 of Directive 1999/45/EC shall also apply to plant protection products and adjuvants not covered by that Directive.
Člen 9 Direktive 1999/45/ES se uporablja tudi za fitofarmacevtska sredstva, ki niso zajeta v navedeni direktivi.
The labelling of plant protection products shall include the classification, labelling and packaging requirements of Directive 1999/45/EC and shall comply with the requirements set out in a Regulation adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Označevanje fitofarmacevtskih sredstev vključuje zahteve glede razvrščanja, označevanja in pakiranja iz Direktive 1999/45/ES in je v skladu z zahtevami, določenimi v uredbi, sprejeti v skladu z regulativnim postopkom s pregledom iz člena 79(4).
That Regulation shall also contain standard phrases for special risks and safety precautions which supplement the phrases provided for by Directive 1999/45/EC.
Ta uredba vključuje tudi standardne stavke za posebna tveganja in varnostne ukrepe, ki dopolnjujejo stavke iz Direktive 1999/45/ES.
It shall incorporate the text of Article 16 of and the text of the Annexes IV and V to Directive 91/414/EEC with any necessary modifications.
Zajema besedilo člena 16 ter prilog IV in V k Direktivi 91/414/EGS z vsemi potrebnimi spremembami.
Member States may require samples or mock-ups of the packaging and drafts of labels and leaflets to be submitted before the authorisation is granted.
Države članice lahko zahtevajo vzorce ali modele embalaže ter osnutke etiket in letakov, ki jih je treba predložiti pred izdajo registracije.
Where a Member State considers that additional phrases are necessary to protect human or animal health or the environment, it shall notify the other Member States and the Commission forthwith and shall forward the additional phrase or phrases and the reasons for these requirements.
Če država članica meni, da so potrebni dodatni stavki za varovanje zdravja ljudi ali živali ali okolja, o tem obvesti druge države članice in Komisijo ter posreduje dodaten stavek ali stavke in razloge za te zahteve.
Such phrases shall be considered for inclusion in the Regulation referred to in paragraph 1.
Pretehta se vključitev takšnih stavkov v uredbo iz odstavka 1.
Pending that inclusion, the Member State may require the use of the additional phrase or phrases.
Do te vključitve lahko država članica zahteva uporabo dodatnega stavka ali stavkov.
Plant protection products which are not authorised shall not be advertised.
Fitofarmacevtska sredstva, ki niso registrirana, se ne oglašujejo.
The words ‘plant protection products’ may be replaced by a more precise description of the product-type, such as fungicide, insecticide or herbicide.
Izraz „fitofarmacevtska sredstva“ lahko nadomesti podrobnejši opis vrste proizvoda, kot so fungicid, insekticid ali herbicid.
The advertisement shall not include information in text or graphic form which could be misleading as regards possible risks to human or animal health or to the environment, such as the terms ‘low risk’, ‘non-toxic’ or ‘harmless’.
Oglas ne vključuje informacij v tekstovni ali grafični obliki, ki bi bile lahko zavajajoče v zvezi z možnimi tveganji za zdravje ljudi ali živali ali okolje, kot so izrazi „majhno tveganje“, „nestrupeno“ ali „neškodljivo“.
Only in the case of low-risk plant protection products shall the term ‘authorised as low-risk plant protection product in accordance with Regulation (EC) No 1107/2009’ be allowed in the advertisement.
Samo v primeru fitofarmacevtskih sredstev z majhnim tveganjem se izraz „registrirano kot fitofarmacevtsko sredstvo z majhnim tveganjem v skladu z Uredbo (ES) št. 1107/2009“ dovoli v oglaševanju.
It cannot be used as a claim on the label of the plant protection product.
Ne sme pa se uporabiti na etiketi fitofarmacevtskega sredstva.
Member States may prohibit or restrict the advertising of plant protection products in certain media, subject to Community law.
Države članice lahko v skladu z zakonodajo Skupnosti prepovejo ali omejijo oglaševanje fitofarmacevtskih sredstev v nekaterih sredstvih javnega obveščanja.
All statements used in advertising shall be technically justifiable.
Vse izjave, ki se uporabljajo pri oglaševanju, so tehnično utemeljene.
Advertisements shall not contain any visual representation of potentially dangerous practices, such as mixing or application without sufficient protective clothing, nor any use near food or use by or in the vicinity of children.
Oglasi ne vsebujejo prikazov morebitnih nevarnih postopkov, kot je mešanje ali uporaba brez ustrezne zaščitne obleke, uporabe v bližini hrane ali uporabe s strani otrok ali v njihovi bližini.
Advertising or promotional material shall draw attention to the appropriate warning phrases and symbols as laid down in the labelling.
Oglas ali promocijski material opozarja na ustrezne opozorilne stavke in simbole, navedene na etiketi.
Producers, suppliers, distributors, importers, and exporters of plant protection products shall keep records of the plant protection products they produce, import, export, store or place on the market for at least 5 years.
Proizvajalci, dobavitelji, distributerji, uvozniki in izvozniki fitofarmacevtskih sredstev vodijo evidenco v zvezi s fitofarmacevtskimi sredstvi, ki jih proizvajajo, uvažajo, izvažajo, skladiščijo, uporabljajo ali dajejo v promet in jo hranijo najmanj pet let.
Professional users of plant protection products shall, for at least 3 years, keep records of the plant protection products they use, containing the name of the plant protection product, the time and the dose of application, the area and the crop where the plant protection product was used.
Poklicni uporabniki fitofarmacevtskih sredstev vodijo evidenco o fitofarmacevtskih sredstvih, ki jih uporabljajo in jo hranijo najmanj tri leta, vključno z imenom fitofarmacevtskega sredstva, časom nanašanja in odmerkom ter površino in kulturo, na kateri je bilo uporabljeno fitofarmacevtsko sredstvo.
They shall make the relevant information contained in these records available to the competent authority on request.
Na zahtevo pristojnega organa dajo na voljo ustrezne podatke iz teh evidenc.
Third parties such as the drinking water industry, retailers or residents, may request access to this information by addressing the competent authority.
Tretje strani, kot je sektor za gospodarjenje s pitno vodo, trgovci na drobno in prebivalci, lahko od pristojnega organa zahtevajo dostop do teh informacij.
The competent authorities shall provide access to such information in accordance with applicable national or Community law.
Pristojni organi zagotovijo dostop do teh informacij v skladu z veljavno nacionalno zakonodajo ali zakonodajo Skupnosti.
By 14 December 2012, the Commission shall present a report to the European Parliament and the Council on the costs and benefits of the traceability of information from users to retailers concerning the applications of plant protection products on agricultural products, accompanied, if necessary, by appropriate legislative proposals.
Komisija Evropskemu parlamentu in Svetu najpozneje do 14. decembra 2012 predloži poročilo o stroških in koristih sledljivosti informacij glede uporabe fitofarmacevtskih sredstev na kmetijskih proizvodih od uporabnikov do trgovcev na drobno, skupaj s poročilom pa po potrebi predloži ustrezne zakonodajne predloge.
Producers of plant protection products shall undertake post-authorisation monitoring on the request of the competent authorities.
Po registraciji proizvajalci fitofarmacevtskih sredstev na zahtevo pristojnih organov zagotovijo spremljanje.
They shall notify the competent authorities of the relevant results.
Pristojne organe obvestijo o ustreznih rezultatih.
Authorisation holders shall provide the competent authorities of the Member States with all data relating to the volume of sales of plant protection products in accordance with Community legislation concerning statistics on plant protection products.
Imetniki registracij zagotovijo pristojnim organom držav članic potrebne podatke o obsegu prodaje fitofarmacevtskih sredstev v skladu z zakonodajo Skupnosti o statistki fitofarmacevtskih sredstev.
Implementing measures to ensure the uniform application of paragraphs 1, 2 and 3 may be adopted in accordance with the regulatory procedure referred to in Article 79(3).
Izvedbeni ukrepi za zagotovitev enotne uporabe odstavkov 1, 2 in 3 se lahko sprejmejo v skladu z regulativnim postopkom iz člena 79(3).
Monitoring and controls
Spremljanje in nadzor
Member States shall carry out official controls in order to enforce compliance with this Regulation.
Države članice izvajajo uradni nadzor za zagotavljanje skladnosti s to uredbo.
They shall finalise and transmit to the Commission a report on the scope and the results of these controls within six months of the end of the year to which the reports relate.
Prav tako dokončajo poročilo o področju uporabe in rezultatih teh nadzorov ter ga posredujejo Komisiji v šestih mesecih od konca leta, na katerega se to poročilo navezuje.
Commission experts shall carry out general and specific audits in the Member States for purposes of verifying the official controls carried out by the Member States.
Strokovnjaki Komisije izvedejo splošne in posebne revizije v državah članicah za preverjanje uradnih nadzorov, ki jih te izvajajo.
A Regulation, adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4), shall set out provisions for the controls, in particular on the production, packaging, labelling, storage, transport, marketing, formulation, parallel trade and use of plant protection products.
Uredba, sprejeta v skladu z regulativnim postopkom s pregledom iz člena 79(4), določa določbe za nadzor, predvsem v zvezi s proizvodnjo, pakiranjem, označevanjem, skladiščenjem, prevozom, trženjem, formulacijo, vzporedno trgovino in uporabo fitofarmacevtskih sredstev.
It shall also contain provisions concerning the collection of information and reporting on suspected poisonings.
Vsebuje tudi določbe v zvezi z zbiranjem podatkov in poročanjem o sumu zastrupitve.
EMERGENCIES
IZREDNE RAZMERE
Where it is clear that an approved active substance, safener, synergist or co-formulant or a plant protection product which has been authorised in accordance with this Regulation is likely to constitute a serious risk to human or animal health or the environment, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, measures to restrict or prohibit the use and/or sale of that substance or product shall be taken immediately in accordance with the regulatory procedure referred to in Article 79(3), either at the own initiative of the Commission or at the request of a Member State.
Če je jasno, da odobrena aktivna snov, varovalo, sinergist ali dodatek ali fitofarmacevtsko sredstvo, registrirano v skladu s to uredbo, verjetno resno ogroža zdravje ljudi ali živali ali okolje in da tega tveganja ni mogoče zadostno preprečiti z ukrepi, ki jih je sprejela zadevna država članica ali so jih sprejele zadevne države članice, se nemudoma izvedejo ukrepi za omejitev ali prepoved uporabe in/ali prodaje te snovi ali sredstva v skladu z regulativnim postopkom iz člena 79(3), na pobudo Komisije ali na zahtevo države članice.
Emergency measures in cases of extreme urgency
Izredni ukrepi v skrajno nujnih primerih
By way of derogation from Article 69, the Commission may in cases of extreme urgency provisionally adopt emergency measures after consulting the Member State or Member States concerned and informing the other Member States.
Z odstopanjem od člena 69 lahko Komisija v skrajno nujnih primerih začasno sprejme izredne ukrepe po posvetovanju z zadevno državo članico ali zadevnimi državami članicami ter obvesti druge države članice.
As soon as possible, and at the latest after 10 working days, those measures shall be confirmed, amended, revoked or extended in accordance with the regulatory procedure referred to in Article 79(3).
Ti ukrepi se čim prej in najpozneje po 10 delovnih dneh potrdijo, spremenijo, prekličejo ali podaljšajo v skladu z regulativnim postopkom iz člena 79(3).
Other emergency measures
Drugi izredni ukrepi