natgillin/translations-raw huggingface dataset:
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
PRILOGA
OECD Series on Testing and Assessment No 150.
Priloga II k Uredbi (ES) št. 1107/2009 se spremeni:
ANNEX
V točki 3.6.5. se za četrtim odstavkom dodajo naslednji odstavki:
Annex II to Regulation (EC) No 1107/2009 is amended as follows:
„Od 20. oktobra 2018 se za aktivno snov, varovalo ali sinergist šteje, da ima lastnosti endokrinega motilca, ki lahko škodljivo učinkuje na ljudi, če je na podlagi točk od (1) do (4) šestega odstavka to snov, ki izpolnjuje vsa naslednja merila, razen če obstajajo dokazi, ki dokazujejo, da ugotovljeni škodljivi učinki niso relevantni za ljudi:
in point 3.6.5 the following paragraphs are added after the fourth paragraph:
škodljivo učinkuje na neokvarjen organizem ali njegove potomce, npr. s spremembo morfologije, fiziologije, rasti, razvoja, razmnoževanja ali življenjske dobe organizma, sistema ali (sub)populacije, kar povzroča okvaro funkcijske zmogljivosti, okvaro zmožnosti za kompenzacijo dodatnega stresa ali večjo dovzetnost za druge vplive;
‘From 20 October 2018, an active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effect in humans if, based on points (1) to (4) of the sixth paragraph, it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant to humans:
ima endokrin način delovanja, tj. spremeni funkcijo(-e) endokrinega sistema;
it shows an adverse effect in an intact organism or its progeny, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;
škodljivi učinek je posledica endokrinega načina delovanja.
it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
Opredelitev aktivne snovi, varovala ali sinergista kot snovi z lastnostmi endokrinega motilca, ki lahko škodljivo učinkuje na ljudi, v skladu s petim odstavkom temelji na naslednjih točkah:
the adverse effect is a consequence of the endocrine mode of action.
vseh zadevnih znanstvenih podatkih, ki so na voljo (študijah in vivo ali ustrezno potrjenih alternativnih preskusnih sistemih, napovednih za škodljive učinke pri ljudeh ali živalih; ter študijah in vivo, in vitro ali, če so na voljo, študijah in silico o endokrinih načinih delovanja):
The identification of an active substance, safener or synergist as having endocrine disrupting properties that may cause adverse effect in humans in accordance with the fifth paragraph shall be based on all of the following points:
znanstvenih podatkih, pridobljenih v skladu z mednarodno sprejetimi študijskimi protokoli, zlasti tistimi iz sporočil Komisije glede določitve zahtevanih podatkov o aktivnih snoveh in fitofarmacevtskih sredstvih, v skladu s to uredbo;
all available relevant scientific data (in vivo studies or adequately validated alternative test systems predictive of adverse effects in humans or animals; as well as in vivo, in vitro, or, if applicable, in silico studies informing about endocrine modes of action):
drugih znanstvenih podatkih, izbranih z uporabo metodologije sistematičnega pregleda, zlasti na podlagi navodil glede podatkov iz literature, navedenih v sporočilih Komisije glede določitve zahtevanih podatkov o aktivnih snoveh in fitofarmacevtskih sredstvih, v skladu s to uredbo;
scientific data generated in accordance with internationally agreed study protocols, in particular those listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;
oceni razpoložljivih zadevnih znanstvenih podatkov na podlagi pristopa teže dokazov, da se ugotovi, ali so izpolnjena merila iz petega odstavka; z uporabo pristopa določitve teže dokazov se pri oceni znanstvenih dokazov zlasti upoštevajo naslednji dejavniki:
other scientific data selected applying a systematic review methodology, in particular following guidance on literature data which is listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;
pozitivni in negativni rezultati;
an assessment of the available relevant scientific data based on a weight of evidence approach in order to establish whether the criteria set out in the fifth paragraph are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall, in particular, consider all of the following factors:
ustreznost zasnov študij za oceno škodljivih učinkov in endokrinega načina delovanja;
both positive and negative results;
kakovost in doslednost podatkov glede na vzorec in doslednost rezultatov znotraj študije in med študijami s podobno zasnovo in različnimi vrstami;
the relevance of the study designs, for the assessment of adverse effects and of the endocrine mode of action;
študije načina izpostavljenosti, toksikokinetične študije in študije presnove;
the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different species;
pojem mejnega odmerka, mednarodne smernice o največjih priporočenih odmerkih in za oceno zavajajočih učinkov prekomerne toksičnosti;
the route of exposure, toxicokinetic and metabolism studies;
z uporabo pristopa teže dokazov se povezava med škodljivimi učinki in endokrinim načinom delovanja vzpostavi na podlagi biološke verjetnosti, ki se določi ob upoštevanju trenutnega znanstvenega znanja in mednarodno sprejetih smernic;
the concept of the limit dose, and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
škodljivi učinki, ki niso specifične sekundarne posledice drugih toksičnih učinkov, se ne upoštevajo pri opredelitvi snovi kot endokrinega motilca.“
using a weight of evidence approach, the link between the adverse effect(s) and the endocrine mode of action shall be established based on biological plausibility, which shall be determined in the light of current scientific knowledge and under consideration of internationally agreed guidelines;
V točki 3.8.2. se za edinim odstavkom dodajo naslednji odstavki:
adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor.’;
„Od 20. oktobra 2018 se za aktivno snov, varovalo ali sinergist šteje, da ima lastnosti endokrinega motilca, ki lahko škodljivo učinkuje na neciljne organizme, če je na podlagi točk od (1) do (4) tretjega odstavka to snov, ki izpolnjuje vsa naslednja merila, razen če obstajajo dokazi, ki dokazujejo, da ugotovljeni škodljivi učinki niso relevantni na ravni (sub)populacije za neciljne organizme:
in point 3.8.2 the following paragraphs are added after the sole paragraph:
škodljivo učinkuje na neciljne organizme, npr. s spremembo morfologije, fiziologije, rasti, razvoja, razmnoževanja ali življenjske dobe organizma, sistema ali (sub)populacije, kar povzroča okvaro funkcijske zmogljivosti, okvaro zmožnosti za kompenzacijo dodatnega stresa ali večjo dovzetnost za druge vplive;
‘From 20 October 2018, an active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effects on non-target organisms if, based on points (1) to (4) of the third paragraph, it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant at the (sub)population level for non-target organisms:
Opredelitev aktivne snovi, varovala ali sinergista kot snovi z lastnostmi endokrinega motilca, ki lahko škodljivo učinkuje na neciljne organizme, v skladu z drugim odstavkom temelji na naslednjih točkah:
it shows an adverse effect in non-target organisms, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;
znanstvenih podatkih, pridobljenih v skladu z mednarodno sprejetimi študijskimi protokoli, zlasti tistimi iz sporočil Komisije glede določitve zahtevanih podatkov o aktivnih snoveh in fitofarmacevtskih sredstvih, v skladu s to uredbo;
The identification of an active substance, safener or synergist as having endocrine disrupting properties that may cause adverse effects on non-target organisms in accordance with the second paragraph shall be based on all of the following points:
drugih znanstvenih podatkih, izbranih z uporabo metodologije sistematičnega pregleda, zlasti na podlagi navodil glede podatkov iz literature, navedenih v sporočilih Komisije glede določitve zahtevanih podatkov o aktivnih snoveh in fitofarmacevtskih sredstvih, v skladu s to uredbo;
scientific data generated in accordance with internationally agreed study protocols, in particular, those listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;
oceni razpoložljivih zadevnih znanstvenih podatkov, ki temeljijo na pristopu teže dokazov, da se ugotovi, ali so izpolnjena merila iz drugega odstavka; z uporabo pristopa določitve teže dokazov se pri oceni znanstvenih dokazov upoštevajo naslednji dejavniki:
other scientific data selected applying a systematic review methodology, in particular following guidance on literature data listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;
pozitivni in negativni rezultati, ki razlikujejo med taksonomskimi skupinami (npr. sesalci, ptice, ribe, dvoživke), kadar je to ustrezno;
an assessment of the available relevant scientific data based on a weight of evidence approach in order to establish whether the criteria set out in the second paragraph are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall consider all of the following factors:
ustreznost zasnove študije za oceno škodljivih učinkov in njene ustreznosti na ravni (sub)populacije ter za oceno endokrinega načina delovanja;
both positive and negative results, discriminating between taxonomic groups (e.g. mammals, birds, fish, amphibians) where relevant;
škodljivi učinki na razmnoževanje, rast in razvoj ter drugi relevantni škodljivi učinki, ki bi najverjetneje vplivali na (sub)populacije.
the relevance of the study design for the assessment of the adverse effects and its relevance at the (sub)population level, and for the assessment of the endocrine mode of action;
Ustrezni, zanesljivi in reprezentativni terenski podatki in/ali rezultati ali podatki in/ali rezultati spremljanja iz modelov populacije se prav tako upoštevajo, kadar so na voljo;
the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely to impact on (sub)populations.
kakovost in doslednost podatkov glede na vzorec in doslednost rezultatov znotraj študije in med študijami s podobno zasnovo in različnimi taksonomskimi skupinami;
Adequate, reliable and representative field or monitoring data and/or results from population models shall as well be considered where available;
pojem mejnega odmerka, mednarodne smernice o največjih priporočenih odmerkih in za oceno zavajajočih učinkov prekomerne toksičnosti;
the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different taxonomic groups;
škodljivi učinki, ki niso specifične sekundarne posledice drugih toksičnih učinkov, se ne upoštevajo pri opredelitvi snovi kot endokrinega motilca za neciljne organizme.“
the concept of the limit dose and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity.
Zato bi bilo treba navedena merila začeti uporabljati od 20. oktobra 2018, razen kadar zadevni odbor do 20. oktobra 2018 glasuje o osnutku uredbe.
Adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor with respect to non-target organisms.’
Komisija bo preučila posledice za vsak nedokončan postopek odobritve v skladu z Uredbo (ES) št. 1107/2009 in po potrebi sprejela ustrezne ukrepe ob ustreznem spoštovanju pravic vlagateljev.
Commission Implementing Regulation (EU) 2018/606
Izvedbena uredba Komisije (EU) 2018/606
conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name ‘Dons’ (PDO)
o zaščiti iz člena 99 Uredbe (EU) št. 1308/2013 Evropskega parlamenta in Sveta za ime „Dons“ (ZOP)
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007, and in particular Article 99 thereof,
ob upoštevanju Uredbe (EU) št. 1308/2013 Evropskega parlamenta in Sveta z dne 17. decembra 2013 o vzpostavitvi skupne ureditve trgov kmetijskih proizvodov in razveljavitvi uredb Sveta (EGS) št. 922/72, (EGS) št. 234/79, (ES) št. 1037/2001 in (ES) št. 1234/2007 ter zlasti člena 99 Uredbe,
In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Dons’ as a Protected Designation of Origin (PDO) sent by Denmark, and has published it in the Official Journal of the European Union.
V skladu s členom 97(2) in (3) Uredbe (EU) št. 1308/2013 je Komisija preučila vlogo za registracijo imena „Dons“ kot zaščitene označbe porekla (ZOP), ki jo je poslala Danska, in jo objavila v Uradnem listu Evropske unije.
The Commission deemed all three objections admissible according to Article 15 of Regulation (EC) No 607/2009.
Danska je svoje pripombe poslala v zahtevanem roku, 4. julija 2016.
By letter dated 24 May 2016, the Commission forwarded these objections to the Danish authorities and invited them to file their related observations within two months, in line with Article 16(1) of Regulation (EC) No 607/2009.
Kot je določeno v členu 16(1) Uredbe (ES) št. 607/2009, je Komisija pripombe danskih organov posredovala v dopisih z dne 12. januarja 2017 trem vložnikom ugovorov in jim dala na voljo dva meseca časa za morebitne pripombe.
Denmark sent its observations within the required deadline, on 4 July 2016.
Komisija je v odgovor prejela še eno sporočilo italijanskega ministrstva za kmetijstvo 10. marca 2017, v katerem je to ponovilo svoj ugovor.
As provided for in Article 16(1) of Regulation (EC) No 607/2009, the Commission communicated the observations from the Danish authorities by letters of 12 January 2017 to the three objectors, and they were given two months for possible comments.
V skladu s členom 16(3) Uredbe (ES) št. 607/2009 bi morala Komisija sprejeti odločitev na podlagi razpoložljivih dokazov.
In reply, the Commission received another communication from the Italian Ministry of Agriculture on 10 March 2017, reiterating its opposition.
Vsi trije vložniki ugovorov trdijo, da se nekatere sorte vinske trte, ki se uporabljajo za proizvodnjo vina „Dons“, namreč „cabernet cortis“, „orion“, „regent“, „rondo“ in „solaris“, in ki se štejejo za križance, pridobljene s križanjem vrste Vitis vinifera z drugimi vrstami rodu Vitis, ne bi smele uporabljati pri proizvodnji zaščitene označbe porekla v skladu s členom 93(1)(a)(iv) Uredbe (EU) št. 1308/2013.
In accordance with Article 16(3) of Regulation (EC) No 607/2009, the Commission should take a decision on the basis of the evidence available to it.
Trdijo tudi, da se sorta, pridobljena s križanjem med vrstami, v nobenem primeru ne more šteti za sorto, ki spada v vrsto Vitis vinifera.
All three objectors claim that certain vine varieties used for the production of ‘Dons’, namely ‘Cabernet Cortis’, ‘Orion’, ‘Regent’, ‘Rondo’ and ‘Solaris’, which they consider to be hybrids obtained from cross-breeding of the species Vitis vinifera with other species of the genus Vitis, should not be used for the production of a Protected Designation of Origin according to Article 93(1)(a)(iv) of Regulation (EU) No 1308/2013.
Po mnenju italijanskega ministrstva za kmetijstvo in FEDERDOC se s pregledom genoma v kateri koli državi Evropske unije lahko ugotovi, ali sorta spada v vrsto Vitis vinifera ali pa je križanec z drugo vrsto rodu Vitis.
They also claim that in no case a variety obtained from an interspecies cross could be considered as belonging to the species Vitis vinifera.
Italijansko ministrstvo za kmetijstvo poleg tega trdi, da je sklicevanje na človeške dejavnike nezadostno, kot tudi vzročna povezava med naravnimi in človeškimi dejavniki ter informacije o kakovosti in značilnostih proizvoda, ki se lahko pripišejo geografskemu območju.
According to the Italian Ministry of Agriculture and FEDERDOC, in any country of the European Union, the examination of the genome makes it possible to determine whether a variety belongs to the species Vitis vinifera or a cross with another species of the genus Vitis.
Poleg tega ta vložnik ugovora trdi, da trditev o tem, da se kislost proizvoda lahko pripiše „izboru razmeroma odpornih sort“, nima nikakršne tehnične in znanstvene podlage, glede na to, da je izbor sort dolgotrajen proces, ki se ne more nanašati na sorte križancev med vrstami.
The Italian Ministry of Agriculture additionally claims that the reference to human factors is insufficient, as is the causal link between natural and human factors, and information on the quality and characteristics of the product attributable to the geographical environment.
Nazadnje italijansko ministrstvo za kmetijstvo meni, da je odvečno navajati zahteve o označevanju sort vinske trte in letu trgatve, ker so take zahteve navedene v členih 61 in 62 Uredbe (ES) št. 607/2009.
Moreover, this objector claims that the assertion that the acidity profile of the product is attributable to the ‘selection of relatively hardy varieties’ is devoid of any technical and scientific basis, taking into account that the selection of varieties is a long-term process which cannot refer to interspecies hybrid varieties.
Komisija je ocenila argumente in dokaze, ki so jih zagotovili vložniki ugovorov in vlagatelj, ter sklenila, da bi bilo treba ime „Dons“ registrirati kot zaščiteno označbo porekla iz razlogov, navedenih v nadaljevanju.
Lastly, the Italian Ministry of Agriculture considers that it is superfluous to state the requirements about the labelling of grape varieties and the vintage year, as such requirements are laid down in Articles 61 and 62 of Regulation (EC) No 607/2009.
V zvezi s trditvami, da proizvod ni pridobljen iz sort vinske trte, ki spadajo v vrsto Vitis vinifera, je bilo upoštevanih več elementov.
The Commission has assessed the arguments and evidence provided by the objectors and the applicant, and concluded that the name ‘Dons’ should be registered as Protected Designation of Origin for the following reasons.
Prvič, na ravni EU ni usklajene razvrstitve sorte vinske trte, ki spada v vrsto Vitis vinifera.
As regards the allegations that the product is not obtained from vine varieties belonging to Vitis vinifera, several elements have to be taken into account.
Poleg tega trenutno ni na voljo referenčni seznam ali znanstveni dokument katerega koli uradnega pristojnega organa, kot je Mednarodna organizacija za trto in vino (OIV), ki bi omogočil nesporno kategorizacijo vrste Vitis vinifera ali križanca med vrsto Vitis vinifera in drugimi vrstami rodu Vitis ali razlikovanje med njima.
Firstly, there is no harmonised classification of a vine variety belonging to Vitis vinifera at EU level.
Na podlagi navedenega bi bilo treba vprašanje znanstvene opredelitve obravnavati predvsem v predhodni nacionalni oceni, ki jo opravijo države članice v skladu s členom 96 Uredbe (EU) št. 1308/2013.
In addition, there is no reference list or scientific document available from any official competent body, such as the International Organisation of Vine and Wine (OIV), which currently would allow to undisputedly categorize Vitis vinifera species or a cross between the Vitis vinifera species and other species of the genus Vitis, or to distinguish between them.
Danska se opira na nemško razvrstitev, po kateri je vseh pet zadevnih sort vinske trte razvrščenih kot sorte, ki spadajo v vrsto Vitis vinifera.
Against this background, the issue of scientific definition should primarily be addressed in the preliminary national assessment conducted by the Member States in accordance with Article 96 of Regulation (EU) No 1308/2013.
Drugič, v skladu s členom 16(3) Uredbe (ES) št. 607/2009 v zvezi s preučitvijo ugovora Komisija sprejme vsako odločitev za zavrnitev ali registracijo označbe porekla na podlagi razpoložljivih dokazov.
Denmark relies on the German classification where all five wine grape varieties in question are classified as belonging to Vitis vinifera.
V obravnavani zadevi vložniki ugovorov niso predložili kakršnih koli trdnih znanstvenih dokazov ali podatkov, ki bi dokazovali, da se proizvod ne pridobiva iz sort vinske trte, ki spadajo v vrsto Vitis vinifera.
Secondly, pursuant to Article 16(3) of Regulation (EC) No 607/2009 regarding the Scrutiny of an objection, the Commission shall take any decision to reject or register the designation of origin on the basis of the evidence available to it.
Nazadnje, Komisija ugotavlja, da več drugih držav članic uporablja zadevne sorte vinske trte pri proizvodnji svojih vin z zaščiteno označba porekla.
In the case at hand the objectors did not provide any solid scientific evidence or data proving that the product is not obtained from vine varieties belonging to Vitis vinifera.
Zaradi zgoraj navedenih razlogov ni mogoče sklepati, da se proizvod z imenom „Dons“ pridobiva iz sort vinske trte, ki ne spadajo v vrsto Vitis vinifera.
Lastly, the Commission notes that several other Member States use the wine grape varieties in question in the production of their wines with Protected Designation of Origin.
Zato je treba ugovore, ki temeljijo na teh razlogih, zavrniti.
For the above reasons, it is not possible to conclude that the product referred to by the name ‘Dons’ is obtained from vine varieties not belonging to Vitis vinifera.
Kar zadeva domnevno manjkajoče informacije o povezavi, Komisija ugotavlja, da je bil opis zadevnih naravnih dejavnikov, prisotnih v geografskem okolju, predložen, kakor tudi njihova povezava s posebno kakovostjo in značilnostmi proizvoda, kar se odraža zlasti v višji vsebnosti mlečne kisline proizvoda, to pa ga ločuje od klasičnih penečih vin.
The objections made on that ground therefore have to be rejected.
Zato je treba skleniti, da so bili vključeni vsi potrebni elementi povezave v skladu s členom 7 Uredbe (ES) št. 607/2009.
As regards the alleged missing information on the link, the Commission observes that a description of the relevant natural factors present in the geographical environment has been provided, as well as their link to the specific quality and characteristics of the product, expressed notably in a higher lactic acidity of the product distinguishing it from classical sparkling wines.
Kar zadeva človeške dejavnike, se za kislost proizvoda šteje, da jo je mogoče pripisati izboru razmeroma odpornih sort v skladu s členom 93(1)(a)(i) Uredbe (EU) št. 1308/2013.