natgillin/translations-raw huggingface dataset:
Organisms belonging to different taxonomic phyla differ biologically on essential traits, involving different endocrine modes of action.
Snovi, katerih predviden biocidni način delovanja je v smislu točke 6.5 naslova 1 Priloge II k Uredbi (EU) št. 528/2012 zatiranje ciljnih organizmov, razen vretenčarjev, prek njihovih endokrinih sistemov, tako predstavljajo način delovanja, ki predvidoma ni relevanten za vretenčarje.
Therefore, a certain endocrine mode of action relevant for a specific phylum may not be biologically plausible for organisms of a different phylum.
Posledično te snovi s takim predvidenim načinom delovanja na splošno ne predstavljajo tveganja za ljudi in vretenčarje v okolju, zato so še zlasti učinkovite in koristne pri integriranem varstvu rastlin pred škodljivimi organizmi.
Substances whose intended biocidal mode of action, within the meaning of point 6.5, Title 1 of Annex II of Regulation (EU) No 528/2012, is to control target organisms other than vertebrates via their endocrine system, therefore present a mode of action which is not expected to be relevant for vertebrates.
Pri določanju meril za ugotavljanje lastnosti endokrinih motilcev, ki bi lahko škodljivo učinkovale na neciljne organizme, je glede na cilje Uredbe (EU) št. 528/2012 in načelo sorazmernosti ustrezno upoštevati navedene znanstvene razmisleke.
These substances consequently do not generally pose a risk via this intended mode of action to humans and vertebrates in the environment and are therefore particularly effective and useful in integrated pest management.
Kadar je predviden način delovanja zatiranje ciljnih organizmov, razen vretenčarjev, prek njihovih endokrinih sistemov, se za namene opredelitve lastnosti endokrinih motilcev za neciljne organizme zato ne smejo upoštevati učinki navedenega predvidenega načina delovanja na organizme, ki pripadajo istemu taksonomskemu deblu kot ciljni organizem.
When setting the criteria for the determination of endocrine-disrupting properties that may cause adverse effects on non-target organisms, it is appropriate, in view of the objectives of Regulation (EU) No 528/2012, and the principle of proportionality, to take account of the above scientific considerations.
Vendar se aktivne snovi s takim predvidenim načinom delovanja lahko odobrijo le, če na podlagi ocene tveganja in ob upoštevanju posebnih zahtev glede podatkov iz Uredbe (EU) št. 528/2012 njihova uporaba ne privede do nesprejemljivih učinkov na neciljne organizme, tudi organizme iz istega debla kot ciljni organizem.
Therefore, where the intended mode of action consists of controlling target organisms other than vertebrates via their endocrine systems, the effects caused by that intended mode of action on organisms of the same taxonomic phylum as the targeted one should not be considered for the purposes of the identification of endocrine-disrupting properties with respect to non-target organisms.
Komisija bi glede na cilje Uredbe (EU) št. 528/2012 morala oceniti izkušnje, pridobljene pri uporabi znanstvenih meril za ugotavljanje lastnosti endokrinih motilcev, uvedenih s to uredbo.
The active substances with such an intended mode of action may however be approved only if, following a risk assessment, and taking into consideration specific data requirements set by the Regulation (EU) No 528/2012, their use does not lead to unacceptable effects on non-target organisms, including on organisms of the same phylum as the target organism.
Merila za ugotavljanje lastnosti endokrinih motilcev odražajo trenutno znanstveno in tehnično znanje ter omogočajo natančnejšo opredelitev snovi z lastnostmi endokrinih motilcev.
The Commission should assess, in light of the objectives of Regulation (EU) No 528/2012, the experience gained from the application of the scientific criteria for the determination of endocrine-disrupting properties introduced by the present Regulation.
Brez poseganja v člen 90(2) Uredbe (EU) št. 528/2012 bi zato bilo treba nova merila začeti uporabljati čim prej, ob upoštevanju časa, ki ga države članice in Evropska agencija za kemikalije potrebujejo, da se pripravijo na uporabo navedenih meril.
The criteria for the determination of endocrine-disrupting properties reflect the current state of scientific and technical knowledge and allow identifying substances having endocrine-disrupting properties more accurately.
To lahko vključuje zahtevo za dodatne informacije vložnika in/ali dodatno mnenje regulativnega organa in/ali revidirano mnenje Evropske agencije za kemikalije –
Without prejudice to Article 90(2) of Regulation (EU) No 528/2012, the new criteria should therefore apply as soon as possible, while taking into account the time necessary for Member States and the European Chemicals Agency to prepare for applying those criteria.
SPREJELA NASLEDNJO UREDBO:
The Commission will consider the implications for each procedure pending under Regulation (EU) No 528/2012 and, where necessary, take appropriate measures with due respect for the rights of the applicants.
Znanstvena merila za ugotavljanje lastnosti endokrinih motilcev v skladu z Uredbo (EU) št. 528/2012 so določena v Prilogi k tej uredbi.
This may include a request for additional information from the applicant and/or for additional input from the regulatory body and/or a revised opinion from the Agency,
Člen 2
HAS ADOPTED THIS REGULATION:
Merila iz Priloge k tej uredbi se uporabljajo od 7. junija 2018, razen za postopke odobritve, za katere je odbor iz člena 82 Uredbe (EU) št. 528/2012 glasoval o osnutku uredbe do 7. junija 2018.
The scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 are set out in the Annex to this Regulation.
Komisija do 7. junija 2025 skupini strokovnjakov („srečanje pristojnih organov za biocide“), ki jo sestavljajo predstavniki pristojnih organov držav članic za biocidne proizvode, predloži oceno izkušenj, pridobljenih pri uporabi znanstvenih meril za ugotavljanje lastnosti endokrinih motilcev, uvedenih s to uredbo.
The criteria laid down in the Annex to this Regulation shall apply as of 7 June 2018, except for procedures where the Committee referred to in Article 82 of Regulation (EU) No 528/2012 has voted on a draft Regulation by 7 June 2018.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Article 3
Uporablja se od 7. junija 2018.
By 7 June 2025, the Commission shall present to the expert group (the ‘Biocides CA meeting’) consisting of representatives of Member States' competent authorities for biocidal products an assessment of the experience gained from the application of the scientific criteria for the determination of endocrine-disrupting properties introduced by the present Regulation.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
Article 4
V Bruslju, 4. septembra 2017
It shall apply from 7 June 2018.
Predsednik
This Regulation shall be binding in its entirety and directly applicable in all Member States.
UL L 167, 27.6.2012, str. 1.
Done at Brussels, 4 September 2017.
SZO/MPKV (Svetovna zdravstvena organizacija/Mednarodni program za kemijsko varnost), 2002.
For the Commission
SZO/MPKV (Svetovna zdravstvena organizacija/Mednarodni program za kemijsko varnost), 2009.
The President
Načela in metode za oceno tveganja kemikalij v živilih (Principles and Methods for the Risk Assessment of Chemicals in Food).
OJ L 167, 27.6.2012, p. 1.
Merila za zdravje okolja (Environmental Health Criteria) 240, na voljo javnosti na: http://www.who.int/foodsafety/publications/chemical-food/en/.
Global Assessment of the State-of-the-science of Endocrine Disruptors.
[6] Uredba (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi, o spremembi in razveljavitvi direktiv 67/548/EGS in 1999/45/ES ter spremembi Uredbe (ES) št. 1907/2006 (UL L 353, 31.12.2008, str. 1).
WHO/PCS/EDC/02.2, publicly available at http://www.who.int/ipcs/publications/new_issues/endocrine_disruptors/en/
Serija OECD o testiranju in ocenjevanju (OECD Series on Testing and Assessment), št. 150.
WHO/IPCS (World Health Organisation/International Programme on Chemical Safety), 2009.
PRILOGA
‘Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment’, EFSA Journal 2013;11(3):3132, doi: 10.2903/j.efsa.2013.3132.
Za snov se šteje, da ima lastnosti endokrinega motilca, ki lahko škodljivo učinkuje na ljudi, če je na podlagi točk (a) do (d) točke 2 to snov, ki izpolnjuje vsa naslednja merila, razen če obstajajo dokazi, ki dokazujejo, da ugotovljeni škodljivi učinki niso relevantni za ljudi:
Scientific Committee on Consumer Safety, Memorandum on Endocrine disruptors, 16.12.2014 (SCCS/1544/14).
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;
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).
ima endokrin način delovanja, tj. spremeni funkcijo(-e) endokrinega sistema;
OECD Series on Testing and Assessment No 150.
škodljivi učinek je posledica endokrinega načina delovanja.
ANNEX
Opredelitev snovi kot snovi z lastnostmi endokrinega motilca, ki lahko škodljivo učinkuje na ljudi v skladu s točko 1, temelji na naslednjih točkah:
A substance shall be considered as having endocrine-disrupting properties with respect to humans or non-target organisms, where it meets the criteria set out in section A or section B.
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):
Section A — Endocrine-disrupting properties with respect to humans
znanstvenih podatkih, pridobljenih v skladu z mednarodno sprejetimi študijskimi protokoli, zlasti tistimi iz prilog II in III k Uredbi (EU) št. 528/2012;
A substance shall be considered as having endocrine-disrupting properties that may cause adverse effect in humans if, based on points (a) to (d) of point (2), 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:
drugih znanstvenih podatkih, izbranih z uporabo sistematičnega pregleda metodologije;
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;
oceni razpoložljivih zadevnih znanstvenih podatkov, ki temeljijo na pristopu teže dokazov, da se ugotovi, ali so izpolnjena merila iz točke 1; z uporabo pristopa določitve teže dokazov se pri oceni znanstvenih dokazov zlasti upoštevajo naslednji dejavniki:
it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
pozitivni in negativni rezultati;
the adverse effect is a consequence of the endocrine mode of action.
ustreznost zasnov študij za oceno škodljivih učinkov in endokrinega načina delovanja;
The identification of a substance as having endocrine-disrupting properties that may cause adverse effect in humans in accordance with point (1) shall be based on all of the following points:
kakovost in doslednost podatkov glede na vzorec in doslednost rezultatov znotraj študije in med študijami s podobno zasnovo in z različnimi vrstami;
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):
študije načina izpostavljenosti, toksikokinetične študije in študije presnove;
scientific data generated in accordance with internationally agreed study protocols, in particular those referred to in Annexes II and III of Regulation (EU) No 528/2012;
pojem mejnega odmerka, mednarodne smernice o največjih priporočenih odmerkih in za oceno zavajajočih učinkov prekomerne toksičnosti;
other scientific data selected applying a systematic review methodology;
z uporabo pristopa teže dokazov se povezava med škodljivim učinkom oz. učinki endokrinega načina delovanja vzpostavi na podlagi biološke verjetnosti, ki se določi ob upoštevanju trenutnega znanstvenega znanja in mednarodno sprejetih smernic;
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 point (1) are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall, in particular, consider all of the following factors:
škodljivi učinki, ki niso specifične sekundarne posledice drugih toksičnih učinkov, se ne upoštevajo pri opredelitvi snovi kot endokrinega motilca.
both positive and negative results;
Oddelek B – lastnosti endokrinega motilca pri neciljnih organizmih
the relevance of the study designs for the assessment of adverse effects and of the endocrine mode of action;
Za snov se šteje, da ima lastnosti endokrinega motilca, ki lahko škodljivo učinkuje na neciljne organizme, če je na podlagi točk (a) do (d) točke 2 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:
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;
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;
the route of exposure, toxicokinetic and metabolism studies;
Opredelitev snovi kot snovi z lastnostmi endokrinega motilca, ki lahko škodljivo učinkuje na neciljne organizme v skladu s točko 1, temelji na naslednjih točkah:
the concept of the limit dose, and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
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):
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;
oceni razpoložljivih zadevnih znanstvenih podatkov, ki temeljijo na pristopu teže dokazov, da se ugotovi, ali so izpolnjena merila iz točke 1; z uporabo pristopa določitve teže dokazov se pri oceni znanstvenih dokazov upoštevajo naslednji dejavniki:
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.
pozitivni in negativni rezultati, ki razlikujejo med taksonomskimi skupinami (npr. sesalci, ptice, ribe, dvoživke), kadar je to ustrezno;
Section B — Endocrine-disrupting properties with respect to non-target organisms
ustreznost zasnove študije za oceno škodljivih učinkov in njene ustreznosti na ravni (sub)populacije ter za oceno endokrinega načina delovanja;
A substance shall be considered as having endocrine-disrupting properties that may cause adverse effects on non-target organisms if, based on points (a) to (d) of point (2), it is a substance that meets all of following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant at the (sub)population level for non-target organisms:
škodljivi učinki na razmnoževanje, rast in razvoj ter drugi relevantni škodljivi učinki, ki bi najverjetneje vplivali na (sub)populacije.
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;
Ustrezni, zanesljivi in reprezentativni terenski podatki in/ali rezultati ali podatki in/ali rezultati spremljanja iz modelov populacije se prav tako upoštevajo, kadar so ti na voljo;
The identification of a substance as having endocrine-disrupting properties that may cause adverse effects on non-target organisms in accordance with point (1) shall be based on all of the following points:
kakovost in doslednost podatkov glede na vzorec in doslednost rezultatov znotraj študije in med študijami s podobno zasnovo in z različnimi taksonomskimi skupinami;
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):
pojem mejnega odmerka, mednarodne smernice o največjih priporočenih odmerkih in za oceno zavajajočih učinkov prekomerne toksičnosti;
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 point 1 are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall consider all of the following factors:
škodljivi učinki, ki niso specifične sekundarne posledice drugih toksičnih učinkov, se ne upoštevajo pri opredelitvi snovi kot endokrinega motilca za neciljne organizme.
both positive and negative results, discriminating between taxonomic groups (e.g. mammals, birds, fish, amphibians) where relevant;
Če je predviden biocidni način delovanja aktivne snovi, ki se ocenjuje, zatiranje ciljnih organizmov, razen vretenčarjev, prek njihovih endokrinih sistemov, se učinki na organizme iz istega taksonomskega debla kot ciljne organizme ne upoštevajo pri opredelitvi snovi kot snovi z lastnostmi endokrinega motilca za neciljne organizme.
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;
Zato bi bilo treba navedena merila začeti uporabljati 7. junija 2018, razen kadar odbor iz člena 82 Uredbe (EU) št. 528/2012 do 7. junija 2018 glasuje o osnutku uredbe.
the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely to impact on (sub)populations.
Komisija bo preučila posledice za vsak nedokončan postopek odobritve v skladu z Uredbo (EU) št. 528/2012 in po potrebi sprejela ustrezne ukrepe ob ustreznem spoštovanju pravic vložnikov.
Adequate, reliable and representative field or monitoring data and/or results from population models shall as well be considered where available;
Globalna ocena znanstvenih dognanj o endokrinih motilcih (Global Assessment of the State-of-the-science of Endocrine Disruptors).
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;
SZO/MPKV/EDC/02.2, na voljo javnosti na: http://www.who.int/ipcs/publications/new_issues/endocrine_disruptors/en/.
the concept of the limit dose and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
Znanstvena merila za ugotavljanje lastnosti endokrinih motilcev v skladu z Uredbo (EU) št. 528/2012 bi bilo treba določiti ob upoštevanju namena navedene uredbe za izboljšanje prostega pretoka biocidnih proizvodov v Uniji, pri tem pa zagotoviti visoko raven varovanja zdravja ljudi in živali ter okolja.
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.
Znanstveno mnenje o oceni nevarnosti endokrinih motilcev: Znanstvena merila za opredelitev endokrinih motilcev in o ustreznosti obstoječih testnih metod za ocenjevanje učinkov, ki jih imajo te snovi na zdravje ljudi in na okolje (Scientific Opinion on the hazard assessment of endocrine disruptors: Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment), EFSA Journal 2013;11(3):3132, doi: 10.2903/j.efsa.2013.3132.
Regulation (EU) 2017/2101 of the European Parliament and of the Council
Uredba (EU) 2017/2101 Evropskega parlamenta in Sveta
amending Regulation (EC) No 1920/2006 as regards information exchange on, and an early warning system and risk assessment procedure for, new psychoactive substances
o spremembi Uredbe (ES) št. 1920/2006 glede izmenjave informacij o novih psihoaktivnih snoveh in sistema zgodnjega opozarjanja na te snovi ter postopka ocene tveganja zanje
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 168(5) Pogodbe,
New psychoactive substances can pose serious cross-border threats to health, in particular due to the large number and diversity of those substances and the speed with which they appear.
Nove psihoaktivne snovi lahko predstavljajo resno čezmejno nevarnost za zdravje, zlasti zaradi velikega števila in raznolikosti teh snovi ter hitrosti, s katero se pojavljajo.
In order to develop responses for addressing those threats, it is necessary to enhance monitoring and the early warning system and to assess the health and social risks associated with new psychoactive substances.
Da bi razvili rešitve za učinkovito obravnavanje te nevarnosti, je treba izboljšati spremljanje in sistem za zgodnje opozarjanje ter ocenjevati zdravstvena in socialna tveganja, povezana z novimi psihoaktivnimi snovmi.
Vulnerable groups, especially young people, are particularly exposed to the health and social risks associated with new psychoactive substances.
Ranljive skupine, zlasti mladi, so še posebno izpostavljeni zdravstvenim in socialnim tveganjem, povezanim z novimi psihoaktivnimi snovmi.
In recent years, Member States have notified an increasing number of new psychoactive substances via the mechanism for rapid exchange of information on such substances, which was established by Council Joint Action 97/396/JHA [3] and further strengthened by Council Decision 2005/387/JHA [4].
V zadnjih letih so države članice prijavljale naraščajoče število novih psihoaktivnih snovi prek mehanizma za hitro izmenjavo informacij o teh snoveh, ki je bil vzpostavljen s Skupnim ukrepom Sveta 97/396/PNZ [3] in dodatno okrepljen s Sklepom Sveta 2005/387/PNZ [4].
New psychoactive substances that pose public health and, where applicable, social risks across the Union should be addressed at Union level.
Nove psihoaktivne snovi, ki predstavljajo tveganja za javno zdravje ali, v nekaterih primerih, socialna tveganja v Uniji, bi bilo treba obravnavati na ravni Unije.