natgillin/translations-raw huggingface dataset:
Those definitions have by now reached the widest consensus among scientists.
Svjetska zdravstvena organizacija (WHO) predložila je 2002. u okviru Međunarodnog programa za sigurnost kemikalija definiciju endokrinih disruptora, a 2009. definiciju štetnih učinaka .
The European Food Safety Authority (‘the Authority’) endorsed those definitions in its Scientific Opinion on endocrine disruptors adopted on 28 February 2013 (hereinafter ‘the Scientific Opinion of the Authority’).
Te su definicije u međuvremenu općenito prihvaćene među znanstvenicima.
Such is also the view of the Scientific Committee on Consumer Safety.
Europska agencija za sigurnost hrane ( „Agencija”) odobrila je te definicije u znanstvenom mišljenju o endokrinim disruptorima donesenom 28. veljače 2013. (dalje u tekstu: „znanstveno mišljenje Agencije”).
It is therefore appropriate to base the criteria for the determination of endocrine disrupting properties on those WHO definitions.
To mišljenje dijeli i Znanstveni odbor za zaštitu potrošača.
In order to implement those criteria, weight of evidence should be applied considering in particular the approach provided for in Regulation (EC) No 1272/2008 of the European Parliament and of the Council on the weight of evidence.
Stoga je primjereno temeljiti kriterije za određivanje svojstava endokrine disrupcije na tim definicijama WHO-a.
Previous experience with the Guidance document on standardised test guidelines for evaluating chemicals for endocrine disruption of OECD should also be considered.
Za provedbu tih kriterija trebalo bi primijeniti pristup utvrđivanja valjanosti i utemeljenosti dokaza, posebno uzimajući u obzir pristup predviđen Uredbom (EZ) br. 1272/2008 Europskog parlamenta i Vijeća za utvrđivanje valjanosti i utemeljenosti dokaza.
In addition, the implementation of the criteria should be based on all relevant scientific evidence, including studies submitted in accordance with the current regulatory data requirements of Regulation (EC) No 1107/2009.
Trebalo bi uzeti u obzir i prethodno iskustvo s primjenom vodiča OECD-a o standardiziranim smjernicama za ispitivanje za ocjenu kemikalija u pogledu endokrine disrupcije.
These studies are mostly based on internationally agreed study protocols.
Osim toga, provedba kriterija trebala bi se temeljiti na svim relevantnim znanstvenim dokazima, uključujući studije dostavljene u skladu s trenutačnim zahtjevima u pogledu podataka iz Uredbe (EZ) br. 1107/2009.
The determination of endocrine disrupting properties with respect to human health should be based on human and/or animal evidence, therefore allowing for the identification of both known and presumed endocrine disrupting substances.
Te se studije uglavnom temelje na međunarodno dogovorenim planovima ispitivanja.
As the specific scientific criteria laid down by this Regulation reflect the current scientific and technical knowledge and are to be applied instead of the criteria currently set out in point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, they should be provided for in that Annex.
Utvrđivanje svojstava endokrine disrupcije u odnosu na ljudsko zdravlje trebalo bi se temeljiti na dokazima koji se odnose na ljude i/ili životinje, čime se omogućava utvrđivanje tvari za koje je poznato ili se pretpostavlja da su endokrino disruptivne.
In order to take into account the current scientific and technical knowledge, specific scientific criteria should also be specified in order to identify active substances, safeners or synergists having endocrine disrupting properties that may cause adverse effects on non-target organisms.
Budući da posebni znanstveni kriteriji utvrđeni ovom Uredbom odražavaju trenutačna znanstvena i tehnička saznanja i potrebno ih je primijeniti umjesto kriterija trenutačno utvrđenih u točki 3.6.5.
Therefore point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 should be amended to introduce these specific criteria.
Priloga II.
The Commission should assess, in light of the objectives of Regulation (EC) No 1107/2009, the experience gained from the application of the scientific criteria for the determination of endocrine disrupting properties introduced by the present Regulation.
Uredbi (EZ) br. 1107/2009, trebalo bi ih propisati u tom Prilogu.
The criteria for the determination of endocrine disrupting properties reflect the current state of scientific and technical knowledge and allow identifying active substances having endocrine disrupting properties more accurately.
Kako bi se uzela u obzir trenutačna znanstvena i tehnička saznanja, trebalo bi odrediti i posebne znanstvene kriterije za utvrđivanje aktivnih tvari, safenera i sinergista koji imaju svojstva endokrine disrupcije koja mogu imati štetne učinke na organizme koji ne pripadaju ciljnoj skupini.
The new criteria should therefore apply as soon as possible, while taking into account the time necessary for Member States and the Authority to prepare for applying those criteria.
Stoga bi točku 3.8.2.
The Commission will consider the implications for each procedure pending under Regulation (EC) No 1107/2009 and, where necessary, take appropriate measures with due respect for the rights of the applicants.
Uredbi (EZ) br. 1107/2009 trebalo izmijeniti radi uvođenja tih posebnih kriterija.
This may include a request for additional information from the applicant and/or for additional scientific input from the rapporteur Member State and the Authority.
Uzimajući u obzir ciljeve Uredbe (EZ) br. 1107/2009 Komisija bi trebala ocijeniti iskustvo stečeno primjenom znanstvenih kriterija za određivanje svojstava endokrine disrupcije uvedenih ovom Uredbom.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Kriteriji za određivanje svojstava endokrine disrupcije odražavaju trenutačna znanstvena i tehnička saznanja i omogućuju točnije utvrđivanje aktivnih tvari koje imaju svojstva endokrine disrupcije.
HAS ADOPTED THIS REGULATION:
Stoga bi se novi kriteriji trebali što prije početi primjenjivati, no potrebno je uzeti u obzir vrijeme koje je državama članicama i Agenciji potrebno kako bi se pripremile za primjenu tih kriterija.
Article 1
To može uključivati zahtjev za dodatne informacije od podnositelja zahtjeva i/ili dodatne znanstvene informacije od države članice izvjestiteljice i Agencije.
Annex II to Regulation (EC) No 1107/2009 is amended in accordance with the Annex to this Regulation.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
Points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by this Regulation, shall apply as of 20 October 2018, except for procedures where the Committee has voted on a draft Regulation by 20 October 2018.
Članak 1.
By 20 October 2025, the Commission shall present to the Committee referred to in Article 79 of Regulation (EC) No 1107/2009 an assessment of the experience gained from the application of the scientific criteria for the determination of endocrine disrupting properties introduced by this Regulation.
Uredbi (EZ) br. 1107/2009 mijenja se u skladu s Prilogom ovoj Uredbi.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Točke 3.6.5. i 3.8.2.
It shall apply from 20 October 2018.
Priloga II.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Uredbi (EZ) br. 1107/2009, kako je izmijenjen ovom Uredbom, primjenjuju se od 20. listopada 2018. osim za postupke u kojima je Odbor glasao o nacrtu uredbe do 20. listopada 2018.
Done at Brussels, 19 April 2018.
Članak 3.
For the Commission
Komisija do 20. listopada 2025. odboru iz članka 79.
The President
Uredbe (EZ) br. 1107/2009 dostavlja ocjenu iskustva stečenog primjenom znanstvenih kriterija za određivanje svojstava endokrine disrupcije uvedenih ovom Uredbom.
OJ L 309, 24.11.2009, p. 1.
Članak 4.
WHO/IPCS (World Health Organization/International Programme on Chemical Safety), 2002.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Global Assessment of the State-of-the-science of Endocrine Disruptors.
Primjenjuje se od 20. listopada 2018.
WHO/PCS/EDC/02.2, publicly available at http://www.who.int/ipcs/publications/new_issues/endocrine_disruptors/en/
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
WHO/IPCS (World Health Organization/International Programme on Chemical Safety), 2009.
Sastavljeno u Bruxellesu 19. travnja 2018.
Principles and Methods for the Risk Assessment of Chemicals in Food.
Za Komisiju
Environmental Health Criteria 240, publicly available at http://www.who.int/foodsafety/publications/chemical-food/en/
Predsjednik
‘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.
SL L 309, 24.11.2009., str. 1.
Scientific Committee on Consumer Safety, Memorandum on Endocrine disruptors, 16.12.2014 (SCCS/1544/14).
WHO/IPCS (Svjetska zdravstvena organizacija / Međunarodni program za sigurnost kemikalija), 2002.
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).
„Global Assessment of the State-of-the-science of Endocrine Disruptors” (Globalna procjena znanstvenih spoznaja o endokrinim disruptorima).
OECD Series on Testing and Assessment No 150.
WHO/PCS/EDC/02.2, javno dostupno na: http://www.who.int/ipcs/publications/new_issues/endocrine_disruptors/en/.
ANNEX
WHO/IPCS (Svjetska zdravstvena organizacija / Međunarodni program za sigurnost kemikalija), 2009.
Annex II to Regulation (EC) No 1107/2009 is amended as follows:
„Principles and Methods for the Risk Assessment of Chemicals in Food”(Načela i metode za procjenu rizika od kemikalija u hrani).
in point 3.6.5 the following paragraphs are added after the fourth paragraph:
„Environmental Health Criteria 240” (Kriteriji za okoliš i zdravlje 240), javno dostupno na: http://www.who.int/foodsafety/publications/chemical-food/en/.
‘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:
„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” (Znanstveno mišljenje o ocjeni opasnosti endokrinih disruptora: znanstveni kriteriji za utvrđivanje endokrinih disruptora i prikladnost postojećih metoda ispitivanja za procjenu učinaka koje te tvari imaju na ljudsko zdravlje i okoliš), EFSA Journal 2013.; 11(3):3132, doi: 10.2903/j.efsa.2013.3132.
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;
Znanstveni odbor za sigurnost potrošača, „Memorandum on Endocrine disruptors” (Memorandum o endokrinim disruptorima), 16.12.2014.
it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
(SCCS/1544/14).
the adverse effect is a consequence of the endocrine mode of action.
Uredba (EZ) br. 1272/2008 Europskog parlamenta i Vijeća od 16. prosinca 2008. o razvrstavanju, označivanju i pakiranju tvari i smjesa, o izmjeni i stavljanju izvan snage Direktive 67/548/EEZ i Direktive 1999/45/EZ i o izmjeni Uredbe (EZ) br. 1907/2006 (SL L 353, 31.12.2008., str. 1.).
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:
OECD Series on Testing and Assessment No. 150 (Publikacije OECD-a o testiranju i ocjenjivanju, br. 150).
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):
PRILOG
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;
Prilog II.
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;
Uredbi (EZ) br. 1107/2009 mijenja se kako slijedi:
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:
U točki 3.6.5. nakon četvrtog stavka dodaju se sljedeći stavci:
both positive and negative results;
„Od 20. listopada 2018. smatra se da aktivna tvar, safener ili sinergist posjeduje svojstva endokrine disrupcije koja mogu imati štetne učinke na ljude ako na temelju točaka od 1. do 4. šestog stavka ta tvar zadovoljava sve kriterije u nastavku, osim ako je dokazano da utvrđeni štetni učinci nisu relevantni za ljude:
the relevance of the study designs, for the assessment of adverse effects and of the endocrine mode of action;
tvar pokazuje štetan učinak na netaknuti organizam ili njegovo potomstvo u obliku promjene u morfologiji, fiziologiji, rastu, razvoju, razmnožavanju ili životnom vijeku organizma, sustava ili (sub)populacije koja uzrokuje ograničenje funkcionalne sposobnosti i sposobnosti nošenja s dodatnim stresom ili povećanje osjetljivosti na druge utjecaje;
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;
tvar ima endokrin način djelovanja, odnosno mijenja funkciju/funkcije endokrinog sustava;
the route of exposure, toxicokinetic and metabolism studies;
štetan učinak posljedica je endokrinog načina djelovanja.
the concept of the limit dose, and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
Utvrđivanje aktivne tvari, safenera ili sinergista kao tvari koja posjeduje svojstva endokrine disrupcije koja mogu imati štetan učinak na ljude u skladu s petim stavkom temelji se na svim sljedećim točkama:
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;
svi raspoloživi relevantni znanstveni podaci (ispitivanja in vivo ili na odgovarajući način potvrđeni alternativni sustavi ispitivanja s pomoću kojih je moguće predvidjeti štetne učinke za ljude ili za životinje te ispitivanja in vivo, in vitro ili, ako je primjenjivo, in silico kojima se dobivaju informacije o endokrinim načinima djelovanja):
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.’;
znanstveni podaci dobiveni u skladu s međunarodno dogovorenim planovima ispitivanja, posebno onima navedenima u komunikacijama Komisije u okviru utvrđivanja zahtjeva u pogledu podataka za aktivne tvari i sredstva za zaštitu bilja, u skladu s ovom Uredbom;
in point 3.8.2 the following paragraphs are added after the sole paragraph:
drugi znanstveni podaci dobiveni primjenom metodologije sustavnog preispitivanja, posebno primjenom smjernica o podacima iz literature iz komunikacija Komisije u okviru utvrđivanja zahtjeva u pogledu podataka za aktivne tvari i sredstva za zaštitu bilja, u skladu s ovom Uredbom;
‘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:
ocjena raspoloživih relevantnih znanstvenih podataka na temelju pristupa utvrđivanja valjanosti i utemeljenosti dokaza kako bi se utvrdilo jesu li kriteriji iz petog stavka ispunjeni; primjenom pristupa utvrđivanja valjanosti i utemeljenosti dokaza pri ocjeni znanstvenih dokaza posebno se uzimaju u obzir svi sljedeći čimbenici:
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;
pozitivni i negativni rezultati;
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:
relevantnost planova ispitivanja za ocjenu štetnih učinaka i endokrinog načina djelovanja;
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;
kvaliteta i dosljednost podataka, pri čemu se uzimaju u obzir struktura i usklađenost rezultata dobivenih u okviru jednog ispitivanja i različitih slično planiranih ispitivanja te rezultata dobivenih ispitivanjem različitih vrsta;
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;
ispitivanja puta izlaganja, toksikokinetička ispitivanja i ispitivanja metabolizma;
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:
pojam granične doze te međunarodne smjernice za najveće preporučene doze i za ocjenjivanje zbunjujućih učinaka prekomjerne toksičnosti;
both positive and negative results, discriminating between taxonomic groups (e.g. mammals, birds, fish, amphibians) where relevant;
primjenom pristupa utvrđivanja valjanosti i utemeljenosti dokaza povezanost između štetnih učinaka i endokrinog načina djelovanja utvrđuje se na temelju biološke vjerojatnosti, koja se određuje s obzirom na trenutačna znanstvena saznanja i uzimajući u obzir međunarodno dogovorene smjernice;
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;
štetni učinci koji su nespecifična sekundarna posljedica drugih toksičnih učinaka ne uzimaju se u obzir pri utvrđivanju tvari kao endokrinog disruptora.”
the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely to impact on (sub)populations.
U točki 3.8.2. nakon jedinog stavka dodaju se sljedeći stavci:
Adequate, reliable and representative field or monitoring data and/or results from population models shall as well be considered where available;
„Od 20. listopada 2018. smatra se da aktivna tvar, safener ili sinergist posjeduje svojstva endokrine disrupcije koja mogu imati štetne učinke na organizme koji ne pripadaju ciljnoj skupini ako na temelju točaka od 1. do 4. trećeg stavka ta tvar zadovoljava sve kriterije u nastavku, osim ako je dokazano da utvrđeni štetni učinci nisu relevantni za organizme koji ne pripadaju ciljnoj skupini na razini (sub)populacije:
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;
tvar pokazuje štetan učinak na organizme koji ne pripadaju ciljnoj skupini u obliku promjene u morfologiji, fiziologiji, rastu, razvoju, razmnožavanju ili životnom vijeku organizma, sustava ili (sub)populacije koja uzrokuje ograničenje funkcionalne sposobnosti i sposobnosti nošenja s dodatnim stresom ili povećanje osjetljivosti na druge utjecaje;
the concept of the limit dose and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity.
Utvrđivanje aktivne tvari, safenera ili sinergista kao tvari koja posjeduje svojstva endokrine disrupcije koja mogu imati štetne učinke na organizme koji ne pripadaju ciljnoj skupini u skladu s drugim stavkom temelji se na svim sljedećim točkama:
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.’
znanstveni podaci dobiveni u skladu s međunarodno dogovorenim planovima ispitivanja, posebno onima navedenima u komunikacijama Komisije u okviru utvrđivanja zahtjeva u pogledu podataka za aktivne tvari i sredstva za zaštitu bilja, u skladu s ovom Uredbom;
Therefore, from 20 October 2018, those criteria should apply except where the relevant Committee has voted on a draft Regulation by 20 October 2018.
drugi znanstveni podaci dobiveni primjenom metodologije sustavnog preispitivanja, posebno primjenom smjernica o podacima iz literature iz komunikacija Komisije u okviru utvrđivanja zahtjeva u pogledu podataka za aktivne tvari i sredstva za zaštitu bilja, u skladu s ovom Uredbom;
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 zaštiti naziva „Dons” (ZOI) u skladu s člankom 99.
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,
uzimajući u obzir Ugovor o funkcioniranju Europske unije,
Whereas:
uzimajući u obzir Uredbu (EU) br. 1308/2013 Europskog parlamenta i Vijeća od 17. prosinca 2013. o uspostavljanju zajedničke organizacije tržišta poljoprivrednih proizvoda i stavljanju izvan snage uredbi Vijeća (EEZ) br. 922/72, (EEZ) br. 234/79, (EZ) br. 1037/2001 i (EZ) br. 1234/2007, a posebno njezin članak 99.,