natgillin/translations-raw huggingface dataset:
The European Parliament, the Council and the Commission agree on the importance of close cooperation in monitoring the implementation of the Trade Agreement between the European Union and its Member States, of the one part, and Colombia and Peru, of the other part [1] as amended by Protocol of Accession to the Trade Agreement between the European Union and its Member States, of the one part, and Colombia and Peru, of the other part, to take account of the accession of Ecuador [2], Regulation (EU) No 19/2013 of the European Parliament and of the Council of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Trade Agreement between the European Union and its Member States, of the one part, and Colombia and Peru, of the other part [3] and Regulation (EU) No 20/2013 of the European Parliament and of the Council of 15 January 2013 implementing the bilateral safeguard clause and the stabilisation mechanism for bananas of the Agreement establishing an Association between the European Union and its Member States, on the one hand, and Central America on the other [4].
Skupna izjava Evropskega parlamenta, Sveta in Komisije
If the European Parliament adopts a recommendation to initiate a safeguard investigation, the Commission will carefully examine whether the conditions under Regulation (EU) No 19/2013 or under Regulation (EU) No 20/2013 for ex-officio initiation are fulfilled.
Zato soglašajo o naslednjem:Komisija bo na zahtevo pristojnega odbora Evropskega parlamenta temu poročala o vseh specifičnih zadevah, ki se nanašajo na izvajanje obvez Ekvadorja, Kolumbije ali Peruja glede trgovine in trajnostnega razvoja.
If the Commission considers that the conditions are not fulfilled, it will present a report to the responsible committee of the European Parliament including an explanation of all the factors relevant to the initiation of such an investigation.
Komisija bo do 1. januarja 2019 ocenila položaj proizvajalcev banan v Uniji.
The Commission will, by 1 January 2019, assess the situation of Union banana producers.
Če se bo ugotovilo, da je prišlo do hudega poslabšanja razmer na trgu ali položaja teh proizvajalcev, se bo lahko preučila možnost podaljšanja obdobja veljavnosti mehanizma ob soglasju pogodbenic Sporazuma.
If a serious deterioration in the state of the market or the situation of Union banana producers is found to have occurred, an extension in the period of validity of the mechanism may be considered with the agreement of the parties to the Agreement.
Komisija bo po prenehanju veljavnosti stabilizacijskega mehanizma še naprej opravljala redne analize razmer na trgu in položaja proizvajalcev banan v Uniji.
The Commission will continue to carry out regular analyses of the state of the market and the situation of Union banana producers after expiry of the stabilisation mechanism.
Če se bo ugotovilo, da je prišlo do hudega poslabšanja razmer na trgu ali položaja teh proizvajalcev, ob upoštevanju pomena sektorja pridelave banan za najbolj oddaljene regije, bo Komisija skupaj z državami članicami in deležniki preučila razmere in se odločila, ali bi bilo treba sprejeti ustrezne ukrepe.
If a serious deterioration in the state of the market or the situation of Union banana producers is found to have occurred, given the importance of the banana sector for outermost regions, the Commission will examine the situation, together with the Member States and the stakeholders, and decide whether appropriate measures should be considered.
Komisija bo lahko sklicala tudi redne sestanke za spremljanje z državami članicami in deležniki.
The Commission could also convene regular monitoring meetings with the Member States and the stakeholders.
Komisija je razvila statistična orodja, ki omogočajo spremljanje in ocenjevanje trendov pri uvozu banan ter razmer na trgu banan v Uniji.
The Commission has developed statistical tools to enable the monitoring and assessment of the trends in imports of bananas and of the situation of the Union banana market.
Komisija bo posebno pozornost namenila pregledu formata podatkov o nadzoru uvoza, da bi bile na voljo redno posodobljene informacije v uporabniku prijaznejši obliki.
The Commission will pay special attention to reviewing the format of the import surveillance data in order to make available regularly updated information in a more user-friendly manner.
UL L 354, 21.12.2012, str.
OJ L 354, 21.12.2012, p.
3.
3.
UL L 356, 24.12.2016, str.
3.
UL L 17, 19.1.2013, str.
OJ L 17, 19.1.2013, p.
1.
1.
UL L 17, 19.1.2013, str.
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response
o spremembi Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta o razvrščanju, označevanju in pakiranju snovi ter zmesi, z dodajanjem priloge o usklajenih informacijah v zvezi z zagotavljanjem nujne zdravstvene pomoči
Having regard to 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 [1], and in particular Article 45(4) and 53(1) thereof,
ob upoštevanju Uredbe (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 [1] in zlasti členov 45(4) in 53(1) Uredbe,
In order to carry out their responsibilities, bodies appointed in accordance with Article 45(1) of Regulation (EC) No 1272/2008 need information about mixtures placed on the market and classified as hazardous on the basis of their health and physical effects.
Da bi lahko organi, imenovani v skladu s členom 45(1) Uredbe (ES) št. 1272/2008, opravljali svoje obveznosti, potrebujejo informacije o zmeseh, ki so dane v promet in razvrščene kot nevarne na podlagi njihovih zdravstvenih in fizičnih učinkov.
That information is submitted to appointed bodies at national level by importers and downstream users and it commonly includes product identification, hazard identification, composition information and toxicological information.
Te informacije pošljejo imenovanim organom na nacionalni ravni uvozniki in nadaljnji uporabniki, običajno pa vključujejo identifikacijo izdelka, identifikacijo nevarnosti, informacije o sestavi in toksikološke informacije.
Poison centres rely on information provided by those appointed bodies, and sometimes constitute such bodies themselves.
Centri za zastrupitve se zanašajo na informacije, ki jih predložijo ti imenovani organi, in so včasih sami takšni organi.
The review concluded that there is considerable variation in the current notification systems, data formats and country-specific requirements regarding the requested information in the Member States.
Pregled je tudi pokazal, da ta različnost vodi v neskladja v informacijah, ki so na voljo zdravstvenemu osebju in splošni javnosti v primerih zastrupitev v različnih državah članicah.
This implies that importers and downstream users placing mixtures on the market in different Member States, need to provide multiple submissions and in different formats, regarding information that is often similar.
Ugotovitve iz pregleda podpira raziskava Komisije o stroških in prednostih, izvedena v marcu 2015 [2], ki je potrdila, da bi uskladitev informacij za predložitev imenovanim organom poleg boljšega zagotavljanja zdravstvene pomoči prinesla tudi pomembne prihranke pri stroških.
The review also showed that this diversity leads to inconsistencies in the information available to medical personnel and the general public in cases of poisoning incidents in different Member States.
Komisija se je posvetovala z zadevnimi interesnimi skupinami, kot je Evropsko združenje centrov za zastrupitve in kliničnih toksikologov (EAPCCT), zlasti glede stroškov in prednosti raziskave ter prek številnih delavnic.
The findings of the review were supported by a Commission costs and benefits study completed in March 2015 [2], which confirmed that, in addition to improved health response, the harmonisation of information to be provided to appointed bodies would lead overall to significant cost savings.
Zato je ustrezen ukrep uskladiti informacije, ki jih prejemajo imenovani organi od uvoznikov in nadaljnjih uporabnikov, kot tudi vzpostaviti obliko za predložitev informacij.
The relevant stakeholders, such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT) have been consulted, in particular in the framework of the costs and benefits study and through a number of workshops.
Treba je določiti, katere informacije se predložijo imenovanemu organu.
It is therefore appropriate to harmonise the information to be received by appointed bodies from importers and downstream users, as well as to establish a format for the submission of the information.
To vključuje informacije v zvezi z identifikacijo zmesi in predlagatelja, identifikacijo nevarnosti in sestavinami zmesi.
It is necessary to specify which information needs to be submitted to an appointed body.
Ker se formulacije zmesi pogosto neznatno spremenijo, kar zelo malo ali sploh ne vpliva na nujno zdravstveno pomoč, ki jo je treba zagotoviti, bi bilo neprimerno zahtevati natančno navedbo sestavin zmesi v odstotkih.
This includes information regarding the identification of the mixture and of the submitter, the hazard identification and the mixture components.
Zato so lahko za sestavine zmesi predložena območja koncentracije.
Due to the fact that mixtures' formulations can be subject to frequent slight modifications with little or no impact on the emergency health response to be provided, requiring information about the components of the mixture in exact percentages would be disproportionate.
Ta območja je treba določiti na podlagi zdravstvenih in fizičnih učinkov sestavin zmesi in pomena informacij za zagotavljanje nujne zdravstvene pomoči.
Therefore, as an alternative, concentration ranges may be submitted for mixture components.
Glede na dejstvo, da lahko zmesi, razvrščene kot nevarne, vsebujejo tudi nerazvrščene sestavine, ki pa imajo lahko tudi škodljive učinke pri nenamerni uporabi (npr. po zaužitju), morajo imeti imenovani organi po potrebi tudi informacije o teh sestavinah, da lahko določijo preventivno ali kurativno ukrepanje.
The width of those ranges should be determined on the basis of the health and physical effects of the mixture components and the relevance of the information for emergency health response.
Oblika predložitve informacij mora biti usklajena, da uvoznikom in nadaljnjim uporabnikom, ki delujejo v različnih državah članicah, omogoči uporabo iste predložitve ali oblike predložitve v različnih državah članicah.
In view of the fact that mixtures classified as hazardous may also contain non-classified components that can nonetheless have adverse effects after unintended use (e.g. following ingestion), appointed bodies should have at their disposal information on the latter components where needed to formulate preventive or curative action.
Predložitev je treba izvesti elektronsko v usklajenem formatu XML, ki ga uporablja Evropska agencija za kemikalije, in mora biti na voljo brezplačno.
The format for the submission of the information should be harmonised in order to allow importers and downstream users operating in different Member States to use the same submission or submission format in different Member States.
Za lažji prenos informacij o namenu uporabe zmesi in za podporo statistične analize sorodnih primerov zastrupitve mora Evropska agencija za kemikalije razviti sistem kategorizacije in ga uporabljati pri predložitvah informacij.
The submissions should be made electronically in a harmonised XML format maintained by the European Chemicals Agency and made available free of charge.
Kot navaja raziskava Komisije o stroških in prednostih, so centri za zastrupitev in drugi imenovani organi poročali o težavah s pravilno identifikacijo zadevne zmesi pri več kot 40 odstotkih klicev, ki jih prejmejo.
In order to facilitate the transmission of information on the intended use of a mixture and to support the statistical analysis of related poisoning cases, a European product categorisation system should be developed by the European Chemicals Agency and used in the submission of information.
To lahko vodi v nepotrebno pretirano zdravljenje pacientov in hospitalizacijo zaradi previdnostnih razlogov.
According to a Commission costs and benefits study, poison centres and other appointed bodies have reported experiencing problems with the correct identification of the mixture concerned in up to 40 % of the calls they receive.
Zato je kot del usklajevanja informacij treba zahtevati identifikacijo zmesi z enolično alfanumerično kodo (enolični identifikator formule), ki mora biti dodana na etiketo.
This could lead to unnecessary overtreatment of patients and hospitalisation for precautionary reasons.
Večina klicev v centre za zastrupitve in druge imenovane organe se nanaša na naključno izpostavljenost nevarnim zmesem, ki jih uporabljajo potrošniki in v manjši meri strokovnjaki.
Therefore, as part of the harmonisation of the information, it is necessary to require identification of a mixture by a unique alphanumeric code (unique formula identifier) to be affixed to the label.
Le manjše število klicev se nanaša na zmesi za industrijsko uporabo, ki se uporabljajo v industrijskih instalacijah.
Most calls to poison centres and other appointed bodies concern accidental exposure to hazardous mixtures used by consumers and to a lesser extent by professionals.
Poleg tega na industrijskih območjih navadno bolje poznajo zmesi, ki jih uporabljajo, in zdravstvena oskrba je na splošno na voljo.
Only a small number of calls concern mixtures for industrial use, which are used in industrial installations.
Zato je treba uvoznikom in nadaljnjim uporabnikom zmesi za industrijsko uporabo dovoliti, da izpolnjujejo omejene zahteve po informacijah.
In addition, on industrial sites there usually is a greater knowledge of the mixtures used and medical treatment is generally available.
Da bo delo v zvezi s sprejemom formata predložitve podatkov lažje potekalo in da bodo omogočene prednostne predložitve podatkov, kjer je to najbolj potrebno, je smiselno in primerno določiti stopenjsko veljavnost novih zahtev po informacijah, določenih s to uredbo, glede na uporabo zmesi.
Therefore, importers and downstream users of mixtures for industrial use should be allowed to fulfil limited information requirements.
Zaradi lažjega prehoda in preprečitve nesorazmernih stroškov bi morale predložitve imenovanim organom, vložene pred datumom začetka veljave te uredbe, veljati še določen čas po tem, ko se ta uredba začne uporabljati.
In order to spread the necessary work of adapting the format for data submission, and to prioritise information provision where it is most needed, it is considered reasonable and proportionate to lay down a stepwise applicability of the new information requirements set by this Regulation according to the use of the mixture.
Toda če med tem časom pride do bistvenih sprememb v formulaciji, identifikatorju izdelka ali toksikologiji zmesi, je posodobitve treba predložiti v skladu s to uredbo.
In order to ensure a smooth transition and avoid disproportionate costs, the submissions provided to appointed bodies before the date of application of this Regulation should remain valid for a certain time after this Regulation starts to apply.
Ukrepi iz te uredbe so v skladu z mnenjem odbora, ustanovljenega s členom 54(1) Uredbe Sveta (ES) št. 1272/2008 –
However, if significant changes in the formulation, product identifier or toxicology of the mixture occur in the meantime, a submission update pursuant to this Regulation should be required.
SPREJELA NASLEDNJO UREDBO:
The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 54(1) of Regulation (EC) No 1272/2008,
Člen 1
HAS ADOPTED THIS REGULATION:
Uredba (ES) št. 1272/2008 se spremeni:
Article 1
v členu 25 se doda naslednji odstavek 7:
Regulation (EC) No 1272/2008 is amended as follows:
V primerih, ko v skladu s Prilogo VIII predlagatelj ustvari edinstveni identifikator formule, se ta doda na etiketo v skladu z določili oddelka 5 dela A navedene priloge“;
In Article 25, the following paragraph 7 is added:
doda se Priloga VIII, kot je določena v Prilogi k tej uredbi.
Where under Annex VIII the submitter creates a unique formula identifier, it shall be included on the label in accordance with the provisions of Section 5 of Part A of that Annex’;
Člen 2
Annex VIII is added as set out in the Annex to this Regulation.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
Article 2
Uporablja se od 1. januarja 2020.
It shall apply from 1 January 2020.
V Bruslju, 22. marca 2017
Done at Brussels, 22 March 2017.
Predsednik
For the Commission
UL L 353, 31.12.2008, str. 1.
The President
Raziskava, ki podpira uskladitev informacij za predložitev centrom za zastrupitve v skladu s členom 45 Uredbe (ES) št. 1272/2008 (uredba CLP), 3.3.2015.
OJ L 353, 31.12.2008, p. 1.
PRILOGA
Study to support the harmonisation of the information to be submitted to poison centres, according to Article 45 of Regulation (EC) No 1272/2008 (CLP Regulation), 3.3.2015.
PRILOGA VIII
ANNEX
Usklajene informacije v zvezi z zagotavljanjem nujne zdravstvene pomoči in preventivnih ukrepov
ANNEX VIII
DEL A
Harmonised information relating to emergency health response and preventative measures
SPLOŠNE ZAHTEVE
PART A
Uporaba
GENERAL REQUIREMENTS
Uvozniki in nadaljnji uporabniki, ki dajejo v promet zmesi za potrošniško uporabo v smislu oddelka 2.4 dela A te priloge, izpolnjujejo zahteve iz te priloge od 1. januarja 2020.
Application
Uvozniki in nadaljnji uporabniki, ki dajejo v promet zmesi za strokovno uporabo v smislu oddelka 2.4 dela A te priloge, izpolnjujejo zahteve iz te priloge od 1. januarja 2021.
Importers and downstream users placing on the market mixtures for consumer use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2020.
Uvozniki in nadaljnji uporabniki, ki dajejo v promet zmesi za industrijsko uporabo v smislu oddelka 2.4 dela A te priloge, izpolnjujejo zahteve iz te priloge od 1. januarja 2024.
Importers and downstream users placing on the market mixtures for professional use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.
Uvozniki in nadaljnji uporabniki, ki so predložili informacije v zvezi z nevarnimi zmesmi organu, imenovanemu v skladu s členom 45(1), pred datumi veljavnosti, navedenimi v oddelkih 1.1, 1.2 in 1.3, ter ki niso v skladu s to prilogo, glede teh zmesi niso zavezani k izpolnjevanju zahtev iz te priloge do 1. januarja 2025.
Importers and downstream users placing on the market mixtures for industrial use within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2024.
Z odstopanjem od oddelka 1.4, če pride do katere od sprememb, opisanih v oddelku 4.1 dela B te priloge, pred 1. januarjem 2025, uvozniki in nadaljnji uporabniki upoštevajo zahteve iz te priloge, preden dajo to spremenjeno zmes v promet.
Importers and downstream users having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability mentioned in Sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025.
Namen, opredelitve in področje uporabe
By way of derogation from Section 1.4, if one of the changes described in Section 4.1 of Part B of this Annex occurs before 1 January 2025, importers and downstream users shall comply with this Annex before placing that mixture, as changed, on the market.
Ta priloga določa zahteve, ki jih morajo uvozniki in nadaljnji uporabniki izpolnjevati, ko dajejo v promet zmesi (v nadaljnjem besedilu: ‚predlagatelji‘), v zvezi s predložitvijo informacij, tako da imenovani organi prejmejo informacije, ki jih potrebujejo za izvajanje nalog, za katere so pristojni v skladu s členom 45.
Purpose, definitions and scope
Ta priloga ne velja za zmesi za znanstvene raziskave in razvoj ter za zmesi za raziskave in razvoj v zvezi z izdelki in s procesi, kot je določeno v členu 3(22) Uredbe (ES) št. 1907/2006.
This Annex sets out the requirements that importers and downstream users placing mixtures on the market, hereinafter “submitters”, shall fulfil in respect of the submission of information so that appointed bodies shall have at their disposal the information to carry out the tasks for which they are responsible under Article 45.
Ta priloga ne velja za zmesi, razvrščene samo za eno ali več naslednjih nevarnosti:
This Annex shall not apply to mixtures for scientific research and development and to mixtures for product and process oriented research and development as defined in Article 3(22) of Regulation (EC) No 1907/2006.
plini pod tlakom;
This Annex shall not apply to mixtures classified only for one or more of the following hazards:
eksplozivi (nestabilni eksplozivi in podrazredi od 1.1 do 1.6).
gases under pressure;
Pri zmeseh, ki so dane v promet samo za industrijsko uporabo, lahko predlagatelji izberejo omejeno predložitev kot alternativo splošnim zahtevam za predložitev v skladu z oddelkom 5.3 tega dela in oddelkom 3.1.1 dela B, če omogočijo hiter dostop do dodatnih podrobnih informacij o izdelku v skladu z oddelkom 1.3 dela B.
explosives (unstable explosives and Divisions 1.1 to 1.6)
V tej prilogi se uporabljajo naslednje opredelitve pojmov:
In the case of mixtures placed on the market for industrial use only, submitters may opt for a limited submission, as an alternative to general submission requirements, in accordance with Section 5.3 of this Part and Section 3.1.1 of Part B, provided that a rapid access to additional detailed product information is available in accordance with Section 1.3 of Part B.
‚zmes za potrošniško uporabo‘ pomeni zmes, ki naj bi jo uporabljali potrošniki;
For the purposes of this Annex the following definitions shall apply:
,zmes za strokovno uporabo' pomeni zmes, ki naj bi jo uporabljali strokovni uporabniki, vendar ne na industrijskih območjih;
“Mixture for consumer use” means a mixture intended to be used by consumers;
‚zmes za industrijsko uporabo‘ pomeni zmes, ki naj bi jo uporabljali samo na industrijskih območjih.
“Mixture for professional use” means a mixture intended to be used by professional users but not at industrial sites;
Kjer imajo zmesi več kot en namen uporabe, se upoštevajo zahteve za vse ustrezne kategorije uporabe.
“Mixture for industrial use” means a mixture intended to be used at industrial sites only.
Zahteve za predložitev
Where mixtures have more than one use, the requirements for all relevant categories of use shall be met.
Preden je zmes dana v promet, predlagatelji predložijo informacije v zvezi z zmesmi, razvrščenimi kot nevarne na podlagi njihovih zdravstvenih ali fizičnih učinkov, organom, imenovanim v členu 45(1) (v nadaljnjem besedilu: ‚imenovani organi‘), v državi članici ali državah članicah, kjer se zmes daje v promet.
Submission requirements
Predložitev vsebuje informacije, določene v delu B. Predložitev se izvede elektronsko v formatu XML, ki ga uporablja Evropska agencija za kemikalije, in je na voljo brezplačno.